C1 Esterase Inhibitor, Human (Intravenous Route, Subcutaneous Route)

Name: C1 Esterase Inhibitor, Human (Intravenous Route, Subcutaneous Route)

US Brand Name

  1. Berinert
  2. Cinryze

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Berinert® in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Cinryze® in children 6 years of age and older. Safety and efficacy have been established.

Appropriate studies have not been performed on the relationship of age to the effects of Haegarda® in children 12 years of age and younger. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of Berinert® in the geriatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Haegarda® or Cinryze® in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving Cinryze®.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Atherosclerosis (blood vessel disease) or
  • Blood clots, history of or
  • Heart or blood vessel disease, history of—Use with caution. May make these conditions worse.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For hereditary angioedema:
    • For injection dosage form:
      • Berinert®:
        • Adults and children—Dose is based on body weight and must be determined by a doctor. The usual dose is 20 International Units (IU) per kilogram (kg) of body weight injected into a vein.
      • Cinryze®:
        • Adults and children 12 years of age and older—1000 units (U) injected into a vein every 3 or 4 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2500 U every 3 or 4 days.
        • Children 6 to 11 years of age—500 U injected into a vein every 3 or 4 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1000 U every 3 or 4 days.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • Haegarda®:
        • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 60 units per kilogram (kg) of body weight injected under the skin 2 times a week (every 3 or 4 days).
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.
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