Bevastim 100 mg/4 ml (IV Infusion)

100 mg vial: ৳ 18,560.00

Medicine Details

Category Details
Generic Bevacizumab
Company Beacon pharmaceuticals plc
Also available as

Indications

  • Metastatic colorectal cancer, with intravenous 5-fluorouracil-based chemotherapy for first-or second-line treatment
  • Metastatic colorectal cancer, with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment
  • Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic disease
  • Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy
  • Metastatic renal cell carcinoma with interferon alfa
  • Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease
  • Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that is: (1) Platinum-resistant in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan. (2) Platinum-sensitive in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Bevastim as a single agent

Pharmacology

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

Dosage

  • Recommended doses: 5 mg/kg or 10 mg/kg every 2 weeks for metastatic colorectal cancer (mCRC)
  • Recommended dose: 15 mg/kg every 3 weeks for Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC)
  • Recommended dose: 10 mg/kg every 2 weeks for Glioblastoma
  • Recommended dose: 10 mg/kg every 2 weeks for Metastatic Renal Cell Carcinoma (mRCC)
  • Recommended dose: 15 mg/kg every 3 weeks for Cervical Cancer
  • Recommended dose: 10mg/kg or 15 mg/kg every 2 weeks for Platinum-Resistant and Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Administration

  • First infusion: Administer infusion over 90 minutes
  • Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated; administer all subsequent infusions over 30 minutes if first infusion over 60 minutes is tolerated
  • Use appropriate aseptic technique for preparation
  • Inspect visually for particulate matter and discoloration prior to administration
  • Dilute in a total volume of 100 ml of 0.9% Sodium Chloride injection, USP

Interaction

  • No significant effect of Bevastim on the pharmacokinetics of irinotecan or its active metabolite SN38

Contraindications

    Side Effects

    • Epistaxis
    • Headache
    • Hypertension
    • Rhinitis
    • Proteinuria
    • Taste alteration
    • Dry skin
    • Rectal hemorrhage
    • Lacrimation disorder
    • Back pain
    • Exfoliative dermatitis

    Pregnancy & Lactation

    • Bevacizumab may cause fetal harm based on findings from animal studies
    • No data available regarding the presence of bevacizumab in human milk
    • Breastfeeding is not recommended during treatment with Bevacizumab

    Precautions & Warnings

    • Discontinue Bevastim if perforation or fistula occurs
    • Discontinue Bevastim for severe arterial thromboembolic events (ATE)
    • Discontinue Bevastim for life-threatening venous thromboembolic events (VTE)
    • Monitor blood pressure and treat hypertension
    • Discontinue Bevastim for posterior reversible encephalopathy syndrome (PRES)
    • Monitor urine protein and discontinue Bevastim for nephrotic syndrome
    • Stop Bevastim for severe infusion reactions
    • Advise females of potential risk to a fetus and the need for use of effective contraception
    • Advise females of the potential risk of ovarian failure

    Use in Special Populations

    • Safety, effectiveness and pharmacokinetic profile of Bevastim in pediatric patients have not been established
    • Bevastim is not approved for use in patients under the age of 18 years
    • Severe adverse events that occurred at a higher incidence in patients aged 65 years or older
    • Effect of Bevastim on overall survival was similar in elderly patients as compared to younger patients

    Overdose Effects

    • Highest dose tested in humans (20 mg/kg IV) was associated with headache in nine out of 16 patients

    Therapeutic Class

    • Targeted Cancer Therapy

    Storage Conditions

    • Store the Bevastim vial in a refrigerator at 2-8°C
    • Keep the vial in the outer carton due to light sensitivity
    • Do not freeze
    • Keep out of reach of children

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