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8/10/2019 Handbook of Systemic Treatments for Cancer - 8th Edition
1/186
8th editionGuidelines for the administration of commonly used
anticancer agents and the nursing care of cancer patients
HANDBOOK OF
SYSTEMIC TREATMENTS
FOR CANCER
8/10/2019 Handbook of Systemic Treatments for Cancer - 8th Edition
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ALP alkaline phosphatase
ALT alanine aminotransferase
AML acute myeloid leukaemia
ARDS acute respiratory distresssyndrome
AST aspartate aminotransferase
AV atrioventricular
BB bundle branch
BMD bone marrow depression
BP blood pressure
BCRP breast cancer resistance protein
BUN blood urea nitrogen
CHF congestive heart failure
CNS central nervous system
CPK creatine phosphokinase
CSF cerebrospinal fluid
CVA cerebrovascular accident
CVAD central venous access device
D5W dextrose (glucose) 5%
dpm drops per minute
DRESS drug rash with eosinophilia andsystemic symptoms
DS dextrose 4% + sodium chloride0.18%
DVT deep vein thrombosis
EGFR epidermal growth factor receptor
FBC full blood count
GGT gamma glutamyl transferase
GI gastrointestinal
GORD gastro-oesophageal reflux disease
GvHD graft versus host disease
IA intra-arterialIBD inflammatory bowel disease
ILD interstitial lung disease
IM intramuscular
INR international normalised ratio
IP intra-peritoneal
IV intravenous
LDH lactate dehydrogenase
LFTs liver function tests
LLN lower limit of normal
LVD left ventricular dysfunction
LVEF left ventricular ejection fraction
MAO monoamine oxidase
MI myocardial infarction
NCI CTCAE National Cancer Institute CommonTerminology Criteria for AdverseEvents
NPSA National Patient Safety Agency
NS sodium chloride 0.9%
P-gp P-glycoprotein
PPE palmar plantarerythrodysaesthesia syndrome
PPI proton pump inhibitor
PRES posterior reversibleencephalopathy syndrome
RTI respiratory tract infection
SC subcutaneous
SIADH syndrome of inappropriate
antidiuretic hormone secretionTEN toxic epidermal necrolysis
TIA transient ischaemic attack
TSH thyroid-stimulating hormone
ULN upper limit of normal
UTI urinary tract infection
VEGF vascular endothelial growth factor
VTE venous thromboembolismWBC white blood cell count
WFI water for injection
Abbreviations
8/10/2019 Handbook of Systemic Treatments for Cancer - 8th Edition
3/186Lilly Handbook of Systemic Treatments for Cancer 8th Edition 1
CONTENTS
Acknowledgments 2
Note from the publisher 3
Preface 4
GENERAL GUIDANCE
Systemic anticancer treatment pathway 5
Suggested 24-hr telephone advice for patients having chemotherapy 9
UKONS oncology/haematology helpline triage tool 10
Recommendations for your safety and protection 12
The management of extravasation 15Suggested algorithm for the treatment of extravasation 16
Suggested cytotoxic spillage kit 17
References 18
Further resources 19
Nursing implications of drug side effects 20
DRUG MONOGRAPHS
List of drug monographs 30
Drug monographs 31
References for drug monographs 151
APPENDICES
Appendix 1: Glossary 163Appendix 2: NCI CTCAE v4.0 171
Appendix 3: The cell cycle 174
Appendix 4: Useful formulae 175
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ACKNOWLEDGMENTS
Lilly Oncology UK and the publisher, Haymarket Medical, would like to acknowledge the following
healthcare professionals for their contributions to updating the administration and nursing guidelines and
drug monographs for the 8th edition of the handbook.
Authors of the 8th edition (2014)
The Royal Marsden NHS Foundation Trust:Lisa Dougherty nurse consultant, IV therapy and lead chemotherapy nurse
Anita McWhirter pharmacy clinical services manager
& the clinical pharmacy team
Greater Midlands Cancer Network:Philippa Jones Macmillan Network lead chemotherapy nurse
Previous editionsWe wish to also extend our special thanks to the following past and present members of staff of the
Royal Marsden Hospital, London and Surrey:
Marilyn Marks and Kerry Jennings for the 1st edition
Val Speechley and Tim Root for the 2nd and 3rd editions
Lisa Dougherty, Julie Mycroft and Tim Root for the 4th edition
Stephen Almond, Judith Earl and Lisa Dougherty for the 6th edition
Lisa Dougherty, Lorraine Hyde, Philippa Jones, Caroline Kay, Louise McNamara, Richard Schorstein and
Anita McWhirter for the 7th edition
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Note from the publisher
Welcome to the 8th edition of the Lilly Handbook of Systemic Treatments for Cancer (2014).
The intent of this handbook is to assist healthcare professionals in their day-to-day patient management
by providing concise information and guidelines for the administration of commonly used pharmacological
agents for the treatment of cancer.
The contents of this handbook have been developed collaboratively by nurse and pharmacist teams
at the Royal Marsden NHS Foundation Trust led by Lisa Dougherty and Anita McWhirter, respectively;
in association with the chemotherapy manager and network lead chemotherapy nurse of the Greater
Midlands Cancer Network Philippa Jones, on behalf of Eli Lilly and Company Ltd (Lilly) and the
publisher, Haymarket Medical.
Lillys role, as the sponsor of this handbook, has been limited to checking the factual accuracy of
information on Lilly products and ensuring compliance with the PMCPA Code of Practice for the
Pharmaceutical Industry.
Save for the above, and the compilation of the Appendices section, the updated contents of the handbook
have been developed independently by the authors in collaboration with the publisher.
The monographs in this handbook were compiled from manufacturers summaries of product
characteristics (SPCs) and other established resources. Some of the information presented may reflect
local practice and the clinical expertise of the healthcare professionals involved.
The monographs of the products contained herein are not intended to be a substitute for the
manufacturers SPCs. Only adverse events deemed to be of particular relevance are included.
The publisher has tried to ensure that the information contained in this handbook is accurate and
up-to-date at the time of publication. It is the users responsibility to check for any variation in the
product SPC subsequently. These can be found at www.medicines.org.uk/emc. It is important not to use
copies of the handbook that are out of date or pass on old editions.
The practice guidance presented in this handbook is offered as recommendations, and does not diminish
the requirement for clinical judgment. Readers are strongly advised to check these recommendations
against their local protocols and guidelines and to make their own further enquiries of manufacturers
or specialists in relation to particular drugs, treatments or advice. Lilly, the publisher and the authors
cannot accept liability for errors or omissions, and disclaim any liability arising out of the use of this
handbook in practice.
2014 Lilly Oncology UK.
No part of this publication may be reproduced. Not for resale.
Published by Haymarket Medical, Teddington Studios, Broom Road, Teddington TW11 9BE.
Printed by Cardiff Printing Company, Llantrisant, South Wales.
Date of preparation: February 2014; UKONC00326
Haymarket is certified by BSI toenvironmental standard ISO14001
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Preface
The range of systemic anticancer therapies has increased dramatically and within the past year over 20
new therapies have become widely available. For the last edition, a change in the title of the handbook
from Cancer Chemotherapy to the Handbook of Systemic Treatments for Cancer, reflected the inclusion
of newer agents that are not purely cytotoxic in nature, such as those targeting specific molecular
receptors and cell signalling pathways.
This handbook is a Lilly initiative to help improve patient care and continues to be used as a definitive
reference and guide to practice by nurses, doctors and pharmacists. The 8th edition updates the existing
84 monographs and includes 24 new drugs. Evidence to support the text has been provided, underpinned
by the principles in the Cancer Services Manual, the requirement of peer review standards and a
comprehensive reference list.
Contributions to this updated edition have been from nursing staff that are involved in the assessment
of patients and the adminstration of chemotherapy on a daily basis, and pharmacists who are involved in
the dispensing and preparation of systemic anticancer therapy, as well as in giving advice to both staff
and patients. It is hoped that all healthcare professionals will find this updated guide useful, and that it
continues to meet their needs in the clinical setting.
Editor
Lisa Dougherty
Nurse consultant, IV therapy and lead chemotherapy nurse, The Royal Marsden NHS Foundation Trust
Ordering additional copies of the handbook
If you would like to order additional copies of the
HANDBOOK OF SYSTEMIC TREATMENTS FOR CANCER
or register your interest to receive future editions, please visit
www.lillyoncology.co.uk
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Systemic anticancer treatment pathway
A number of national reports and guidelines recommend the implementation of key steps in the systemicanticancer treatment (SACT) pathway to ensure the safe and appropriate delivery of treatment.
The pathway presented here has been developed to reflect the recommendations contained in the followingdocuments:
1. For better, for worse? National Confidential Enquiry into Patient Outcome and Death, November 2008.12. Chemotherapy Services in England: Ensuring quality and safety. A report from the National
Chemotherapy Advisory Group, 2009.2
3. Manual for Cancer Services: Chemotherapy Measures (2.0), 2013.3
Prior to commencing a course of treatmentIt is recommended that the key actions shown below are taken prior to commencing a course of treatmentand it is advisable that there is a procedure in place to check that this happens.
2 Physical assessment1,3
The results of a comprehensive assessment of the patients physical condition and suitability fortreatment should be recorded. This will include a record of the patients performance status at thetime of the decision to treat.
Baseline observations of BP, pulse and respiratory rates should be taken and recorded as pertreatment protocol.
Baseline blood tests should be performed including FBC, urea and electrolytes and renal function. Treatment- or disease-specific investigations, for example specific tumour markers, should
be performed. The results of all pre-treatment investigations should be reviewed prior to treatment
administration.
1 Decision to treat, consent and treatment plan1-3
The decision to initiate the course of SACT should have been made at consultant level unless thereare exceptional circumstances.
There should be a completed standardised consent form that includes reason for and intention oftreatment, as well as common and serious toxicities which have been discussed with the patient.
Patients should be fully involved in decision-making regarding their care and treatment.Written information should always be provided for the patient and this should be recorded on theconsent form.
There should be a treatment plan for each course of SACT detailing: Diagnosis and staging according to an internationally recognised staging system
Performance status and co-morbidities Treatment intent Tests required pre-SACT Planned number of cycles Frequency and method of assessment of response to treatment Any deviation from protocol and reason for this
This treatment plan should be authorised and signed by a consultant oncologist orhaemato-oncologist.
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4 Prescribing and dispensing3
Prescribing, prescription verification and dispensing of SACT should only be undertaken byappropriately trained staff.
All SACT prescriptions should be checked by an oncology pharmacist who has undergone specialisttraining, demonstrated appropriate competence and is locally authorised/accredited for the task.
3 The individual assessment by oncology nurses/pharmacists prior to the start of the course of SACTshould include1
Patient and carer information, education, support and advice. Each patient should be provided with a card containing key information about the treatment and
contact details of the 24-hr telephone advice service that is available for patients receiving SACT. The importance of contacting the telephone advice service, if there are worries about symptoms
that may be related to treatment, should be explained clearly.
6 Discharge following administrationThe following checks should be performed prior to allowing the patient to go home: The patient should have all the supportive drugs they are prescribed and understand the
importance of taking them as instructed. The patient should have an appointment for their next cycle and/or review. The patient should have a request form for pre-treatment investgations if required. Reinforce the availability of the 24-hr telephone advice service.
5 Administration of treatment3,4
Administration should only be undertaken by appropriately trained nurses who have been deemedcompetent by their employing organisation.
All SACT should be checked by a second nurse prior to administration. The prescription should be checked against the patient with the following details confirmed:
patient identity, allergy status, consent, patient understanding of the SACT they are to receive andtheir fitness to receive treatment.
The prepared drugs should be checked to ensure they match the prescription for date, dose andpatient details, as well as checking the volume, route of administration, diluent, correct method(infusion or bolus injection) and expiry date/time.
The patient should have an appropriate vascular access device (VAD) in situ or one should beinserted by an appropriately trained nurse.
During administration, the nurse should monitor the patient and the VAD site for any side effectsand manage them accordingly.
The nurse should wear appropriate personal protective clothing and dispose of all equipment inthe appropriate sharps bins or clinical waste bags.
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Prior to commencing each cycle of treatmentTo ensure continued safe and appropriate delivery of SACT, it is vital that the following key actions are takenprior to commencing each cycleof treament and it is advisable that there is a procedure in place to checkthat this happens.
2 Pre-treatment review
Treatment plan are there any changes to the plan, for example dose modifications or alterationsto supportive medications? Have these changes happened?
Assessment of response should the patient have had a senior review and necessaryinvestigations to assess response to treatment prior to this cycle? Has this been completed?
1 Pre-treatment assessment1-3
The results of an assessment of the patients physical condition and suitability for treatment should berecorded, including:
Assessment of toxicityClinicians assessing patients for SACT must perform a full assessment of toxicities that the patient mayhave experienced at any time since receiving their previous cycle of treatment. This assessment shouldbe recorded in the patients treatment record and any significant toxicity experienced by the patientshould be discussed with the prescriber prior to treatment administration as there may be a need tomodify the treatment plan. The Manual for Cancer Services: Chemotherapy Measures, recommends the
use of the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE).3,5
Physical assessment A review and record of the patients performance status with action taken if deterioration is noted.
The Manual for Cancer Services: Chemotherapy Measures recommends the use of the WHOsystem for grading of performance status, but the Eastern Co-operative Oncology Group (ECOG)system can also be used.3,6
Observations and recording of BP, pulse and respiratory rates, temperature and body weight,as indicated
Standard blood tests, including FBC, urea and electrolytes and renal function, should beperformed. The results should be within acceptable/agreed treatment parameters.
Treatment- or disease-specific investigations, such as specific tumour markers, mustbe performed.
The results of all pre-treatment investigations should be reviewed prior to treatment administration.
3 Patient and carer information, education, support and advice3
The provision of information, education and support is an ongoing process and the needs andrequirements of the patient should be assessed regularly throughout treatment. The assessmentand any action arising from it should be recorded in the patients medical record.
The importance of contacting the 24-hr telephone advice service, if the patient is worried about
symptoms that may be related to their treatment, should be reinforced throughout treatment.
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4 Prescribing and dispensing3
Prescribing, prescription verification and dispensing of SACT should only be undertaken byappropriately trained staff.
All SACT prescriptions should be checked by an oncology pharmacist, who has undergonespecialist training, demonstrated their appropriate competence and is locally authorised/accredited for the task.
6 Discharge following administrationThe following checks should be performed prior to allowing the patient to go home: The patient should have all the supportive drugs they are prescribed and understand the
importance of taking them as instructed. The patient should have an appointment for their next cycle and/or review. The patient should have a request form for pre-treatment investigations if required.
5 Administration of treatment3,4
Administration should only be undertaken by appropriately trained nurses who have been deemedcompetent by their employing organisation.
All SACT should be checked by a second nurse prior to administration. The prescription should be checked against the patient to confirm patient identity, allergy status,
consent and fitness to receive treatment. The prepared drugs must be checked to ensure they match the prescription for date, dose and
patient details as well as volume, route, diluent, correct method (infusion or bolus injection) andexpiry date/time. The patient should have an appropriate vascular access device (VAD) in situ or one should be
inserted by an appropriately trained nurse. During administration, the nurse should monitor the patient and the VAD site for any side effects
and manage them accordingly. The nurse should wear appropriate personal protective clothing and dispose of all equipment in
the appropriate sharps bins or clinical waste bags.
7 End of treatment3
Following the final cycle of a course of treatment, the patient and their primary care team should beprovided with a plan for further care and informed who will take responsibility for its provision.
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Suggested 24-hr telephone advice for patients having chemotherapy
The Manual for Cancer Services: Chemotherapy Measures recommends that cancer networks andacute trusts ensure that patients receiving SACT who may be experiencing side effects or complicationsrelated to their treatment have access to 24-hr telephone advice on how to obtain help and treatment. 3The United Kingdom Oncology Nursing Society (UKONS) central west chemotherapy nurses group hasdeveloped a 24-hr triage tool that can be used to risk-assess patients who contact a helpline or present as
an emergency.7UKONS recommend that there be a programme of training and assessment of competencyprior to using the tool; however, a brief explanation of the assessment process and a copy of theassessment tool are included in this book for your information.
The UKONS 24-hr triage tool is a recognised tool that is a simple, reliable, evidence-based process thatgrades toxicities according to the significance of presenting symptoms and advises action accordingly.
It identifies patients who require: Referral to acute oncology teams for urgent assessment Clinical monitoring or review
The risk assessment process includes a Red Amber Green (RAG) cumulative scoring system to guidedecision-making. It is important that the effects of treatment are not underestimated and that thesignificance of the cumulative effects of a number of lower-level toxicities is recognised.
Risk assessment processIt is vitally important that the process is methodical and thorough in order for it to be useful and providean accurate triage assessment.
There are a number of questions to ask and information that will need to be collected to make sure thatthe correct advice is given.
Step 1The user moves methodically down the triage assessment tool, asking appropriate questions, forexample, does the patient have any nausea?If NO, tick greenand move on.If YES, use the questions provided to help you grade the problem and tick either amberor red.
Step 2Advice is given and action taken according to the guidelines below:
RED any toxicity graded here takes priority and assessment should follow immediately. Redtriage requires face-to-face consultation and assessment by an appropriately trained and qualifiedmember of the clinical team. This assessment should take place in a suitable area that has accessto investigation and treatment facilities. Patients should be asked to attend as soon as possible forassessment.
x2 AMBER two or more amber toxicities should be escalated to red. Action and assessment shouldfollow immediately.
AMBER a single amber toxicity should be reviewed/followed up within 24 hrs. This may be atelephone consultation or an urgent review clinic appointment. The caller should be instructed to callback if they continue to have concerns or their condition deteriorates.
GREEN patients should be given reassurance that the problem at present does not give cause for
concern but they should be vigilant and if the situation gets worse or does not improve they should callback immediately.
Step 3
A record of the assessment and advice given should be made in the patients medical record.
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GRADE GRADE GRADE GRADE
TOXICITY 0 1 2 3 4
Feverand receiving cytotoxic chemotherapyor immunocompromised
IF TEMP 37.5C or ABOVE or BELOW 36C or GENERALLY UNWELL URGENT Assessment AND MEDICAL REVIEW Follow neutropenia pathwayALERT Pts on steroids/analgesics or dehydrated may not present with pyrexia but may still have infection (If in doubt do a count)
Chest painOnset? What makes it worse?Radiation? Any cardiac historySTOP CAPECITABINE or INFUSIONAL SFU
None Advise URGENT A&E for medical assessment
Performance StatusHas there been a recent change in performance status?
Asymptomatic Symptomatic but completelyambulant
Symptomatic, 50% in bed, butnot bed bound
Bed bound
NauseaHow many days? What is the patients oral intake?Is the patient taking antiemetics as prescribed?Access patients urinary output
None Able to eat/drink reasonableintakeReview antiemetics asprescibed
Can eat/drink but intakesignificantly decreasedReview antiemetics according tolocal policy
No significant intakeArrange urgent assessmentand review
VomitingHow many days/episodes?What is the patients oral intake?Does the patient have constipation or diarrhoea?(see specific toxicity)Assess patients urinary output
None 1 episode in 24 hoursReview antiemetics asprescibed
2-5 episodeds in 24 hoursReview antiemetics according tolocal policy
6-10 episodes in 24 hoursArrange urgent assessmentand review
>10 episodes in 24 hoursArrange urgent assessmentand review
Oral/stomatitisHow many days?Is there evidence of mouth ulcers?Is there evidence of infection?Are they able to eat/drink?Assess patients urinary output
None Painless ulcers, erythema, mildsoreness able to eat/drinkUse mouthwash asrecommended
Painful erythema. oedema orulcers but can eat/drinkContinue to use mouthwash,drink plenty of fluids. Usepainkillers either as a tablet ormouthwash
Painful erythema difficultywith eating and drinkingArrange urgent assessmentand review
Mucosal necrosis and/orrequires parenteral or enteralsupportArrange urgent assessmentand review
DiarrhoeaConsider infection!How many days has this occurred for?How many times in a 24hr period?Does the patient have any abdominal pain/discomfort?
For how long? Has the patient taken any medication?See specific toxicity for painNB. If taking CAPECITABINE chemotherapy, follow
specific pathway
None Increase to 2-3 bowelmovements a day overpre-treatment movementsDrink more fluidsObtain stool sample
?consider regimen specificantidiarrhoeal
Increase to 4-6 episodes a day ornocturnal movement/ moderatecrampingDrink plenty of fluidsObtain stool sample
?obtain regimen specificantidiarrhoeal
Increase to 7-9 episodes a dayor incontinenceSevere crampingArrange urgent assessmentand review
Increase to >10 episodes a dayor grossly bloody diarrhoea orneed for parenteral supportArrange urgent assessmentand review
ConstipationHow long since bowels opened?What is normal?Doed the patient have any abdominal pain/vomiting?Has the patient taken any medication?
None Mild no bowel movement inlast 24 hoursDietary advice, increase fluidintake, review supportivemedication
Moderate no bowel movementin last 48 hoursIf associated with pain/vomitingmove to redReview fluid and dietary intakeRecommend laxative
Severe no bowelmovement in last 72 hoursArrange urgent assessmentand review
Paralytic ileum >96 hoursArrange urgent assessmentand review
FeverNOT receiving chemotherapy Normal n/a >37.5C - 38CCheck in 1 hr and contact againif still pyrexial see red
>38-40CArrange urgent assessmentand review
>40CArrange urgent assessmentand review
Infection If Pyrexial see fever toxicityHas the patient taken their temperature? When?Has the patient experienced any shivering, chills or shakingepisodes?
None Generally well Generally wellArrange Review
Severe symptomaticinfectionArrange urgent assessmentand review
Life threatening sepsisArrange urgent assessmentand review
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TRIAGE TOOLONCOLOGY/HAEMATOLOGY HELPLINE
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Palmar - plantar syndromeNB. If taking CAPECITABINE chemotherapy, follow
specific pathway
N one Numbness, tingling, painlesserythema and swellingAdvise patient to rest handsand feet. Use emolient cream
Painful erythema and swelling? Arrange review(mayrequire dose reduction or defertreatment). Advise analgesia
Moist desquamation,ulceration, blistering andsevere painArrange review (may require
dose reduction or defertreatment)Advise analgesia
FatigueHow many days has this occured for?Any other associated symptoms?
None Increased fatigue but notaltering normal activitiesRest accompanied withintermittent mild activity
Moderate or causing difficultyperforming some activities? Arrange review
Severe or loss of ability toperform some activitiesArrange review
Bedridden or disablingArrange urgent assessmentand review
AnorexiaWhat was their weight before? What is appetite like?Any contributory factors e.g. dehydration, diarrhoea,vomiting, mucositus and nausea? link to specific toxicity
None Loss of appetite withoutalteration in eating habitsDietary advise
Oral intake altered withoutsignificant weight loss ormalnutrition:? Arrange review
Oral intake altered inassociation with significantweight loss/malnutritionArrange urgent assessmentand review
Life threatening complicationse.g. collapseArrange urgent assessmentand review
Dyspnoea/shortness of breathIs it a new symptom? Is dyspnoea worsening?Is there any chest pain? link to specific toxicityHow long for?What can the patient do? (? alteration in PS)CONSIDER SVCO/ANAEMIA/PULMONARY EMBOLISM
None No new symptoms Dyspnoea on exertion? Arrange review
Dyspnoea at normal levelof activityWill need urgent assessmentand review
Dyspnoea at rest or requiringventilatory supportArrange urgent assessmentand review
RashIs it localised or generalised?How long has it been there?
Any signs of infection? Is it itchy?HAEMATOLGY FOLLOW LOCAL GUIDANCE
None Macular or papular eruptionor erythema withoutassociated symptoms
Localised rash, otherwise well
Macular or papular eruption orerythema with Pruritus or otherassociated symptoms
Arrange review
Symptomatic unwellArrange urgent assessmentand review
Symptomatic unwellArrange urgent assessmentand review
Neurosensory/motorWhen did the problem start? Is it continuous?Is it getting worse? Is it affecting mobility/functionAny constipation or urinary incontinence?Consider Spinal Cord Compression
None Mild parasthesia, subjectiveweakness; no objectivefindingsMonitor and contactimmediately if deteriorates
Mild or moderate sensory loss,moderate parasthesia, mildweakness with no loss of functionImmediate contact if deterioratesArrange review
Severe sensory loss,parasthesia or weakness thatinterferes with functionArrange urgent assessmentand review
ParalysisArrange urgent assessmentand review
BleedingIs it a new problem? Is it continuous? What amount?Where from? Is the patient on anticoagulants?HAEMATOLOGY FOLLOW LOCAL POLICY
None Mild self limited controlled byconservative measures
Gross 1-2 unitsUrgent assessment to A&E
Gross 3-4 units per episodeUrgent assessment to A&E
Massive >4 units per episodeUrgent assessment to A&E
PainIs it a new? Where is it? How long have you had it?Have you taken any analgesia?Consider thrombosis? Any swelling/redness?
None Mild painNot interfering with functionAdvise/discuss analgesea
Has painPain or analgesea interferingwith function, but not ADLArrange review
Severe painPain or Analgesia interferingADLArrange urgent assessmentand review
Severe pain, disabling!Arrange urgent assessmentand review
BruisingIs it a new problem? Is it local/generalised?Is there any trauma involved?
None Petechia/bruising, localisedArrange review
Moderate Petechia/purpuraGeneralised bruisingArrange urgent assessmentand review
Generalised petechia/purpuraArrange urgent assessmentand review
ExtravasationAny problems immediately after administration?When did the problem start?Is the problem around the injection site?Has the patient got a central venous catheter?Explain the reaction?
Non vesicantReview next day
VesicantArrange urgent assessmentand review
4 P. Jones et al/UKONS/GMCN Endorsed by:
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Recommendations for your safety and protection
The following recommendations concern the safe reconstitution and handling of cytotoxic agents inorder to prevent self contamination. Ideally, all drugs will be reconstituted by trained pharmacy staff in amicrobiological safety cabinet or isolator. Where a nurse may be required to reconstitute a cytotoxic drugit must be carried out in an isolator that is not on the ward/department or by using a closed reconstitutiondevice. It should only be carried out when absolutely necessary. Local instructions for isolator use should
be followed.8,9
The administration of SACT
1 General1.1 All drugs should be handled with respect, taking great care to avoid spillage.8
1.2 A pre-treatment assessment should be carried out folowing the steps in the pre-treatment pathway(pages 5-8). Drug dosage (according to the protocol) should be checked prior to administration ofany SACT.1,3,8,10
1.3 Strict aseptic technique should be observed at each stage of the procedure, for example, when
adding any drug to an IV solution or via an administration set/injection cap.10
2 RoutesThere are a number of routes for the administration of SACT.
2.1 Oral
The term oral anticancer medicine refers to drugs with direct antitumour activity, administered viathe oral route, including traditional cytotoxic chemotherapy (eg, capecitabine, vinorelbine), small-molecule treatments (eg, imatinib, erlotinib) and other agents such as thalidomide.8
2.2 Intravenous
This is the administration of cytotoxic drugs via a peripheral or central vein. It is the most commonlyused route of administration.8
2.2.1 Vein selectionThe vein used should be firm, bouncy, straight and, if possible, previously unused. Bruisedand inflamed areas should be avoided. Ideally the injection or infusion should be giveninto a large, easily visible, superficial vein. Any limb with a compromised circulation, forexample, as a result of mastectomy, lymphoedema, thrombophlebitis or trauma, should beavoided.11The antecubital fossa should be avoided, especially when administering vesicantdrugs.8,11In everyones interest, it is suggested that a practitioner should have no more than
two attempts at device placement and should then seek the advice of a more experiencedpractitioner.11Where no suitable veins are available or the patient is to receive regularadministration of highly irritant/vesicant infusions, then consideration should be given to theplacement of a CVAD.8
2.2.2 Device selectionCannulae (22 or 24g) should be selected following vein assessment, choosing the smallestgauge and shortest length appropriate for the type and length of therapy. The smaller thedevice, the less trauma to the vein and the better the blood flow around the device. Thisincreases dilution and rapid removal of the irritant and makes chemical phlebitis less likely.However, longer cannulae (22 or 20g) may be necessary to reduce the risk of dislodgment or
associated infiltration and extravasation.8
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2.2.3 Administration
(a) Each device must always be tested with NS before injecting SACT, and similarly flushedafter administration. If several drugs are to be given, the device should be flushed aftereach one to prevent possible interactions. This can be accomplished by attaching anddetaching a syringe of NS after each drug or by attaching a compatible infusion to thedevice and using one of the following techniques:10
(i) A fast-running infusion into which the drug is administered simultaneously via
the side arm if the vein can accommodate it or if this method is specified in theliterature. This is useful for highly irritant drugs but may not be necessary whenadministering via a CVAD.
(ii) A stop/start flushing technique if the vein is fragile or small and cannotaccommodate a large fluid flow.
(b) Any drug known to be a vesicant should be given first when multiple drugs areprescribed (but after any pre-medication). It is at this time that the integrity of the veinis greatest and extravasation is least likely. For practical reasons, drugs to be given byinfusion, for example, dacarbazine, should be administered last.8,11
(c) A number of cytotoxic drugs are vesicant and will cause extreme tissue damage if
leakage occurs from the vein. Even a very small leak is a serious situation and caremust be taken to ensure that all the drug enters the vein. Consequently, drugs shouldbe given slowly and the area around the device observed throughout the administration.8The practitioner should regularly assess the comfort of the patient, observe the site forswelling or skin colour changes and check vein patency by checking for blood return.8Ifthe nurse has any doubt about the patency of the device and vein then the administrationshould stop and the site should be checked before continuing. If extravasation issuspected then follow the management of extravasation guidance on page 15. 8,11
(d) Drug solutions that are stored in the refrigerator may cause venospasm and an achingsensation along the vein. It is important to distinguish between this and the sharpburning sensation which may indicate the extravasation of a vesicant.8
(e) With repeated injections of some drugs, veins may become very sensitive. The key iseither to dilute the drug or increase vasodilation. The following may help:(i) Inject the drug slowly or administer as an infusion.(ii) Make use of frequent NS flushes.(iii) Give the injection via a fast-running NS infusion.(iv) Use the smallest gauge cannula to increase blood flow around the device and
ensure more rapid circulation of the drug.(v) Apply a heat pack above the cannula site to increase vasodilation.
2.3 Intrathecal
This is the administration of cytotoxic drugs into the CNS via the CSF using a lumbar puncture.8
SACT administered via this route has the potential to cause great harm and has been associatedwith the deaths of at least 13 patients since 1985. Since 2001, all Trusts that administer intrathecalSACT have been required to comply with the national guidance on safe administration, mostrecently updated in 2008.12,13 Guidance issued by the NPSA means that from 2013, Trusts mustnow ensure that all spinal (intrathecal) bolus doses and lumbar punctures are performed usingsyringes, needles and other devices with connectors that cannot connect with intravenous Luerconnectors.14,15
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The key requirements of the 2008 guidance include:12
Only trained, designated personnel whose names are recorded on the appropriate intrathecalregister are authorised to prescribe, dispense, check or administer intrathecal SACT.
All staff involved in the intrathecal SACT process must undertake a formal competency-basedinduction programme and update annually.
In adults, IV drugs must be administered BEFORE intrathecal drugs are issued (or afterIV continuous infusions have been started).
Children receiving intrathecal therapy under general anaesthetic will have their intrathecaltreatment first in theatre. IV drugs (excluding vinca alkaloids) may be given later in day care or onthe ward, but never in theatre.
Intrathecal chemotherapy should always be administered in a designated area, within normalworking hours; out-of-hours administration must only occur in exceptional circumstances.
Checks must be made by medical, nursing and pharmacy staff at relevant stages throughout theprescribing, preparation and administration process.
This guidance predominantly relates to treatment given intrathecally, by lumbar puncture
(via spinal injection) but is also relevant to intra-ventricular chemotherapy (via injection into theventricles of the brain).
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The management of extravasation
Extravasation is the leakage of vesicants (any solution or medication that causes the formation of blisterswith subsequent tissue necrosis and may be DNA- and non-DNA binding) into local tissue. It requiresimmediate action if local tissue damage is to be prevented. If any doubt arises about patency of the vein,the injection or infusion should be stopped and recommenced in another vein if necessary, preferably inthe other arm. If this is not possible, use of a vein proximal to that already used will prevent leakage from
the earlier puncture site.8,16
Extravasation should be suspected if:8
the patient complains of a sharp stinging or burning sensation around the cannula site. swelling or leakage occurs at the site of the cannula. no flashback of blood is obtained (but absence of this, seen alone, is not necessarily an indication
of extravasation). resistance is felt on the plunger of the syringe during bolus administration. free flow of fluid is absent if an infusion is in progress.
When using a CVAD, blood return must always be established prior to administration.17If there is no bloodreturn, the Trust should have a local policy that describes the steps to be taken by the practitioner in orderto ascertain that the tip of the CVAD is in the correct position. Prevention is key and nurses should knowwhich patients are at most risk.
Clinical practice guidelines on the management of extravasation have been issued by the European Societyfor Medical Oncology (ESMO) and the European Oncology Nursing Society (EONS); however, guidance mayvary according to local policy.18,19 The policy detailed here is the current policy of the Royal Marsden NHSFoundation Trust. It is included for reference only. All staff who administer SACT should ensure that theirTrust or hospital develops its own extravasation policy.
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SUGGESTED ALGORITHM FOR THE TREATMENT OF EXTRAVASATION
SUSPECT EXTRAVASATION IF:(a) Patient complains of burning or stinging pain OR(b) There is evidence of swelling, induration, leakage at site OR(c) There is resistance on plunger of syringe or absence of free flow of infusion OR(d) There is no blood return (if found in isolation via a peripheral cannula this should not be regarded as an indication
of a non patent vein. However, in the event of no blood return from a CVAD follow algorithm for persistentwithdrawal occlusion)
ELEVATE THE LIMB
Apply hydrocortisone cream to reduce local inflammation. Where appropriate apply dimethyl sulfoxide every 2 hrs for24 hrs and then 6 hourly for up to 7 days
Document in duplicate one copy in patients notes and one copy to the nurse consultant IV therapy. Complete a clinicalincident form
INFORM THE MEDICAL STAFF
GIVE PATIENT A PATIENT INFORMATION SHEET
CATEGORY A DRUGSVinca alkaloids, paclitaxel Inject 1500 iu hyaluronidase
SC around the site Apply a warm pack to aid
absorption of hyaluronidase Warm pack to remain in situ
for 2-4 hrs
STOP THE INJECTION / INFUSION WITHDRAW AS MUCH OF THE DRUG AS POSSIBLE (INJECTION ONLY) REMOVE THE PERIPHERAL CANNULA COLLECT THE EXTRAVASATION PACK CONSIDER CONTACTING THE EXTRAVASATION TEAM TO PERFORM FLUSH OUT TECHNIQUE
CATEGORY B DRUGSDactinomycin, dacarbazine, daunorubicin, doxorubicin,epirubicin, idarubicin, mitomycin C, streptozocin, trabectedin
Apply cold pack to cause vasoconstriction for
15-20 mins, 3-4 times a day for at least 24 hrsIf extravasation is with any of the following: mitomycin C,doxorubicin, idarubicin, epirubicin, dactinomycin
Draw around area of extravasation with indelible pen
Put on gloves
Apply thin layer of dimethyl sulfoxide topically to the
marked area using the small plastic spatula in lid ofthe bottle
Allow it to dry and apply gauze This should be applied within 10-25 minsIf extravasation of doxorubicin, idarubicin, epirubicin ordaunorubicin occurs (ie, 3.5ml or more peripherally orany volume via a CVAD), then stop cold pack, do not applydimethyl sulfoxide and contact member of extravasationteam to advise on use of dexrazoxane
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Suggested cytotoxic spillage kit8
Particulate respirator mask
Plastic apron Gown Paper towels Plastic bucket Copy of spillage procedure
Essential equipment
Two plastic overshoes
Two disposable armlets Two clinical waste bags Two pairs of disposable non-sterile latex or
nitrile gloves Goggles (non-disposable): EN 166-8
1 Act immediately. Assess the level of exposure of any individual and isolate them from the spill.
2 Collect spillage kit.
3 Put on both pairs of gloves, goggles and a gown and then a disposable plastic apron over the gown.Ifthere is visible powder spill, put on a good-quality particulate respirator mask.Ifspillage is on the floor, put on overshoes.
Procedure
4 Wipe up powder spillage quickly with well dampened paper towels, starting at the outer edge of the spillarea and working in a circular motion towards the middle to contain spill and dispose of them as high-risk waste.
5 Mop up liquids which have been spilled on a hard surface with paper towels, starting at the outer edge ofthe spill area and working in a circular motion towards the middle to contain spill and dispose of them ashigh-risk waste.
6 Wash hard surfaces at least twice with copious amounts of cold, soapy water and dry with paper towels.The floor should then be given a routine clean as soon afterwards as possible. If spillage has occurred ona carpet it will require cleaning as soon as possible.
Ifspillage is on clothing, remove it as soon as possible and treat as soiled linen.Ifspillage has penetrated clothing, wash contaminated skin liberally with soap and cold water.Ifspillage is on bed linen put on gloves and an apron, change it immediately and treat as soiled linen.Ifan accident or spillage involving direct skin contact occurs, the area should be washed thoroughly with
soapy water as soon as possible. In the event of a cytotoxic splash to the eye, irrigate thoroughly with NS ortap water for at least 15 minutes.
Post-procedure
7 Any accident or spillage by nursing staff involving direct skin contact with a cytotoxic drug must bereported to the occupational health department and manager as soon as possible after the first aid isperformed and appropriate documentation completed.
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References
1. National Confidential Enquiry into Patient Outcome and Death. For better, for worse? A review of the care of patientswho died within 30 days of receiving systemic anti-cancer therapy. London, NCEPOD, 2008. Available from: http://www.ncepod.org.uk/2008report3/Downloads/SACT_report.pdf (accessed 14 January 2014).
2. National Chemotherapy Advisory Group. Chemotherapy services in England: Ensuring quality and safety. London,NCAG, 2009. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_104501.pdf (accessed 14 January 2014).
3. National Cancer Peer Review - National Cancer Action Team. National Cancer Peer Review Programme. Manualfor Cancer Services: Chemotherapy Measures, v2.0. London, NCAT, 2013. Available from: http://www.cquins.nhs.uk/?menu=resources (accessed 14 January 2014).
4. Nursing and Midwifery Council. Standards for medicines management. London, NMC, 2010. Available from:http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf (accessed14 January 2014).
5. US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. CommonTerminology Criteria for Adverse Events (CTCAE) v4.03; June 2010. NIH Publication No.09-5410. Available from: http://www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf (accessed accessed 14 January 2014).
6. Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group.Am JClin Oncol 1982; 5: 649-55.
7. UK Oncology Nursing Society. Oncology/Haematology 24-hour triage rapid assessment and access tool. October 2010.
Available from: http://www.ukons.org/ (accessed 14 January 2014).8. Hall K, Hyde L, Schorstein R. Chapter 19. Cytotoxic therapy. In: Dougherty L, Lister S (eds). The Royal Marsden Hospital
Manual of Clinical Nursing Procedures. 8th edition. Oxford, Wiley-Blackwell, 2011.9. Health and Safety Executive. Safe handling of cytotoxic drugs. HSE Information Sheet MISC615. London, HSE, 2003.
Available from: http://www.hse.gov.uk/pubns/misc615.pdf (accessed 14 January 2014).10. Dougherty L. Chapter 10. Intravenous management. In: Brighton D, Woods M (eds). The Royal Marsden Hospital
Handbook of Cancer Chemotherapy a guide for the multidisciplinary team . Edinburgh, Elsevier ChurchillLivingstone, 2005.
11. Dougherty L. Chapter 9. Obtaining peripheral venous access. In: Dougherty L, Lamb J (eds). Intravenous Therapy inNursing Practice. 2nd edition. Oxford, Blackwell, 2008.
12. Department of Health. Health Service Circular. HSC 2008/001 Updated national guidance on the safe administrationof intrathecal chemotherapy. London, DH, 2008. Available from: http://webarchive.nationalarchives.gov.
uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_086844.pdf (accessed 14 January 2014).
13. National Patient Safety Agency. Using Vinca Alkaloid Minibags (Adult/Adolescent Units) NPSA/2008/RRR004. London,NPSA, 2008. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=59890 (accessed 14 January 2014).
14. National Patient Safety Agency. Safer spinal (intrathecal), epidural and regional devices - Part A: update. NPSA/2011/PSA001. London, NPSA, 2011. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=94529 (accessed 14January 2014).
15. National Patient Safety Agency. Safer spinal (intrathecal), epidural and regional devices Part B. NPSA/2009/PSA004B.London, NPSA, 2009. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=94529 (accessed 14 January 2014).
16. Dougherty L. IV therapy: recognizing the differences between infiltration and extravasation. Br J Nurs2008; 17: 896,898-901.
17. Masoorli S. Extravasation injuries associated with the use of central vascular access devices.JVAD2003; 8: 21-3.
18. Prez Fidalgo JA, Garca Fabregat L, Cervantes A et al; ESMO Guidelines Working Group. Management of chemotherapyextravasation: ESMO-EONS Clinical Practice Guidelines.Ann Oncol2012; 23 Suppl 7: vii167-73.
19. Dougherty L, Oakley C. Advanced practice in the management of extravasation. Cancer Nursing Practice2011; 10: 16-22.20. Polovich M, Whitford JM, Olsen M. Chapter VII. Side Effects of Cancer Therapy. In: Polovich M, Whitford JM, Olsen M
(eds). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. 3rd edition. Pittsburgh, OncologyNursing Society, 2009.
21. Dolan S. Chapter 21. Anaemia. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of CancerChemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
22. Dougherty L. Chapter 23. Alopecia. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of CancerChemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
23. Dolan S. Chapter 25. Electrolyte abnormalities. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbookof Cancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
24. Wolf L. Chapter 26. Skin and nail changes. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook ofCancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
25. Stephens M. Chapter 29. Pulmonary effects. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook ofCancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
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Further resources
British Oncology Pharmacy Association. Position statement on safe practice and the pharmaceutical care ofpatients receiving oral anti-cancer chemotherapy. London, BOPA, 2004. Available from: http://www.bopawebsite.org/publications/docs/position-statements (accessed 29 January 2014).
Department of Health. Reference guide to consent for examination or treatment, second edition 2009. London,DH, 2009.
El-Saghir N, Otrock Z, Mufarrij A et al. Dexrazoxane for anthracycline extravasation and GM-CSF for skin ulceration and
wound healing. Lancet Oncol2004; 5: 320-1. Goodin S. Safe handling of oral chemo agents in community settings. Pharmacy Times 2007 (Sep 1). Available from:
http://www.pharmacytimes.com/publications/issue/2007/2007-09/2007-09-6789 (accessed 29 January 2014). Griffin E. Safety considerations and safe handling of oral chemotherapy agents. Clin J Oncol Nurs2003; 7(6 Suppl): 25-9. Langer SW, Sehested M, Jensen PB. Treatment of anthracycline extravasation with dexrazoxane. Clin Cancer Res2000;
6: 3680-6. Nursing and Midwifery Council. The code: Standards of conduct, performance and ethics for nurses and midwives.
London, NMC, 2008. Rickard CM, Webster J, Wallis MC et al. Routine versus clinically indicated replacement of peripheral intravenous
catheters: a randomised controlled equivalence trial. Lancet2012; 380: 1066-74. Royal College of Nursing. Standards for infusion therapy. The RCN IV Therapy Forum. 3rd edition. London, RCN, 2010. Schulmeister L. Chapter 18. Antineoplastic therapy. In: Infusion Nurses Society, Alexander M, Corrigan A et al (eds).
Infusion Nursing. 3rd Edition. Philadelphia, Saunders Elsevier, 2009. Sewell G, Summerhayes M, Stanley A. Administration of chemotherapy. In: Allwood M, Stanley A, Wright P (eds). The
Cytotoxics Handbook. 4th edition. Oxford, Radcliffe Medical Press, 2002. Toft B. External Inquiry into the adverse incident that occurred at Queens Medical Centre, Nottingham, 4th January
2001. London, Department of Health, 2001. Vidall C, Roe H, Dougherty L et al. Dexrazoxane: a management option for anthracycline extravasations. Br J Nurs2013;
22: S6 -12.
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Nursing implications of drug side effects8,20-25
These are ordered to provide the following:
Patient education
Observations/assessment
Monitoring Action
Haematological toxicity
1 Anaemia encourage good dietary intake, eg, food high in iron such as liver or broccoli/spinach observations for pallor, dizziness, shortness of breath regular FBC
blood transfusion usually packed cells administer erythropoietin as appropriate
2 Leucopenia
encourage meticulous hand hygiene in staff, patients and carers teach patient to recognise early signs of infection and report give chemotherapy alert card to ensure immediate attention at A&E department prevent exposure to adults or children with known infection close observation of patient on steroids take regular swabs and specimens if at risk regular monitoring of white blood cells
administer prophylactic granulyte colony-stimulating factor (GCSF) administer antibiotics and GCSF as required ensure appropriate isolation when WBC very low
3 Thrombocytopenia
warn patient to avoid physical injury avoid use of razor (use electric) avoid IM injections advise use of soft toothbrush teach patient how to recognise early signs and report
avoid drugs that interfere with platelet function, eg, aspirin, alcohol observation for bleeding including petechiae, haematuria regular platelet count administer platelet transfusion
4 Haemorrhagic tendency teach patient to watch for signs of bleeding, epistaxis, haematuria, bruising eliminate other reasons for bleeding, eg, low platelet count
5 Infection/sepsis
explain possibility to patient
give advice about how to prevent infection, recognise signs and symptoms and when to call for advice give chemotherapy alert card to ensure immediate attention at A&E department administer antibiotics within 1 hr of assessment ensure appropriate isolation if required
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Gastrointestinal toxicity
6 Stomatitis
advise patient to avoid extremely hot and cold food, heavy spices and citrus fruits, alcohol and smoking regular observation of entire mouth using an oral assessment tool where appropriate check for fungal infections regular mouth washes, every 2-3 hrs and always after meals
soft diet if severe administer analgesics and/or antifungals administer barrier preparation (eg, sucralfate or Gelclair) for local relief
7 Taste aberration (dysgeusia)(i) At time of treatment
offer strongly flavoured sweets during injection(ii) At other times
provide dietary advice advise sipping drinks/chewing gum/sweets
concentrate on foods that taste good sharp tasting drinks may be refreshing
8 Anorexia
encourage meals early in the day as better tolerated advise patient to try small frequent meals consider how food is presented determine dietary habits from nursing history weigh patient regularly offer food supplements provide artificial saliva, if due to dry mouth
refer to dietician
9 Dyspepsia
educate patient administer medications (PPIs, antacids) as indicated
10 Nausea and vomiting
inform patient of what to expect and when advise patient to try dry crackers for nausea suggest patient try distraction, meditation, relaxation, acupressure bands or acupuncture
consider patient preference regarding techniques prior to procedure administer antiemetics prior to chemotherapy and assess effectiveness for highly emetogenic drugs ensure appropriate antiemetics administered pre-SACT and then
regularly, for at least three days after each course maintain fluids and observe for electrolyte imbalance
11 Constipation
warn patient of possibility encourage diet high in fibre encourage fluids provide prophylactic laxatives
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12 Diarrhoea
warn patient of possibility advise a low roughage diet suggest good perianal hygiene (NB, anal fistulae are more common in immunosuppressed patients) observe for signs of dehydration and electrolyte imbalance provide/administer antidiarrhoea agents
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Skin toxicity
13 Venous discolouration
explain possibility to patient reassure patient it is temporary
14 Venous/injection site pain
administer injection slowly with frequent flushes of NS whenever pain occurs always distinguish vein pain from extravasation dilute injection further (if pharmaceutically acceptable) use local heat to aid vasodilation suggest CVAD insertion if pain is difficult to tolerate during infusion
15 Nail discolouration and ridging explain possibility to patient reassure patient it is temporary
16 Skin pigmentation explain reason to patient reassure patient it is temporary advise against prolonged exposure to bright sunlight
17 Phlebitis
(i) Chemical administer drugs with NS flushes administer drugs slowly use large vein with good blood flow use small gauge needle
apply local heat or glyceryl trinitrate patch to increase vasodilation(ii) Thrombophlebitis
inform patient of possibility and that it is temporary apply symptomatic relief (heat/cold) use heparinoid or steroid cream suggest application of anti-inflammatory cream or gel, eg, ibuprofen
18 Flushing(i) If a local flush along vein in arm at time of administration
advise patient that it is temporary
administer hydrocortisone injection/apply cream(ii) If body flushing at time of injection reassure patient that it is temporary slow drug administration
19 Dermatitis/rash inform patient of possibility observe for changes or pain (? shingles) seek dermatology opinion administer antihistamine IV or orally as required apply calamine or similar
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20 Palmar plantar erythrodysaesthesia (PPE)
advise patient to protect skin from sun encourage and apply greasy emollient to ensure skin is kept supple observe severity and administer pyridoxine administer antibiotics as prescribed
21 Pruritis
educate patient offer antihistamines
22 Erythema multiforme/Stevens-Johnson syndrome/toxic epidermal necrolysis (TEN)
discontinue any medication that could be responsible correct fluid and electrolyte imbalance and nutritional deficits provide analgesia, physiotherapy and wound dressings administer antibiotics for secondary infection
23 Alopecia
explain possibility to patient and advise degree of hair loss provide patient an opportunity to discuss reassure patient that hair will grow back order wig before hair loss encourage patient to cut long hair to prevent the weight pulling on roots advise on hair care frequency of washing, use of a neutral pH shampoo, use of brushes and comb advise against perms and colourants encourage patient to see own hairdresser for support use scalp hypothermia where appropriate
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Organ toxicity
24 Hepatic toxicity/abnormal liver function
observe for signs of jaundice test urine for bilirubin monitor LFTs
25 Cardiac toxicity/cardiac symptoms (chest pain, palpitations, arrhythmias, change in ECG pattern) baseline ECG or multiple-gated aquisition (MUGA) scan before treatment and monitor watch for cumulative effect check when reaching total cumulative dose of drug refer to cardiologist
26 Pulmonary toxicity (dyspnoea, cough, pneumonitis, bronchitis) observe for onset of symptoms shortness of breath, wheezing, etc and report ensure a baseline chest X-ray prior to starting treatment check chest X-ray prior to each treatment
advise anaesthetist before surgery treat infection as required
27 Sexual dysfunction
Female warn of amenorrhoea normally reversible after treatment stops advise patient to continue barrier contraception warn of early menopause/infertility discuss options for future fertilityMale discuss pre-treatment sperm banking
warn about possibility of sterility reassure that changes do not cause impotence
28 Discolouration of urine inform patient of possibility reassure patient that it is temporary
29 Haemorrhagic cystitis if patient is receiving high-dose therapy, test urine for blood increase fluid intake before and after treatment
measure fluid intake and output (for very high doses of drug, patient should be catheterised to ensureaccurate measurement of output; forced diuresis may be necessary) mesna given concurrently will protect bladder mucosa from cyclophosphamide and ifosfamide
30 Nephrotoxicity
monitor renal function before treatment and ascertain baseline EDTA or creatinine clearance test urine for pH alkalinisation may be required during treatment record fluid intake and output during treatment ensure adequate hydration; forced diuresis to maintain output may be necessary
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31 Tumour lysis syndrome
observe for signs and symptoms (tachypnoea, tachycardia, hypotension, pulmonary oedema) monitor and correct electrolyte levels as necessary administer hydration and monitor fluid balance administer allopurinol or rasburicase
32 Peripheral nerve toxicity (paraesthesia and peripheral sensory neuropathy)
explain to patient symptoms they might experience such as laryngo- or bronchospasm encourage patient to wear hat, scarf and gloves in cold weather and avoid cold drinks for 6 hrs after
drugs such as oxaliplatin observations to determine severity reassure patient symptoms will usually disappear 4-6 weeks after stopping treatment change to drug of lesser toxicity
33 CNS toxicity
(i) Observe for signs of problems neurological assessment
exclude cerebral secondaries(ii) Mood swings depression may occur provide patient an opportunity to talk, along with psychological and emotional support
throughout treatment
34 Pain (headache/myalgia, arthralgia) warn patient of possibility and advise not to take aspirin-based analgesia explain need to report any pain that does not resolve administer analgesia as appropriate
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Sensory toxicity
35 Ototoxicity
observe for patient reports of tinnitus (high frequency hearing loss often first symptom) ensure baseline audiology testing prior to treatment refer as appropriate
36 Nasal stuffiness explain to patient that it is transient
37 Photosensitivity
advise use of sunglasses advise avoidance of bright lights reassure patient that it is temporary
38 Eye problems (dry eyes/conjunctivitis/blurred vision) explain possibility to patient
advise who to contact if it should occur
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Metabolic toxicity
39 Hypo/hyperglycaemia
observation for signs dizziness, pallor, sweating, confusion monitor for blood glucose levels provide extra glucose/ensure food available (hypo) administer insulin as required (hyper)
administer certain infusions slowly
40 Hyperuricaemia encourage fluid intake observe urinary output administration of allopurinol
41 Hypo/hypercalcaemia
observation for increased neural and muscular excitability (hypo) administration of calcium (unless this is a required effect) (hypo)
observe for complaints of bone/abdominal pain, polyuria, nausea and vomiting, depression and anxiety(hyper) administration of hydration, bisphosphonates or calcitonin (hyper)
42 Hypomagnesaemia/hypophosphataemia observe for signs and symptoms (nervous system excitability, arrhythmia, muscle cramp) (Mg) administration of magnesium replacements (Mg) observe for muscle dysfunction and weakness, white cell dysfunction and mental status changes
(Phos) administration of IV potassium phosphate (Phos)
43 MAO inhibitor usually only very mild reactions warn patient to watch for reactions with high tyramine containing foods eg, alcohol, cheese,
Marmite.
44 Hypo/hyperkalaemia monitor potassium level observe for signs and symptoms (constipation, fatigue, muscle weakness) (hypo) administration of potassium replacement (mild = oral; more severe = IV) (hypo) observe for malaise, palpitations and muscle weakness (hyper)
administration of calcium; may require haemodialysis
45 Hyper/hypothyroidism
observe for signs and symptoms (fatigue, thin brittle hair and dry skin, weakness, unintentional weightgain) (hypo)
administration of medication, eg, levothyroxine (hypo) observe for tremors, anxiety, irritability, tachycardia and increased sweating and restlessness (hyper) administer antithyroid drugs, beta blockers, may require surgery or radioiodine to treat (hyper)
46 Hyperlipidaemia/hypercholesterolaemia
provide dietary advice
monitor levels may require statins
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Other toxicity
47 Gynaecomastia
explain possibility to patient
48 Tumour pain reassure patient that effect will pass
administration of analgesia
49 Jaw pain usually of trigeminal neuralgia type reassure patient that effect will pass administer analgesia
50 Carcinogenesis
offer counselling if this occurs or is likely to occur
51 Flu-like symptoms advise patient of possible symptoms fever, chills, headache advise patient that it is temporary administer prophylactic hydrocortisone
52 Hypersensitivity/anaphylaxis
regular nursing observations during drug administration have appropriate drugs ready if anaphylaxis is a possibility (hydrocortisone, chlorphenamine,
adrenaline) check sensitivity to drug with test doses (particularly if previous reaction) following a
desensitisation protocol
add hydrocortisone cover to drug regimen
53 Fatigue
inform patient of possibility explain when it may occur (may be worse when blood cell count is low 10-14 days after SACT) and how
long it might last advise patient to plan activities and have regular rest periods encourage family/friend involvement
54 Hypo/hypertension
monitor BP administer antihypertensive as prescribed if indicated
55 Reactivation of radiation sites explain possibility to patient
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List of drug monographs
A Afatinib E Epirubicin Panitumumab
Aflibercept Eribulin Pazopanib
Aldesleukin Erlotinib Pemetrexed
Alemtuzumab Estramustine Pentostatin
Arsenic trioxide Etoposide Pertuzumab
Asparaginase Etoposide phosphate Pixantrone
Axitinib Everolimus Pomalidomide
Azacitidine F Fludarabine Ponatinib
B Bendamustine 5-fluorouracil Procarbazine
Bevacizumab Folinic acid R Raltitrexed
Bexarotene G Gefitinib Regorafenib
Bleomycin Gemcitabine Rituximab
Bortezomib H Hydroxycarbamide RuxolitinibBosutinib I Idarubicin S Sorafenib
Brentuximab vedotin Ifosfamide Streptozocin
Busulfan Imatinib Sunitinib
C Cabazitaxel Interferon alfa T Tegafur/gimeracil/oteracil
Capecitabine Ipilimumab Temozolomide
Carboplatin Irinotecan Temsirolimus
Cetuximab L Lapatinib Thalidomide
Chlorambucil Lenalidomide Thiotepa
Cisplatin Lomustine TioguanineCladribine M Melphalan Topotecan
Clofarabine Mercaptopurine Trabectedin
Crizotinib Mesna Trastuzumab
Cyclophosphamide Methotrexate Trastuzumab emtansine
Cytarabine Mifamurtide Treosulfan
D Dacarbazine Mitomycin Tretinoin
Dactinomycin Mitotane V Vandetanib
Dasatinib Mitoxantrone Vemurafenib
Daunorubicin liposomal N Nelarabine Vinblastine
Daunorubicin non-liposomal Nilotinib Vincristine
Decitabine O Ofatumumab Vindesine
Docetaxel Oxaliplatin Vinflunine
Doxorubicin liposomal P Paclitaxel albumin Vinorelbine
Doxorubicin non-liposomal Paclitaxel non-albumin Vismodegib
The Yellow Card Reporting scheme is in place to help the Medicines and Healthcare products Regulatory
Agency (MHRA) monitor the safety of medicines and vaccines in the market.
If you suspect an adverse reaction that may be related to one or more drugs, please complete a Yellow Card.
These can be found in the BNF, MIMS or online at yellowcard.mhra.gov.uk
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A
Guide to frequency of side effects
Very common(1/10)Common (1/100 to
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AFATINIBGeneric name Afatinib
Trade name Giotrif
Drug action EGFR tyrosine kinase inhibitor.
Specificinformation
Afatinib is a substrate of P-gp. P-gp inhibitors or inducers could affect exposure toafatinib and dose adjustments may be required.
Methods ofadministration
Oral. Tablets should be taken on an empty stomach. Food should not be consumedfor at least 3 hrs before and at least 1 hr after taking the dose. For patients withswallowing difficulties, the tablets may be dropped in 100ml of non-carbonatedwater and stirred occasionally until dispersed (this may take up to 15 mins), thendrunk immediately. The dispersion can also be administered through a gastric tube.
Side effects Immediate Short-term Long-term
Very common None selected* Anorexia 8 , stomatitis 6 ,diarrhoea 12 , skin reactions(rash, dermatitis acneiform,pruritus, dry skin) 19 21 ,
epistaxis 4
Paronychia
Common None selected* Dyspepsia 9 , dysgeusia 7 ,dehydration, cystitis,conjunctivitis 38 , dry eye 38 ,rhinorrhoea, fever, musclespasm, cheilitis, increasedALT and ALP 25 ,hypokalaemia 44
PPE 20 , renal impairment 30 ,weight loss 8
Uncommon None selected* Keratitis ILD 26
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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AFLIBERCEPTGeneric name Aflibercept
Trade name Zaltrap
Drug action Blocks the activation of VEGF receptors, inhibiting the growth of new blood vesselsto the tumour.
Specific
information
Check BP and proteinuria before each dose.
Methods ofadministration
IV infusion over 1 hr, using an infusion set containing a 0.2 micron filter.
Side effects Immediate Short-term Long-term
Very common None selected* Infections 5 , leucopenia 2 ,neutropenia,thrombocytopenia 3 ,headache 34 ,hypertension 54 ,haemorrhage 4 ,
dyspnoea 26 , PPE 20 ,proteinuria, diarrhoea 12
Stomatitis 6 , anorexia 8 ,weight loss, dysphonia,increased AST and ALT 24 ,increased serum creatinine,asthenia
Common Hypersensitivity Neutropenic infections/sepsis 5 , UTI,nasopharyngitis
Fistula, dehydration, arterialand venousthromboembolism,oropharyngeal pain,rhinorrhoea, skinhyperpigmentation 16
Uncommon None selected* GI perforation, impairedwound healing
PRES, nephrotic syndrome,thrombotic microangiopathy
Rare None selected* None selected* None selected*Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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ALDESLEUKINGeneric name Aldesleukin, interleukin-2, IL-2
Trade name Proleukin
Drug action Immunomodulator. Mechanism not completely understood.
Specificinformation
May cause potentially fatal capillary leak syndrome which is associated withhypotension, pulmonary oedema and reduced organ perfusion. Careful monitoring
of circulatory and respiratory function is required. Frequency and severity of theseside effects are lower with SC administration than with IV infusion.May exacerbate disease symptoms in patients with unrecognised or untreated CNSmetastases.May exacerbate effusions from serosal surfaces; consider treatment beforeinitiation of therapy.Should be discontinued in patients developing severe lethargy or somnolence;continued administration may result in coma.Pre-existing bacterial infections should be treated prior to initiation of aldesleukin.Toxicities associated with aldesleukin may be exacerbated by concurrent bacterialinfections.
Possible disturbances in glucose metabolism; monitor blood glucose.Perform pre-treatment chest X-rays and ECG.May exacerbate pre-existing autoimmune disease.The solution may be slightly yellow.
Methods ofadministration
SC injection; or IV infusion in 500ml D5W with 0.1% human albumin solution.
Side effects Immediate Short-term Long-term
Very common Erythema 19 , rash(including exfoliativedermatitis) 19 ,
injection sitereactions 14 , fever,chills, malaise,asthenia/fatigue 53 ,pruritus 21 , sweating
Anxiety 33 , confusion 33 ,depression, insomnia,headache 34 , dizziness,
paraesthesia,somnolence 33 ,dyspnoea 26 , cough 26 ,nausea and vomiting 10 ,diarrhoea 12 , anorexia 8 ,stomatitis 6 ,hypotension 54 , tachycardia;chest pain (includingangina) 25 , oliguria, weightchanges
Anaemia 1 ,thrombocytopenia 3 ,increased serum urea and
creatinine,hypothyroidism 45
Common
(continued onfollowing page)
Phlebitis 17 ,hypothermia Constipation11 , pulmonaryoedema 26 , pleural
effusions, hypoxia,haemoptysis, epistaxis,rhinitis, cyanosis,cardiovascular disorders(including heart failure),irritability, agitation,hallucinations,musculoskeletal pain 34 ,conjunctivitis, dysphagia,
dyspepsia, GI haemorrhage,ascites, gastritis, RTI 5 ,acidosis, hyperglycaemia 39 ,hypocalcaemia 41 ,
Leucopenia 2 , eosinophilia,hypertension 54 ,coagulopathy, arrhythmia,neuropathy, increased LFTsand LDH, hepatomegaly orhepatosplenomegaly 24 ,haematuria,hyperthyroidism 45
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Common
(Aldesleukinside effectscontinued fromprevious page)
hyperkalaemia 44 ,dehydration, neuropathy,syncope, speech disorders,ageusia, lethargy,hypertension 54 ,haematuria, renal failure 30 ,anuria, alopecia 23 ,mucositis 6
Uncommon Hypersensitivity 52 ,thrombosis,haemorrhage
Hypoglycaemia, coma,seizures, paralysis,myasthenia, pancreatitis,intestinal obstruction, GIperforation, cholecystitis,vitiligo, angioedema,myopathy, myositis
Neutropenia 2 , liver failurewith fatal outcome 24
Rare Anaphylaxis 52 ,pulmonary embolism,ARDS
Optic nerve disorder,vesiculobullous rash,Stevens-Johnson
syndrome 22
Agranulocytosis, diabetes,activation of Crohns disease
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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ALEMTUZUMABGeneric name Alemtuzumab
Trade name MabCampath
Drug action Monoclonal antibody specific for the CD52 antigen expressed on B and Tlymphocytes.
Specific
information
No longer licensed in the UK but available on a named-patient basis.
Administered in escalating doses during first week: 3mg on day 1, 10mg on day 2and 30mg on day 3. Standard dose is then 30mg 3 times weekly on alternate days.If acute moderate to severe adverse reactions occur at either the 3mg or 10mg doselevels, then those doses should be repeated daily until they are well tolerated beforefurther dose escalation is attempted.If therapy is withheld for more than 7 days, gradual dose escalation is necessary.Patients should be premedicated with oral or IV steroids, an antihistamine andanalgesic 30-60 mins prior to each infusion during dose escalation and as clinicallyindicated thereafter. Since prolonged lymphocyte depletion results from treatment,prophylaxis against Pneumocystis jirovecipneumonia (eg, twice-daily co-trimoxazole3 times weekly) and an antiviral should be initiated and continued until CD4+ count
has recovered. Any blood products needed should be irradiated to prevent GvHD.Methods ofadministration
IV infusion over 2 hrs in 100ml NS or D5W.
Side effects Immediate Short-term Long-term
Very common Infusion-relatedreactions (fever,hypotension, chills,rash) 21
Rash 19 , nausea,dyspnoea 26 , fatigue 53 ,CMV infection 5
BMD 1 2 3
Common Hypersensitivity/anaphylaxis 52
Pruritus 21 , vomiting 10 ,diarrhoea 12 ,constipation 11 ,bronchospasm, back pain,chest pain, stomatitis 6 ,myalgia 34 , headache 34 ,confusion 33 , anxiety,somnolence, depression,insomnia, tremor, dizziness,GI haemorrhage
Hypertension 54 ,tachycardia 25 , flushing 18 ,palpitations, hyponatraemia,hypocalcaemia 41 ,dehydration
Uncommon None selected* Ageusia 7 None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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ARSENIC TRIOXIDEGeneric name Arsenic trioxide
Trade name Trisenox
Drug action Not completely understood. Induces DNA fragmentation and degradation.
Specificinformation
Induction treatment is given daily for a maximum of 50 doses. Consolidation therapyshould begin 3-4 weeks later.
Potentially fatal differentiation syndrome can occur, which is characterised by fever,dyspnoea, weight gain, lung infiltrates, pleural or pericardial effusions andleucocytosis. This requires immediate treatment with high-dose steroids(eg, dexamethasone 10mg IV twice daily).Can cause QT prolongation and complete AV block.Caution is advised when coadministered with other drugs known to cause QTprolongation (eg, macrolide antibiotics, the antipsychotic thioridazine), or thoseknown to cause hypokalaemia or hypomagnesaemia. Prior to initiating therapy, a12-lead ECG must be performed and serum electrolytes (potassium, calcium, andmagnesium) and creatinine must be assessed.Pre-existing electrolyte abnormalities must be corrected and, if possible, drugs that
are known to cause QT prolongation must be discontinued.Methods ofadministration
IV infusion over 1-2 hrs in 100-250ml NS or D5W. May be extended to 4 hrs ifvasomotor reactions (tachycardia) are observed.
Side effects Immediate Short-term Long-term
Very common Tachycardia 25 Hyperglycaemia 39 ,hypokalaemia 44 ,hypomagnesaemia 42 ,differentiation syndrome(see Specific information),dyspnoea 26 , fatigue 53 ,
fever, paraesthesia,dizziness, headache 34 ,nausea and vomiting 10 ,diarrhoea 12 , pruritus, rash,myalgia, oedema, pain
ECG abnormalities 25 ,increased ALT and AST 24
Common Hypotension 54 Arthralgia 34 , bone pain 34 ,pleural effusion 26
BMD 1 2 3 ,hyperbilirubinaemia, weightgain
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* Pneumonitis 26
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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ASPARAGINASEGeneric name Asparaginase, crisantaspase
Trade name Erwinase
Drug action An enzyme that breaks down exogenous asparagine that leukaemic cells dependupon for survival.
Specific
information
Treatment may be preceded by an intradermal test dose. Asparaginase-induced
pancreatic dysfunction may cause hyperglycaemia which may be detected by urineor blood glucose monitoring.
Methods ofadministration
Given by IV, IM or SC injection.Avoid froth formation due to excessive or vigorous shaking. The solution should berejected if there are any visible particles due to excessive shaking.The solution should be administered within 15 mins of reconstitution. If a delay ofmore than 15 mins between reconstitution and administration is unavoidable, thesolution should be withdrawn into a glass or polypropylene syringe for the period ofthe delay. The solution should then be used within 8 hrs.Daily clotting screen is necessary owing to the potential for clotting derangement.
Side effects Immediate Short-term Long-termVery common None selected* Coagulation abnormalities None selected*
Common Hypersensitivity (eg,urticaria, fever,aches) 52 ,dyspnoea 26
Increased serum amylasesand lipase 24
Hepatic impairment(increased LFTs andcholesterol, liver toxicity) 24 ,acute pancreatitis,diarrhoea 12 , CNS toxicity(lethargy, depression,drowsiness, seizures,coma) 33
Uncommon Anaphylaxis 52 None selected* None selected*Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1 2 3 etc) see pages 20-29. *None selected for the purposes of this handbook
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AXITINIBGeneric name Axitinib
Trade name Inlyta
Drug action Selective inhibitor of VEGF receptors 1, 2 and 3.
Specificinformation
Axitinib is metabolised in the liver by cytochrome P450 enzymes. Drugs that arepotent inhibitors or inducers of these enzymes should be avoided.
Methods ofadministration
Oral. Tablets should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected* Dysgeusia 7 , headache 34 ,haemorrhage 4 ,dysphonia 35 , GI upset(diarrhoea 12 ,nausea and vomiting 10 ,constipation 11 ), rash/dryskin 19 , stomatitis 6 ,
proteinuria, fatigue 53 ,mucositis 6
Hypothyroidism 45 ,anorexia/weight loss 8 ,PPE 20 , hypertension 54
Common None selected* Dehydration, dizziness,tinnitus 35 , dyspnoea 26 ,cough, dyspepsia 9 ,flatulence, haemorrhoids,pruritus 21 , erythema 19 ,pain (musculoskeletal,oropharyngeal, extremities,abdominal) 34
Alopecia 23 , increased lipaseand LFTs 24 , embolic andthrombotic events, renalfailure 30 , increased TSH,anaemia 1 ,thrombocytopenia 3
Uncommon None selected* None selected* Polycythaemia, neutropenia,leucopenia 2 ,hyp
Recommended