Kalydeco 150 mg

Product Information:

Kalydeco is prescribed for the treatment of cystic fibrosis in patients over 1 month and 3 kg, up to 16 years of age, including adults.

It can be administered to kids above 6 years as a Kalydeco oral tablet. It can also be administered to kids 1 month to under 6 years old as a Kalydeco oral granule.

Cystic fibrosis is a congenital disorder that affects respiration, digestion, and reproduction in people 1 month of age or older.

Kalydeco is only for people with a particular genetic mutation associated with cystic fibrosis. Your doctor may ask for a blood test before deciding whether Kalydeco is an appropriate drug for your condition.

Kalydeco is a class of drugs known as cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. Ivacaftor acts by improving the activity of a protein in the body, which helps reduce the amount of thick mucus built up within the lungs and other symptoms of cystic fibrosis.

How to take Kalydeco:

Use Kalydeco exactly as directed by your doctor. Follow all directions that appear on the prescription label and follow all instructions provided with the medicine. Your doctor may change your dose from time to time.

Swallow the tablet whole without crushing, biting, or breaking it.

Mix the KALYDECO granules with a scoopful of soft food like pureed fruits or vegetables, yogurt, applesauce, water, breast milk, infant formula, milk, or juice. Mix a dose at a time and administer it within 1 hour. Administer a high-fat food to the child before or after giving the mixture.

Kalydeco should be taken at regular intervals, 12 hours apart.

Dose is based on body weight in children. Also, your child’s dose may be adjusted if his or her body weight changes.

You will require frequent blood tests to determine your liver function.

Your child will require regular vision testing.
Store the medicine in room temperature, away from moisture and heat. Always store the medications in the original packing.

Uses:

For use in the treatment of cystic fibrosis in patients with one mutation in the cystic fibrosis transmembrane conductance regulator gene that can be corrected by ivacaftor potentiation, based on clinical and/or in vitro test results.
Typical Pediatric Dosages for Cystic Fibrosis:
Oral Granules:

Age: 4 months to less than 6 months:
Weighing:5 kg or more: Dosage: 25 mg every 12 hours Consumer Information:
Its use is contraindicated in situations of accompanying hepatic impairment as well as with concurrent moderate or strong inhibitors of CYP450 3A enzymatic activity

Age: 6 months or older?:
Weight: 5 to Less than 7 kg: 25 mg orally every 12 hours
Zidovudine Dose
Weight: 7 to less than 14 kg: 50 mg orally every 12

Gross body weight:
14 kg or greater
75 mg orally every 12 hours
Oral Tablet:

Age: Over 6 years: 150 mg orally every 12 hours

Dosing information:

Usual Adult Dose for Cystic Fibrosis:

150 mg orally every 12 hours with fat-containing food

Warnings:

Before you start taking Kalydeco, inform your doctor about liver and kidney conditions.

Kalydeco must be co-administered with a fatty food source. This may include foods such as butter, peanut butter, eggs, cheese pizza, or whole-milk dairy products like whole milk, cheese, and yogurt. These must each be followed strictly according to the physician’s advice.

Grapefruit, grapefruit juice, and oranges used in preparing Seville oranges may interact with Kalydeco. Therefore, the consumption of grapefruit or oranges should be put into perspective when consulting a doctor.

Of course, it is a good idea that, to make sure Kalydeco is not causing harmful side effects, your liver functions may need to be evaluated by regular blood tests. There are various other medications that interact with ivacaftor. Be sure to discuss all of the medications you are taking with your physician. These include prescription drugs, non-prescription medications, vitamins, and herbs. Do not take any new medications without first speaking with your physician.

Kalydeco Side Effects:

Seek emergency medical attention if you have any of these signs of an allergic reaction to Kalydeco:

hives; difficulty breathing;

swelling of your face, lips,

tongue, or throat.

Kalydeco can cause severe side effects. If any of these symptoms occur, a person should contact their doctor immediately: blurred vision, eye pain or redness, vision of halos around lights. low blood sugar–headache, hunger, weakness, sweating, confusion, irritability, dizziness, rapid heart rate, or shaky feeling; or Liver problems: loss of appetite, nausea, vomiting, stomach pain – upper right quadrant, fatigue, itching, dark urine, pale or light-colored stool, jaundice: yellowing of the skin or eyes.