Firazyr®(Icatibant Acetate) | Haegarda®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Subcutaneous. Learn more. | Subcutaneous . Learn more. |
Dosing | |
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 60 International Units per kg body weight twice weekly (every 3 or 4 days).. Learn more. |
Latin Shorthand | |
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. | Administer 60 IU/kg BW BID (q3-4d).. Learn more. |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
Assistance Expiration | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
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. | Adverse reactions occurring in more than 4% of subjects treated with HAEGARDA
were injection site reactions, hypersensitivity, nasopharyngitis and dizziness.. Learn more. |
Mechanism of Actions (MoA) | |
Drugs used in Hereditary Angioedema. Learn more. | Drugs used in Hereditary Angioedema. Learn more. |
Special Populations | |
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 it safe to use HAEGARDA during pregnancy? There are no prospective clinical data from HAEGARDA use in pregnant women. However, limited retrospective data suggest that C1-INH treatment during pregnancy did not lead to adverse events. The estimated background risk of birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively. 2. What is known about HAEGARDA use during lactation? There is no information available about the presence of HAEGARDA in human milk, its impact on breastfed infants, or its effects on milk production. The decision to breastfeed should consider the benefits of breastfeeding and the mother's clinical need for HAEGARDA, while also evaluating potential adverse effects on the breastfed infant. 3. Has HAEGARDA been tested in pediatric patients? Yes, the safety and effectiveness of HAEGARDA were evaluated in a subgroup of patients aged 8 to <17 years in clinical trials, and the results were consistent with overall study results. 4. Is HAEGARDA suitable for use in geriatric patients? Clinical studies of HAEGARDA did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. However, reported clinical experience has not identified differences in responses between the elderly and younger patients. Dosing for elderly patients should be cautious and typically start at the lower end of the dosing range, considering factors like decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies. |