Firazyr and Orladeyo Comparison

Firazyr®(icatibant)	Orladeyo®(berotralstat)
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...	Prescription Only Orladeyo is prescribed to prevent hereditary angioedema (HAE) attacks in individuals aged 12 and above. It should not be used to treat an ongoing HAE attack. The safety and...
Administration
Subcutaneous. Learn more.	Oral. 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.	One capsule (150 mg) taken orally once daily with food.. 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.	1 capsule po qd w/food.. Learn more.
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
Learn more.	Learn more.
Assistance Expiration
Learn more.	Calendar year. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
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.	Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.. 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.

Firazyr®(icatibant)

Orladeyo®(berotralstat)

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...

Prescription Only

Orladeyo is prescribed to prevent hereditary angioedema (HAE) attacks in individuals aged 12 and above. It should not be used to treat an ongoing HAE attack. The safety and...

Dosage & Administration

Administration

Subcutaneous. Learn more.

Oral. 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.

One capsule (150 mg) taken orally once daily with food.. 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.

1 capsule po qd w/food.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

Annual Cap

Learn more.

Assistance Expiration

Learn more.

Calendar year. Learn more.

Generics

No lower-cost generic available

Physician Advisory

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.

Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.. Learn more.

Mechanism of Actions (MoA)

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.

Firazyr® Alternatives