WG mpA A mpprod.rituxan.gene.s3.amazonaws.com/aav/hcp/assets/WGMPA...ther serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including

INDICATION: Rituxan®

(rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA).

Rituxan is not recommended for treatment of patients with severe active infections.

ImpOrTANT SAfeTy INfOrmATION: Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pmL).

Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.

Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.

For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide.

WG& mpA

© 2012 Genentech USA, Inc., So. San Francisco, CA and Biogen Idec Inc., Cambridge, MA RRA0000762400

CONTACT yOur rHeumATOLOGy CLINICAL COOrDINATOr (rCC) fOr INfuSION AND TrAINING SuppOrTn Call 1-877-317-5179

Monday through Friday, 9 am-8 pm ET

rituxan for WG and mpA

Administration Tear padTHe fIrST AND ONLy fDA-ApprOveD THerApy fOr WeGeNer’S GrANuLOmATOSIS (WG) AND mICrOSCOpIC pOLyANGIITIS (mpA)

INDICATION: Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA).Rituxan is not recommended for treatment of patients with severe active infections.ImpOrTANT SAfeTy INfOrmATION: Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pmL).Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide. Attention healthcare provider: provide medication Guide to patient prior to rituxan infusion.For healthcare professional use only. Not to be distributed to patients.

INSIDe: Patient Checklist and Chart Record

Preparation and Administration Checklist

Infusion Flow Sheet

Important Safety Information

WG& mpA

GLUE GLUE

The enclosed tear pad will provide you with:

Sheet 1: Patient Checklist and Chart Record Checklist to help you prepare your patients prior to scheduling the infusion

Checklist for assessing patients on infusion day Record of important notes for the physician to include in the patient’s chart

Sheet 2: Rituxan Preparation Worksheet Guidelines for preparing the Rituxan solution and a worksheet for the calculations

Mixing tables to help you prepare Rituxan to the desired concentration

Sheet 3: Administration Checklist Premedication and patient preparation information

Administration and adverse event information

Sheet 4: Infusion Flow Sheet A flow sheet for recording the patient’s vitals

A drip-rate chart to use during Rituxan infusions

WG& mpA

Because Rituxan is administered intravenously, an appropriate healthcare professional will need to become familiar with the use, preparation, administration, contraindications, and infusion-related adverse events of Rituxan in order to provide necessary patient care.

This guide is not a substitute for the medical judgment and discretion of the trained medical professional administering therapy.

TheSe 4 SheeTS TeAR oFF AS one PIeCe. You CAn Then SePARATe Them Along The PeRFoRATIonS, And ReFeR To The lAbel on The ToP-leFT CoRneR To PlACe Them In oRdeR.

For additional information about administering a Rituxan infusion, consult the rituxan for WG and mpA Dosing and Administration pocket Guide (pictured here). If you need a copy of the guide, please contact your Genentech representative.

Laboratory Monitoring: Obtain CBC and platelet counts at 2- to 4-month intervals during Rituxan therapy. The duration of cytopenias caused by Rituxan can extend months beyond the treatment period.Concomitant Use With Immunosuppressants Other Than Corticosteroids in Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA): Use of concomitant immunosuppressants other than corticosteroids has not been studied in WG or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan. Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.Retreatment in Patients With Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA): Limited data are available on the safety and efficacy of subsequent courses of Rituxan in patients with WG and MPA. In the active-controlled, double-blind study, subsequent courses of Rituxan were allowed for patients experiencing a relapse of disease. The safety and efficacy of retreatment with Rituxan have not been established.Adverse EventsIn a clinical trial, the most common adverse events occurring in ≥10 of Rituxan-treated patients (N=99) and >5% more frequently than in the cyclophosphamide group (N=98) were infections (62% vs 47%), peripheral edema (16% vs 6%), and hypertension (12% vs 5%). Infusion Reactions: Among the 99 patients treated with Rituxan, 12% experienced at least one infusion-related reaction compared with 11% of the 98 patients in the cyclophosphamide group. Infusion-related reactions included cytokine release syndrome, flushing, throat irritation, and tremor. In the Rituxan group, the proportion of patients experiencing an infusion-related reaction was 12%, 5%, 4%, and 1% following the first, second, third, and fourth infusions, respectively. Patients were pre-medicated with antihistamine

and acetaminophen before each Rituxan infusion and were on background oral corticosteroids, which may have mitigated or masked an infusion reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion reactions.Infections: In a clinical trial, 62% (61/99) of patients in the Rituxan group experienced an infection of any type compared to 47% (46/98) of patients in the cyclophosphamide group by Month 6. The most common infections in the Rituxan group were upper respiratory tract infections, urinary tract infections, and herpes zoster. The incidence of serious infections was 11% in the Rituxan-treated patients and 10% in the cyclophosphamide-treated patients, with rates of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection was pneumonia.Immunogenicity: A total of 23/99 (23%) Rituxan-treated patients with WG or MPA tested positive for HACA by 18 months. The clinical relevance of HACA formation in Rituxan-treated patients is unclear.General Counseling InformationPatients should be provided the Rituxan Medication Guide and provided an opportunity to read it prior to each treatment session. It is important that the patient’s overall health be assessed at each visit and the risks of Rituxan therapy and any questions resulting from the patient’s reading of the Medication Guide be discussed. Rituxan is detectable in serum for up to 6 months following completion of therapy.

Individuals of childbearing potential should use effective contraception during treatment and for 12 months after Rituxan therapy.

To report SUSPECTED ADVERSE REACTlONS, contact Genentech at 1-888-835-2555 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full prescribing information, including BOXED WARNINGS and Medication Guide.

IMPORTANT SAFETY INFORMATION

BOxED WARNINGSFatal Infusion Reactions: Rituxan administration can result in serious, including fatal, infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions.Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with Rituxan. Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients treated with Rituxan. Warnings and PrecautionsSevere Infusion Reactions: Rituxan can cause severe, including fatal, infusion reactions. Severe reactions typically occurred during the first infusion with time to onset of 30 to 120 minutes. Rituxan-induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death. Interrupt the infusion for severe reactions. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed.Premedicate patients with an antihistamine and acetaminophen prior to dosing. For WG and MPA patients, glucocorticoids are given in combination with Rituxan.

Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in Rituxan-treated patients with hematologic malignancies or autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML have received Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had a history of prior, or concurrent, immunosuppressive therapy and were diagnosed with PML within 12 months of the patient’s last infusion of Rituxan. Hepatitis B Reactivation With Related Fulminant Hepatitis, Sometimes Fatal: Persons at high risk of HBV infection should be screened before initiation of Rituxan and HBV carriers should be monitored during and several months after therapy. Discontinue Rituxan if reactivation occurs, and consult a Hepatologist.Infections: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and up to one year following the completion of Rituxan-based therapy. Pneumocystis pneumonia (PCP) prophylaxis is also recommended for patients with WG and MPA during treatment and for at least 6 months following the last Rituxan infusion.Cardiovascular: Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of Rituxan for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.Immunization: The safety of immunization with live viral vaccines following Rituxan therapy has not been studied, and vaccination with live vaccines is not recommended in patients receiving Rituxan. Follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of Rituxan.

Please see full prescribing information, including BOXED WARNINGS and Medication Guide.

© Global 2012 Genentech USA, Inc., So. San Francisco, CA and Biogen Idec Inc.,

Cambridge, MA RRA0000762400

During and After the InfusionInstruct patients and family members or attendants about symptoms to watch for and what actions to take in the event of infusion-related symptoms such as:

n Hives or rash n Weaknessn Itching n Dizziness or feeling faintn Swelling of the lips, n Palpitations tongue, throat, or face n Chest painn Sudden coughn Shortness of breath, difficulty breathing, or wheezing

Instruct patients and family members or attendants to seek immediate medical attention if they notice any of the above symptoms.

Limited data are available on the safety and efficacy of subsequent courses of Rituxan in patients with WG and MPA. In the active-controlled, double-blind study, subsequent courses of Rituxan were allowed for patients experiencing a relapse of disease. The safety and efficacy of retreatment with Rituxan have not been established.

Request the Rituxan for WG and MPA Administration Tear Pad

The tear pad includes patient evaluation forms, a Rituxan preparation worksheet, administration checklists, an infusion flow sheet, and a drip-rate chart.

Request your tear pad from a Rheumatology Clinical Coordinator (RCC) or Rituxan representative. RCCs are also available for infusion training and support.

INDICATION: Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA). Rituxan is not recommended for treatment of patients with severe active infections.IMPORTANT SAFETY INFORMATIONBOxED WARNINGSRituxan administration can result in serious, including fatal, adverse reactions. These include:• infusion reactions • severe mucocutaneous reactions• tumor lysis syndrome (TLS) • progressive multifocal

leukoencephalopathy (PML)Warnings and PrecautionsRituxan administration can also result in additional serious, including fatal, adverse reactions including:• hepatitis B reactivation • cardiovascular events• other infections including bacterial, fungal, new or reactivated

viral infectionsUse of concomitant immunosuppressants other than corticosteroids has not been studied in WG or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan.Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide.Attention healthcare provider: Provide Medication Guide to patient prior to Rituxan infusion.For healthcare professional use only. Not to be distributed to patients.

CONTINUED ON baCk COvEr.

WG& MPA

References: 1. Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc and Genentech USA, Inc; April 2011. 2. Data on file, Genentech USA/Biogen Idec.

DosingRituxan® (rituximab) is administered by intravenous (IV) infusion at a dose of 375 mg/m2 (ie, body surface area dosing) once weekly for 4 weeks.1

The dosing amount per patient will vary. Calculating the patient’s dose prior to his or her scheduled date of infusion will help you order the correct number of vials needed. See the steps for calculating the dose below.

Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of Rituxan and may continue during and after the 4-week course of Rituxan treatment.

PCP prophylaxis is also recommended for patients with WG or MPA during treatment and for at least 6 months following the last Rituxan infusion.

The following dosing instructions apply to Rituxan for WG and MPA.

When administering Rituxan for rheumatoid arthritis (RA), refer to the Rituxan for RA Infusion Tool Kit.

STEP 1:Calculate body surface area (BSA) of the patient using his or her height and weight.2

n The calculation requires the patient’s actual body weight and height, measured no more than 14 days before administering Rituxan

n The formula for calculating BSA used in the clinical trial was:

BSA in m2 = (weight in kg)0.425 x (height in cm)0.725 x 0.007184

STEP 2:Using the patient’s BSA, calculate the weekly Rituxan dose with the following formula.

Weekly dose = BSA (m2) x 375 mg

THE FIRST AND ONLY FDA-APPROVED THERAPY FOR WEGENER’S GRANULOMATOSIS (WG) AND MICROSCOPIC POLYANGIITIS (MPA)

Rituxan for WG & MPA Dosing and Administration Pocket Guide

WG& MPAWG& MPA

RAHC1i0134A_WG_Pocket_Guide_for_MixTbl_r12_FSU.indd 1 12/9/11 3:17 PM

Advise YOUR PATieNT AbOUT The fOllOwiNg:

One course of Rituxan consists of 4 separate infusions, one infusion given weekly for 4 weeks. Confirm infusion dates, times, and locations for all infusions1

The length of the infusion depends on the patient’s Rituxan dose, which is based on the patient’s body surface area (BSA). Each infusion could take 3 to 5 hours, so the patient should plan accordingly1

The patient should wear comfortable clothes on the day of each infusion and bring some form of entertainment— a book, some music, or even a friend to chat with. Remind the patient to eat before arriving for the infusion. In addition, if the facility where the patient will be receiving the Rituxan infusion allows it, consider encouraging the patient to bring some food along in case he or she gets hungry during the infusion

Tell the patient that 30 minutes before each infusion, he or she may be given acetaminophen and an antihistamine to prevent or reduce side effects1

Explain that infusions are a form of treatment used for a variety of conditions. Unlike other forms of treatment, infusions are given by a trained healthcare professional who is there to help manage the process

iMPORTANT NOTes fOR The PhYsiCiAN

Healthcare Provider Signature Date

Preparing patients prior to scheduling the infusionReview the Medication Guide with your patient before each infusion and answer any questions he or she may have. Be sure to discuss the information about serious side effects and Boxed Warnings.

AsK YOUR PATieNT:

Have you received a Rituxan infusion before?

Do you have a current or ongoing infection?

Do you have any scheduled vaccinations in the next month?

Vaccination: Date:

Have you had any dental work or surgery in the last month?

Description: Date:

ANY Of The AbOve CONdiTiONs COUld ReqUiRe delAYiNg OR ReCONsideRiNg TReATMeNT wiTh RiTUxAN. PleAse CONsUlT The PhYsiCiAN.

Have you disclosed all the prescription and/or nonprescription medications you are currently taking, including blood pressure medication, vitamins, or herbal supplements?

Are you breast-feeding, pregnant, or planning to become pregnant?

iNfORM The PATieNT ThAT The effeCT Of RiTUxAN ON PRegNANCY is NOT KNOwN ANd ThAT wOMeN Of ChildbeARiNg POTeNTiAl shOUld Use effeCTive CONTRACePTiON dURiNg TReATMeNT ANd fOR 12 MONThs AfTeR TheRAPY. wOMeN shOUld TAlK TO TheiR dOCTOR AbOUT bReAsT-feediNg while TAKiNg RiTUxAN.

sTORe iN The PATieNT file Of:

Check here if there are important notes for the physician. Use the space provided to record important information for the physician.

PleAse NOTe: This CheCKlisT is fOR PATieNTs wiTh wegeNeR’s gRANUlOMATOsis (wg) OR MiCROsCOPiC POlYANgiiTis (MPA)

IMPORTANT SAFETY INFORMATIONRituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide.Reference: 1. Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc and Genentech USA, Inc; April 2011.

Patient Preparation Checklist and Chart RecordsheeT 1

WG& MPA

Preparing the Rituxan solution DO NOT ADMINISTER AS IV PuSh OR BOLuS Always use aseptic technique. A hood is not required to mix Rituxan

The length of the infusion depends on the patient’s Rituxan dose, which is based on the patient’s body surface area (BSA). For more information on calculating Rituxan doses and preparing Rituxan, please see the Rituxan for WG and MPA Dosing and Administration Pocket Guide

Prepare an IV bag of normal saline or D5W, containing the appropriate amount needed to dilute Rituxan to the proper concentration as follows:

using Mixing Tables found on the back of this sheet, refer to the table that corresponds with the desired Rituxan concentration (4 mg/mL, 2 mg/mL, or 1 mg/mL) and locate the row with the patient’s BSA

Read across to the diluent* volume column to identify the amount of normal saline or D5W that should be left in the IV bag

Withdraw and discard the unneeded normal saline or D5W. (NOTE: This amount will vary according to each patient’s BSA, the Rituxan dose, and the desired Rituxan concentration)

Read across to the Rituxan volume to withdraw column to identify the Rituxan volume needed based on the BSA-calculated dose. Carefully withdraw that amount of Rituxan. Gentle air injection or push-pull method can be used to ease the withdrawal of Rituxan

Gently add Rituxan to the IV bag. The final IV bag volume should be equal to the total infusion volume column on the Mixing Tables

Gently invert IV bag to mix. Do not shake Infuse the total volume of the IV bag to account for possible overfilling of the IV bag Rituxan solution may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Protect from direct sunlight. Do not freeze

worksheet for preparing the Rituxan solution

1. Select a Mixing Table based on the following desired Rituxan concentration.

Desired Rituxan concentration (mg/mL):

2. Select a row based on the patient’s BSA.

BSA (m2):

3. Use the following formula to determine what volume of saline to remove from the bag so that the desired diluent volume is left in the bag.

4. Write down the patient’s Rituxan dose based on his or her BSA.

Rituxan dose (mg):

5. Write down the Rituxan volume to withdraw from the Rituxan vial based on the patient’s BSA and Rituxan dose.

Rituxan volume to withdraw (mL):

6. The Rituxan volume to withdraw plus the diluent volume will equal the total infusion volume.

Normal saline or D5W bag volume (mL)

Diluent volume (mL)

Normal saline or D5W volume to remove from the bag (mL)

– =

Rituxan volume to withdraw (mL)

Diluent volume (mL)

Total infusion volume (mL)

+ =

*Normal saline or D5W.

PATieNT NAMe

dATe Of iNfUsiON

RiTUxAN lOTs/viAl NUMbeRs

IMPORTANT SAFETY INFORMATIONRituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML).Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide.

Rituxan for WG and MPA: Preparation WorksheetsheeT 2

WG& MPA

dosing Rituxan is administered by intravenous (IV) infusion at a dose of 375 mg/m2 (ie, body surface area dosing) once weekly for 4 weeks.



Premedication Review the physician’s order to determine if premedications are to be administered prior to Rituxan infusion. Recommended premedications are acetaminophen and an antihistamine.

Administering Rituxan Use standard IV setups

CAuTION: DO NOT ADMINISTER AS IV PuSh OR BOLuS

Rituxan should not be mixed or diluted with other medications

first infusion (day 1) Begin infusion at rate of 50 mg/h1

If an infusion reaction does not occur, escalate the infusion rate in 50-mg/h increments every 30 minutes, to a maximum of 400 mg/h1

If an infusion reaction develops, stop or slow the infusion and give supportive care as necessary. In most cases, the infusion can be resumed at 50% reduction in rate if the reaction has been resolved1

Infusion times will vary from patient to patient depending upon the dose administered, which is based on the patient’s body surface area (BSA)1

subsequent infusions (days 8, 15, and 22) If the patient experienced an infusion reaction during the first infusion, start at the same rate as the first infusion (50 mg/h) and follow directions noted above1

If the patient tolerated the infusion well, begin at a rate of 100 mg/h1

If an infusion reaction does not occur, continue to escalate the infusion rate in 100-mg/h increments every 30 minutes, to a maximum of 400 mg/h1


Infusion times will vary from patient to patient depending upon the dose administered, which is based on the patient’s body surface area (BSA)1 CONTiNUed ON ReveRse side.

PATieNT NAMe

dATe Of iNfUsiON



Rituxan for WG and MPA: Administration ChecklistsheeT 3

WG& MPA

Name of patient Date of birth

Name of nurse Initials Date

Rituxan lots/Vial numbers Rituxan dose infused (mg)

Wastage* (mg)

Current diagnosis

Allergies

History of arrhythmia or angina Yes No

Using antibiotics currently or recently Yes No

Temperature

Labs drawn N/A Time

Labs drawn N/A Time

Last infusion tolerated well Yes No Comments

IV site Rituxan IV: Start time End time Pump Gravity*Rituxan amount not infused.

Use This iNfUsiON flOw sheeT TO dOCUMeNT YOUR PATieNT’s viTAls dURiNg eACh iNfUsiON

IV discontinued intact Yes No

Notes on the infusion

TiMe MediCATiON ROUTe

TiMe TeMP heART RATe ResPiRATORY RATe blOOd PRessURe RATe Of dRUg iv siTe COMMeNTs

Rituxan for WG and MPA: Infusion Flow SheetsheeT 4


WG& MPA










AsK YOUR PATieNT:




Vaccination: Date:


Description: Date:










WG& MPA














BSA (m2):



Rituxan dose (mg):





Diluent volume (mL)


– =


Diluent volume (mL)


+ =


PATieNT NAMe

dATe Of iNfUsiON




WG& MPA

















PATieNT NAMe

dATe Of iNfUsiON




WG& MPA




Wastage* (mg)

Current diagnosis

Allergies



Temperature

Labs drawn N/A Time

Labs drawn N/A Time










WG& MPA










AsK YOUR PATieNT:




Vaccination: Date:


Description: Date:










WG& MPA














BSA (m2):



Rituxan dose (mg):





Diluent volume (mL)


– =


Diluent volume (mL)


+ =


PATieNT NAMe

dATe Of iNfUsiON




WG& MPA

















PATieNT NAMe

dATe Of iNfUsiON




WG& MPA




Wastage* (mg)

Current diagnosis

Allergies



Temperature

Labs drawn N/A Time

Labs drawn N/A Time










WG& MPA










AsK YOUR PATieNT:




Vaccination: Date:


Description: Date:










WG& MPA














BSA (m2):



Rituxan dose (mg):





Diluent volume (mL)


– =


Diluent volume (mL)


+ =


PATieNT NAMe

dATe Of iNfUsiON




WG& MPA

















PATieNT NAMe

dATe Of iNfUsiON




WG& MPA




Wastage* (mg)

Current diagnosis

Allergies



Temperature

Labs drawn N/A Time

Labs drawn N/A Time










WG& MPA


AsK YOUR PATieNT:

Have you had any recent medication changes or health changes?


Are you currently taking antibiotics?

Do you have or have you had viral hepatitis? Do you have heart or lung problems?

Are you pregnant?

Have you had infusion reactions during or after previous Rituxan infusions?

Have you had any vaccinations in the last month?

Vaccination:

Date:


Description:

Date:



If, during or after the infusion, the patient experiences symptoms such as shortness of breath, fever, rash, aching joints, flu-like symptoms, stomach pain, or sudden change in thinking, walking, strength, vision, or other problems that last over several days, he or she should seek immediate medical attention. These may be signs of serious side effects

Be sure the patient is aware that some common side effects may include1:

Remind the patient to notify you immediately if and when any such reactions occur.

Has the patient experienced any new symptoms?

If the patient has any questions, he or she can call 1-877-317-5179 or visit www.Rituxan.com/WG-MPA/patient



Assessing patients on infusion day Review the enclosed Medication Guide with your patient before each infusion and answer any questions he or she may have. Be sure to discuss the information about serious side effects and Boxed Warnings.

Infusion reactions Chills Infections

Body aches Tiredness Low white blood cell count

Infusion Day Checklist and Chart RecordsheeT 1 (continued)

Reference: 1. Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc and Genentech USA, Inc; April 2011.


WG& MPA

Rituxan for WG and MPA: Mixing TablessheeT 2 (continued)


* For ease of reconstitution, some numbers have been rounded. †Normal saline or D5W.

WG& MPA

TO DELIVER 375 mg/m2 AT A CONCENTRATION OF 1 mg/mL OF RITuxAN

BSA (m2) Rituxan dose (mg)

Rituxan volume to withdraw

(mL*)

Diluent volume†

(mL)

Total infusion volume

(mL)

1.3 488 49 439 488

1.4 525 53 427 525

1.5 563 56 507 563

1.6 600 60 540 600

1.7 638 64 574 638

1.8 675 68 607 675

1.9 713 71 642 713

2.0 750 75 675 750

2.1 788 79 709 788

2.2 825 83 742 825

2.3 863 86 777 863

2.4 900 90 810 900

2.5 938 94 844 938

2.6 975 98 877 975

2.7 1013 101 912 1013

2.8 1050 105 945 1050

2.9 1088 109 979 1088

3.0 1125 113 1012 1125

3.1 1163 116 1047 1163

3.2 1200 120 1080 1200

3.3 1238 124 1114 1238

1 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 74 123

1.4 525 53 79 132

1.5 563 56 84 140

1.6 600 60 90 150

1.7 638 64 96 160

1.8 675 68 102 170

1.9 713 71 107 178

2.0 750 75 113 188

2.1 788 79 119 198

2.2 825 83 124 207

2.3 863 86 130 216

2.4 900 90 135 225

2.5 938 94 141 235

2.6 975 98 147 245

2.7 1013 101 152 253

2.8 1050 105 158 263

2.9 1088 109 164 273

3.0 1125 113 169 282

3.1 1163 116 175 291

3.2 1200 120 180 300

3.3 1238 124 186 310

4 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 195 244

1.4 525 53 210 263

1.5 563 56 225 281

1.6 600 60 240 300

1.7 638 64 255 319

1.8 675 68 270 338

1.9 713 71 286 357

2.0 750 75 300 375

2.1 788 79 315 394

2.2 825 83 330 413

2.3 863 86 346 432

2.4 900 90 360 450

2.5 938 94 375 469

2.6 975 98 390 488

2.7 1013 101 406 507

2.8 1050 105 420 525

2.9 1088 109 435 544

3.0 1125 113 450 563

3.1 1163 116 466 582

3.2 1200 120 480 600

3.3 1238 124 495 619

2 mg/mL

important information about infusion reactions

Rituxan can cause severe, including fatal, infusion reactions

Rituxan-induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Among the 99 patients treated with Rituxan, 12% experienced at least one infusion-related reaction, compared with 11% of the 98 patients in the cyclophosphamide group. Infusion-related reactions included cytokine release syndrome, flushing, throat irritation, and tremor. In the Rituxan group, the proportion of patients experiencing an infusion-related reaction was 12%, 5%, 4%, and 1% following the first, second, third, and fourth infusions, respectively

if A seveRe iNfUsiON ReACTiON OCCURs:

Interrupt the infusion

Medications and supportive care measures should be available and instituted as medically indicated for use in the event of a reaction during administration. These may include, but are not limited to:

Make sure to follow your office protocol.

In most cases, the infusion can be resumed at 50% of the previous rate (eg, 100 mg/h to 50 mg/h) when symptoms have completely resolved1

during and after the infusion Instruct patients and family members or attendants about symptoms to watch for and what actions to take in the event of infusion-related symptoms such as1:

Instruct patients and family members or attendants to seek immediate medical attention if they notice any of the above symptoms


Common adverse events In a clinical trial, the most common adverse events occurring in ≥10% of Rituxan-treated patients (N=99) and >5% more frequently than in the cyclophosphamide group (N=98) were: infections (62% vs 47%), peripheral edema (16% vs 6%), and hypertension (12% vs 5%).

infections In the active controlled, double-blind study, 62% (61/99) of patients in the Rituxan group experienced an infection of any type compared to 47% (46/98) of patients in the cyclophosphamide group by Month 6. The most common infections in the Rituxan group were upper respiratory tract infections, urinary tract infections, and herpes zoster.

The incidence of serious infections was 11% in the Rituxan-treated patients and 10% in the cyclophosphamide-treated patients, with rates of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection was pneumonia.

IV fluids Glucocorticoids Antihistamines Acetaminophen

Epinephrine Bronchodilators Oxygen

Hives or rash Itching Swelling of the lips, tongue, throat, or face

Sudden cough Shortness of breath, difficulty breathing, or wheezing

Weakness Dizziness or feeling faint

Palpitations Chest pain



Rituxan for WG and MPA Administration ChecklistsheeT 3 (continued)

WG& MPA


RITuxAN IS ONLY ADMINISTERED AS A SLOW IV INFuSION AND NEVER AS AN IV PuSh OR BOLuS. The table below will help you calculate the drip rate for Rituxan infusions.

To achieve desired concentration when preparing Rituxan, refer to the Mixing Tables in the Rituxan for WG and MPA Dosing and Administration Pocket Guide.

Rituxan for WG and MPA Infusion Drip RatessheeT 4 (continued)

fiNAl desiRed RiTUxAN CONCeNTRATiON 1 mg/mL

50 8 13 17 50 50100 17 25 33 100 100150 25 38 50 150 150200 33 50 67 200 200250 42 63 83 250 250300 50 75 100 300 300350 58 88 117 350 350400 67 100 133 400 400

fiNAl desiRed RiTUxAN CONCeNTRATiON 2 mg/mL50 4 6 8 25 25

100 8 13 17 50 50

150 13 19 25 75 75

200 17 25 33 100 100

250 21 31 42 125 125

300 25 38 50 150 150

350 29 44 58 175 175

400 33 50 67 200 200

if YOUR desiRed mg/h is:

dROPs PeR MiNUTe bAsed ON A TUbe wiTh A deliveRY RATe Of: UsiNg AN iNfUsiON PUMP, YOUR

mL/h shOUld be:10 dROPs/mL 15 dROPs/mL 20 dROPs/mL 60 dROPs/mL


100 4 6 8 25 25

150 6 9 13 38 38

200 8 13 17 50 50

250 10 16 21 63 63

300 13 19 25 75 75

350 15 22 29 88 88

400 17 25 33 100 100

PLEASE NOTE ThAT RITuxAN PREPARATION INSTRuCTIONS ARE DIFFERENT FOR RhEuMATOID ARThRITIS (RA).When preparing Rituxan for RA, please refer to the Rituxan for RA Infusion Tool Kit.

WG& MPA


AsK YOUR PATieNT:





Are you pregnant?



Vaccination:

Date:


Description:

Date:
















WG& MPA




WG& MPA




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 439 488

1.4 525 53 427 525

1.5 563 56 507 563

1.6 600 60 540 600

1.7 638 64 574 638

1.8 675 68 607 675

1.9 713 71 642 713

2.0 750 75 675 750

2.1 788 79 709 788

2.2 825 83 742 825

2.3 863 86 777 863

2.4 900 90 810 900

2.5 938 94 844 938

2.6 975 98 877 975

2.7 1013 101 912 1013

2.8 1050 105 945 1050

2.9 1088 109 979 1088

3.0 1125 113 1012 1125

3.1 1163 116 1047 1163

3.2 1200 120 1080 1200

3.3 1238 124 1114 1238

1 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 74 123

1.4 525 53 79 132

1.5 563 56 84 140

1.6 600 60 90 150

1.7 638 64 96 160

1.8 675 68 102 170

1.9 713 71 107 178

2.0 750 75 113 188

2.1 788 79 119 198

2.2 825 83 124 207

2.3 863 86 130 216

2.4 900 90 135 225

2.5 938 94 141 235

2.6 975 98 147 245

2.7 1013 101 152 253

2.8 1050 105 158 263

2.9 1088 109 164 273

3.0 1125 113 169 282

3.1 1163 116 175 291

3.2 1200 120 180 300

3.3 1238 124 186 310

4 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 195 244

1.4 525 53 210 263

1.5 563 56 225 281

1.6 600 60 240 300

1.7 638 64 255 319

1.8 675 68 270 338

1.9 713 71 286 357

2.0 750 75 300 375

2.1 788 79 315 394

2.2 825 83 330 413

2.3 863 86 346 432

2.4 900 90 360 450

2.5 938 94 375 469

2.6 975 98 390 488

2.7 1013 101 406 507

2.8 1050 105 420 525

2.9 1088 109 435 544

3.0 1125 113 450 563

3.1 1163 116 466 582

3.2 1200 120 480 600

3.3 1238 124 495 619

2 mg/mL

























WG& MPA






50 8 13 17 50 50100 17 25 33 100 100150 25 38 50 150 150200 33 50 67 200 200250 42 63 83 250 250300 50 75 100 300 300350 58 88 117 350 350400 67 100 133 400 400


100 8 13 17 50 50

150 13 19 25 75 75

200 17 25 33 100 100

250 21 31 42 125 125

300 25 38 50 150 150

350 29 44 58 175 175

400 33 50 67 200 200





100 4 6 8 25 25

150 6 9 13 38 38

200 8 13 17 50 50

250 10 16 21 63 63

300 13 19 25 75 75

350 15 22 29 88 88

400 17 25 33 100 100


WG& MPA


AsK YOUR PATieNT:





Are you pregnant?



Vaccination:

Date:


Description:

Date:
















WG& MPA




WG& MPA




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 439 488

1.4 525 53 427 525

1.5 563 56 507 563

1.6 600 60 540 600

1.7 638 64 574 638

1.8 675 68 607 675

1.9 713 71 642 713

2.0 750 75 675 750

2.1 788 79 709 788

2.2 825 83 742 825

2.3 863 86 777 863

2.4 900 90 810 900

2.5 938 94 844 938

2.6 975 98 877 975

2.7 1013 101 912 1013

2.8 1050 105 945 1050

2.9 1088 109 979 1088

3.0 1125 113 1012 1125

3.1 1163 116 1047 1163

3.2 1200 120 1080 1200

3.3 1238 124 1114 1238

1 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 74 123

1.4 525 53 79 132

1.5 563 56 84 140

1.6 600 60 90 150

1.7 638 64 96 160

1.8 675 68 102 170

1.9 713 71 107 178

2.0 750 75 113 188

2.1 788 79 119 198

2.2 825 83 124 207

2.3 863 86 130 216

2.4 900 90 135 225

2.5 938 94 141 235

2.6 975 98 147 245

2.7 1013 101 152 253

2.8 1050 105 158 263

2.9 1088 109 164 273

3.0 1125 113 169 282

3.1 1163 116 175 291

3.2 1200 120 180 300

3.3 1238 124 186 310

4 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 195 244

1.4 525 53 210 263

1.5 563 56 225 281

1.6 600 60 240 300

1.7 638 64 255 319

1.8 675 68 270 338

1.9 713 71 286 357

2.0 750 75 300 375

2.1 788 79 315 394

2.2 825 83 330 413

2.3 863 86 346 432

2.4 900 90 360 450

2.5 938 94 375 469

2.6 975 98 390 488

2.7 1013 101 406 507

2.8 1050 105 420 525

2.9 1088 109 435 544

3.0 1125 113 450 563

3.1 1163 116 466 582

3.2 1200 120 480 600

3.3 1238 124 495 619

2 mg/mL

























WG& MPA






50 8 13 17 50 50100 17 25 33 100 100150 25 38 50 150 150200 33 50 67 200 200250 42 63 83 250 250300 50 75 100 300 300350 58 88 117 350 350400 67 100 133 400 400


100 8 13 17 50 50

150 13 19 25 75 75

200 17 25 33 100 100

250 21 31 42 125 125

300 25 38 50 150 150

350 29 44 58 175 175

400 33 50 67 200 200





100 4 6 8 25 25

150 6 9 13 38 38

200 8 13 17 50 50

250 10 16 21 63 63

300 13 19 25 75 75

350 15 22 29 88 88

400 17 25 33 100 100


WG& MPA


AsK YOUR PATieNT:





Are you pregnant?



Vaccination:

Date:


Description:

Date:
















WG& MPA




WG& MPA




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 439 488

1.4 525 53 427 525

1.5 563 56 507 563

1.6 600 60 540 600

1.7 638 64 574 638

1.8 675 68 607 675

1.9 713 71 642 713

2.0 750 75 675 750

2.1 788 79 709 788

2.2 825 83 742 825

2.3 863 86 777 863

2.4 900 90 810 900

2.5 938 94 844 938

2.6 975 98 877 975

2.7 1013 101 912 1013

2.8 1050 105 945 1050

2.9 1088 109 979 1088

3.0 1125 113 1012 1125

3.1 1163 116 1047 1163

3.2 1200 120 1080 1200

3.3 1238 124 1114 1238

1 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 74 123

1.4 525 53 79 132

1.5 563 56 84 140

1.6 600 60 90 150

1.7 638 64 96 160

1.8 675 68 102 170

1.9 713 71 107 178

2.0 750 75 113 188

2.1 788 79 119 198

2.2 825 83 124 207

2.3 863 86 130 216

2.4 900 90 135 225

2.5 938 94 141 235

2.6 975 98 147 245

2.7 1013 101 152 253

2.8 1050 105 158 263

2.9 1088 109 164 273

3.0 1125 113 169 282

3.1 1163 116 175 291

3.2 1200 120 180 300

3.3 1238 124 186 310

4 mg/mL




(mL*)

Diluent volume†

(mL)


(mL)

1.3 488 49 195 244

1.4 525 53 210 263

1.5 563 56 225 281

1.6 600 60 240 300

1.7 638 64 255 319

1.8 675 68 270 338

1.9 713 71 286 357

2.0 750 75 300 375

2.1 788 79 315 394

2.2 825 83 330 413

2.3 863 86 346 432

2.4 900 90 360 450

2.5 938 94 375 469

2.6 975 98 390 488

2.7 1013 101 406 507

2.8 1050 105 420 525

2.9 1088 109 435 544

3.0 1125 113 450 563

3.1 1163 116 466 582

3.2 1200 120 480 600

3.3 1238 124 495 619

2 mg/mL

























WG& MPA






50 8 13 17 50 50100 17 25 33 100 100150 25 38 50 150 150200 33 50 67 200 200250 42 63 83 250 250300 50 75 100 300 300350 58 88 117 350 350400 67 100 133 400 400


100 8 13 17 50 50

150 13 19 25 75 75

200 17 25 33 100 100

250 21 31 42 125 125

300 25 38 50 150 150

350 29 44 58 175 175

400 33 50 67 200 200





100 4 6 8 25 25

150 6 9 13 38 38

200 8 13 17 50 50

250 10 16 21 63 63

300 13 19 25 75 75

350 15 22 29 88 88

400 17 25 33 100 100


WG& MPA

INDICATION: Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA).

Rituxan is not recommended for treatment of patients with severe active infections.

ImpOrTANT SAfeTy INfOrmATION: Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pmL).

Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.

Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.

For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide.

WG& mpA

© 2012 Genentech USA, Inc., So. San Francisco, CA and Biogen Idec Inc., Cambridge, MA RRA0000762400

CONTACT yOur rHeumATOLOGy CLINICAL COOrDINATOr (rCC) fOr INfuSION AND TrAINING SuppOrTn Call 1-877-317-5179

Monday through Friday, 9 am-8 pm ET

rituxan for WG and mpA

Administration Tear padTHe fIrST AND ONLy fDA-ApprOveD THerApy fOr WeGeNer’S GrANuLOmATOSIS (WG) AND mICrOSCOpIC pOLyANGIITIS (mpA)

INDICATION: Rituxan®

(rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA).Rituxan is not recommended for treatment of patients with severe active infections.ImpOrTANT SAfeTy INfOrmATION: Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (pmL).Other serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including bacterial, fungal, new or reactivated viral infections, and cardiovascular events.Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.For additional safety information, please see full prescribing information, including BOXED WARNINGS and Medication Guide. Attention healthcare provider: provide medication Guide to patient prior to rituxan infusion.For healthcare professional use only. Not to be distributed to patients.

INSIDe: Patient Checklist and Chart Record

Preparation and Administration Checklist

Infusion Flow Sheet

Important Safety Information

WG& mpA

Documents

WG mpA A mpprod.rituxan.gene.s3.amazonaws.com/aav/hcp/assets/WGMPA...ther serious, potentially fatal adverse reactions include hepatitis B reactivation, other infections including