Trikafta Dosage
Generic name: Elexacaftor 100mg, Tezacaftor 50mg, Ivacaftor 75mg; Ivacaftor 150mg
Dosage form: kit
Drug class: CFTR combinations
Medically reviewed by Drugs.com. Last updated on Dec 26, 2024.
Recommended Laboratory Testing Prior to TRIKAFTA Initiation and During Treatment
Prior to initiating TRIKAFTA, obtain liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) for all patients. Monitor liver function tests every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test elevations at baseline.
Recommended Dosage in Adults and Pediatric Patients Aged 2 Years and Older
Recommended dosage for adult and pediatric patients aged 2 years and older is provided in Table 1. Administer TRIKAFTA tablets (swallow the tablets whole) or oral granules orally with fat-containing food, in the morning and in the evening approximately 12 hours apart. Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs, peanut butter, cheeses, nuts, whole milk, or meats.
Administer each dose of TRIKAFTA oral granules immediately before or after ingestion of fat-containing food. Mix entire contents of each packet of oral granules with one teaspoon (5 mL) of age-appropriate soft food or liquid that is at or below room temperature. Some examples of soft food or liquids include pureed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Once mixed, the product should be consumed completely within one hour.
Age | Weight | Oral Morning Dose | Oral Evening Dose |
---|---|---|---|
2 to less than 6 years | Less than 14 kg | One packet (containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) oral granules | One packet (containing ivacaftor 59.5 mg) oral granules |
14 kg or more | One packet (containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) oral granules | One packet (containing ivacaftor 75 mg) oral granules | |
6 to less than 12 years | Less than 30 kg | Two tablets of elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg (total dose of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) | One tablet of ivacaftor 75 mg |
30 kg or more | Two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg) | One tablet of ivacaftor 150 mg | |
12 years and older | — | Two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg) | One tablet of ivacaftor 150 mg |
Recommended Dosage for Patients with Hepatic Impairment
- Severe Hepatic Impairment (Child-Pugh Class C): Should not be used. 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.
- Moderate Hepatic Impairment (Child-Pugh Class B): Treatment is not recommended. Use of TRIKAFTA in patients with moderate hepatic impairment should only be considered when there is a clear medical need, and the benefit outweighs the risk. If used, TRIKAFTA should be used with caution at a reduced dose (see Table 2). Liver function tests should be closely monitored. Recommended dosage for patients with moderate hepatic impairment (Child-Pugh Class B) is provided in Table 2.
Age | Weight | Oral Morning Dose | Oral Evening Dose |
---|---|---|---|
2 to less than 6 years | Less than 14 kg | Weekly dosing schedule is as follows:
|
No evening dose of ivacaftor oral granules. |
14 kg or more | Weekly dosing schedule is as follows:
|
No evening dose of ivacaftor oral granules. | |
6 to less than 12 years | Less than 30 kg | Alternating daily dosing schedule is as follows:
|
No evening ivacaftor tablet dose. |
30 kg or more | Alternating daily dosing schedule is as follows:
|
No evening ivacaftor tablet dose. | |
12 years and older | — | Alternating daily dosing schedule is as follows:
|
No evening ivacaftor tablet dose. |
- Mild Hepatic Impairment (Child-Pugh Class A): No dose adjustment is recommended. See Table 1 for recommended dosage of TRIKAFTA. Liver function tests should be closely monitored.
Dosage Modification for Patients Taking Drugs that are CYP3A Inhibitors
Table 3 describes the recommended dosage modification for TRIKAFTA when used concomitantly with strong (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin) or moderate (e.g., fluconazole, erythromycin) CYP3A inhibitors. Administer TRIKAFTA orally with fat-containing food. Avoid food or drink containing grapefruit during TRIKAFTA treatment.
Age | Weight | Moderate CYP3A Inhibitors | Strong CYP3A Inhibitors |
---|---|---|---|
2 to less than 6 years | Less than 14 kg | Alternating daily dosing schedule is as follows:
|
One packet (containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) in the morning twice a week, approximately 3 to 4 days apart. No evening packet of ivacaftor oral granules. |
14 kg or more | Alternating daily dosing schedule is as follows:
|
One packet (containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) in the morning twice a week, approximately 3 to 4 days apart. No evening packet of ivacaftor oral granules. |
|
6 to less than 12 years | Less than 30 kg | Alternating daily dosing schedule is as follows:
|
Two tablets of elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg (total dose of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) in the morning twice a week, approximately 3 to 4 days apart. No evening ivacaftor tablet dose. |
30 kg or more | Alternating daily dosing schedule is as follows:
|
Two tablets elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg) in the morning twice a week, approximately 3 to 4 days apart. No evening ivacaftor tablet dose. |
|
12 years and older | Alternating daily dosing schedule is as follows:
|
Two tablets elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg) in the morning twice a week, approximately 3 to 4 days apart. No evening ivacaftor tablet dose. |
Recommendations Regarding Missed Dose(s)
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.
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