Cinryze®()

Kalbitor®(Ecallantide)

Prescription Only

Cinryze is a synthetic version of a protein found naturally in the bloodstream, which plays a vital role in regulating inflammation in the body. Individuals with a condition known...

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...

Dosage & Administration

Administration

Intravenous. Learn more.

Subcutaneous. Learn more.

Dosing

Adults and Children >12: 1,000 IU Intravenous every 3 or 4 days. Children 6-11: 500 IU Intravenous every 3 or 4 days.. Learn more.

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.

Latin Shorthand

Adults and Children >12: 1,000 IU IV q3-4d. Children 6-11: 500 IU IV q3-4d.. Learn more.

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.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

Learn more.

Annual Cap

$40,000. Learn more.

Learn more.

Assistance Expiration

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

The most common adverse reactions (≥5%) observed were headache, nausea, rash, vomiting, and fever.. Learn more.

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.

Mechanism of Actions (MoA)

Drugs used in Hereditary Angioedema. Learn more.

Special Populations

1. Is CINRYZE safe to use during pregnancy?

There are no specific data available regarding the use of CINRYZE in pregnant women. Animal studies have not been conducted to assess its effects on pregnancy. Whether CINRYZE can cause harm to a developing fetus or affect reproductive capacity in pregnant women is unknown. It should only be administered to a pregnant woman if it is clearly needed.

2. What is the background risk of birth defects and miscarriage in the general U.S. population?

In the U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4%, and the risk of miscarriage is estimated to be 15 to 20%.

3. Is there any information on the use of CINRYZE during lactation?

There is no available data regarding the presence of CINRYZE in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of CINRYZE, the benefits of breastfeeding, both for the infant's development and the mother's clinical need, should be weighed against any potential adverse effects on the breastfed child.

4. Has CINRYZE been tested in pediatric patients?

Yes, the safety and effectiveness of CINRYZE have been evaluated in pediatric subjects with hereditary angioedema (HAE) aged 7 to 11 years old. Additionally, some subjects under the age of 18 were included in trials, and overall, the safety and tolerability of CINRYZE were found to be similar in pediatric, adolescent, and adult subjects. The pharmacokinetics of CINRYZE were also assessed in pediatric subjects aged 7 to 11 years old.

5. Is CINRYZE suitable for use in geriatric patients?

Clinical studies of CINRYZE did not include a sufficient number of subjects aged 65 and over to determine if they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients. Dosing for an elderly patient should be cautious, typically starting at the lower end of the dosing range, considering the higher likelihood of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies.

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.

Cinryze®()	Kalbitor®(Ecallantide)

Prescription Only Cinryze is a synthetic version of a protein found naturally in the bloodstream, which plays a vital role in regulating inflammation in the body. Individuals with a condition known...	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...
Dosage & Administration	Dosage & Administration comparison data
Administration
Intravenous. Learn more.	Subcutaneous. Learn more.
Dosing
Adults and Children >12: 1,000 IU Intravenous every 3 or 4 days. Children 6-11: 500 IU Intravenous every 3 or 4 days.. Learn more.	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.
Latin Shorthand
Adults and Children >12: 1,000 IU IV q3-4d. Children 6-11: 500 IU IV q3-4d.. Learn more.	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.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	Learn more.
Annual Cap
$40,000. 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 (≥5%) observed were headache, nausea, rash, vomiting, and fever.. Learn more.	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.
Mechanism of Actions (MoA)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations
1. Is CINRYZE safe to use during pregnancy? There are no specific data available regarding the use of CINRYZE in pregnant women. Animal studies have not been conducted to assess its effects on pregnancy. Whether CINRYZE can cause harm to a developing fetus or affect reproductive capacity in pregnant women is unknown. It should only be administered to a pregnant woman if it is clearly needed. 2. What is the background risk of birth defects and miscarriage in the general U.S. population? In the U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4%, and the risk of miscarriage is estimated to be 15 to 20%. 3. Is there any information on the use of CINRYZE during lactation? There is no available data regarding the presence of CINRYZE in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of CINRYZE, the benefits of breastfeeding, both for the infant's development and the mother's clinical need, should be weighed against any potential adverse effects on the breastfed child. 4. Has CINRYZE been tested in pediatric patients? Yes, the safety and effectiveness of CINRYZE have been evaluated in pediatric subjects with hereditary angioedema (HAE) aged 7 to 11 years old. Additionally, some subjects under the age of 18 were included in trials, and overall, the safety and tolerability of CINRYZE were found to be similar in pediatric, adolescent, and adult subjects. The pharmacokinetics of CINRYZE were also assessed in pediatric subjects aged 7 to 11 years old. 5. Is CINRYZE suitable for use in geriatric patients? Clinical studies of CINRYZE did not include a sufficient number of subjects aged 65 and over to determine if they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between the elderly and younger patients. Dosing for an elderly patient should be cautious, typically starting at the lower end of the dosing range, considering the higher likelihood of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies.	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.

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