Orladeyo®(Berotralstat Hydrochloride)

Ruconest®()

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...

Prescription Only

Ruconest is a synthetic version of the naturally occurring c1 esterase inhibitor protein in the bloodstream, which plays a crucial role in regulating swelling in the body....

Dosage & Administration

Administration

Oral. Learn more.

Intravenous. Learn more.

Dosing

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

Weight <84 kg: 50 U per kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.

Latin Shorthand

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

Weight <84 kg: 50 U/kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

Learn more.

Annual Cap

Learn more.

Assistance Expiration

Calendar year. Learn more.

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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

The serious adverse reaction reported in clinical trials was anaphylactic reaction. The common adverse reactions (≥ 2%) reported in clinical trials were headache, nausea, and diarrhea.. Learn more.

Mechanism of Actions (MoA)

Drugs used in Hereditary Angioedema. Learn more.

Special Populations

1. Is RUCONEST safe to use during pregnancy?

There are no adequate and well-controlled studies of RUCONEST in pregnant women. Limited postmarketing data suggest no adverse effects in pregnant women treated with RUCONEST. A retrospective case collection study involving 14 pregnant women who received RUCONEST did not report adverse events related to RUCONEST treatment, and all women delivered healthy babies. However, the data's ability to definitively establish absence of risk is limited due to the study's small sample size and non-randomized design.

2. What do we know about RUCONEST use during lactation?

There is no available data on the presence of RUCONEST in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of RUCONEST, the developmental and health benefits of breastfeeding should be balanced with the mother's clinical need, while also assessing potential adverse effects on the breastfed child from RUCONEST or the maternal condition.

3. Has RUCONEST been tested in pediatric patients?

Yes, the safety and efficacy of RUCONEST were evaluated in 17 adolescent patients aged 13-17 years who were treated for HAE attacks. Some adverse reactions were observed in these patients, with the most common being abdominal pain, headache, and oropharyngeal pain. However, no serious adverse reactions were reported.

4. Is RUCONEST suitable for use in geriatric patients?

Clinical studies of RUCONEST included seven patients older than 65 years, but the number of patients in this age group was insufficient to determine whether they respond differently from younger patients.

Orladeyo®(Berotralstat Hydrochloride)	Ruconest®()

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...	Prescription Only Ruconest is a synthetic version of the naturally occurring c1 esterase inhibitor protein in the bloodstream, which plays a crucial role in regulating swelling in the body....
Dosage & Administration	Dosage & Administration comparison data
Administration
Oral. Learn more.	Intravenous. Learn more.
Dosing
One capsule (150 mg) taken orally once daily with food.. Learn more.	Weight <84 kg: 50 U per kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.
Latin Shorthand
1 capsule po qd w/food.. Learn more.	Weight <84 kg: 50 U/kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	Learn more.
Annual Cap
Learn more.	Learn more.
Assistance Expiration
Calendar year. Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.. Learn more.	The serious adverse reaction reported in clinical trials was anaphylactic reaction. The common adverse reactions (≥ 2%) reported in clinical trials were headache, nausea, and diarrhea.. Learn more.
Mechanism of Actions (MoA)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations
	1. Is RUCONEST safe to use during pregnancy? There are no adequate and well-controlled studies of RUCONEST in pregnant women. Limited postmarketing data suggest no adverse effects in pregnant women treated with RUCONEST. A retrospective case collection study involving 14 pregnant women who received RUCONEST did not report adverse events related to RUCONEST treatment, and all women delivered healthy babies. However, the data's ability to definitively establish absence of risk is limited due to the study's small sample size and non-randomized design. 2. What do we know about RUCONEST use during lactation? There is no available data on the presence of RUCONEST in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of RUCONEST, the developmental and health benefits of breastfeeding should be balanced with the mother's clinical need, while also assessing potential adverse effects on the breastfed child from RUCONEST or the maternal condition. 3. Has RUCONEST been tested in pediatric patients? Yes, the safety and efficacy of RUCONEST were evaluated in 17 adolescent patients aged 13-17 years who were treated for HAE attacks. Some adverse reactions were observed in these patients, with the most common being abdominal pain, headache, and oropharyngeal pain. However, no serious adverse reactions were reported. 4. Is RUCONEST suitable for use in geriatric patients? Clinical studies of RUCONEST included seven patients older than 65 years, but the number of patients in this age group was insufficient to determine whether they respond differently from younger patients.

Orladeyo® Alternatives