Generic name: lumacaftor 200mg, ivacaftor 125mg
Dosage form: tablet, film coated
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2.1 Dosing Information in Adults and Children Age 6 Years and Older
|Age||ORKAMBI Dose||Total Daily Dose|
|6 through 11 years||Take two lumacaftor 100 mg/ivacaftor 125 mg tablets every 12 hours with fat-containing food.||lumacaftor 400 mg/ivacaftor 500 mg|
|12 years and older||Take two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours with fat-containing food.||lumacaftor 800 mg/ivacaftor 500 mg|
Examples of appropriate fat-containing foods include eggs, avocados, nuts, butter, peanut butter, cheese pizza, whole-milk dairy products (such as whole milk, cheese, and yogurt), etc. If a patient misses a dose and remembers the missed dose within 6 hours, the patient should take the dose with fat-containing food. If more than 6 hours elapsed after the usual dosing time, the patient should skip that dose and resume the normal schedule for the following dose. A double dose should not be taken to make up for the forgotten dose [see Clinical Pharmacology (12.3) and Patient Counseling Information (17)].
Dosage Adjustment for Patients with Hepatic Impairment
No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A). A dose reduction to 2 tablets in the morning and 1 tablet in the evening is recommended for patients with moderate hepatic impairment (Child-Pugh Class B).
Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C), but exposure is expected to be higher than in patients with moderate hepatic impairment. Therefore, use with caution at a maximum dose of 1 tablet in the morning and 1 tablet in the evening, or less, in patients with severe hepatic impairment after weighing the risks and benefits of treatment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].
Dosage Adjustment for Patients Taking CYP3A Inhibitors
No dose adjustment is necessary when CYP3A inhibitors are initiated in patients already taking ORKAMBI. However, when initiating ORKAMBI in patients currently taking strong CYP3A inhibitors (e.g., itraconazole), reduce ORKAMBI dose to 1 tablet daily for the first week of treatment. Following this period, continue with the recommended daily dose.
If ORKAMBI is interrupted for more than 1 week and then re-initiated while taking strong CYP3A inhibitors, patients should reduce ORKAMBI dose to 1 tablet daily for the first week of treatment re-initiation. Following this period, continue with the recommended daily dose.
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