Haegarda and Orladeyo Comparison

Haegarda®(C1 esterase inhibitor (human))	Orladeyo®(berotralstat)
Prescription Only Haegarda is a synthetic version of a blood protein that regulates swelling in the body. Individuals with Hereditary Angioedema (HAE) lack sufficient levels of this protein,...	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
Administer 60 International Units per kg body weight twice weekly (every 3 or 4 days).. Learn more.	One capsule (150 mg) taken orally once daily with food.. Learn more.
Latin Shorthand
Administer 60 IU/kg BW BID (q3-4d).. Learn more.	1 capsule po qd w/food.. Learn more.
Out-Of-Pocket Costs With Copay Card
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
Adverse reactions occurring in more than 4% of subjects treated with HAEGARDA were injection site reactions, hypersensitivity, nasopharyngitis and dizziness.. 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 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.

Haegarda®(C1 esterase inhibitor (human))

Orladeyo®(berotralstat)

Prescription Only

Haegarda is a synthetic version of a blood protein that regulates swelling in the body. Individuals with Hereditary Angioedema (HAE) lack sufficient levels of this protein,...

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

Administer 60 International Units per kg body weight twice weekly (every 3 or 4 days).. Learn more.

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

Latin Shorthand

Administer 60 IU/kg BW BID (q3-4d).. Learn more.

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

Financial Assistance

Out-Of-Pocket Costs With Copay Card

Learn more.

$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

Adverse reactions occurring in more than 4% of subjects treated with HAEGARDA were injection site reactions, hypersensitivity, nasopharyngitis and dizziness.. 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 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.

Haegarda® Alternatives