INDICATIONS AND USAGE（适应症）

Non–Hodgkin's Lymphoma (NHL)

RITUXAN (rituximab) 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.

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.

DOSAGE（服用剂量）

Important Dosing Information

Administer only as an Intravenous Infusion.

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.

Premedicate before each infusion.

Prior to First Infusion: Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RITUXAN. 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. 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: 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.

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 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 ≥5,000/mm3 before Cycle 2 should not be administered the 90-minute infusion.

Interrupt the infusion or slow the infusion rate for infusion-related reactions. 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.

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.

ADVERSE REACTIONS（不良反应）

Infusion-related reactions

Severe mucocutaneous reactions

Hepatitis B reactivation with fulminant hepatitis

Progressive multifocal leukoencephalopathy

Tumor lysis syndrome

Infections

Cardiovascular adverse reactions

Renal toxicity

Bowel obstruction and perforation

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b172773b-3905-4a1c-ad95-bab4b6126563/spl-doc?hl=rituximab

Ristovainformation