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Bevalast

Bevalast Dosage/Direction for Use

bevacizumab

Manufacturer:

BIOCAD

Distributor:

Qualimed
Full Prescribing Info
Dosage/Direction for Use
Bevacizumab must be administered under the supervision of a physician, experienced in the use of antineoplastic medicinal products.
Dosage: Metastatic carcinoma of the colon or rectum (mCRC): The recommended dose of Bevacizumab, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Metastatic breast cancer (mBC): The recommended dose of Bevacizumab is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Non-small cell lung cancer (NSCLC): First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy: Bevacizumab is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Bevacizumab as a single agent until disease progression.
The recommended dose of Bevacizumab is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib: EGFR mutation testing should be performed prior to initiation of treatment with the combination of Bevacizumab and erlotinib. It is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
The recommended dose of Bevacizumab when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that the treatment with Bevacizumab in addition to erlotinib is continued until disease progression.
For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
Advanced and/or metastatic renal cell cancer (mRCC): The recommended dose of Bevacizumab is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Epithelial ovarian, fallopian tube and primary peritoneal cancer: Front-line treatment: Bevacizumab is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Bevacizumab as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier. The recommended dose of Bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Treatment of platinum-sensitive recurrent disease: Bevacizumab is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of Bevacizumab as single agent until disease progression. The recommended dose of Bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Treatment of platinum-resistant recurrent disease: Bevacizumab is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin. The recommended dose of Bevacizumab is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. When Bevacizumab is administered in combination with topotecan (given on days 1-5, every 3 weeks), the recommended dose of Bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. It is recommended that treatment be continued until disease progression or unacceptable toxicity.
Cervical Cancer: Bevacizumab is administered in combination with one of the following chemotherapy regimens: paclitaxel and cis-platin or paclitaxel and topotecan.
The recommended dose of Bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Special populations: Elderly patients: No dose adjustment is required in the patients ≥65 years of age.
Patients with renal impairment: The safety and efficacy have not been studied in patients with renal impairment.
Patients with hepatic impairment: The safety and efficacy have not been studied in patients with hepatic impairment.
Paediatric population: The safety and efficacy of bevacizumab in children aged less than 18 years old have not been established.
There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Dose reduction for adverse reactions is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended.
Method of administration: The initial dose should be delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
It should not be administered as an intravenous push or bolus.
Dose reduction for adverse reactions is not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended.
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