ZIRABEV Rx

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).

Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after major surgery and until adequate healing. The safety of resuming therapy after resolution of wound healing complications has not been established. Do not administer if recent history of hemoptysis of ≥ ½-teaspoon of red blood. Avoid in those with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction. Discontinue if GI perforations, tracheoesophageal fistula, grade 4 fistula occurs, or fistula formation involving any organ. Discontinue if necrotizing fasciitis, Grade 3 or 4 hemorrhage, severe arterial thromboembolic event, grade 4 venous thromboembolic event, hypertensive crisis or encephalopathy, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion-related reactions, or CHF develops; withhold if uncontrolled severe hypertension (resume once controlled) or proteinuria ≥2g/24hrs (resume when <2g/24hrs) occurs. History of arterial thromboembolism. Diabetes. Monitor BP every 2–3 weeks. Monitor proteinuria by dipstick urine analysis; if ≥2+, do further assessment with a 24-hour urine collection. Elderly. Increased risk of ovarian failure (premenopausal women). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers: not recommended (during and for 6 months after last dose).