Avastin 100 mg/4 ml (IV Infusion)

Indications

• Treatment of metastatic colorectal cancer with intravenous 5-fluorouracil-based chemotherapy
• Treatment of metastatic colorectal cancer with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy
• First-line treatment of non-squamous non-small cell lung cancer with carboplatin and paclitaxel
• Treatment of glioblastoma as a single agent for patients with progressive disease
• Treatment of metastatic renal cell carcinoma with interferon alfa
• Treatment of cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan
• Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan
• Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment in combination with carboplatin and paclitaxel or carboplatin and gemcitabine

Pharmacology

• Recombinant humanized monoclonal IgG1 antibody
• Binds and inhibits biologic activity of vascular endothelial growth factor (VEGF)
• Produced in a mammalian cell expression system
• Clear to slightly opalescent, colorless to pale brown, sterile, pH 6.2 solution

Dosage

• Recommended doses for different types of cancer
• Different dosages for metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, platinum-resistant and platinum-sensitive recurrent epithelial ovarian cancer

Administration

• Infusion duration for first and subsequent infusions
• Preparation for administration using aseptic technique
• Dilution in 0.9% Sodium Chloride injection, USP

Interaction

• Study demonstrating no significant effect on the pharmacokinetics of irinotecan
• Administered as part of the FOLFIRI regimen

Contraindications

• No contraindications listed in the manufacturer’s labeling

Side Effects

• Most common adverse reactions

Pregnancy & Lactation

• Potential for fetal harm based on animal studies
• No data available regarding the presence in human milk
• Recommendation against breastfeeding during treatment

Precautions & Warnings

• Discontinuation in cases of perforation, fistula, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, infusion reactions
• Advising females of potential risk to fetus and need for effective contraception
• Potential risk of ovarian failure
• Geriatric use and pediatric use

Use in Special Populations

• Safety, effectiveness and pharmacokinetic profile in pediatric patients not established
• Cases of non-mandibular osteonecrosis observed in patients under 18 years
• Insufficient information to determine the safety and efficacy in children with glioblastoma
• Physeal dysplasia observed in juvenile cynomolgus monkeys

Overdose Effects

• Effect of highest tested dose in humans
• Associated adverse reactions

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

• Refrigeration at 2-8°C
• Protect from light and freezing
• Keep out of reach of children

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