Dosage & Administration
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Rituxan Prescribing Information
Infusion-Related Reactions
RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].
Severe Mucocutaneous Reactions
Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN [see Warnings and Precautions (5.2)].
Hepatitis B Virus (HBV) Reactivation
HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3)].
Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].
Non–Hodgkin's Lymphoma (NHL)
RITUXAN is indicated for the treatment of adult patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with:
- Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.
Chronic Lymphocytic Leukemia (CLL)
RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
Rheumatoid Arthritis (RA)
RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).
Pemphigus Vulgaris (PV)
RITUXAN is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Important Dosing Information
Administer only as an Intravenous Infusion [see Dosage and Administration (2.8)]. Do not administer as an intravenous push or bolus.
RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur [see Warnings and Precautions (5.1)].
Premedicate before each infusion [see Dosage and Administration (2.8)].
Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RITUXAN [see Warnings and Precautions (5.3)]. Obtain complete blood counts (CBC) including platelets prior to the first dose.
During RITUXAN Therapy: In patients with lymphoid malignancies, during treatment with RITUXAN monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RITUXAN course. During treatment with RITUXAN and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias [see Adverse Reactions (6.1)]. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RITUXAN therapy. Continue to monitor for cytopenias after final dose and until resolution.
- First Infusion:
Standard Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
For Pediatric Patients with mature B-cell NHL/B-AL:
Initiate infusion at a rate of 0.5 mg/kg/hr (maximum 50 mg/hr). In the absence of infusion toxicity, increase infusion rate by 0.5 mg/kg/hr every 30 minutes, to a maximum of 400 mg/hr. - Subsequent Infusions: Standard Infusion: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr.
For Previously Untreated Follicular NHL and DLBCL adult patients:
If patients did not experience a Grade 3 or 4 infusion-related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen.
Initiate at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5,000/mm3 before Cycle 2 should not be administered the 90-minute infusion [see Clinical Studies (14.4)].
For Pediatric Patients with mature B-cell NHL/B-AL:
Initiate infusion rate of 1 mg/kg/hr (maximum 50 mg/hr). In the absence of infusion toxicity, increase rate by 1 mg/kg/hr every 30 minutes, to a maximum of 400 mg/hr. - Interrupt the infusion or slow the infusion rate for infusion-related reactions [see Boxed Warning, Warnings and Precautions (5.1)]. Continue the infusion at one-half the previous rate upon improvement of symptoms.
Recommended Dose for Non-Hodgkin's Lymphoma (NHL)
The recommended dose is 375 mg/m2 as an intravenous infusion according to the following schedules:
- Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses. - Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 doses. - Previously Untreated, Follicular, CD20-Positive, B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 doses. In patients with complete or partial response, initiate RITUXAN maintenance eight weeks following completion of a rituximab product in combination with chemotherapy. Administer RITUXAN as a single-agent every 8 weeks for 12 doses. - Non-progressing, Low-Grade, CD20-Positive, B-Cell NHL, after first-line CVP chemotherapy
Following completion of 6–8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses. - Diffuse Large B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions. - Pediatric patients aged 6 months and older with previously untreated mature B-cell NHL/B-AL
RITUXAN is given in combination with systemic Lymphome Malin B (LMB) chemotherapy. In total, six infusions of RITUXAN are given, two doses during each of the induction courses, COPDAM1 and COPDAM2, and one dose during each of the two consolidation courses of CYM/CYVE (for details see Table 1).
| Cycle | Day of treatment | Administration details |
|---|---|---|
| COP = Cyclophosphamide, Oncovin (vincristine), Prednisone; COPDAM = Cyclophosphamide, Oncovin (vincristine), Prednisolone, Adriamycin (doxorubicin), Methotrexate; CYM = CYtarabine (Aracytine, Ara-C), Methotrexate; CYVE = CYtarabine (Aracytine, Ara-C), VEposide (VP16) | ||
| Prephase (COP) | No RITUXAN given | - |
| Induction courses 1 and 2 (COPDAM1 and COPDAM2) | Day -2 1st and 3rd RITUXAN infusions | During the 1st induction course, prednisone is given as part of the chemotherapy course, and should be administered prior to RITUXAN. |
| Day 1 2nd and 4th RITUXAN infusions | RITUXAN will be given 48 hours after the first infusion of RITUXAN. | |
| Consolidation courses 1 and 2 (CYM/CYVE) | Day 1 5th and 6th RITUXAN infusions | - |
Recommended Dose for Chronic Lymphocytic Leukemia (CLL)
The recommended dose is 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2–6 (every 28 days).
Recommended Dose as a Component of Zevalin® for treatment of NHL
- When used as part of the Zevalin therapeutic regimen, infuse 250 mg/m2 in accordance with the Zevalin package insert. Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.
Recommended Dose for Rheumatoid Arthritis (RA)
- Administer RITUXAN as two-1,000 mg intravenous infusions separated by 2 weeks.
- Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion-related reactions.
- Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks.
- RITUXAN is given in combination with methotrexate.
Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Induction Treatment of Adult Patients with Active GPA/MPA
- Administer RITUXAN as a 375 mg/m2 intravenous infusion once weekly for 4 weeks for patients with active GPA or MPA.
- Glucocorticoids administered as methylprednisolone 1,000 mg intravenously per day for 1 to 3 days followed by oral prednisone as per clinical practice. This regimen should begin within 14 days prior to or with the initiation of RITUXAN and may continue during and after the 4 week induction course of RITUXAN treatment.
Follow up Treatment of Adult Patients with GPA/MPA who have achieved disease control with induction treatment
- Administer RITUXAN as two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.
- If induction treatment of active disease was with a rituximab product, initiate follow up treatment with RITUXAN within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product.
- If induction treatment of active disease was with other standard of care immunosuppressants, initiate RITUXAN follow up treatment within the 4 week period that follows achievement of disease control.
Induction treatment of Pediatric Patients with Active GPA/MPA
- Administer RITUXAN as a 375 mg/m2 intravenous infusion once weekly for 4 weeks.
- Prior to the first RITUXAN infusion, administer intravenous methylprednisolone 30 mg/kg (not to exceed 1g/day) once daily for 3 days.
- Following intravenous methylprednisolone administration, oral steroids should be continued per clinical practice.
Follow up Treatment of Pediatric Patients with GPA/MPA who have achieved disease control with induction treatment
- Administer RITUXAN as two 250 mg/m2 intravenous infusions separated by two weeks, followed by a 250 mg/m2 intravenous infusion every 6 months thereafter based on clinical evaluation.
- If induction treatment of active disease was with a rituximab product, initiate follow up treatment with RITUXAN within 24 weeks after the last induction infusion with a rituximab product or based on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product.
- If induction treatment of active disease was with other standard of care immunosuppressants, initiate RITUXAN follow up treatment within the 4 week period following achievement of disease control.
Recommended Dose for Pemphigus Vulgaris (PV)
- Administer RITUXAN as two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids.
- Maintenance treatment
Administer RITUXAN as a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation. - Treatment of relapse
Administer RITUXAN as a 1,000 mg intravenous infusion on relapse, and consider resuming or increasing the glucocorticoid dose based on clinical evaluation.
Subsequent infusions of RITUXAN may be administered no sooner than 16 weeks following the previous infusion.
Recommended Dose for Premedication and Prophylactic Medications
Premedicate with acetaminophen and an antihistamine before each infusion of RITUXAN. For adult patients administered RITUXAN according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies (14.4)].
For pediatric patients with mature B-cell NHL/B-AL, premedication with acetaminophen and H1 antihistamine (diphenhydramine or equivalent) should be administered 30 to 60 minutes before the start of each RITUXAN intravenous infusion.
For RA, GPA and MPA, and PV patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion.
Provide prophylaxis treatment for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate [see Warnings and Precautions (5.6)].
PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last RITUXAN infusion.
PCP prophylaxis should be considered for patients with PV during and following RITUXAN treatment.
Administration and Storage
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. RITUXAN should be a clear, colorless liquid. Do not use vial if particulates or discoloration is present.
Administration
Use a sterile needle and syringe to prepare RITUXAN. Withdraw the necessary amount of RITUXAN and dilute to a final concentration of 1 mg/mL to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. Gently invert the bag to mix the solution. Do not mix or dilute with other drugs. Discard any unused portion left in the vial.
Storage
Diluted RITUXAN solutions for infusion may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours. Diluted RITUXAN solutions for infusion have been shown to be stable for an additional 24 hours at room temperature. However, since RITUXAN solutions do not contain a preservative, diluted solutions should be stored refrigerated (2°C to 8°C). No incompatibilities between RITUXAN and polyvinylchloride or polyethylene bags have been observed.
Injection: RITUXAN is a colorless, clear solution for intravenous infusion:
- 100 mg/10 mL (10 mg/mL) in a single-dose vial
- 500 mg/50 mL (10 mg/mL) in a single-dose vial
Pregnancy
Risk Summary
Based on human data, RITUXAN can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to RITUXAN in-utero (see Clinical Considerations). In animal reproduction studies, intravenous administration of rituximab to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Advise pregnant women of the risk to a fetus.
Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated populations is unknown. The estimated background risk in the U.S. general population of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Observe newborns and infants for signs of infection and manage accordingly.
Data
Human data
Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. Rituximab was detected postnatally in the serum of infants exposed in-utero.
Animal Data
An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). Rituximab was administered as loading doses on post coitum (PC) Days 20, 21 and 22, at 15, 37.5 or 75 mg/kg/day, and then weekly on PC Days 29, 36, 43 and 50, at 20, 50 or 100 mg/kg/week. The 100 mg/kg/week dose resulted in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Rituximab crosses the monkey placenta. Exposed offspring did not exhibit any teratogenic effects but did have decreased lymphoid tissue B cells.
A subsequent pre-and postnatal reproductive toxicity study in cynomolgus monkeys was completed to assess developmental effects including the recovery of B cells and immune function in infants exposed to rituximab in utero. Animals were treated with a loading dose of 0, 15, or 75 mg/kg every day for 3 days, followed by weekly dosing with 0, 20, or 100 mg/kg dose. Subsets of pregnant females were treated from PC Day 20 through postpartum Day 78, PC Day 76 through PC Day 134, and from PC Day 132 through delivery and postpartum Day 28. Regardless of the timing of treatment, decreased B cells and immunosuppression were noted in the offspring of rituximab-treated pregnant animals. The B-cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum.
Lactation
There are limited data on the presence of rituximab in human milk and the effect on the breastfed child, and there are no data on the effect on milk production. Rituximab is detected in the milk of lactating cynomolgus monkeys, and maternal IgG is present in human breast milk. Rituximab has also been reported to be excreted at low concentrations in human breast milk. Given that the clinical significance of this finding for children is not known, advise women not to breastfeed during treatment with RITUXAN and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children.
Females and Males of Reproductive Potential
RITUXAN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating RITUXAN.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with RITUXAN and for 12 months after the last dose.
Pediatric Use
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
RITUXAN is indicated for the treatment of GPA and MPA in pediatric patients 2 years of age and older with GPA and MPA. RITUXAN is not indicated in pediatric patients less than 2 years of age with GPA or MPA.
The use of RITUXAN for the treatment of pediatric patients with GPA and MPA 6 years of age and older is supported by evidence from adequate and well-controlled studies of RITUXAN in adults with GPA and MPA; a trial in pediatric patients 6 years of age and older with active GPA and MPA; and population pharmacokinetic (PK) analyses showing similar drug exposure levels in adults and pediatric patients 6 years to 17 years of age. The use of RITUXAN for the treatment of pediatric patients with GPA and MPA ages 2 to less than 6 years of age is supported by PK modeling in patients 2 years of age and older and safety data from pediatric patients less than 6 years of age treated with rituximab.
The pediatric trial was a multicenter, open-label, single arm study (GPA/MPA Study 4) to evaluate the safety, PK and exploratory efficacy of RITUXAN or non-U.S.-licensed rituximab in 25 pediatric patients (6 patients 6 years to less than 12 years of age and 19 patients 12 years to 17 years of age) with active GPA and MPA over a 6-month remission induction phase and minimum 12-month follow-up phase, up to 54 months [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.7)].
Mature B-Cell NHL/B-AL
The safety and effectiveness of RITUXAN in combination with chemotherapy for the treatment of previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL have been established in pediatric patients aged 6 months and older. Use of RITUXAN for this indication is supported by evidence from an adequate and well-controlled study in pediatric patients aged 1 year and older on the basis that the course of advanced disease is expected to be similar between pediatric patients aged 6 months to less than 1 year to that of pediatric patients aged 1 year and older to allow extrapolation of data to younger pediatric patients and use pharmacokinetic modeling [see Clinical Pharmacology (12.3), Clinical Studies (14.2)]. Patients younger than 3 years had a higher incidence of infections compared to patients 3 years and older [see Adverse Reactions (6.1)].
The safety and effectiveness of RITUXAN in combination with chemotherapy for previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL have not been established in pediatric patients less than 6 months of age.
The safety and effectiveness of RITUXAN have not been established in pediatric patients with CLL.
Rheumatoid Arthritis and Pemphigus Vulgaris
The safety and effectiveness of RITUXAN have not been established in pediatric patients with PV or RA.
RITUXAN was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (PJIA) due to concerns regarding the potential for prolonged immunosuppression as a result of B-cell depletion in the developing juvenile immune system.
Geriatric Use
Diffuse Large B-Cell NHL
Among patients with DLBCL evaluated in three randomized, active-controlled trials, 927 patients received RITUXAN in combination with chemotherapy. Of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. No overall differences in effectiveness were observed between these patients and younger patients. Cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. Serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis.
Low-Grade or Follicular Non-Hodgkin's Lymphoma
Patients with previously untreated follicular NHL evaluated in NHL Study 5 were randomized to RITUXAN as single-agent maintenance therapy (n=505) or observation (n=513) after achieving a response to RITUXAN in combination with chemotherapy. Of these, 123 (24%) patients in the RITUXAN arm were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other clinical studies of RITUXAN in low-grade or follicular, CD20-positive, B-cell NHL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.
Chronic Lymphocytic Leukemia
Among patients with CLL evaluated in two randomized active-controlled trials, 243 of 676 RITUXAN-treated patients (36%) were 65 years of age or older; of these, 100 RITUXAN-treated patients (15%) were 70 years of age or older.
In exploratory analyses defined by age, there was no observed benefit from the addition of RITUXAN to fludarabine and cyclophosphamide among patients 70 years of age or older in CLL Study 1 or in CLL Study 2; there was also no observed benefit from the addition of RITUXAN to fludarabine and cyclophosphamide among patients 65 years of age or older in CLL Study 2 [see Clinical Studies (14.5)]. Patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of RITUXAN. In CLL Study 1, the dose intensity of RITUXAN was similar in older and younger patients, however in CLL Study 2 older patients received a lower dose intensity of RITUXAN.
The incidence of Grade 3 and 4 adverse reactions was higher among patients receiving R-FC who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (CLL Study 1); 56% vs. 39% (CLL Study 2)], febrile neutropenia [16% vs. 6% (NHL Study 10 (NCT00719472)], anemia [5% vs. 2% (CLL Study 1); 21% vs. 10% (CLL Study 2)], thrombocytopenia [19% vs. 8% (CLL Study 2)], pancytopenia [7% vs. 2% (CLL Study 1); 7% vs. 2% (CLL Study 2)] and infections [30% vs. 14% (CLL Study 2)].
Rheumatoid Arthritis
Among the 2578 patients in global RA studies completed to date, 12% were 65–75 years old and 2% were 75 years old and older. The incidences of adverse reactions were similar between older and younger patients. The rates of serious adverse reactions, including serious infections, malignancies, and cardiovascular events were higher in older patients.
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis
Of the 99 RITUXAN-treated GPA and MPA patients in GPA/MPA Study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. No overall differences in efficacy were observed between patients that were 65 years old and over and younger patients. The overall incidence and rate of all serious adverse events was higher in patients 65 years old and over. The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.
In GPA/MPA Study 2, 30 (26%) of the enrolled patients were at least 65 years old, of which 12 patients were exposed to non-U.S.-licensed rituximab and 18 were exposed to azathioprine. The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects.
Pemphigus Vulgaris
Of the 46 patients treated with non-U.S.-licensed rituximab, 15 (33%) patients were 65 years of age and older. The clinical study did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
None.