-------------------------RECENT MAJOR CHANGES-----------------------------
---------------------------INDICATIONS AND USAGE----------------------------Avastin is a vascular endothelial growth factor directed antibody indicated for the treatment of:• Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first-or second-line treatment.
------------------------DOSAGE AND ADMINISTRATION---------------------Do not administer Avastin for 28 days following major surgery and until surgical wound is fully healed. (2.1) Metastatic colorectal cancer (2.2)• 5 mg/kg every 2 weeks with bolus-IFL • 10 mg/kg every 2 weeks with FOLFOX4• 5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line Avastin containing regimen First-Line Non-squamous non-small cell lung cancer (2.3)• 15 mg/kg every 3 weeks with carboplatin and paclitaxel Recurrent glioblastoma (2.4)• 10 mg/kg every 2 weeks Metastatic renal cell cancer (2.5)• 10 mg/kg every 2 weeks with interferon alfa Persistent, recurrent, or metastatic cervical cancer (2.6) • 15 mg/kg every 3 weeks with paclitaxel and cisplatin, or paclitaxel and topotecan Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (2.7)• 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week • 15 mg/kg every 3 weeks with topotecan given every 3 weeks Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (2.7)• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6-8 cycles, followed by 15 mg/kg every 3 weeks as a single agent • 15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6-10 cycles, followed by 15 mg/kg every 3 weeks as a single agent Administer as an intravenous infusion. (2.8)
-----------------------DOSAGE FORMS AND STRENGTHS--------------------Injection: 100 mg/4 mL (25 mg/mL)or 400 mg/16 mL (25 mg/mL)in a single dose vial (3)
---------------------------CONTRAINDICATIONS---------------------------------
None (4) -----------------------WARNINGS AND PRECAUTIONS------------------------•
------------------------------ADVERSE REACTIONS------------------------------Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-----------------------------USE IN SPECIFIC POPULATIONS------------------
INDICATIONS AND USAGE 1.Metastatic Colorectal Cancer (mCRC)Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer.Avastin, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxalip...