Firazyr

Question 1

1. Is it safe to use FIRAZYR during pregnancy?

Accepted Answer

Available data from published literature and the pharmacovigilance database have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with FIRAZYR use in pregnant women. Animal studies showed some effects on fetal development in rabbits at high doses, but no such effects were observed in rats. The estimated background risk of major birth defects and miscarriage in the general population is 2% to 4% and 15% to 20%, respectively.

Question 2

2. What do we know about FIRAZYR use during lactation?

Accepted Answer

There is no data on the presence of icatibant (FIRAZYR) in human milk, its effects on the breastfed infant, or its impact on milk production. Icatibant was found in rat milk following subcutaneous administration, suggesting it might be present in human milk. However, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. When considering the use of FIRAZYR, the potential benefits of breastfeeding for the infant's development and health should be weighed against the mother's clinical need for FIRAZYR and any potential adverse effects on the breastfed child from FIRAZYR or the maternal condition.

Question 3

3. Is FIRAZYR safe for use in pediatric patients?

Accepted Answer

Safety and effectiveness of FIRAZYR have not been established in pediatric patients below the age of 18 years. There is evidence of potential juvenile toxicity in young male rats, including delayed sexual maturation and impaired fertility, but no such effects were observed in females.

Question 4

4. Is FIRAZYR suitable for use in geriatric patients?

Accepted Answer

Clinical studies of FIRAZYR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are likely to have increased systemic exposure to FIRAZYR, but no dose adjustment is recommended as there have been no identified differences in efficacy and safety between elderly and younger patients.

Question 5

5. How does hepatic impairment affect FIRAZYR use?

Accepted Answer

FIRAZYR was studied in patients with mild to moderate hepatic impairment, and no change in systemic exposure was noted. Therefore, no dose adjustment is required in patients with hepatic impairment.

Question 6

6. How does renal impairment affect FIRAZYR use?

Accepted Answer

While a formal renal impairment study has not been conducted, FIRAZYR is cleared non-renally and is not expected to show any change in systemic exposure in patients with impaired renal function. No dose adjustment is required in patients with renal impairment.