Kalbitor and Firazyr Comparison

Kalbitor®(ecallantide)	Firazyr®(icatibant)
Prescription Only Kalbitor is employed to manage hereditary angioedema attacks, an immune system disorder. It is suitable for adults and children aged 12 years and older. It's important to note...	Prescription Only Firazyr is employed to address hereditary angioedema attacks, an immune system disorder, in adults. It's important to note that Firazyr does not provide a cure for hereditary...
Administration
Subcutaneous. Learn more.	Subcutaneous. Learn more.
Dosing
30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. . Learn more.	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.
Latin Shorthand
30 mg (3 mL), administered SC in three 10 mg (1 mL) injections. If the attack persists, an additional 30 mg dose can be given within 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
Learn more.	$0. Learn more.
Annual Cap
Learn more.	Learn more.
Assistance Expiration
Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
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.	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)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations
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.	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.

Kalbitor®(ecallantide)

Firazyr®(icatibant)

Prescription Only

Kalbitor is employed to manage hereditary angioedema attacks, an immune system disorder. It is suitable for adults and children aged 12 years and older. It's important to note...

Prescription Only

Firazyr is employed to address hereditary angioedema attacks, an immune system disorder, in adults. It's important to note that Firazyr does not provide a cure for hereditary...

Dosage & Administration

Administration

Subcutaneous. Learn more.

Dosing

30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. . Learn more.

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.

Latin Shorthand

30 mg (3 mL), administered SC in three 10 mg (1 mL) injections. If the attack persists, an additional 30 mg dose can be given within 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.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

Learn more.

$0. Learn more.

Annual Cap

Learn more.

Assistance Expiration

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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.

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)

Drugs used in Hereditary Angioedema. Learn more.

Special Populations

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.

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.

Kalbitor® Alternatives