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XYNTHA® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe Use in Specific Populations (antihemophilic factor [Recombinant])

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

It is not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with XYNTHA.

There is no information available on the effect of factor VIII replacement therapy on labor and delivery. XYNTHA should be used only if clinically indicated.

In the U.S. general population, the estimated background risk of major birth defects 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 XYNTHA in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYNTHA and any potential adverse effects on the breastfed child from XYNTHA or from the underlying maternal condition.

8.4 Pediatric Use

Safety and efficacy with XYNTHA were evaluated in clinical studies in 68 pediatric subjects <17 years of age (18 subjects aged 12 to <17 years, 50 subjects aged ≤12 years). There were no apparent differences in the efficacy and safety in pediatric subjects as compared to adults [see Adverse Reactions (6.1) and Clinical Studies (14)].

In comparison to the pharmacokinetic parameters reported in adults, children have shorter half-lives, larger volumes of distribution and lower recovery of factor VIII after XYNTHA administration. The clearance (based on per kg body weight) is approximately 40% higher in children. Higher or more frequent doses may be required to account for the observed differences in pharmacokinetic parameters [see Clinical Pharmacology (12.3)].

8.5 Geriatric Use

Clinical studies of XYNTHA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

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