|Weight:||400 mg/16 ml|
|Therapeutic Class:||Targeted Cancer Therapy|
|Manufacturer:||Roche Bangladesh Limited|
|Last Updated:||2020-11-20 18:15:00|
Avastin IV Infusion contains Bevacizumab. Avastin uses:
Bevacizumab is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of
• 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 in patients who have progressed on a first-line Bevacizumab containing regimen
• 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
• Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Bevacizumab.
• 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
• Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan
Limitation of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
Avastin IV Infusion contains Bevacizumab 400 mg/16 ml. Avastin doses:
Bevacizumab should not be administered as an IV push or bolusBevacizumab should not be initiated for 28 days following major surgery and until surgical wound is fully healed
• Metastatic colorectal cancer5 mg/kg IV every 2 weeks with bolus-IFL10 mg/kg IV every 2 weeks with FOLFOX45 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line Bevacizumab containing regimen
• Non-squamous non-small cell lung cancer15 mg/kg IV every 3 weeks with carboplatin/paclitaxel• Glioblastoma10 mg/kg IV every 2 weeks
• Metastatic renal cell carcinoma (mRCC)10 mg/kg IV every 2 weeks with interferon alfa
• Persistent, recurrent, or metastatic carcinoma of the cervix15 mg/kg IV every 3 weeks with paclitaxel/cisplatin or paclitaxel/topotecan
• Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer10 mg/kg IV every 2 weeks with paclitaxel, pegylated liposomal doxorubicin or weekly topotecan 15 mg/kg IV every 3 weeks with topotecan given every 3 weeks
Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Do not initiate Bevacizumab until at least 28 days following major surgery. Administer Bevacizumab after the surgical incision has fully healed.
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 infusion over 60 minutes is tolerated.
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw necessary amount of Bevacizumab and dilute in a total volume of 100 ml of 0.9% Sodium Chloride Injection, USP. Discard any unused portion left in a vial, as the product contains no preservatives.
Most common adverse reactions incidence (> 10% and at least twice the control arm rate) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. Some of the adverse reactions are commonly seen with chemotherapy; however, Bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents. Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine peripheral sensory neuropathy with paclitaxel or oxaliplatin, and nail disorders or alopecia with paclitaxel.
Bevacizumab is a sterile solution for intravenous infusion. It is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems.
Perforation or Fistula: Bevacizumab should be discontinued if perforation or fistula occurs.
Arterial Thromboembolic Events (e.g., myocardial infarction, cerebral infarction): Bevacizumab should be discontinued for severe ATE.
Venous Thromboembolic Events: Bevacizumab should be discontinued for life-threatening VTEHypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Avastin if not medically controlled. Bevacizumab should be discontinued for hypertensive crisis or hypertensive encephalopathy
Posterior Reversible Encephalopathy Syndrome (PRES): Bevacizumab should be discontinuedProteinuria: Urine protein should be monitored. Bevacizumab should be discontinued for nephrotic syndrome. Bevacizumab should be temporarily discontinued for moderate proteinuria.
Infusion Reactions: Bevacizumab should be stopped in case of severe infusion reactions.
Embryo-fetal Toxicity: Females should be advised of the potential risk to a fetus and the need for use of effective contraception
Ovarian Failure: Females should be advised of the potential risk
A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Bevacizumab. The results demonstrated no significant effect of Bevacizumab on the pharmacokinetics of irinotecan or its active metabolite SN38.
In a randomized study in 99 patients with NSCLC, based on limited data, there did not appear to be a difference in the mean exposure of either carboplatin or paclitaxel when each was administered alone or in combination with Bevacizumab. However, 3 of the 8 patients receiving Bevacizumab plus paclitaxel/carboplatin had substantially lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel/carboplatin without Bevacizumab had a greater paclitaxel exposure at Day 63 than at Day 0.
Bevacizumab may cause fetal harm based on findings from animal studies and the drug’s mechanism of action. Pregnant women should be advised of the potential risk to a fetus.
No data are available regarding the presence of Bevacizumab in human milk, the effects on the breast fed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from Bevacizumab, nursing woman should be advised that breastfeeding is not recommended during treatment with Bevacizumab.
Pediatric UseSafety and effectiveness of Bevacizumab have not been established in pediatric patients.
There are no contraindications listed in the manufacturer’s labeling.
The safety, effectiveness and pharmacokinetic profile of Bevacizumab in pediatric patients have not been established. In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who have received Bevacizumab. Bevacizumab is not approved for use in patients under the age of 18 years.
Antitumor activity was not observed among eight children with relapsed glioblastoma treated with Bevacizumab and irinotecan. There is insufficient information to determine the safety and efficacy of Bevacizumab in children with glioblastoma.
The highest dose tested in humans (20 mg/kg IV) was associated with headache in nine of 16 patients and with severe headache in three of 16 patients.
A drug interaction study was performed in which Irinotecan was administered as part of the FOLFIRI regimen with or without Bevacizumab. The results demonstrated no significant effect of Bevacizumab on the pharmacokinetics of Irinotecan or its active metabolite SN38.
Bevacizumab vials are stable at 2 to 8° C. Bevacizumab vials should be protected from light. Do not freeze or shake. Diluted Bevacizumab solutions may be stored at 2 to 8° C for up to 8 hours. Store in the original carton until time of use. No incompatibilities between Bevacizumab and polyvinylchloride or polyolefin bags have been observed.
Avastin IV Infusion price in Bangladesh 127.40