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Cinryze®(C1 esterase inhibitor)
Ruconest®(C1 esterase inhibitor)
|Dosage & Administration
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Mechanism of Actions (MoA)
1. Is CINRYZE safe to use during pregnancy?
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.
2. What is the background risk of birth defects and miscarriage in the general U.S. population?
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%.
3. Is there any information on the use of CINRYZE during lactation?
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.
4. Has CINRYZE been tested in pediatric patients?
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.
5. Is CINRYZE suitable for use in geriatric patients?
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.
1. Is RUCONEST safe to use during pregnancy?
There are no adequate and well-controlled studies of RUCONEST in pregnant women. Limited postmarketing data suggest no adverse effects in pregnant women treated with RUCONEST. A retrospective case collection study involving 14 pregnant women who received RUCONEST did not report adverse events related to RUCONEST treatment, and all women delivered healthy babies. However, the data's ability to definitively establish absence of risk is limited due to the study's small sample size and non-randomized design.
2. What do we know about RUCONEST use during lactation?
There is no available data on the presence of RUCONEST in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of RUCONEST, the developmental and health benefits of breastfeeding should be balanced with the mother's clinical need, while also assessing potential adverse effects on the breastfed child from RUCONEST or the maternal condition.
3. Has RUCONEST been tested in pediatric patients?
Yes, the safety and efficacy of RUCONEST were evaluated in 17 adolescent patients aged 13-17 years who were treated for HAE attacks. Some adverse reactions were observed in these patients, with the most common being abdominal pain, headache, and oropharyngeal pain. However, no serious adverse reactions were reported.
4. Is RUCONEST suitable for use in geriatric patients?
Clinical studies of RUCONEST included seven patients older than 65 years, but the number of patients in this age group was insufficient to determine whether they respond differently from younger patients.
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