Bevastim 400 mg/16 ml (IV Infusion)

Title

• Bevastim

Categories

• Medicine
• Cancer Therapy
• Targeted Therapy

Description

• Vascular endothelial growth factor-specific angiogenesis inhibitor
• Treatment for metastatic colorectal cancer
• Treatment for non-squamous non-small cell lung cancer
• Treatment for glioblastoma
• Treatment for metastatic renal cell carcinoma
• Treatment for cervical cancer
• Treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Recommended dosage of 5 mg/kg or 10 mg/kg
• Dosage frequency: every 2 weeks or every 3 weeks
• Infusion duration: 90 minutes for first infusion, 60 minutes for subsequent infusions, 30 minutes for subsequent infusions if tolerated
• Dosage continuation until disease progression or unacceptable toxicity
• Storage at 2-8°C in a refrigerator
• Do not freeze
• Keep out of reach of children

Dimensions

• Vial size

Color Options

• Colorless
• Slightly opalescent
• Pale brown

Functions

• Angiogenesis inhibition
• Binding and inhibition of vascular endothelial growth factor (VEGF)
• Inhibits biologic activity of human VEGF
• Treatment of various cancers
• Safety and efficacy in pediatric patients not established
• Prevention of breastfeeding during treatment

Materials

• Recombinant humanized monoclonal IgG1 antibody
• Human framework regions
• Murine antibody

Technical Specifications

• Molecular weight: approximately 149 kD
• Produced in a mammalian cell (Chinese Hamster Ovary) expression system
• Sterile, pH 6.2 solution for intravenous infusion
• Gentamicin-free

Design Elements

• Clear solution
• Parenteral drug product inspection before administration
• Aseptic technique for preparation and administration

Usability Features

• Indicated for first-line and second-line treatments
• No contraindications listed in labeling
• Dosage recommendations for specific cancer types
• Advisory on administration following major surgery

Interactions

• No significant effect on pharmacokinetics of irinotecan

Contradictions

• None listed in labeling

Side Effects

• Most common adverse reactions: epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis

Pregnancy & Lactation

• Potential fetal harm
• No data on presence in human milk or effects on breastfed infant

Precautions & Warnings

• Discontinue if perforation or fistula occurs
• Discontinue for severe arterial or venous thromboembolic events
• Hypertension monitoring and treatment
• Discontinue for serious infusion reactions
• Advisory on potential embryo-fetal toxicity

Use in Special Populations

• Safety and effectiveness in pediatric patients not established
• Cases of non-mandibular osteonecrosis observed in patients under 18 years
• Not approved for use in patients under 18 years
• Severe adverse events in patients aged 65 years and older

Overdose Effects

• Highest tested dose associated with severe headache

Therapeutic Class

• Targeted Cancer Therapy

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