Trikafta Dosage

General Dosing Information

Swallow the tablets whole.

TRIKAFTA should be taken with fat-containing food. Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs, cheeses, nuts, whole milk, or meats [see Clinical Pharmacology (12.3)].

Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older

The recommended dosage is two tablets (each containing elexacaftor 100 mg, tezacaftor 50 mg and ivacaftor 75 mg) taken in the morning and one ivacaftor tablet (containing ivacaftor 150 mg) taken in the evening, administered orally, approximately 12 hours apart.

Information for Missed Doses:

If 6 hours or less have passed since the missed morning or evening dose, the patient should take the missed dose as soon as possible and continue on the original schedule.

If more than 6 hours have passed since:

• the missed morning dose, the patient should take the missed dose as soon as possible and should not take the evening dose. The next scheduled morning dose should be taken at the usual time.
• the missed evening dose, the patient should not take the missed dose. The next scheduled morning dose should be taken at the usual time.

Morning and evening doses should not be taken at the same time.

Recommended Dosage for Patients with Hepatic Impairment

​No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh Class A) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3), and Patient Counseling Information (17)]. See Table 1. Liver function tests should be closely monitored [see Warnings and Precautions (5.1)].

​Treatment is not recommended for patients with moderate hepatic impairment (Child-Pugh Class B). Use of TRIKAFTA in patients with moderate hepatic impairment should only be considered when there is a clear medical need and the benefit exceeds the risk. If used, TRIKAFTA should be used with caution at a reduced dose (see Table 1) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3), and Patient Counseling Information (17)]. Liver function tests should be closely monitored [see Warnings and Precautions (5.1)].

​TRIKAFTA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), but the exposure is expected to be higher than in patients with moderate hepatic impairment. TRIKAFTA should not be used in patients with severe hepatic impairment.

Dosage Adjustment for Patients Taking Drugs that are CYP3A Inhibitors

Table 2 describes the recommended dosage modification for TRIKAFTA when co-administered with strong (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin) or moderate (e.g., fluconazole, erythromycin) CYP3A inhibitors. Avoid food or drink containing grapefruit during TRIKAFTA treatment [see Warnings and Precautions (5.3), Drug Interactions (7.2), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].