ZIRABEV (bevacizumab-bvzr) injection is a clear to slightly opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a carton containing one single-dose vial in the following strengths:
100 mg/4 mL (25 mg/mL) (NDC 0069-0315-01) 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 biosimilar* to AVASTIN (bevacizumab).
INDICATIONS AND USAGE
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1)
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)
Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer. (1.1)
Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2)
Recurrent glioblastoma in adults. (1.3)
Metastatic renal cell carcinoma in combination with interferon alfa. (1.4)
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. (1.5)
DOSAGE AND ADMINISTRATION
Do not administer ZIRABEV for 28 days following major surgery and until surgical wound is fully healed. (2.1)
Metastatic colorectal cancer (2.2)
5 mg/kg every 2 weeks with bolus-IFL
10 mg/kg every 2 weeks with FOLFOX4
5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line bevacizumab product containing regimen
First-line non?squamous non?small cell lung cancer (2.3)
15 mg/kg every 3 weeks with carboplatin and paclitaxel
Recurrent glioblastoma (2.4)
10 mg/kg every 2 weeks
Metastatic renal cell carcinoma (2.5)
10 mg/kg every 2 weeks with interferon alfa
Persistent, recurrent, or metastatic cervical cancer (2.6)
15 mg/kg every 3 weeks with paclitaxel and cisplatin or paclitaxel and topotecan
Administer as an intravenous infusion. (2.8)
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)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ. (5.1)
Surgery and Wound Healing Complications: Discontinue in patients who develop wound healing complications that require medical intervention or necrotizing fasciitis. Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for at least 28 days after surgery, and until the wound is fully healed. (5.2)
Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3�4 hemorrhage. (5.3)
Arterial Thromboembolic Events (ATE): Discontinue for severe ATE. (5.4)
Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE. (5.5)
Hypertension: Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy. (5.6)
Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue. (5.7)
Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine. (5.8)
Infusion�Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy. (5.9)
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception. (5.10, 8.1, 8.3)
Ovarian Failure: Advise females of the potential risk. (5.11, 8.3)
Congestive Heart Failure (CHF): Discontinue ZIRABEV in patients who develop CHF. (5.12)
ADVERSE REACTIONS
Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal 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.
*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of ZIRABEV has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
Revised: 6/2019
400 mg/16 mL (25 mg/mL) (NDC 0069-0342-01)
Store refrigerated at 2�C to 8�C (36�F to 46�F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.
