BENEFIX® Use in Specific Populations

(Coagulation Factor IX (Recombinant))

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no data with BeneFIX use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with BeneFIX. It is not known whether BeneFIX can affect reproductive capacity or cause fetal harm when given to pregnant women.

In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

8.2 Lactation

Risk Summary

There is no information regarding the presence of BeneFIX in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BeneFIX and any potential adverse effects on the breastfed child from BeneFIX or from the underlying maternal condition.

8.4 Pediatric Use

Safety, efficacy, and pharmacokinetics of BeneFIX have been evaluated in previously treated (PTP) and previously untreated pediatric patients (PUP) [see Clinical Studies (14) and Adverse Reactions (6)]. On average, lower recovery, shorter half-life and higher clearance (based on kg body weight) have been observed in children younger than 12 years old [see Clinical Pharmacology (12.3)]. Dose adjustment may be needed [see Dosage and Administration (2.1)].

8.5 Geriatric Use

Clinical trials of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be individualized [see Dosage and Administration (2.1)].

Find BENEFIX® medical information:

Find BENEFIX® 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.

BENEFIX® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no data with BeneFIX use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with BeneFIX. It is not known whether BeneFIX can affect reproductive capacity or cause fetal harm when given to pregnant women.

In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

8.2 Lactation

Risk Summary

There is no information regarding the presence of BeneFIX in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BeneFIX and any potential adverse effects on the breastfed child from BeneFIX or from the underlying maternal condition.

8.4 Pediatric Use

Safety, efficacy, and pharmacokinetics of BeneFIX have been evaluated in previously treated (PTP) and previously untreated pediatric patients (PUP) [see Clinical Studies (14) and Adverse Reactions (6)]. On average, lower recovery, shorter half-life and higher clearance (based on kg body weight) have been observed in children younger than 12 years old [see Clinical Pharmacology (12.3)]. Dose adjustment may be needed [see Dosage and Administration (2.1)].

8.5 Geriatric Use

Clinical trials of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be individualized [see Dosage and Administration (2.1)].
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.