Ivacaftor (Oral Route)

Name: Ivacaftor (Oral Route)

Descriptions

Ivacaftor is used to treat cystic fibrosis (CF) in patients 2 years of age and older. It is only used for patients who have the following mutations in the CF transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, or S549R mutations. Your doctor will use a test to check for the mutation before you receive the medicine. This medicine is a CFTR potentiator, and works by moving more chloride into the cells of your body.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Granule
  • Tablet

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

Information about this ivacaftor-oral-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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:

  • Cataracts—Use with caution. May make this condition worse.
  • Kidney disease, severe or
  • Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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 oral dosage forms (granules or tablets):
    • For cystic fibrosis:
      • Adults and children 6 years of age and older—150 milligrams (mg) every 12 hours, taken with fat-containing food.
      • Children 2 to 5 years of age and weighing 14 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually one 75 mg packet every 12 hours, taken with fat-containing food.
      • Children 2 to 5 years of age and weighing less than 14 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually one 50 mg packet every 12 hours, taken with fat-containing food.
      • Children younger than 2 years of age—Use is not recommended.
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