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