Generic Name and Formulations:
Bevacizumab 100mg, 400mg; per vial; soln for IV infusion after dilution; preservative-free.
Company:
Genentech, Inc.
| 02/21/13 |
| Added second-line treatment of metastatic colorectal cancer to Indications. |
Metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.
Give by IV infusion after chemotherapy. Infuse 1st dose over 90 minutes; if tolerated, infuse 2nd dose over 60 minutes, and subsequent doses over 30 minutes. 10mg/kg every 2 weeks with interferon alfa.
Not established.
Angiogenesis inhibitor.
Do not start therapy before or for at least 28 days after surgery; allow surgical incisions to completely heal (see full lableing). History of hemoptysis of ≥½ teaspoon of red blood: do not administer. Discontinue if GI perforation, significant wound dehiscence, serious hemorrhage, severe arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, non-GI fistula formation, or reversible posterior leukoencephalopathy syndrome occurs; suspend therapy if severe hypertension, moderate to severe proteinuria, or severe infusion reaction occurs. Cardiovascular disease. Renal or hepatic impairment. Monitor BP every 2–3 weeks. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Epistaxis, headache, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation, wound dehiscence/impaired healing, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, infusion reactions.
NO
Single-use vial—1
| 02/21/13 |
| Added second-line treatment of metastatic colorectal cancer to Indications. |
Glioblastoma, as a single agent for patients with progressive disease following prior therapy.
Give by IV infusion after chemotherapy. Infuse 1st dose over 90 minutes; if tolerated, infuse 2nd dose over 60 minutes, and subsequent doses over 30 minutes. 10mg/kg every 2 weeks.
Not established.
Angiogenesis inhibitor.
Do not start therapy before or for at least 28 days after surgery; allow surgical incisions to completely heal (see full lableing). History of hemoptysis of ≥½ teaspoon of red blood: do not administer. Discontinue if GI perforation, significant wound dehiscence, serious hemorrhage, severe arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, non-GI fistula formation, or reversible posterior leukoencephalopathy syndrome occurs; suspend therapy if severe hypertension, moderate to severe proteinuria, or severe infusion reaction occurs. Cardiovascular disease. Renal or hepatic impairment. Monitor BP every 2–3 weeks. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Epistaxis, headache, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation, wound dehiscence/impaired healing, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, infusion reactions.
NO
Single-use vial—1
| 02/21/13 |
| Added second-line treatment of metastatic colorectal cancer to Indications. |
Metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy for first- or second-line treatment; or in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine oxaliplatin-based therapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen.
Give by IV infusion after chemotherapy. Infuse 1st dose over 90 minutes; if tolerated, infuse 2nd dose over 60 minutes, and subsequent doses over 30 minutes. 5mg/kg (when used with bolus-IFL) or 10mg/kg (when used with FOLFOX-4) once every 2 weeks until disease progression detected; 5mg/kg every 2 weeks or 7.5mg/kg every 3 weeks (when used with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy).
Not established.
Angiogenesis inhibitor.
Do not start therapy before or for at least 28 days after surgery; allow surgical incisions to completely heal (see full lableing). History of hemoptysis of ≥½ teaspoon of red blood: do not administer. Discontinue if GI perforation, significant wound dehiscence, serious hemorrhage, severe arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, non-GI fistula formation, or reversible posterior leukoencephalopathy syndrome occurs; suspend therapy if severe hypertension, moderate to severe proteinuria, or severe infusion reaction occurs. Cardiovascular disease. Renal or hepatic impairment. Monitor BP every 2–3 weeks. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Epistaxis, headache, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation, wound dehiscence/impaired healing, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, infusion reactions.
NO
Single-use vial—1
| 02/21/13 |
| Added second-line treatment of metastatic colorectal cancer to Indications. |
First-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel.
Give by IV infusion after chemotherapy. Infuse 1st dose over 90 minutes; if tolerated, infuse 2nd dose over 60 minutes, and subsequent doses over 30 minutes. 15mg/kg once every 3 weeks with carboplatin/paclitaxel.
Not established.
Angiogenesis inhibitor.
Do not start therapy before or for at least 28 days after surgery; allow surgical incisions to completely heal (see full lableing). History of hemoptysis of ≥½ teaspoon of red blood: do not administer. Discontinue if GI perforation, significant wound dehiscence, serious hemorrhage, severe arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, non-GI fistula formation, or reversible posterior leukoencephalopathy syndrome occurs; suspend therapy if severe hypertension, moderate to severe proteinuria, or severe infusion reaction occurs. Cardiovascular disease. Renal or hepatic impairment. Monitor BP every 2–3 weeks. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Epistaxis, headache, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis; GI perforation, wound dehiscence/impaired healing, hemorrhage, non-GI fistula formation, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, infusion reactions.
NO
Single-use vial—1