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Lumacaftor/Ivacaftor is available in the following:

• Tablets: lumacaftor 100 mg and ivacaftor 125 mg; lumacaftor 200 mg and
• Ivacaftor 125 mg.
• Oral granules: Unit-dose packets of lumacaftor 75 mg and ivacaftor
• 94 mg; lumacaftor 100 mg and ivacaftor 125 mg; lumacaftor 150 mg and
• Ivacaftor 188 mg.

Lumacaftor/Ivacaftor is a combination medication used to treat cystic fibrosis (CF) in people aged 2 years and older.

Lumacaftor/Ivacaftor is a combination of two medications:

• Ivacaftor is a CFTR potentiator. It works by keeping chloride “gates” on the CFTR protein open so that salt and water can move freely in the lungs. This helps prevent mucus buildup in the lungs.
• Lumacaftor is a CFTR corrector. It works by correcting the shape of the CFTR protein, which is often misshaped in people with CF. Once the CFTR protein forms the correct 3-D shape, it’s able to move to the surface of cells in the body and work properly.

Lumacaftor/Ivacaftor is typically dosed as follows:

• Adults and children age 12 years and older: 2 tablets by mouth every 12 hours with a high-fat meal. Each tablet for this age group contains 200 mg/125 mg (Lumacaftor/Ivacaftor).
• Children age 6 to 11 years old: 2 tablets by mouth every 12 hours with a high-fat meal. Each tablet for this age group contains 100 mg/125 mg (Lumacaftor/Ivacaftor).
• Children younger than 6 years of age: The dose and strength will depend on the child’s age and weight. The typical dose is 1 packet of oral granules by mouth every 12 hours with a high-fat meal. The oral granules come in two strengths: 100 mg/125 mg or 150 mg/188 mg (Lumacaftor/Ivacaftor).

Lumacaftor/Ivacaftor is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Lumacaftor/Ivacaftor:

• Shortness of breath and chest tightness
• Upper respiratory tract infections
• Nausea
• Diarrhea
• Tiredness
• Rash
• Gas
• Flu or flu-like symptoms

Serious side effects are rare with Lumacaftor/Ivacaftor. Contact your healthcare provider immediately if you experience any of the following Liver damage: upper right stomach pain or discomfort, dark-colored urine, pale-colored stools, yellowing of the skin or eyes Hypersensitivity reactions High blood pressure

There are many medications that interact with Lumacaftor/Ivacaftor. Some medications, including Lumacaftor/Ivacaftor, may need to have the dosages adjusted or you might need to stop taking them altogether. Be sure to tell your doctor about all of the medications you take, including prescription drugs, over-the-counter medications, and supplements.

Various FDA-approved generic manufacturers

It is not known whether this medication is safe for you and your unborn baby during pregnancy. Talk to your doctor if you are already pregnant or if you have plans on becoming pregnant. They will recommend what is best for you.

• Orkambi