Berinert and Ruconest Comparison

Berinert®(C1 esterase inhibitor (human))	Ruconest®(C1 esterase inhibitor (recombinant))
Prescription Only Berinert is a synthetic version of a protein naturally found in the bloodstream, which plays a role in regulating swelling within the body. Individuals with hereditary angioedema...	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....
Administration
Intravenous. Learn more.	Intravenous. Learn more.
Dosing
Administer 20 International Units per kg body weight.. Learn more.	Weight <84 kg: 50 U per kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.
Latin Shorthand
Administer 20 IU/kg BW.. Learn more.	Weight <84 kg: 50 U/kg. Weight ≥84 kg: 4200 U (2 vials).. Learn more.
Out-Of-Pocket Costs With Copay Card
Learn more.	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 serious adverse reaction reported in subjects who received BERINERT was an increase in the severity of pain associated with HAE. •The most common adverse reaction reported in greater than 4% of the subjects and greater than placebo among subjects who received BERINERT in the placebo-controlled clinical trial was dysgeusia.. 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.

Berinert®(C1 esterase inhibitor (human))

Ruconest®(C1 esterase inhibitor (recombinant))

Prescription Only

Berinert is a synthetic version of a protein naturally found in the bloodstream, which plays a role in regulating swelling within the body. Individuals with hereditary angioedema...

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

Intravenous. Learn more.

Dosing

Administer 20 International Units per kg body weight.. Learn more.

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

Latin Shorthand

Administer 20 IU/kg BW.. 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

Learn more.

Annual Cap

Learn more.

Assistance Expiration

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

The most serious adverse reaction reported in subjects who received BERINERT was an increase in the severity of pain associated with HAE. •The most common adverse reaction reported in greater than 4% of the subjects and greater than placebo among subjects who received BERINERT in the placebo-controlled clinical trial was dysgeusia.. 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.

Berinert® Alternatives