Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. | - •
- Gastrointestinal perforation, any grade
- •
- Tracheoesophageal fistula, any grade
- •
- Fistula, Grade 4
- •
- Fistula formation involving any internal organ
| Discontinue ZIRABEV |
Wound Healing Complications [see Warnings and Precautions (5.2)]. | - •
- Any
| Withhold ZIRABEV until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. |
- •
- Necrotizing fasciitis
| Discontinue ZIRABEV |
Hemorrhage [see Warnings and Precautions (5.3)]. | - •
- Grade 3 or 4
| Discontinue ZIRABEV |
- •
- Recent history of hemoptysis of 1/2 teaspoon (2.5 mL) or more
| Withhold ZIRABEV |
Thromboembolic Events [see Warnings and Precautions (5.4, 5.5)]. | - •
- Arterial thromboembolism, severe
| Discontinue ZIRABEV |
- •
- Venous thromboembolism, Grade 4
| Discontinue ZIRABEV |
Hypertension [see Warnings and Precautions (5.6)]. | - •
- Hypertensive crisis
- •
- Hypertensive encephalopathy
| Discontinue ZIRABEV |
- •
- Hypertension, severe
| Withhold ZIRABEV if not controlled with medical management; resume once controlled |
Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.7)]. | - •
- Any
| Discontinue ZIRABEV |
Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. | - •
- Nephrotic syndrome
| Discontinue ZIRABEV |
- •
- Proteinuria greater than or equal to 2 grams per 24 hours in absence of nephrotic syndrome
| Withhold ZIRABEV until proteinuria less than 2 grams per 24 hours |
Infusion-Related Reactions [see Warnings and Precautions (5.9)]. | - •
- Severe
| Discontinue ZIRABEV |
- •
- 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 ZIRABEV |