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ZIRABEV (bevacizumab-bvzr)

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Full Patient Information

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17 PATIENT COUNSELING INFORMATION

Gastrointestinal Perforations and Fistulae

Bevacizumab products may increase the risk of developing gastrointestinal perforations and fistulae. Advise patients to immediately contact their health care provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, or vomiting [see

Surgery and Wound Healing Complications

Bevacizumab products can increase the risk of wound healing complications. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider [see

Hemorrhage

Bevacizumab products can increase the risk of hemorrhage. Advise patients to immediately contact their health care provider for signs and symptoms of serious or unusual bleeding including coughing or spitting blood [see

Arterial and Venous Thromboembolic Events

Bevacizumab products increase the risk of arterial and venous thromboembolic events. Advise patients to immediately contact their health care provider for signs and symptoms of arterial or venous thromboembolism [see

Hypertension

Bevacizumab products can increase blood pressure. Advise patients that they will undergo routine blood pressure monitoring and to contact their health care provider if they experience changes in blood pressure [see

Posterior Reversible Leukoencephalopathy Syndrome

Posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab products treatment. Advise patients to immediately contact their health care provider for new onset or worsening neurological function [see

Renal Injury and Proteinuria

Bevacizumab products increase the risk of proteinuria and renal injury, including nephrotic syndrome. Advise patients that treatment with ZIRABEV requires regular monitoring of renal function and to contact their health care provider for proteinuria or signs and symptoms of nephrotic syndrome [see

Infusion-Related Reactions

Bevacizumab products can cause infusion-related reactions. Advise patients to contact their health care provider immediately for signs or symptoms of infusion-related reactions [see

Congestive Heart Failure

Bevacizumab products can increase the risk of developing congestive heart failure. Advise patients to contact their health care provider immediately for signs and symptoms of CHF [see

Embryo-Fetal Toxicity

Advise female patients that bevacizumab products may cause fetal harm and to inform their health care provider with a known or suspected pregnancy [see

Ovarian Failure

Bevacizumab products may lead to ovarian failure. Advise patients of potential options for preservation of ova prior to starting treatment [see

Lactation

Advise women not to breastfeed during treatment with ZIRABEV and for 6 months after the last dose [see Use in Specific Populations (8.2)].

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