Brand Name: Abevmy
®
Generic name: Bevacizumab for Injection
SKU: 100 mg/ 440 mg
How supplied: Vial
Storage Conditions (As per PI): Store vials at 2°C–8°C. Keep out of reach of children. Keep vial in the outer carton in order to protect from light.
Abbreviated prescribed information:
Each Abevmy
® 100 mg in 4 ml vial contains 100 mg and each Abevmy
® 400 mg in 16 ml vial contains 400 mg of bevacizumab concentrate for solution for IV infusion.
Indications:
Metastatic carcinoma of the colon or rectum: Treatment of adult patients with metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine-based chemotherapy.
Non-squamous Non-small Cell Lung Cancer (NSCLC): First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy and for first-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib.
Glioblastoma: As a single agent for adult patients with progressive disease following prior therapy.
Advanced and/or metastatic renal cell cancer (mRCC): First-line treatment in combination with interferon alpha-2a of adult patients with advanced and/or metastatic renal cell cancer. Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: Front-line treatment in combination with carboplatin and paclitaxel of adult patients. Treatment in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by use as a single agent for adult patients with platinum-sensitive recurrent cancer who have not received prior therapy with bevacizumab, other VEGF inhibitors, or VEGF receptor–targeted agents. Treatment in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin of adult patients with platinum-resistant recurrent cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab, other VEGF inhibitors, or VEGF receptor–targeted agents.
Metastatic carcinoma of the cervix: Treatment of persistent, recurrent, or metastatic carcinoma of the cervix in adult patients, in combination with paclitaxel and cisplatin; or, alternatively, paclitaxel and topotecan for those who cannot receive platinum therapy.
Dosage and Administration: Deliver the initial bevacizumab dose as an IV infusion, over 90 minutes. The second infusion can be administered over 60 minutes, if the first is well tolerated; and subsequent infusions can be administered over 30 minutes, if infusion over 60 minutes is tolerated.
Metastatic Colorectal Cancer (mCRC): The recommended dose of bevacizumab, administered as an IV, 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.
NSCLC: 15 mg/kg of body weight given once every 3 weeks.
Glioblastoma: 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.
mRCC: 10 mg/kg of body weight given as an IV infusion once every 2 weeks, in combination with interferon alpha.
Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: Front line: 15 mg/kg of body weight given once every 3 weeks up to six cycles of treatment; thereafter, continue bevacizumab as a single agent for 15 months or until disease progression, whichever occurs earlier. For recurrent ovarian cancer 15 mg/kg of bodyweight given once every 3 weeks. Metastatic carcinoma of the cervix: 15 mg/kg of body weight given once every 3 weeks. For majority of the indications, continue bevacizumab treatment until progression of the underlying disease or unacceptable toxicity.
Disclaimer: For more details refer to full prescribing information leaflet.