|
全民健康保險藥品給付規定 / 健保碼及健保價 |
|
See related Mabthera inj[莫須瘤 注射劑] information |
|
|
|
製造商 |
Roche |
|
代理/經銷商 |
Roche |
|
成份 |
Rituximab |
|
適應症 |
Treatment relapsed or chemoresistant indolent B-cell non-Hodgkin's lymphoma. In combination with CHOP or other chemotherapy agents in the treatment of diffuse large B-cell lymphoma patients. In combination with CVP chemotherapy agents in the untreated advanced follicular B-cell non-Hodgkin's lymphoma. Treatment of follicular lymphoma as maintenance treatment, after response to induction therapy. In combination with methotrexate for treatment of adults with active RA who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies. 1st-line treatment of chronic lymphocytic leukaemia (CLL) with Binet C or Binet A/B but with Richter's syndrome. |
|
用量 |
Low grade or follicular non-Hodgkin's lymphoma Monotherapy: Adult 375 mg/m2 by IV infusion once weekly for 4 weeks. Combination therapy wth CVP (Cyclophosphamide, vincristine, prednisolone): 375 mg/m2 for 8 cycles (21 days/cycle) on day 1 of each chemotherapy cycle, after IV administration of the glucocorticoid component of chemotherapy. Retreatment for relapse: 375 mg/m2 by IV infusion once weekly for 4 weeks. Maintenance for those who responsed to induction therapy: 375 mg/m2 once every 3 months until disease progression or for a max period of 2 years. Diffuse large B-cell NHL in combination with CHOP (cyclophosphamide, doxorubicin, prednisone, vincristine) chemotherapy 375 mg/m2 for 8 cycles on day 1 of each chemotherapy cycle, after IV infusion of the glucocorticoid component of CHOP. The other components of CHOP should be given after MabThera administration. CLL Prophylaxis with adequate hydration & administration of uricostatics starting 48 hr prior to start of therapy. For patients whose lymphocyte counts are > 25 x 109/L, administer prednisone/prednisolone 100 mg intravenous shortly before infusion with MabThera. In combination with chemotherapy: 375 mg/m2 on day 1 of 1st chemotherapy cycle, followed by 500 mg/m2 on day 1 of each subsequent cycle for 6 cycles in total. RA 500-1,000 mg IV infusion, followed by 500-1,000 mg IV infusion 2 weeks later. 100 mg methylprednisolone should be infused 30 mins prior administration of MabThera. 1st infusion of each course: initial rate is 50 mg/hr; after the first 30 mins, it can be escalated in 50 mg/hr increments every 30 mins, to max 400 mg/hr. 2nd infusion of each course: subsequent doses can be infused at initial rate of 100 mg/hr, & increased by 100 mg/hr increments at 30-mins intervals, to max 400 mg/hr. |
|
過量 |
View Mabthera[莫須瘤] overdosage for action to be taken in the event of an overdose. |
|
美國食品藥物管理局之懷孕等級 |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
|
禁忌 |
Hypersensitivity to rituximab or murine proteins. Pregnancy, lactation. |
|
注意事項 |
High number (> 25 x 109/L) of circulating malignant cells or high tumour burden who may be at higher risk of severe infusion-related reactions. History of pulmonary insufficiency or pulmonary tumour infiltration. History of cardiac disease. Neutrophil count < 1.5 x 109/L &/or platelet count < 75 x 109/L. History of hepatitis B infection. Use of vaccines. Progressive multifocal leukoencephalopathy. Withholding antihypertensives 12 hr prior administration as hypotension may occur. Should not be administered in active infection or severely immunocompromized patient. Women of childbearing age should employ effective contraception during & for up to 12 months post-treatment. |
|
不良反應 |
Bacterial or viral infections, neutropenia, leucopenia, angioedema, nausea, pruritis, rash, fever, chills, asthenia, headache, decreased IgG levels. Sepsis, pneumonia, febrile infection, herpes zoster, respiratory tract infection, fungal infections, infections of unknown aetiology; anemia, thrombocytopenia; hypersensitivity; hyperglycemia, weight decrease, peripheral edema, face edema, increased LDH, hypocalcemia; paresthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety; lacrimation disorder, conjunctivitis; tinnitus, ear pain; cardiac disorders; HTN, orthostatic hypotension, hypotension; bronchospasm, respiratory disease, chest pain, dyspnea, cough, rhinitis; GI disturbances; urticaria, alopecia, sweating, night sweats; hypertonia, myalgia, arthralgia, back pain, neck pain, pain; tumour pain, flushing, malaise, cold syndrome.
View ADR Monitoring Website[參閱藥物不良反應監測表格] |
|
交互作用 |
[Click for Mabthera[莫須瘤] detailed prescribing infomation]
View more drug interactions with Mabthera[莫須瘤] |
|
使用上注意 |
For caution against possible variation of physical aspect of medicine... click to view Mabthera[莫須瘤] detailed prescribing infomation |
|
儲存 |
View Mabthera[莫須瘤] storage conditions for details to ensure optimal shelf-life. |
|
描述 |
View Mabthera[莫須瘤] description for details of the chemical structure and excipients (inactive components). |
|
作用 |
View Mabthera[莫須瘤] mechanism of action for pharmacodynamics and pharmacokinetics details. |
|
本商品之市售規格 |
|
劑型 |
包裝 |
圖片 |
|
Mabthera 注射劑 |
|
Mabthera 10 mg/1 mL x 10 mL |
|
Mabthera 10 mg/1 mL x 50 mL |
|
|
|
Manufacturer: |
Roche |
|
Distributor: |
Roche
|
|
|
|
