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Erbitux [爾必得舒]

2013-10-09 16:06:18 来源: 作者: 【大中小】浏览:835次评论:0条

See related Erbitux soln for infusion[爾必得舒注射液] information

製造商

Merck Serono

代理/經銷商

Merck Serono

成份

Cetuximab

適應症

In combination with Folinic acid/5-FU/Irinotecan for the 1st-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer. In combination with radiation therapy for the treatment of locally advanced squamous cell cancer of the head & neck (oropharynx, hypopharynx, larynx). In combination with platinum-based chemotherapy for recurrent &/or metastatic squamous cell cancer of the head & neck.

用量

Prior to infusion, patients must receive premedication with an antihistamine & a corticosteroid. Initial dose: 400 mg/m² once weekly with infusion period of 120 mins. Subsequent doses: 250 mg/m² once weekly with infusion period of 60 mins. Max infusion rate must not exceed 10 mg/min. Colorectal cancer Same dose of irinotecan is administered in the last cycles of the prior irinotecan-containing regimen. Irinotecan must not be administered earlier than 1 hr after the end of Erbitux infusion. Squamous cell cancer of the head & neck Locally advanced squamous cell cancer of the head & neck: Start Erbitux therapy 1 week before radiation therapy & to continue until the end of the radiation therapy period. Recurrent &/or metastatic squamous cell cancer of the head & neck: Used in combination with platinum-based chemotherapy followed by Erbitux as maintenance therapy until disease progression. Chemotherapy must not be administered earlier than 1 hr after the end of the Erbitux infusion.

過量

View Erbitux[爾必得舒] 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

Known severe (grade 3 or 4; NCI-CTC) hypersensitivity reactions to cetuximab.

注意事項

Monitor for infusion-related reactions. Patient with reduced performance status & pre-existing cardiopulmonary disease. Discontinue if interstitial lung disease is diagnosed. Interrupt treatment in case of severe skin reactions (grade 3; NCI-CTC). Monitor serum electrolyte levels. Combination with platinum-based chemotherapy increases risk of severe neutropenia which may lead to infectious complications eg febrile neutropenia, pneumonia or sepsis. Should not be used in treatment fo colorectal cancer patients whose tumours have KRAS mutations or for whom KRAS tumour status is not unknown. Pregnancy & lactation.

不良反應

Mild or moderate infusion-related reactions eg fever, chills, dizziness or dyspnea; mild to moderate mucositis, increase in liver enzyme levels; skin reactions mainly as acne-like rash; headache; conjunctivitis; diarrhea, nausea, vomiting; dehydration, hypocalcemia, anorexia; fatigue.
View ADR Monitoring Website[參閱藥物不良反應監測表格]

交互作用

[Click for Erbitux[爾必得舒] detailed prescribing infomation]
View more drug interactions with Erbitux[爾必得舒]

使用上注意

For caution against possible variation of physical aspect of medicine... click to view Erbitux[爾必得舒] detailed prescribing infomation

儲存

View Erbitux[爾必得舒] storage conditions for details to ensure optimal shelf-life.

描述

View Erbitux[爾必得舒] description for details of the chemical structure and excipients (inactive components).

作用

View Erbitux[爾必得舒] mechanism of action for pharmacodynamics and pharmacokinetics details.

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劑型