Kalydeco Oral Tablet 150Mg Drug Medication Dosage Information
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KALYDECO: Oral tablet (150mg)

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Drug Image file DrugItem_15198.JPG
KALYDECO 150mg Tablet
Vertex Pharmaceuticals Inc
Pill Identification: V 150 

What is this Medicine?

IVACAFTOR (EYE va KAF tor) is used to treat cystic fibrosis (CF) in patients who have certain mutations in their CF gene.

In-Depth Information

KALYDECO 150mg Tablet

NDC: 511670200
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Cystic Fibrosis

Storage Information
Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
KALYDECO 150mg Tablet
Drug Image file DrugItem_15198.JPG
Vertex Pharmaceuticals Inc
Pill Identification: V 150 
Shape: oblong
Color: blue

Reported Side Effects for KALYDECO 150mg Tablet

Elevated Hepatic Enzymes Incidence:
2.0-15.0%*
Severity: MODERATE
Onset: DELAYED
Wheezing Incidence:
4.0-7.0%*
Severity: MODERATE
Onset: RAPID
Rhinitis Incidence:
4.0-7.0%*
Severity: MILD
Onset: EARLY
Muscle And/Or Bone Pain Incidence:
4.0-7.0%*
Severity: MILD
Onset: EARLY
Increased Blood Sugar Incidence:
4.0-7.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Pain Incidence:
4.0-7.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
4.0-24.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
4.0-7.0%*
Severity: MILD
Onset: DELAYED
Acne Incidence:
4.0-7.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
5.0-9.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
10.0-13.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
10.0-12.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
15.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
16.0%*
Severity: MILD
Onset: EARLY
Stuffy Nose Incidence:
16.0-20.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
16.0-22.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for KALYDECO 150mg Tablet

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Grapefruit juice and KALYDECO 150mg Tablet(Ivacaftor)
Grapefruit juice and Ivacaftor(Ivacaftor)
Do not take Ivacaftor and grapefruit juice or Seville oranges together. Grapefruit juice and Seville oranges may increase the amount of Ivacaftor in your blood. Side effects from Ivacaftor may get worse if you use grapefruit juice or Seville oranges. Notify your prescriber if you have any new or worsening side effects.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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