Avastin Injection, Tablet, Iv Infusion, Solution, Intravenous Solution
Avastin 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.
Avastin is a vascular endothelial growth factor-specific angiogenesis inhibitor used 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 Avastin 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 Avastin.
• 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: Avastin is not used for adjuvant treatment of colon cancer.
Avastin is also used to associated treatment for these conditions: Cervical Cancer Metastatic, Metastatic Colorectal Cancer (MCRC), Metastatic Non-Squamous Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma, Persistent Cervical Cancer, Recurrent Cervical Cancer, Recurrent Glioblastoma, Stage III epithelial ovarian cancer following initial surgical resection, Stage IV epithelial ovarian cancer following initial surgical resection, Fallopian tube cancer following initial surgical resection, Locally advanced nonsquamous non-small cell lung cancer, Primary peritoneal cancer following initial surgical resection, Recurrent Non-Squamous Non-Small Cell Lung Cancer, Recurrent Platinum-Sensitive Epithelial Ovarian Cancer, Recurrent Platinum-resistant Epithelial Ovarian Cancer, Recurrent platinum drug resistant Fallopian tube cancer, Recurrent platinum drug resistant primary peritoneal cancer, Recurrent platinum sensitive primary peritoneal cancer, Recurrent platinum-sensitive fallopian tube cancer, Unresectable Non-Squamous Non-Small-Cell Lung Cancer
|Other Names||Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF monoclonal antibody, Bevacizumab, bevacizumab-awwb, rhuMAb-VEGF|
|Weight||100mg, 400mg, 400mg/16ml, 100mg/4ml, , 25mg/ml, awwb25mg/ml, bvzr25mg/ml|
|Type||Injection, Tablet, Iv Infusion, Solution, Intravenous Solution|
>97% of serum VEGF is bound to bevacizumab.
|Therapeutic Class||Targeted Cancer Therapy|
|Manufacturer||Roche Limited, Roche Pakistan Ltd,, Roche Bangladesh Limited, Roche Products Limited, Roche & Co Ltd|
|Available Country||India, Pakistan, Bangladesh, United Kingdom, Canada, Australia, Saudi Arabia, United States, France, Italy, Netherlands, Portugal, Spain,|
|Last Updated:||June 23, 2021 at 9:00 am|
Table Of contents
Avastin should not be administered as an IV push or bolusAvastin 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 Avastin 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 Avastin until at least 28 days following major surgery. Administer Avastin 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 Avastin 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, Avastin 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.
Perforation or Fistula: Avastin should be discontinued if perforation or fistula occurs.
Arterial Thromboembolic Events (e.g., myocardial infarction, cerebral infarction): Avastin should be discontinued for severe ATE.
Venous Thromboembolic Events: Avastin should be discontinued for life-threatening VTEHypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Avastin if not medically controlled. Avastin should be discontinued for hypertensive crisis or hypertensive encephalopathy
Posterior Reversible Encephalopathy Syndrome (PRES): Avastin should be discontinuedProteinuria: Urine protein should be monitored. Avastin should be discontinued for nephrotic syndrome. Avastin should be temporarily discontinued for moderate proteinuria.
Infusion Reactions: Avastin 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 Avastin. The results demonstrated no significant effect of Avastin 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 Avastin. However, 3 of the 8 patients receiving Avastin 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 Avastin had a greater paclitaxel exposure at Day 63 than at Day 0.
Food InteractionNo interactions found.
Volume of Distribution
The volume of distribution of bevacizumab is approximately 3.29 L and 2.39 L for the average male and female, respectively.
The half-life of bevacizumab is estimated to be 20 days (range of 11-50 days).
The clearance (CL) of bevacizumab is approximately 0.207 L/day. The CL of bevacizumab can increase or decrease by 30% in patients who weigh >114 kg or 14 Males tend to clear bevacizumab at a faster rate than females (26% faster on average). Other factors including alkaline phosphatase (ALP), serum aspartate aminotransferase (AST), serum albumin, and tumor burden may cause the CL to fluctuate.
Pregnancy & Breastfeeding use
Avastin 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 Avastin 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 Avastin, nursing woman should be advised that breastfeeding is not recommended during treatment with Avastin.
Pediatric UseSafety and effectiveness of Avastin have not been established in pediatric patients.
There are no contraindications listed in the manufacturer’s labeling.
The safety, effectiveness and pharmacokinetic profile of Avastin 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 Avastin. Avastin 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 Avastin and irinotecan. There is insufficient information to determine the safety and efficacy of Avastin 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.
Interaction with other Medicine
A drug interaction study was performed in which Irinotecan was administered as part of the FOLFIRI regimen with or without Avastin. The results demonstrated no significant effect of Avastin on the pharmacokinetics of Irinotecan or its active metabolite SN38.
Avastin vials are stable at 2 to 8° C. Avastin vials should be protected from light. Do not freeze or shake. Diluted Avastin 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 Avastin and polyvinylchloride or polyolefin bags have been observed.