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Ruconest®(C1 esterase inhibitor)
|Dosage & Administration
30 mg injected subcutaneously in the abdominal area. If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. Do not administer more than 3 injections in 24 hours.. Learn more.
Administer 30 mg SC in the abdominal area. If insufficient response or symptom recurrence, give additional 30 mg injections at intervals of at least 6 hours. Do not exceed 3 injections within 24 hours.. Learn more.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.. Learn more.
Mechanism of Actions (MoA)
1. Is it safe to use FIRAZYR during pregnancy?
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.
2. What do we know about FIRAZYR use during lactation?
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.
3. Is FIRAZYR safe for use in pediatric patients?
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.
4. Is FIRAZYR suitable for use in geriatric patients?
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.
5. How does hepatic impairment affect FIRAZYR use?
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.
6. How does renal impairment affect FIRAZYR use?
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.
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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