Bevacizumab
Dosing in kidney impairment
Metastatic Renal Cell Carcinoma The recommended dosage is 10 mg/kg intravenously every 2 weeks in combination with interferon alfa.
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. | Gastrointestinal perforation, any gradeTracheoesophageal fistula, any gradeFistula, Grade 4Fistula formation involving any internal organ | Discontinue VEGZELMA |
| Wound Healing Complications [see Warnings and Precautions (5.2)]. | Any | Withhold VEGZELMA until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. |
| Necrotizing fasciitis | Discontinue VEGZELMA | |
| Hemorrhage [see Warnings and Precautions (5.3)]. | Grade 3 or 4 | Discontinue VEGZELMA |
| Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more | Withhold VEGZELMA | |
| Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)]. | Arterial thromboembolism, severe | Discontinue VEGZELMA |
| Venous thromboembolism, Grade 4 | Discontinue VEGZELMA | |
| Hypertension [see Warnings and Precautions (5.6)]. | Hypertensive crisisHypertensive encephalopathy | Discontinue VEGZELMA |
| Hypertension, severe | Withhold VEGZELMA if not controlled with medical management; resume once controlled | |
| Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)]. | Any | Discontinue VEGZELMA |
| Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. | Nephrotic syndrome | Discontinue VEGZELMA |
| Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome | Withhold VEGZELMA until proteinuria less than 2 grams per 24 hours | |
| Infusion-Related Reactions [see Warnings and Precautions (5.9)]. | Severe | Discontinue VEGZELMA |
| Clinically significant | Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve | |
| Mild, clinically insignificant | Decrease infusion rate | |
| Congestive Heart Failure [see Warnings and Precautions (5.12)]. | Any | Discontinue VEGZELMA |
Preparation and administration
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.
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) bags 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.
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. | Gastrointestinal perforation, any gradeTracheoesophageal fistula, any gradeFistula, Grade 4Fistula formation involving any internal organ | Discontinue VEGZELMA |
| Wound Healing Complications [see Warnings and Precautions (5.2)]. | Any | Withhold VEGZELMA until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. |
| Necrotizing fasciitis | Discontinue VEGZELMA | |
| Hemorrhage [see Warnings and Precautions (5.3)]. | Grade 3 or 4 | Discontinue VEGZELMA |
| Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more | Withhold VEGZELMA | |
| Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)]. | Arterial thromboembolism, severe | Discontinue VEGZELMA |
| Venous thromboembolism, Grade 4 | Discontinue VEGZELMA | |
| Hypertension [see Warnings and Precautions (5.6)]. | Hypertensive crisisHypertensive encephalopathy | Discontinue VEGZELMA |
| Hypertension, severe | Withhold VEGZELMA if not controlled with medical management; resume once controlled | |
| Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)]. | Any | Discontinue VEGZELMA |
| Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. | Nephrotic syndrome | Discontinue VEGZELMA |
| Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome | Withhold VEGZELMA until proteinuria less than 2 grams per 24 hours | |
| Infusion-Related Reactions [see Warnings and Precautions (5.9)]. | Severe | Discontinue VEGZELMA |
| Clinically significant | Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve | |
| Mild, clinically insignificant | Decrease infusion rate | |
| Congestive Heart Failure [see Warnings and Precautions (5.12)]. | Any | Discontinue VEGZELMA |