BEQVEZ™ Medication Guide

(fidanacogene elaparvovec-dzkt)

17 PATIENT COUNSELING INFORMATION

Inform patients that:

Pre-infusion blood tests will be necessary to look for factor IX inhibitors and detect pre-existing antibodies to AAVRh74var. If these tests are positive the patient will not be a candidate for BEQVEZ [see Dosage and Administration (2)].
Adverse reactions may occur during and after infusion.
o
Inform patients that infusion reactions, including hypersensitivity reactions, may occur. Patients will be monitored during and for at least 3 hours after infusion [see Warnings and Precautions (5.2)].
o
Educate patients on possible symptoms of infusion reactions during and after infusion and advise them to immediately inform medical staff if they experience such a reaction [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].
BEQVEZ can elevate certain liver enzymes. Baseline and periodic blood tests will be required to assess liver health and bleeding risk. Corticosteroid treatment may be necessary if this occurs, and patients should be encouraged to complete the course as prescribed [see Warnings and Precautions (5.1)].
It is important to maintain or improve hepatic health. Potential hepatotoxic medicinal substances, herbal supplements, and alcohol may reduce the efficacy of BEQVEZ, and the risk of serious hepatic reactions may increase following BEQVEZ administration [see Drug Interactions (7)].
If bleeding occurs following administration of BEQVEZ, then blood tests will be performed for factor IX activity and factor IX inhibitors [see Dosage and Administration (2.3)].
Tapering factor IX concentrates/hemostatic agents may be necessary. Counsel patients on whether and how to continue or restart their use, and on actions in case of invasive procedures, surgery, trauma, or bleeds [see Dosage and Administration (2.3)].
Not all patients may respond to BEQVEZ and that currently it is not possible to predict who will respond and how long the treatment response will continue. Counsel patients, as necessary, on when they may need to re-instate prophylactic use of factor IX concentrates/hemostatic agents [see Dosage and Administration (2.3)].
Vector distribution in blood (within the body), and vector shedding in semen and other excreta and secreta occurs post-infusion. Patients should not donate blood, organs, tissues, or cells for transplantation [see Clinical Pharmacology (12.3)].
Male patients refrain from donating sperm, be abstinent or use a male condom for up to 6 months after receiving BEQVEZ [see Use in Specific Populations (8.3)].
Temporary vector shedding of intravenously administered AAV-based gene therapies occurs primarily through urine and feces, and to some extent saliva, mucus, and semen. Advise patients and/or their caregivers on the proper handling of any materials that have come into contact with patient bodily waste or fluids; recommended procedures include storage of waste material in sealed bags prior to disposal into regular trash. Provide instructions to patients and/or their caregivers regarding proper hand hygiene when coming into direct contact with patient secretions or excretions. These precautions should be followed for 6 months after BEQVEZ infusion [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.3)].
Adjustments to their vaccination schedule may be necessary during corticosteroid use. Inform patients where feasible, if corticosteroid use is needed, their vaccination schedule should be adjusted appropriately.
BEQVEZ is a liver-directed AAV therapy, there may be a theoretical risk of hepatocellular carcinoma. Patients with risk factors of hepatocellular carcinoma should be monitored for 5 years with regular ultrasound and blood tests. No malignancies were observed to date in the BEQVEZ clinical studies. Since the vector can insert into DNA of any cell, other malignancies may also occur [see Warnings and Precautions (5.3)].
They should be enrolled in a 15-year registry to evaluate the long-term efficacy and safety of hemophilia treatments.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For medical information about BEQVEZ, please visit www.pfizermedinfo.com or call 1-800-438-1985.

Manufactured by
Pfizer Inc.
New York, NY 10001
US License No. 2001

Pfizer logo

LAB-1513-1.0

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Medication Guide

17 PATIENT COUNSELING INFORMATION

Inform patients that:

Pre-infusion blood tests will be necessary to look for factor IX inhibitors and detect pre-existing antibodies to AAVRh74var. If these tests are positive the patient will not be a candidate for BEQVEZ [see Dosage and Administration (2)].
Adverse reactions may occur during and after infusion.
o
Inform patients that infusion reactions, including hypersensitivity reactions, may occur. Patients will be monitored during and for at least 3 hours after infusion [see Warnings and Precautions (5.2)].
o
Educate patients on possible symptoms of infusion reactions during and after infusion and advise them to immediately inform medical staff if they experience such a reaction [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].
BEQVEZ can elevate certain liver enzymes. Baseline and periodic blood tests will be required to assess liver health and bleeding risk. Corticosteroid treatment may be necessary if this occurs, and patients should be encouraged to complete the course as prescribed [see Warnings and Precautions (5.1)].
It is important to maintain or improve hepatic health. Potential hepatotoxic medicinal substances, herbal supplements, and alcohol may reduce the efficacy of BEQVEZ, and the risk of serious hepatic reactions may increase following BEQVEZ administration [see Drug Interactions (7)].
If bleeding occurs following administration of BEQVEZ, then blood tests will be performed for factor IX activity and factor IX inhibitors [see Dosage and Administration (2.3)].
Tapering factor IX concentrates/hemostatic agents may be necessary. Counsel patients on whether and how to continue or restart their use, and on actions in case of invasive procedures, surgery, trauma, or bleeds [see Dosage and Administration (2.3)].
Not all patients may respond to BEQVEZ and that currently it is not possible to predict who will respond and how long the treatment response will continue. Counsel patients, as necessary, on when they may need to re-instate prophylactic use of factor IX concentrates/hemostatic agents [see Dosage and Administration (2.3)].
Vector distribution in blood (within the body), and vector shedding in semen and other excreta and secreta occurs post-infusion. Patients should not donate blood, organs, tissues, or cells for transplantation [see Clinical Pharmacology (12.3)].
Male patients refrain from donating sperm, be abstinent or use a male condom for up to 6 months after receiving BEQVEZ [see Use in Specific Populations (8.3)].
Temporary vector shedding of intravenously administered AAV-based gene therapies occurs primarily through urine and feces, and to some extent saliva, mucus, and semen. Advise patients and/or their caregivers on the proper handling of any materials that have come into contact with patient bodily waste or fluids; recommended procedures include storage of waste material in sealed bags prior to disposal into regular trash. Provide instructions to patients and/or their caregivers regarding proper hand hygiene when coming into direct contact with patient secretions or excretions. These precautions should be followed for 6 months after BEQVEZ infusion [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.3)].
Adjustments to their vaccination schedule may be necessary during corticosteroid use. Inform patients where feasible, if corticosteroid use is needed, their vaccination schedule should be adjusted appropriately.
BEQVEZ is a liver-directed AAV therapy, there may be a theoretical risk of hepatocellular carcinoma. Patients with risk factors of hepatocellular carcinoma should be monitored for 5 years with regular ultrasound and blood tests. No malignancies were observed to date in the BEQVEZ clinical studies. Since the vector can insert into DNA of any cell, other malignancies may also occur [see Warnings and Precautions (5.3)].
They should be enrolled in a 15-year registry to evaluate the long-term efficacy and safety of hemophilia treatments.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For medical information about BEQVEZ, please visit www.pfizermedinfo.com or call 1-800-438-1985.

Manufactured by
Pfizer Inc.
New York, NY 10001
US License No. 2001

Pfizer logo

LAB-1513-1.0

Medication Guide

Health Professional Information

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