Kalbitor®(Ecallantide)

Ruconest®()

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

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

Subcutaneous. Learn more.

Intravenous. 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.

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

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 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 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 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 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.

Kalbitor®(Ecallantide)	Ruconest®()

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 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
Subcutaneous. Learn more.	Intravenous. 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.	Weight <84 kg: 50 U per kg. Weight ≥84 kg: 4200 U (2 vials).. 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.	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
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
Physician Advisory	Physician Advisory comparison data
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 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 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 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.

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