Proper Use

Drug information provided by: IBM Micromedex

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with fat-containing foods such as avocado, butter, cheese pizza, eggs, nuts, peanut butter, or whole milk dairy products (eg, whole milk, cheese, yogurt).

If you are using the granules, mix the entire content of each packet with 1 teaspoon (5 milliliters [mL]) of cool to room temperature soft food (eg, puréed fruits, flavored yogurt, pudding) or liquid (eg, milk, juice). Take this mixture within 1 hour.

Tell your doctor if you stopped taking this medicine for more than 1 week. Your doctor may need to change your dose of Orkambi® or other medicines you take.

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 form (granules, tablets):
    • For cystic fibrosis:
      • Adults and children 12 years of age and older—2 tablets every 12 hours, taken with fat-containing food. Each tablet contains 200 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children 6 to 11 years of age—2 tablets every 12 hours, taken with fat-containing food. Each tablet contains 100 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children 2 to 5 years of age and weighing 14 kilograms (kg) or more—1 packet of granules every 12 hours, taken with fat-containing food. Each packet contains 150 milligrams (mg) lumacaftor and 188 mg ivacaftor.
      • Children 2 to 5 years of age and weighing less than 14 kg—1 packet of granules every 12 hours, taken with fat-containing food. Each packet contains 100 milligrams (mg) lumacaftor and 125 mg ivacaftor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is 6 hours or less from the time you normally take your medicine, take a dose as soon as you can. If it is more than 6 hours, wait until then to use the medicine and skip the missed dose. Do not take extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.