ZIRABEV Highlights

(bevacizumab-bvzr)

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 biosimilar* to AVASTIN (bevacizumab).

RECENT MAJOR CHANGES

Dosage and Administration, Preparation and Administration (2.9)

8/2024

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)
•
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
o
in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. (1.6)
o
in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. (1.6)
o
in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. (1.6)

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)

•
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.

Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection. (2.7)

•
15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.

Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. (2.7)

•
10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week.
•
15 mg/kg every 3 weeks with topotecan given every 3 weeks

Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (2.7)

•
15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6–8 cycles, followed by 15 mg/kg every 3 weeks as a single agent.
•
15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6–10 cycles, followed by 15 mg/kg every 3 weeks as a single agent.

Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. (2.8, 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)

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: In patients who experience wound healing complications during ZIRABEV treatment, withhold ZIRABEV until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis. (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, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 and https://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: 8/2024

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Highlights

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 biosimilar* to AVASTIN (bevacizumab).

RECENT MAJOR CHANGES

Dosage and Administration, Preparation and Administration (2.9)

8/2024

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)
•
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
o
in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. (1.6)
o
in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. (1.6)
o
in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. (1.6)

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)

•
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.

Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection. (2.7)

•
15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles.

Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. (2.7)

•
10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week.
•
15 mg/kg every 3 weeks with topotecan given every 3 weeks

Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (2.7)

•
15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6–8 cycles, followed by 15 mg/kg every 3 weeks as a single agent.
•
15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6–10 cycles, followed by 15 mg/kg every 3 weeks as a single agent.

Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. (2.8, 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)

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: In patients who experience wound healing complications during ZIRABEV treatment, withhold ZIRABEV until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer ZIRABEV for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis. (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, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 and https://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: 8/2024
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