BEQVEZ™ Highlights

(fidanacogene elaparvovec-dzkt)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BEQVEZ safely and effectively. See full prescribing information for BEQVEZ.

BEQVEZTM (fidanacogene elaparvovec-dzkt) injection, for intravenous infusion
Initial U.S. Approval: 2024

INDICATIONS AND USAGE

BEQVEZ is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:

•
Currently use factor IX prophylaxis therapy, or
•
Have current or historical life-threatening hemorrhage, or
•
Have repeated, serious spontaneous bleeding episodes, and,
•
Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. (1)

DOSAGE AND ADMINISTRATION

For one-time single-dose intravenous infusion only. (2)

•
Perform baseline testing to select patients, including testing for pre-existing antibodies to AAVRh74var, factor IX inhibitor presence, and liver health tests. (2.1)
•
The recommended dose of BEQVEZ is 5 × 1011 vector genomes per kg (vg/kg) of body weight. Dose based on adjusted body weight for those with a BMI >30 kg/m2. (2.1)
•
Administer BEQVEZ as an intravenous infusion after dilution in 0.9% sodium chloride with 0.25% human serum albumin (HSA) with a final volume of 200 mL over approximately 60 minutes. (2.3)

DOSAGE FORMS AND STRENGTHS

BEQVEZ is a suspension for intravenous infusion after dilution. (3)

BEQVEZ has a nominal concentration of 1 × 1013 vg/mL, and each vial contains an extractable volume of 1 mL. (3)

The total number of vials will be customized to meet dosing requirements for individual patients based on their weight. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Monitor transaminases and factor IX activity levels once or twice weekly for at least 4 months after BEQVEZ administration to mitigate the risk of potential hepatotoxicity. Consider corticosteroid treatment for transaminase elevation or a decline in factor IX activity. (2.3, 5.1)
•
Infusion Reactions: Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or stop administration. Restart infusion at a slower rate once reaction has resolved. (5.2)
•
Malignancy: Monitor patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following administration. In the event that a malignancy occurs after treatment with BEQVEZ, contact Pfizer Inc. at 1-800-438-1985. (5.3)
•
Monitoring laboratory tests: Monitor for factor IX activity and factor IX inhibitors. (5.4)

ADVERSE REACTIONS

The most common adverse reaction (incidence ≥5%) was an increase in transaminases. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
There is limited information on the safety and effectiveness of BEQVEZ in patients with HIV infection. (8.8)
•
The safety and effectiveness of BEQVEZ in patients with prior or active factor IX inhibitors have not been established. (8.9)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2024

Find BEQVEZ™ medical information:

Find BEQVEZ™ medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

BEQVEZ™ Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BEQVEZ safely and effectively. See full prescribing information for BEQVEZ.

BEQVEZTM (fidanacogene elaparvovec-dzkt) injection, for intravenous infusion
Initial U.S. Approval: 2024

INDICATIONS AND USAGE

BEQVEZ is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who:

•
Currently use factor IX prophylaxis therapy, or
•
Have current or historical life-threatening hemorrhage, or
•
Have repeated, serious spontaneous bleeding episodes, and,
•
Do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. (1)

DOSAGE AND ADMINISTRATION

For one-time single-dose intravenous infusion only. (2)

•
Perform baseline testing to select patients, including testing for pre-existing antibodies to AAVRh74var, factor IX inhibitor presence, and liver health tests. (2.1)
•
The recommended dose of BEQVEZ is 5 × 1011 vector genomes per kg (vg/kg) of body weight. Dose based on adjusted body weight for those with a BMI >30 kg/m2. (2.1)
•
Administer BEQVEZ as an intravenous infusion after dilution in 0.9% sodium chloride with 0.25% human serum albumin (HSA) with a final volume of 200 mL over approximately 60 minutes. (2.3)

DOSAGE FORMS AND STRENGTHS

BEQVEZ is a suspension for intravenous infusion after dilution. (3)

BEQVEZ has a nominal concentration of 1 × 1013 vg/mL, and each vial contains an extractable volume of 1 mL. (3)

The total number of vials will be customized to meet dosing requirements for individual patients based on their weight. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Monitor transaminases and factor IX activity levels once or twice weekly for at least 4 months after BEQVEZ administration to mitigate the risk of potential hepatotoxicity. Consider corticosteroid treatment for transaminase elevation or a decline in factor IX activity. (2.3, 5.1)
•
Infusion Reactions: Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or stop administration. Restart infusion at a slower rate once reaction has resolved. (5.2)
•
Malignancy: Monitor patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following administration. In the event that a malignancy occurs after treatment with BEQVEZ, contact Pfizer Inc. at 1-800-438-1985. (5.3)
•
Monitoring laboratory tests: Monitor for factor IX activity and factor IX inhibitors. (5.4)

ADVERSE REACTIONS

The most common adverse reaction (incidence ≥5%) was an increase in transaminases. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
There is limited information on the safety and effectiveness of BEQVEZ in patients with HIV infection. (8.8)
•
The safety and effectiveness of BEQVEZ in patients with prior or active factor IX inhibitors have not been established. (8.9)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2024
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.