HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZIRABEV safely and effectively. See full prescribing information for ZIRABEV.
ZIRABEV™ (bevacizumab-bvzr) injection, for intravenous use
Initial U.S. Approval: 2019
ZIRABEV (bevacizumab-bvzr) is biosimilar1 to AVASTIN (bevacizumab).
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer. (1.1)
DOSAGE AND ADMINISTRATION
Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for 28 days following major surgery and until adequate wound healing. (2.1)
Metastatic colorectal cancer. (2.2)
First-line non−squamous non−small cell lung cancer. (2.3)
Recurrent glioblastoma. (2.4)
Metastatic renal cell carcinoma. (2.5)
Persistent, recurrent, or metastatic cervical cancer. (2.6)
Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection. (2.7)
Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. (2.7)
Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (2.7)
Administer as an intravenous infusion. (2.9)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) in a single-dose vial. (3)
WARNINGS AND PRECAUTIONS
Most common adverse reactions incidence (incidence >10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 and www.Pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
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