Pediatric and pregnancy information from HAEGARDA clinical trials

There are no prospective clinical data from HAEGARDA use in pregnant women

There is no information regarding the excretion of HAEGARDA 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 HAEGARDA and any potential adverse effects on the breastfed infant.

Pediatrics

In the COMPACT Phase 3 pivotal study and the COMPACT open-label extension study, the safety and effectiveness of HAEGARDA were evaluated in a subgroup of 9 patients 8 to <17 years of age
Results of subgroup analysis by age were consistent with overall study results

Pregnancy

In the COMPACT open-label extension study, 4 pregnant women with type I HAE and ranging in age from 19 to 32 years received HAEGARDA
Patients received 40–60 IU/kg per S.C. administration for 4–8 weeks (9–15 doses) during the first trimester
These women reported no complications during delivery and all women delivered healthy babies

To find additional data on the use of C1-INH during pregnancy and lactation, refer to section 8 of the prescribing information.

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