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Indications & Uses
Vegzelma is indicated for:
Pharmacology
Bevacizumab is a recombinant, humanized monoclonal IgG1 antibody. It binds to human vascular endothelial growth factor (VEGF) and blocks its biological activity, as shown in both in-vitro and in-vivo assay systems. Its framework regions are human, while the complementarity-determining regions come from a murine antibody that binds VEGF. The molecule weighs roughly 149 kD.
Bevacizumab is made in Chinese Hamster Ovary cells, grown in a nutrient medium that contains the antibiotic gentamicin. Gentamicin cannot be detected in the final product. What reaches the patient is a clear to slightly opalescent, colourless to pale brown, sterile solution with a pH of 6.2, given by intravenous infusion.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage: Patients should continue treatment until the disease progresses or the side effects become unacceptable. Metastatic Colorectal Cancer (mCRC): The recommended doses are 5 mg/kg or 10 mg/kg every 2 weeks when used in combination with intravenous 5-FU-based chemotherapy. Give 5 mg/kg when used in combination with bolus-IFL. Give 10 mg/kg when used in combination with FOLFOX4. Give 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks when used in combination with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy regimen in patients whose disease has progressed on a first-line Bevacizumab-containing regimen. Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC): The recommended dose is 15 mg/kg every 3 weeks in combination with carboplatin and paclitaxel. Glioblastoma: The recommended dose is 10 mg/kg every 2 weeks. Metastatic Renal Cell Carcinoma (mRCC): The recommended dose is 10 mg/kg every 2 weeks in combination with interferon alfa. Cervical Cancer: The recommended dose of Bevacizumab is 15 mg/kg every 3 weeks, given as an intravenous infusion in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin, or paclitaxel and topotecan. Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer: The recommended dose is 10 mg/kg every 2 weeks in combination with one of the following intravenous chemotherapy regimens: paclitaxel, pegylated liposomal doxorubicin, or topotecan (weekly); or 15 mg/kg every 3 weeks in combination with topotecan (every 3 weeks). Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: The recommended dose is 15 mg/kg every 3 weeks when given in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of Bevacizumab 15 mg/kg every 3 weeks as a single agent until the disease progresses. Alternatively, 15 mg/kg every 3 weeks when given in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles, followed by continued use of Bevacizumab 15 mg/kg every 3 weeks as a single agent until the disease progresses.
Side Effects
The most common side effects of Bevacizumab (those occurring in more than 10% of patients and at least twice as often as in the control group) are nosebleeds, headache, high blood pressure, runny or inflamed nose, protein in the urine, changes in taste, dry skin, rectal bleeding, tear-production problems, back pain and severe peeling or flaking of the skin.
Cautions & Contraindications
Warnings & Precautions
Perforation or fistula: Discontinue Bevixa if perforation or fistula occurs. Arterial thromboembolic events (ATE), such as myocardial infarction or cerebral infarction: Discontinue Bevixa for severe ATE. Venous thromboembolic events (VTE): Discontinue Bevixa for life-threatening VTE. Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Bevixa if blood pressure is not medically controlled. Discontinue Bevixa for hypertensive crisis or hypertensive encephalopathy. Posterior reversible encephalopathy syndrome (PRES): Discontinue Bevixa. Proteinuria: Monitor urine protein. Discontinue Bevixa for nephrotic syndrome. Temporarily suspend Bevixa for moderate proteinuria. Infusion reactions: Stop Bevixa for severe infusion reactions. Embryo-fetal toxicity: Advise females of the potential risk to a fetus and the need to use effective contraception. Ovarian failure: Advise females of the potential risk.
Contraindications
The manufacturer’s labeling does not list any contraindications for this medicine.
Pregnancy & Breastfeeding
Pregnancy: Based on animal studies and its mechanism of action, bevacizumab may cause fetal harm.
Lactation: No data are available on whether bevacizumab passes into human milk, or on its effects on milk production or on a breastfed infant. Human IgG is known to be present in breast milk, but published data suggest that antibodies in breast milk do not enter the neonatal and infant circulation in significant amounts. Because of the risk of serious adverse reactions in breastfed infants, nursing mothers are advised not to breastfeed while being treated with Bevacizumab.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use
The safety, effectiveness and pharmacokinetic profile of Bevacizumab in pediatric patients have not been established. Published reports describe cases of non-mandibular osteonecrosis in patients under 18 years who received Bevacizumab. The medicine is not approved for use in patients under 18 years. Among eight children with relapsed glioblastoma treated with Bevacizumab and irinotecan, no antitumor activity was seen. There isn't enough information to decide whether Bevacizumab is safe and effective in children with glioblastoma.
Animal Data
Juvenile cynomolgus monkeys with open growth plates developed physeal dysplasia after 4 to 26 weeks of exposure at 0.4 to 20 times the recommended human dose (based on mg/kg and exposure). The incidence and severity of physeal dysplasia were dose-related, and they were partially reversible once treatment stopped.
Geriatric Use
In Study: severe adverse events that occurred more often (≥2%) in patients aged ≥65 years than in younger patients were asthenia, sepsis, deep thrombophlebitis, hypertension, hypotension, myocardial infarction, congestive heart failure, diarrhea, constipation, anorexia, leukopenia, anemia, dehydration, hypokalemia and hyponatremia. The effect of Bevacizumab on overall survival was similar in elderly patients and in younger patients.
Overdose
In trials of Bevacizumab, the highest dose given to people was 20 mg/kg by IV. At that dose, headache occurred in nine out of 16 patients, and in three out of 16 patients it was severe.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep the Bevacizumab vial in a refrigerator at 2 to 8°C. The vial is sensitive to light, so leave it in its outer carton until it's needed. Don't freeze it. Keep it out of reach of children.
Drug Interactions
Common questions about Vegzelma 100 mg/4 ml
What is Vegzelma 100 mg/4 ml IV Infusion?
Vegzelma 100 mg/4 ml IV Infusion is a medicine that contains Bevacizumab. It is made by ZAS Corporation. It belongs to the Targeted Cancer Therapy group of medicines.
What is Vegzelma used for?
Vegzelma is used for: Cancer.
What are the side effects of Vegzelma?
The most common side effects of Bevacizumab (those occurring in more than 10% of patients and at least twice as often as in the control group) are nosebleeds, headache, high blood pressure, runny or inflamed nose, protein in the urine, changes in taste, dry skin, rectal bleeding, tear-production problems, back pain and severe peeling or flaking of the skin.
Can I take Vegzelma during pregnancy or while breastfeeding?
Pregnancy: Based on animal studies and its mechanism of action, bevacizumab may cause fetal harm. Lactation: No data are available on whether bevacizumab passes into human milk, or on its effects on milk production or on a breastfed infant. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Vegzelma?
In trials of Bevacizumab, the highest dose given to people was 20 mg/kg by IV. At that dose, headache occurred in nine out of 16 patients, and in three out of 16 patients it was severe. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Vegzelma?
Keep the Bevacizumab vial in a refrigerator at 2 to 8°C. The vial is sensitive to light, so leave it in its outer carton until it's needed.
Do I need a prescription for Vegzelma?
Vegzelma is a prescription (Rx) medicine. Take it as your doctor advises.