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Haegarda®(C1 esterase inhibitor)
|Dosage & Administration
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
The most common adverse reactions occurring in ≥3% of KALBITOR-treated patients and greater than placebo are headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.. Learn more.
Mechanism of Actions (MoA)
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.
1. Is it safe to use KALBITOR during pregnancy?
Available data from the pharmacovigilance database for KALBITOR have not indicated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies showed some effects on fetal development in rats at higher doses, but no such effects were observed in rabbits. 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 KALBITOR use during lactation?
There is no data available on the presence of ecallantide (KALBITOR) in human milk, its effects on the breastfed infant, or its impact on milk production. When considering the use of KALBITOR, the potential benefits of breastfeeding for the infant's development and health should be weighed against the mother's clinical need for KALBITOR, while also assessing potential adverse effects on the breastfed child from KALBITOR or the maternal condition.
3. Is KALBITOR safe for use in pediatric patients?
The safety and effectiveness of KALBITOR have been established in patients aged 12 to 17 years. The safety profile observed in pediatric patients aged 12-17 years was similar to the adverse reactions observed in the overall clinical trial population. However, the safety and effectiveness of KALBITOR have not been established in patients less than 12 years of age.
4. Is KALBITOR suitable for use in geriatric patients?
Clinical trials of KALBITOR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, taking into account the higher likelihood of decreased hepatic, renal, or cardiac function, and the presence of concomitant diseases or other drug therapy.
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