藥品異動通知2024.01.04

藥理作用/作用機轉

Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes. 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. B-cells are believed to play a role in the development and progression of rheumatoid arthritis. Signs and symptoms of rheumatoid arthritis are reduced by targeting B-cells and the progression of structural damage is delayed.

適應症/

劑量

IV,

【Adult】

　●Chronic lymphoid leukemia: 375 mg/m2 on the day prior to fludarabine/cyclophosphamide in cycle 1, then 500 mg/m2 on day 1 Q4W of cycles 2 to 6.

　●Granulomatosis with polyangiitis (GPA; Wegener granulomatosis), Microscopic polyangiitis (MPA): 375 mg/m2 once weekly for 4 doses (in combination with methylprednisolone IV for 1 to 3 days followed by daily prednisone)

　●Non-Hodgkin lymphoma (NHL; relapsed/refractory, low-grade or follicular CD20-positive , B-cell):

　　* Single agent: 375 mg/m2 once weekly for 4 or 8 doses.

　　* Re-treatment following disease progression: 375 mg/m2 once weekly for 4 doses.

　　* Maintenance therapy (as a single agent, in patients with response to induction therapy ): 375 mg/m2 every 3 months until disease progression or maximum duration of 2 years.

　●NHL (diffuse large B-cell): 375 mg/m2 on day 1 of each chemotherapy cycle for up to 8 doses (in combination with CHOP or other anthracycline-based regimen).

　●NHL (follicular, CD20-positive, B-cell, previously untreated):

　　* Combination with first-line chemotherapy: 375 mg/m2 given on day 1 of each chemotherapy cycle for up to 8 doses.

　　* Maintenance therapy (as a single agent, in patients with partial or complete response; begin 8 weeks after completion of rituximab in combination with chemotherapy): IV: 375 mg/m2 once Q8W for 12 doses.

　●NHL (nonprogressing, low-grade, CD20-positive, B-cell, after 6 to 8 cycles of first line CVP are completed): IV: 375 mg/m2 once weekly for 4 doses every 6 months for a maximum of 16 doses (as a single agent).

　●NHL: Combination therapy with ibritumomab: IV: 250 mg/m2 IV day 1; repeat in 7 to 9 days with ibritumomab.

　●Rheumatoid arthritis:1000 mg on days 1 and 15 (in combination with MTX); subsequent courses may be administered every 24 weeks (based on clinical evaluation), if necessary may be repeated no sooner than every 16 weeks

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to rituximab products.

警告/預防

Bowel obstruction/perforation, Cytopenias, Renal toxicity, Tumor lysis syndrome

不良反應

【>10%】 Peripheral edema, HTN, fatigue, chills, neuropathy, headache, insomnia, pain, skin rash, pruritus, night sweats, weight gain , nausea, diarrhea, lymphocytopenia, myelosuppression, cytopenia, increased ALT, angioedema, antibody development, infection, weakness, muscle spasm, arthralgia, cough, rhinitis, epistaxis, infusion related reaction, fever

【1%-10%】Hypotension, flushing, dizziness, anxiety, migraine, paresthesia, urticaria, hyperglycemia, increased lactate dehydrogenase, vomiting, dyspepsia, viral infection, fungal infection, myalgia

【<1%】Not referred here, please see package insert or other references.

懷孕用藥分級(FDA)

C /避免使用，除非有治療必要

健保規範

• 藥品說明：

• 藥品理由：

比照10R008.10R024

其他

Premedicate before each infusion with acetaminophen and an antihistamine, consider TLS prophylaxis in patients at high-risk.

premedication: administer a glucocorticoid 30 min prior to each infusion (such as methylprednisolone 100 mg IV or its equivalent) and with acetaminophen and an antihistamine.

核對用法: IV滴 (50-400mg/hr)

首次輸注:50mg/hr為起始

以N/S或D5W稀釋成 1~4mg/ml

原瓶冷藏2-8℃可保存至有效期.

泡製後冷藏2-8℃可保存24小時.

泡製後25℃可保存12小時.