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Trikafta Dosage

Drug Detail:Trikafta (Elexacaftor, ivacaftor, and tezacaftor)

Generic Name: Elexacaftor 100mg, Tezacaftor 50mg, Ivacaftor 75mg; Ivacaftor 150mg

Dosage Form: kit

Drug Class: CFTR combinations

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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. The morning and the evening dose should be taken approximately 12 hours apart. TRIKAFTA is for oral use.

Table 1: Recommended Dosage of TRIKAFTA for Adult and Pediatric Patients Aged 2 Years and Older
​Age Weight Morning Dose 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

  • Mild Hepatic Impairment (Child-Pugh Class A): No dose adjustment is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. See Table 1 for recommended dosage of TRIKAFTA. Liver function tests should be closely monitored [see Warnings and Precautions (5.1) and Adverse Reactions (6)].
  • 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 exceeds the risk. If used, TRIKAFTA should be used with caution at a reduced dose (see Table 2) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Liver function tests should be closely monitored [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Recommended dosage for patients with moderate hepatic impairment (Child-Pugh Class B) is provided in Table 2.
Table 2: Recommended Dosage of TRIKAFTA, if used, in Patients with Moderate Hepatic Impairment (Child-Pugh Class B)
Age Weight Morning Dose Evening Dose
2 to less than 6 years Less than 14 kg Weekly dosing schedule as follows:
  • Days 1-3: One packet (containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) oral granules each day
  • Day 4: no dose
  • Days 5-6: One packet (containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) oral granules each day
  • Day 7: no dose
 No evening dose of ivacaftor oral granules.
14 kg or more Weekly dosing schedule as follows:
  • Days 1-3: One packet (containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) oral granules each day
  • Day 4: no dose
  • Days 5-6: One packet (containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) oral granules each day
  • Day 7: no dose
 No evening dose of ivacaftor oral granules.
6 years to less than 12 years Less than 30 kg Alternating daily dosing schedule as follows:
  • Day 1: 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)
  • Day 2: One tablet of elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg
 No evening ivacaftor tablet dose.
30 kg or more Alternating daily dosing schedule as follows:
  • Day 1: Two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg)
  • Day 2: One tablet elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
 No evening ivacaftor tablet dose.
12 years and older Alternating daily dosing schedule as follows:
  • Day 1: Two tablets of elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg (total dose of elexacaftor 200 mg/tezacaftor 100 mg/ivacaftor 150 mg)
  • Day 2: One tablet elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg
 No evening ivacaftor tablet dose.
  • 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. [see Warnings and Precautions (5.1), Adverse Reactions (6), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Dosage Modification for Patients Taking Drugs that are CYP3A Inhibitors

Table 3 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) and Clinical Pharmacology (12.3)].

Table 3: Dosage Modification for Concomitant Use of TRIKAFTA with Moderate and Strong CYP3A Inhibitors
​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:
  • Day 1: One packet (containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg) in the morning
  • Day 2: One packet (containing ivacaftor 59.5 mg) oral granules in the morning
No evening packet of ivacaftor oral granules.		 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:
  • Day 1: One packet (containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg) in the morning
  • Day 2: One packet (containing ivacaftor 75 mg) oral granules in the morning
No evening packet of ivacaftor oral granules.		 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 years and older Less than 30 kg Alternating daily dosing schedule is as follows:
  • Day 1: 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
  • Day 2: One tablet of ivacaftor 75 mg in the morning
No evening ivacaftor tablet dose.		 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:
  • Day 1: 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
  • Day 2: One tablet of ivacaftor 150 mg in the morning
No evening ivacaftor tablet dose.		 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:
  • Day 1: 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
  • Day 2: One tablet of ivacaftor 150 mg in the morning
No evening ivacaftor tablet dose.		 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.

Administration Information

Administer TRIKAFTA tablets or oral granules with fat-containing food. 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 [see Clinical Pharmacology (12.3)].

Instructions for Administration of Tablets

For oral use and swallow TRIKAFTA tablets whole.

​Instructions for Administration of Oral Granules

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.

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