Drug Detail:Vegzelma (Bevacizumab [ bev-a-ciz-oo-mab ])
Generic Name: BEVACIZUMAB 100mg in 4mL
Dosage Form: injection, solution
Drug Class: VEGF/VEGFR inhibitors
Important Administration Information
Withhold for at least 28 days prior to elective surgery. Do not administer VEGZELMA until at least 28 days following major surgery and until adequate wound healing.
Metastatic Colorectal Cancer
The recommended dosage when VEGZELMA is administered in combination with intravenous fluorouracil-based chemotherapy is:
- 5 mg/kg intravenously every 2 weeks in combination with bolus-IFL.
- 10 mg/kg intravenously every 2 weeks in combination with FOLFOX4.
- 5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy in patients who have progressed on a first-line bevacizumab product-containing regimen.
First-Line Non-Squamous Non-Small Cell Lung Cancer
The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel.
Metastatic Renal Cell Carcinoma
The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.
Persistent, Recurrent, or Metastatic Cervical Cancer
The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Stage III or IV Disease Following Initial Surgical Resection
The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by VEGZELMA 15 mg/kg every 3 weeks as a single agent for a total of up to 22 cycles or until disease progression, whichever occurs earlier.
Recurrent Disease
Platinum Resistant
The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week).
The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with topotecan (every 3 weeks).
Platinum Sensitive
The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by VEGZELMA 15 mg/kg every 3 weeks as a single agent until disease progression.
The recommended dosage is 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by VEGZELMA 15 mg/kg every 3 weeks as a single agent until disease progression.
Dosage Modifications for Adverse Reactions
Table 1 describes dosage modifications for specific adverse reactions. No dose reductions for VEGZELMA are recommended.
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. |
|
Discontinue VEGZELMA |
| Wound Healing Complications [see Warnings and Precautions (5.2)]. |
|
Withhold VEGZELMA until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. |
|
Discontinue VEGZELMA | |
| Hemorrhage [see Warnings and Precautions (5.3)]. |
|
Discontinue VEGZELMA |
|
Withhold VEGZELMA | |
| Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)]. |
|
Discontinue VEGZELMA |
|
Discontinue VEGZELMA | |
| Hypertension [see Warnings and Precautions (5.6)]. |
|
Discontinue VEGZELMA |
|
Withhold VEGZELMA if not controlled with medical management; resume once controlled | |
| Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)]. |
|
Discontinue VEGZELMA |
| Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. |
|
Discontinue VEGZELMA |
|
Withhold VEGZELMA until proteinuria less than 2 grams per 24 hours | |
| Infusion-Related Reactions [see Warnings and Precautions (5.9)]. |
|
Discontinue VEGZELMA |
|
Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve | |
|
Decrease infusion rate | |
| Congestive Heart Failure [see Warnings and Precautions (5.12)]. |
|
Discontinue VEGZELMA |
Preparation and Administration
Preparation
- Use appropriate aseptic technique.
- Use sterile needle and syringe to prepare VEGZELMA.
- Visually inspect vial for particulate matter and discoloration prior to preparation for administration. Discard vial if solution is cloudy, discolored, or contains particulate matter.
- Withdraw necessary amount of VEGZELMA and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection, USP. DO NOT ADMINISTER OR MIX WITH DEXTROSE SOLUTION.
- Discard any unused portion left in a vial, as the product contains no preservatives.
- Diluted VEGZELMA solution may be stored at 2°C to 8°C (36°F to 46°F) for up to 24 hours, or at room temperature up to 30°C (86°F) for up to 4 hours, if not used immediately.
- No incompatibilities between VEGZELMA and polyolefin (polypropylene and polyethylene) bag have been observed.
Administration
- Administer as an intravenous infusion.
- 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 second infusion over 60 minutes is tolerated.
