Cinryze

Question 1

1. Is CINRYZE safe to use during pregnancy?

Accepted Answer

There are no specific data available regarding the use of CINRYZE in pregnant women. Animal studies have not been conducted to assess its effects on pregnancy. Whether CINRYZE can cause harm to a developing fetus or affect reproductive capacity in pregnant women is unknown. It should only be administered to a pregnant woman if it is clearly needed.

Question 2

2. What is the background risk of birth defects and miscarriage in the general U.S. population?

Accepted Answer

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

Question 3

3. Is there any information on the use of CINRYZE during lactation?

Accepted Answer

There is no available data regarding the presence of CINRYZE in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of CINRYZE, the benefits of breastfeeding, both for the infant's development and the mother's clinical need, should be weighed against any potential adverse effects on the breastfed child.

Question 4

4. Has CINRYZE been tested in pediatric patients?

Accepted Answer

Yes, the safety and effectiveness of CINRYZE have been evaluated in pediatric subjects with hereditary angioedema (HAE) aged 7 to 11 years old. Additionally, some subjects under the age of 18 were included in trials, and overall, the safety and tolerability of CINRYZE were found to be similar in pediatric, adolescent, and adult subjects. The pharmacokinetics of CINRYZE were also assessed in pediatric subjects aged 7 to 11 years old.

Question 5

5. Is CINRYZE suitable for use in geriatric patients?

Accepted Answer

Clinical studies of CINRYZE did not include a sufficient number of subjects aged 65 and over to determine if they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients. Dosing for an elderly patient should be cautious, typically starting at the lower end of the dosing range, considering the higher likelihood of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies.

Indication	Dose	Infusion rate
* Doses up to 2,000 IU (not exceeding 80 IU/kg) every 3 or 4 days may be considered based on individual patient response.
Routine prophylaxis against HAE attacks	1,000 IU Intravenous every 3 or 4 days *	1 mL/min (10 min)

Indication	Dose	Infusion rate
* Doses up to 1,000 IU every 3 or 4 days may be considered based on individual patient response.
Routine prophylaxis against HAE attacks	500 IU Intravenous every 3 or 4 days *	1 mL/min (5 min)

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