Zirabev (Bevacizumab-Bvzr)

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  • Product Details

    Description

    Zirabev (bevacizumab-bvzr) is a biosimilar to Avastin (bevacizumab), a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor A (VEGF-A), preventing its interaction with VEGF receptors on endothelial cells. This action inhibits angiogenesis, the formation of new blood vessels, thereby suppressing tumor growth and metastasis. Zirabev is indicated for the treatment of various cancers, including metastatic colorectal cancer, non-squamous non–small cell lung cancer, glioblastoma, renal cell carcinoma, and cervical cancer, among others, depending on the regimen and clinical context.

    Fact Table

    Formula

    C6638H10160N1720O2108S44

    License

    US FDA (2019), EMA (2019)

    Bioavailability

    Intravenous only (100% systemic availability)

    Legal status

    Rx-only

    Chemical Name

    Bevacizumab-awwb (Zirabev, biosimilar of bevacizumab)

    Elimination half-life

    ~20 days

    Dosage (Strength)

    100 mg/4 mL and 400 mg/16 mL vials for IV infusion

    Pregnancy

    Category D – positive evidence of risk

    Brands

    Zirabev (Pfizer); biosimilar to Avastin

    Protein binding

    High (monoclonal antibody; binds VEGF-A)

    PubChem CID

    24873459

    MedlinePlus

    a607001

    ChEBI

    CHEBI:134722

    ATC code

    L01XC07

    DrugBank

    DB00112

    KEGG

    D03141

    Routes of administration

    Intravenous infusion

    Directions

    Zirabev is administered by intravenous infusion. Dosage and administration schedules vary depending on the type of cancer and treatment regimen. For example:

    • Metastatic colorectal cancer: 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy.
    • Non–small cell lung cancer: 15 mg/kg every 3 weeks in combination with carboplatin and paclitaxel.

    Zirabev should be infused over 90 minutes initially. If tolerated, subsequent infusions may be administered over 60 minutes, then 30 minutes. It should not be administered as an intravenous push or bolus. Premedication is not typically required unless the patient experiences an infusion-related reaction.

    Ingredients

    Each mL of Zirabev contains:

    • Bevacizumab-bvzr (25 mg/mL)
    • Trehalose dihydrate
    • Sodium phosphate monobasic monohydrate
    • Sodium phosphate dibasic anhydrous
    • Polysorbate 20
    • Water for injection

    The solution is preservative-free and must be diluted before infusion.

    Contraindications

    Zirabev is contraindicated in patients with:

    • Known hypersensitivity to bevacizumab-bvzr, bevacizumab, or any of the formulation components
    • Recent hemoptysis (=½ teaspoon of red blood) in patients with non–small cell lung cancer
    • Untreated central nervous system metastases (in certain indications due to bleeding risk)

    Cautions

    Zirabev increases the risk of gastrointestinal perforations, wound healing complications, and hemorrhage. It should not be initiated for at least 28 days following major surgery and until surgical wounds are fully healed. Proteinuria and hypertension are common and may require dose modification or treatment discontinuation. Patients should be monitored regularly for blood pressure, urine protein, thromboembolic events, and signs of bleeding or infection. Use during pregnancy may cause fetal harm; effective contraception should be used during treatment and for at least 6 months after the last dose.

    Side Effects

    Common side effects of Zirabev include:

    • Hypertension
    • Proteinuria
    • Epistaxis
    • Headache
    • Fatigue
    • Diarrhea
    • Mucositis
    • Arthralgia
    • Abdominal pain
    • Rash

    Serious adverse effects may include:

    • Gastrointestinal perforation
    • Hemorrhage (e.g., pulmonary, GI, CNS)
    • Arterial thromboembolism
    • Delayed wound healing
    • Nephrotic syndrome
    • Reversible posterior leukoencephalopathy syndrome (RPLS)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14594

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