Vegzelma

Vegzelma 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 Vegzelma containing regimen.

... Read more Vegzelma 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 Vegzelma 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 of Vegzelma is based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Vegzelma.

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 Vegzelma as a single agent.

Limitation of Use: Vegzelma is not indicated for adjuvant treatment of colon cancer.

Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in-vitro and in-vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Bevacizumab has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. Bevacizumab is a clear to slightly opalescent, colorless to pale brown, sterile, pH 6.2 solution for intravenous infusion.

Patients should continue treatment until disease progression or unacceptable toxicity. 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.

Administer 5 mg/kg when used in combination with bolus-IFL.

Administer 10 mg/kg when used in combination with FOLFOX4.

Administer 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 who have 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 as an intravenous infusion administered 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 10mg/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 administered 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 disease progression. Alternatively, 15 mg/kg every 3 weeks when administrated 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 disease progression.

A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Vegzelma. The results demonstrated no significant effect of Vegzelma on the pharmacokinetics of irinotecan or its active metabolite SN38.

There are no contraindications listed in the manufacturer’s labeling.

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.

Pregnancy : Bevacizumab may cause fetal harm based on findings from animal studies and the drug’s mechanism of action. Lactation : 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. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential for serious adverse reactions in breastfed infants from bevacizumab, advise a nursing woman that breastfeeding is not recommended during treatment with Bevacizumab.

Perforation or Fistula : Discontinue Vegzelma if perforation or fistula occurs. Arterial Thromboembolic Events or ATE (e.g., myocardial infarction, cerebral infarction): Discontinue Vegzelma for severe ATE. Venous Thromboembolic Events or VTE : Discontinue Vegzelma for lifethreatening VTE. Hypertension : Monitor blood pressure and treat hypertension. Temporarily suspend Vegzelma if not medically controlled. Discontinue Vegzelma for hypertensive crisis or hypertensive encephalopathy. Posterior Reversible Encephalopathy Syndrome (PRES) : Discontinue Vegzelma. Proteinuria : Monitor urine protein. Discontinue Vegzelma for nephrotic syndrome. Temporarily suspend Vegzelma for moderate proteinuria. Infusion Reactions : Stop Vegzelma for severe infusion reactions. Embryo-fetal Toxicity : Advise females of potential risk to a fetus and the need for use of effective contraception. Ovarian Failure : Advise females of the potential risk.

The highest dose tested in humans (20 mg/kg IV) was associated with headache in nine out of 16 patients and with severe headache in three out of 16 patients.

Store the Vegzelma 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.