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Issue 16, June 2015
Wirral Drug & Therapeutic Committee ....................................................................................................................................... 1 Current Issues ............................................................................................................................................................................. 1 Topic of the Month ..................................................................................................................................................................... 3 Query Corner .............................................................................................................................................................................. 5 Drug Tariff .................................................................................................................................................................................. 6 Safety ......................................................................................................................................................................................... 9
Wirral Drug & Therapeutic Committee
RECOMMENDATIONS
DABIGATRAN capsules (Pradaxa®)
Approved for treatment and secondary prevention of VTE in line with NICE TA 327.
INFLIXIMAB intravenous infusion (Remicade®), ADALIMUMAB injection (Humira®) and GOLIMUMAB (Simponi®) injection
These drugs were approved in line with NICE TA 329 for treating moderately to severely active ulcerative colitis after
the failure of conventional therapy. Prescribing is limited to Consultant Luminal Gastroenterologists or approved IBD
Nurse Prescribers after a decision to treat has been made by the Consultant.
RITUXIMAB concentrate for intravenous infusion (MabThera®)
Approved for auto-immune haemolytic anaemia.
DARBEPOETIN ALFA injection (Aranesp®)
Approved for the treatment of anaemia in people with cancer having chemotherapy in line with NICE TA 323.
Current Issues Yogurt and Hay Fever
A recent media article entitled ‘Is Yoghurt the secret to easing hay fever?’ reported a study carried out by
researchers from the University School of Medicine in Nashville, US. The study's funding is not mentioned. It was
published in the peer reviewed medical journal, International Forum of Allergy and Rhinology.
Most of the UK media coverage reported the study’s headline results uncritically, suggesting that yoghurt could be a
cure for hay fever symptoms. However, not all yoghurt is probiotic, and it is not clear whether the people in these
studies were taking these probiotics in the form of yoghurt or capsules. The study was not specific to people with
hay fever, as it included people with allergic rhinitis not associated with seasonal allergens. The study did not find an
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overall effect on standard symptom scores, and the study authors did not recommend probiotics as a standalone
cure.
Overall, the review cannot answer with certainty how much benefit probiotics may have, and as the researchers say,
better-quality evidence is needed.
For further information NHS Choices website has a very good ‘Behind the Headlines’ response to this article accessed
via the link. http://www.nhs.uk/news/2015/05May/Pages/Probiotic-yoghurts-may-help-hay-fever.aspx
Medicines Management Team Work Plan A summary of the work the medicines management team are currently working on or plan to start in the next few months is detailed below:
Project Wirral
Proton Pump Inhibitors (PPI’s) stepping
down
Topiramate switching capsules to tablets
Dicycloverine review C
Oxycodone – switch to Longtec®/Shortec® C
Quetiapine MR review C
Special unlicensed medications review
Pregabalin review C
Fentanyl patches to Fencino® C*
Omeprazole tablets to capsules
Gaviscon to Peptac® switch
New oral anticoagulants (NOACs) audit C
Ciprofibrate review
Topical NSAID switch to Fenbid® C
Switch tolterodine to Neditol® C
Brand to generic review C
Review of LABA and ICS inhalers and switch
to combined inhaler C
Switch venlafaxine CR to Vensir®
Venlafaxine CR capsules to tablets C*
Prasugrel and ticagrelor review
Switch insulin pen needles to GlucoRx® brand C
Temazepam review C
Mucolytic review
Switch mesalazine MR to Octasa® C
Ciclosporin review to prescribe by brand
Switch dutasteride to finasteride C
Switch Nexium® and generic tablets to
esomeprazole capsules C*
Methylphenidate MR switch to Xenidate®
MR tablets
Fluoxetine liquid to Olena® dispersible
tablets
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C indicates work was completed in 2014/15 * Switch has been completed to a different brand.
Topic of the Month
MANAGING MEDICINES IN CARE HOMES
NICE Guidance and Quality standard published
Following Managing medicines in care homes (2014) NICE guideline SC1, NICE has developed a quality standard QS85
for managing medicines in care homes Managing medicines in care homes | Guidance and guidelines | NICE.
The NICE guidance and quality standard aim to improve the safety of medicines administration for care home
residents and ensure that a person-centred approach to medicines in care homes is taken. Residents are supported
to take an active role in decisions about their treatment and, wherever possible, to self-administer their medicines.
The Quality Statements
The quality statements have implications for General Practice and Community Pharmacy as well as care home staff.
Statement 1
People who transfer into a care home have their medicines listed by the care home on the day that they transfer.
GP practices and community pharmacies may be asked to support this by providing the home with an accurate list of current medication.
Statement 2
Providers of health or social care services send a discharge summary, including details of the person's current medicines, with a person who transfers to or from a care home.
Statement 3
People who live in care homes are supported to self-administer their medicines if they wish to and it does not put them or others at risk.
The home will be responsible for assessing if residents can self-administer their medications but health care professionals need to be aware of this when carrying out a multi-disciplinary medication review and pharmacies when dispensing medication.
Statement 4
Prescribers responsible for people who live in care homes provide comprehensive instructions for using and monitoring all newly prescribed medicines.
These include:
Switch unlicensed magnesium to licensed
Magnaspartate® tablets
Switch prednisolone to new cost effective
preparations (includes liquid and high
strength tablets)
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o recording clear instructions on how a medicine should be used, including how long the resident is expected to need the medicine and, if important, how long the medicine will take to work and what it has been prescribed for (use of the term 'as directed' should be avoided)
o providing any extra details the resident and/or care home staff may need about how the medicine should be taken
o any tests needed for monitoring When prescribing variable dose and 'when required' medicine(s), information should include:
o dosage instructions on the prescription (including the maximum amount to be taken in a day and how long the medicine should be used, as appropriate) so that this can be included on the medicine's label.
Instructions for: o when and how to take or use the medicine (e.g. 'when low back pain is troublesome take one tablet') o monitoring o the effect the medicine is expected to have
If directions are not clear care homes are required to follow this up with the Prescriber or Pharmacist
Statement 5
People who live in care homes have medication reviews undertaken by a multidisciplinary team.
The guidance and quality standard gives clear guidance of what should be included in the medication review and states that Health and social care practitioners should discuss and review the following during a medication review:
o the purpose of the medication review o what the resident (and/or their family members or carers, as appropriate, and in line with the resident's
wishes) thinks about the medicines and how much they understand o the resident's (and/or their family member or carer's, as appropriate, and in line with the resident's wishes)
concerns, questions or problems with the medicines o all prescribed, over-the-counter and complementary medicines that the resident is taking or using, and what
these are for o how safe the medicines are, how well they work, how appropriate they are, and whether their use is in line
with national guidance o any monitoring tests that are needed o any problems the resident has with the medicines, such as side effects or reactions, taking the medicines
themselves (for example, using an inhaler) and difficulty swallowing o helping the resident to take or use their medicines as prescribed (medicines adherence) o any more information or support that the resident (and/or their family members or carers) may need.
Statement 6
Adults who live in care homes and have been assessed as lacking capacity are only administered medicine covertly if a management plan is agreed after a best interests meeting.
Further information can be found at:
http://mm.wirral.nhs.uk/document_uploads/newsletters/TABLETS_Issue_7.pdf
The covert administration of medicines should only be used in exceptional circumstances when such a means of administration is judged necessary, in accordance with the Mental Capacity Act 2005. However, once a decision has been made to covertly administer a particular medicine (following an assessment of the capacity of the resident to make a decision regarding their medicines and a best interests meeting), it is also important to consider and plan how the medicine can be covertly administered, whether it is safe to do so and to ensure that need for continued covert administration is regularly reviewed (as capacity can fluctuate over time). Medicines should not be administered covertly until after a best interests meeting has been held. If the situation is urgent,
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it is acceptable for a less formal discussion to occur between the care home staff, prescriber and family or advocate making an urgent decision. However, a formal meeting should be arranged as soon as possible.
Query Corner
Is there a safer alternative to Seretide 500 accuhaler® for a COPD Patient who has suffered community acquired pneumonia twice?
A patient has COPD with FEV=59% and has suffered community acquired pneumonia twice in June 2014 and May 2015. Patient is currently prescribed Seretide 500 accuhaler®, Spiriva handihaler® 18mcg/dose and Salamol® inhaler. The TORCH study6 reported that there was an increased risk of pneumonia for patients on Seretide® vs placebo and this prompted the query.
The Wirral COPD Inhaled Drug Therapy Guideline5 states “Inhaled corticosteroid use by patients with COPD is associated with an increased risk of serious pneumonia.”
NICE evidence summary1 (ESNM47) for Fostair® (beclomethasone/formoterol) in COPD reports on a randomized controlled trial (n=419), in which beclomethasone/formoterol statistically significantly improved the onset of bronchodilation in people with moderate to severe COPD compared with fluticasone/salmeterol (Seretide®), although it is unclear whether the improvement is clinically significant. The treatments were equivalent in improving dyspnoea over 12 weeks. Serious adverse events were statistically significantly more common with Seretide®. From the published data Fostair® appears to work as well in COPD as the 2 commonly used inhaled corticosteroid/ Long Acting Beta Agonist (ICS/LABA) combinations. It can be used with a spacer, which many people with COPD need.
Serious adverse events occurred statistically more often in the Seretide® group than the Fostair® group (13 people [6.3%] vs 4 people [1.9%]. p=0.024)
NICE COPD guidelines2 advise practitioners to be aware of the potential risk of side effects (including non-fatal pneumonia) in people with COPD treated with ICS, and to be prepared to discuss this risk with patients. The potential benefit of ICS in people with COPD needs to be balanced against the risk of side effects; particularly when they are used at a high dose for long-term treatment. Prolonged use of high doses of ICS carries a risk of systemic side effects, including adrenal suppression, decrease in bone mineral density, cataracts and glaucoma. ICS have also been associated with a dose-related increased risk of diabetes onset and diabetes progression, and with an increased risk of fracture. The MHRA has reminded health professionals to remain vigilant for the development of pneumonia and other infections of the lower respiratory tract when using ICS to treat people with COPD, because the clinical features of such infections and exacerbations frequently overlap.
Pneumonia is listed as an undesirable effect in the SPCs for both Fostair® and Seretide® 500 accuhaler®3,4. For Fostair®
it is listed as uncommon (≥1/1,000 and <1/100) and for Seretide® it is listed as common (≥1/100 to <1/10)
Summary
There is a potential risk of side effects, including non-fatal pneumonia, developing in people with COPD treated with inhaled corticosteroids. Prescribers should discuss this with the patient and review their medication.
Options available if Seretide® 500 accuhaler® is to be reviewed;
1. Stop the Seretide® 500 accuhaler® and prescribe a LABA. Formoterol Easyhaler® dry powder inhaler 12mcg/dose, 1 puff twice a day is first line in Wirral COPD Inhaled Drug Therapy Guideline.
2. Try an alternative LABA/ ICS. Replace Seretide® 500 Accuhaler® with Fostair®. This is available as a metered dose inhaler so can be used with a spacer, which may be of benefit to COPD patients. For this patient, with an FEV of 59%, prescribing would be off-label.
References
1. NICE advice [ESNM47] Chronic obstructive pulmonary disease: beclometasone/formoterol (Fostair) Published date: September 2014 2. NICE CG 101 COPD Management in adults in primary and secondary care
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3. Summary Product Characteristics (SPC) Fostair http://www.medicines.org.uk/emc/medicine/21006 4. Summary Product Characteristics (SPC) Seretide 500 accuhaler http://www.medicines.org.uk/emc/medicine/2317 5. Wirral COPD Inhaled Drug Therapy Guideline http://mm.wirral.nhs.uk/document_uploads/guidelines/COPDguidelinesv2.pdf 6. Cardiovascular events in patients with COPD: TORCH Study results. Calverley PMA et al.Thorax 2010;65:719-725
Drug Tariff
PRICE CHANGES
Top 10 monthly price reductions
Disopyramide 150mg capsules [1 x 84] £18.76 (-£8.82) Tafluprost 15micrograms/ml eye drops 0.3ml unit dose preservative free [1 x 30] £12.20 (-£5.21) Isradipine 2.5mg tablets [1 x 56] £187.27 (-£3.26) Dexamethasone 10mg/5ml oral solution sugar free [1 x 150] £97.66 (-£3.22) Aripiprazole 30mg tablets [1 x 28] £181.41 (-£2.67) Methadone 50mg/5ml solution for injection ampoules [1 x 10] £16.33 (-£2.61) Thiamine 100mg tablets [1 x 100] £9.18 (-£2.37) Famciclovir 500mg tablets [1 x 14] £155.12 (-£1.42) Isosorbide mononitrate 25mg modified-release capsules [1 x 28] £3.40 (-£1.38) Aripiprazole 10mg tablets [1 x 28] £90.71 (-£1.33)
Top 10 monthly price increases
Chlortalidone 50mg tablets [1 x 30] £88.00 (+£71.85) Olsalazine 500mg tablets [1 x 60] £85.00 (+£63.82) Olsalazine 250mg capsules [1 x 112] £75.00 (+£55.23) Carbimazole 20mg tablets [1 x 100] £208.17 (+£19.86) Diethylstilbestrol 5mg tablets [1 x 28] £208.00 (+£15.33) Flutamide 250mg tablets [1 x 84] £71.03 (+£11.48) Dicycloverine 10mg/5ml oral solution [1 x 120] £111.09 (+£8.64) Griseofulvin 500mg tablets [1 x 100] £100.17 (+£8.34) Carbimazole 5mg tablets [1 x 100] £84.80 (+£8.31) Chloral hydrate 143.3mg/5ml oral solution BP [1 x 150] £180.61 (+£7.68)
Top 100 annual price reductions
http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201505.pdf Top 100 annual price increases, October 2014 http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201505.pdf
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DRUG AVAILABILITY
Medication supply issues
The following generic drugs have supply issues and hence are incurring increased costs; they have been given a
NCSO (NO CHEAPER STOCK OBTAINABLE) status for May 2015. Please consider the costs of the following drugs
before prescribing.
Product Quantity Price
Concession
Baclofen 10mg tablets 84 £7.20
Clonidine 25microgram tablets 112 £9.00
Diclofenac sodium 50mg gastro-resistant tablets(new) 28 £2.65
Digoxin 125microgram tablets 28 £4.99
Digoxin 250microgram tablets 28 £4.40
Digoxin 62.5microgram tablets 28 £4.99
Exemestane 25mg tablets 30 £29.00
Fosinopril 10mg tablets 28 £14.05
Fosinopril 20mg tablets 28 £15.49
Lisinopril 20mg / hydrochlorothiazide 12.5mg tablets 28 £8.43
Lofepramine 70mg tablets 56 £22.00
Mebeverine 135mg tablets 100 £15.00
Mefenamic acid 250mg capsules 100 £15.00
Mefenamic acid 500mg tablets 28 £14.95
Sodium cromoglicate 2% eye drops 13.5ml £5.50
Trimethoprim 100mg tablets 28 £7.35
Trimethoprim 200mg tablets 14 £6.50
Trimethoprim 200mg tablets 6 £2.79
Other drugs with long-term supply issues
The following drugs have long-term supply issues. The table below shows the reason for the supply issue and expected return to stock dates.
Description Due date Comment
Anusol Hc® suppositories x12 and x24 (Johnson&Johnson)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Aptamil® lactose free milk powder x400g (Danone Nutricia)
Supplier unable to confirm Stock on allocation from supplier
Betnesol® eye ointment 0.1% x3g (Focus Pharma)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Bisacodyl suppositories 10mg End of June Manufacturing issue is causing a delay in supply
Caverject® dual chamber 20 micrograms (Pfizer)
January 2016 Manufacturing issue is causing a delay in supply. Medical information enquiries -
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0845 608 8866
Colofac® tablets 135mg x100 (Bgp Products)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Co-Phenotrope tablets 2.5/0.025mg x100 (Amco Rwa and Mercury Pharma)
June 2015 Supplier issue is causing a delay in supply
Creon® 40 000 capsules x100
January 2016 Manufacturing issue is causing a delay in supply
Diclofenac sodium ec tablets 50mg (various brands)
Supplier unable to confirm Market shortage is causing a delay in supply
Ferrous fumerate tablets 210mg x84 (Amco Rwa and Mercury Pharma)
June 2015 Manufacturing issue is causing a delay in supply
FreeStyle® blood glucose test strip x50 (Abbott)
Limited supplies ongoing Ongoing supply issue
Genticin® eye/ear drop 0.3% 10ml (Amco and Amdipharm)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Hormonin® tablets x84 (Amco Rwa)
Limited supplies ongoing Supplier issue is causing a delay in supply
Methotrexate tablets 2.5mg x24 (AMCo)
October 2015 Market shortage is causing a delay in supply
Modrasone® cream 50g (Teva)
June 2015 Manufacturing issue is causing a delay in supply
Sno Tears® 10ml (Bausch&Lomb)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Synalar® cream 30g (Derma UK)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Synalar® cream 1:4 Dilution 50g (Derma UK)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
Traxam® gel 3% 100g (Amco Rwa and Mercury Pharma)
October 2015 Supplier issue is causing a delay in supply
Traxam® pain relief gel 30g (Amco Rwa and Mercury Pharma)
October 2015 Supplier issue is causing a delay in supply
Unilet C® touch lancets 28Gx0.38Mm x100
Supplier unable to confirm Supplier issue is causing a delay in supply
Vita-Pos® (preservative free oint) 5g
Supplier unable to confirm Supplier issue is causing a delay in supply
Zacin® Cream 0.025% 45g (Teva)
Supplier unable to confirm Manufacturing issue is causing a delay in supply
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For any further information regarding supply problems please contact your Medicines Management Team.
Safety
FDA warning SGLT2 Inhibitors may lead to ketoacidosis
The US Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis. From March 2013 to 6th June 2014 there have been 20 cases identified via the FDA Adverse Event Reporting System (FAERS) database of diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors. In all of these cases hospital care was required. Ketoacidosis is a serious condition where the body produces high levels of blood acids called ketones that may require hospitalisation. The safety issue is being investigated to determine if changes are required in the prescribing of this drug group. Patients should be informed to seek medical attention if they experience signs of ketoacidosis. The signs patients should look out for are, symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. For further information: http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
Topical ketoprofen and risk of photosensitivity
Topical ketoprofen has caused photo allergic reactions and in some cases this has been serious, leading to hospitalisation. The European medicines regulators have reviewed the side effects of this topical non-steroidal anti-inflammatory drug (NSAID) and provided recommendations for prescribers and pharmacists to minimise this risk. Prescribers are advised to strictly follow the contraindications when prescribing topical ketoprofen. Prescribers and pharmacists should advise patients to:
Wash hands thoroughly after each application
Not to expose treated areas of skin to sunlight (even when weather conditions are cloudy), or to
Use UVA during treatment and for two weeks after stopping treatment
Protect treated areas of skin from sunlight by wearing clothing
Not to use topical ketoprofen under occlusive bandaging
Stop treatment immediately if you have any kind of skin reaction to this product An information sheet for patients should be provided and prescribers and pharmacists must make sure that the patient fully understands the risk of skin reactions and how the risk should be minimised. All patient should be given a copy of the ‘Information Sheet For Patients’ and informed to read this along with the Patient Information Leaflet that comes with the gel. Any suspected side effects should be reported to the MHRA through the Yellow Card Scheme. For further information: https://assets.digital.cabinet-office.gov.uk/media/555c335ce5274a74ca000009/Ketoprofen_DHPC_sent_20-04-2015.pdf
Influenza Season 2014/15 – Prescribing and supply of antiviral medicines
Influenza levels in the community have returned to baseline and consequently GPs and non-medical prescribers are to no longer prescribe, at NHS expense, antiviral medicines for the prophylaxis and treatment of influenza in primary care. This is in accordance with NICE guidance and Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of drugs etc) Regulations 2004), commonly known as the Grey List or Selected List Scheme (SLS). This will remain the case until further communication is sent when the next use of antivirals is triggered.
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If there is an outbreak in people who are in the at risk groups e.g. living in long term care homes then advice should be sought from the local Public Health England centre staff. In secondary care, antivirals can be prescribed for patients whose illness is confirmed or strongly suspected to be due to flu where hospitalisation is required. For further information: https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=102144
Fingolimod (Gilenya®▼): First report of progressive multifocal leukoencephalopathy in a multiple sclerosis patient
Novartis have issued a letter to health care professionals informing them that there has been a first reported case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis patient taking fingolimod (without previous treatment with natalizumab or other immunosuppressive medicines). The case was reported in February 2015 when PML was confirmed in a patient taking fingolimod for four years. The drug was stopped immediately and the patient did not experience any clinical signs or symptoms of PML. Fingolimod is licensed as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis patients. Health care professionals are being advised to be vigilant of the risks of PML in patients taking fingolimod and to report all suspected adverse drug reactions to the MHRA via the yellow card reporting scheme. For further information: https://assets.digital.cabinet-office.gov.uk/media/555c338ced915d7ae5000007/Gilenya_DHPC_sent_29_April.pdf
MHRA DRUG SAFETY UPDATE
Hydroxyzine (Atarax®, Ucerax®): Risk of QT interval prolongation and Torsade de pointes
A European review has been undertaken to check the safety and efficacy of hydroxyzine following concerns of heart rhythm abnormalities in patients taking this medicine. It was concluded that hydroxyzine is associated with a small risk of QT interval prolongation and Torsade de pointes. The recommendation has therefore been made that the maximum adult daily dose should now not exceed 100mg. It should not be prescribed in people who have a prolonged QT interval or risk factors for QT interval prolongation. Hydroxyzine is an antihistamine used to treat pruritus in adults and children and is also used to treat anxiety in adults. The MHRA has now issued the following guidance when using hydroxyzine:
Avoid use in elderly (more susceptible to side effects than younger patients)
Consider risk of Torsade de pointes and QT interval prolongation before prescribing to patients taking medicines that lower heart rate or potassium levels
Do not use in patients who have QT interval prolongation or have risk factors for QT interval prolongation The risk factors which should be considered are:
Cardiovascular disease
Family history of sudden cardiac death
Significant electrolyte imbalance (low potassium/magnesium levels)
Significant bradycardia
Concomitant use of medicines that prolong QT interval The maximum daily dose is now:
100mg for adults
50mg in elderly (if use cannot be avoided)
2mg/kg body weight for children up to 40mg in weight
The lowest effective dose should be prescribed for the shortest time possible
Report any suspected side effects on a yellow card (www.mhra.gov.uk/yellowcard)
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For further information: https://www.gov.uk/drug-safety-update/hydroxyzine-atarax-ucerax-risk-of-qt-interval-prolongation-and-torsade-de-pointes The Medicines Management Team can provide a list of patients for review if required.
Minimising risk of medication errors with high strength, fixed combination and biosimilar insulin products
There are several new insulin products which will be released on the market and potential errors may be likely due to them being high strength, fixed combination and biosimilar insulin products. There are three new insulin brands which have a strength of insulin higher than the 100units/ml (Tresiba®▼, Humalog®, Toujeo®▼), a fixed combination product of insulin degludec and liraglutide (Xultophy®▼) and a biosimilar of insulin glargine (Abasaglar®▼).In order to minimise the risk of medication errors with these new products, guidance is being developed by the EMA. Toujeo®▼and Abasaglar®▼have not yet been launched in UK. The consultation is open for comments up to the 14th of June 2015. For further information: https://www.gov.uk/drug-safety-update/high-strength-fixed-combination-and-biosimilar-insulin-products-minimising-the-risk-of-medication-error
Epoetin beta (NeoRecormon®): increased risk of retinopathy in preterm infants cannot be excluded
There is a possible increased risk of retinopathy when premature infants are given epoetin beta for preventing anaemia of prematurity. Epoetin beta (NeoRecormon®) is licensed for the prevention of anaemia of prematurity in infants with a birth weight of 0.75 to 1.5 kg and a gestational age of less than 34 weeks. Infants born before 31 weeks of gestation, particularly those weighing less than 1.25 kg have an underlying risk of retinopathy of prematurity. A European review was conducted to assess the risk of retinopathy and two Cochrane systemic reviews assessed the effectiveness of epoetin beta to treat anaemia in premature and low birth weight infants. The data from these two reviews suggest that epoetin beta may increase the underlying risk of retinopathy in premature infants. More data will be required to draw firm conclusions but from the reviews conducted so far, the risk of retinopathy cannot be excluded. For further information: https://www.gov.uk/drug-safety-update/epoetin-beta-neorecormon-increased-risk-of-retinopathy-in-preterm-infants-cannot-be-excluded
Pomalidomide (Imnovid®▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity
Pomalidomide is licensed in combination with dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two treatments, including lenalidomise and bortezomib, and whose disease has worsened since the last treatment. In light of the new risks of cardiac failure, interstitial lung disease and hepatotoxicity as identified by the MHRA and other EU medicine regulators, guidance has been issued of new monitoring requirements. New monitoring guidance for health care professionals when using pomalidomide are: in patients with cardiac disease or cardiac risk factors, use with caution and if used, monitor for signs or
symptoms of cardiac failure carefully assess patients with any acute onset or unexplained worsening of respiratory symptoms to confirm or
exclude interstitial lung disease (ILD); stop pomalidomide treatment during assessment if ILD is confirmed, treat appropriately and only resume pomalidomide treatment after thoroughly evaluating the
benefits and risks
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regularly monitor liver function for the first 6 months of pomalidomide treatment and as clinically indicated thereafter
please continue to report suspected adverse drug reactions to pomalidomide or any other medicines on a Yellow Card
Cardiac failure and interstitial lung disease are considered as common side effects (i.e. occurs in between 1/10 and 1/100 patients) who take pomalidomide. Serious hepatotoxicity can occur in patients taking pomalidomide, mainly acute hepatitis and this is considered to be an uncommon side effect (i.e. occurs in between 1/100 and 1/1,000 patients who take pomalidomide).
For further information: https://www.gov.uk/drug-safety-update/pomalidomide-imnovid-risks-of-cardiac-failure-interstitial-lung-disease-and-hepatotoxicity
Medicines Management Team contacts:
Victoria Vincent [email protected] 0151 643 5319
For any feedback or suggestions on content, please email [email protected]
