#高警訊藥品

慢性淋巴球性白血病、肉芽腫性血管炎及顯微多發性血管炎、非何杰金氏淋巴瘤、類風濕性關節炎
Chronic lymphocytic leukemia (CLL): Previously untreated or treated CD20-positive CLL in adults (in combination with fludarabine and cyclophosphamide)
Granulomatosis with polyangiitis and Microscopic polyangiitis: Treatment of polyangiitis (in combination with glucocorticoids) in adults and pediatric patients ≥2 years of age
Non-Hodgkin lymphomas (NHL): Treatment of CD20-positive NHL
1. In adults with relapsed or refractory B-cell NHL (as a single agent)
2. In adults with follicular B-cell NHL, previously untreated (in combination with first-line chemotherapy, and as single-agent maintenance therapy in patients achieving a complete or partial response to rituximab with chemotherapy)
3. In adults with nonprogressing, low-grade B-cell NHL (as a single agent after first-line cyclophosphamide, vincristine, and prednisone)
4. In adults with diffuse large B-cell NHL, previously untreated (in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or other anthracycline-based regimen)
5. In pediatric patients ≥6 months with previously untreated, advanced stage diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia (in combination with chemotherapy)
Rheumatoid arthritis (RA): Treatment of moderately to severely active RA (in combination with methotrexate) in adults with inadequate response to one or more tumor necrosis factor-antagonist therapies.

Antineoplastic Agent, Anti-CD20 Monoclonal Antibody
CD20 regulates cell cycle initiation; and, possibly, functions as a calcium channel. Rituximab binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.

Non-Hodgkin lymphomas:
1. Onset: Within 3 weeks
2. Duration: B-cell depletion is sustained for up to 6 to 9 months and B-cell recovery begins ~6 months following completion of treatment
3. Median terminal half-life: 22 days
Rheumatoid arthritis:
1. Onset: Within 2 weeks
2. Duration: B-cell depletion persists for at least 6 months
3. Distribution: 3.1 L
4. Mean terminal half-life: 18 days
5. Clearance: 0.335 L/day
Polyangiitis:
1. Distribution: (Children 6-17 y/o) 2.28 L; (Adults) 3.12 L
2. Half-life elimination: (Children 6-17 y/o) 22 days; (Adults) 25 days
3. Clearance: (Children 6-17 y/o) 0.222 L/day; (Adults) 0.279 L/day
Chronic lymphocytic leukemia:
1. Half-life elimination: 32 days

Type 1 hypersensitivity or anaphylactic reaction to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or any component of the formulation.

C

It is not known whether rituximab is distributed into milk in humans.

Fever, fatigue, chills, headache, nausea, vomiting, angioedema, insomnia, pain, Peripheral edema, lymphopenia, leucopenia, neutropenia, thrombocytopenia, anemia, Infusion-related reactions

Chronic lymphocytic leukemia (CLL):
375 mg/m2 on the day prior to fludarabine/cyclophosphamide in cycle 1, then 500 mg/m2 on day 1 (every 28 days) of cycles 2 to 6 (in combination with fludarabine and cyclophosphamide)
Granulomatosis with polyangiitis and Microscopic polyangiitis:
1. Induction therapy: IV 375 mg/m2 once weekly for 4 doses; for either dosing regimen, administer in combination with a systemic glucocorticoid.
2. Maintenance therapy: IV 500 mg once every 2 weeks for 2 doses, then 500 mg or 1 g once every 4 to 6 months.
Non-Hodgkin lymphomas (NHL):
1. Diffuse large B-cell, previously untreated: 375 mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses (in combination with CHOP).
2. Follicular, CD20-positive, B-cell, previously untreated: 375 mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses (in combination with first-line chemotherapy).
3. Nonprogressing, low-grade, CD20-positive, B-cell, after 6 to 8 cycles of first-line CVP are completed: 375 mg/m2 once weekly for 4 doses every 6 months for a maximum of 16 doses.
4. Relapsed/Refractory, low-grade or follicular CD20-positive, B-cell: 375 mg/m2 once weekly for 4 or 8 doses (as a single agent); Re-treatment following disease progression: 375 mg/m2 once weekly for 4 doses.
Rheumatoid arthritis (RA):
Initial 1 g once every 2 weeks for 2 doses; subsequent courses of 1 g once every 2 weeks for 2 doses may be administered every 24 weeks or as indicated based on clinical evaluation, but no sooner than every 16 weeks.

1. Renal impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling.
2. Renal toxicity during treatment: Discontinue rituximab with increasing serum creatinine or oliguria.

There are no dosage adjustments provided in the manufacturer's labeling.

Rituximab solutions for infusion are stable for 24 hours at 2-8℃ and an additional 24 hours at room temperature.