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Symdeko Dosage

Generic name: Tezacaftor 100mg, Ivacaftor 150mg; Ivacaftor 150mg
Dosage form: kit

Medically reviewed by Drugs.com. Last updated on Jan 2, 2020.

Dosing Information in Adults, Adolescents, and Children Age 6 Years and Older

Adults, adolescents, and children age 6 years and older should be dosed according to Table 1.

Table 1: Dosing Recommendations for Patients Age 6 Years and Older
Age Morning
(one tablet)
Evening
(one tablet)
6 to <12 years weighing <30 kg tezacaftor 50 mg/ivacaftor 75 mg ivacaftor 75 mg
6 to <12 years weighing ≥30 kg tezacaftor 100 mg/ivacaftor 150 mg ivacaftor 150 mg
≥12 years tezacaftor 100 mg/ivacaftor 150 mg ivacaftor 150 mg

The morning and the evening dose should be taken approximately 12 hours apart. SYMDEKO is for oral use. Instruct patients to swallow the tablets whole. SYMDEKO should be taken with fat-containing food, such as food recommended in standard nutritional guidelines. 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)].

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 or evening dose, the patient should not take the missed dose. The next scheduled dose can be taken at the usual time. More than one dose should not be taken at the same time.

Dose Adjustment for Patients with Hepatic Impairment

For dose adjustment for patients with hepatic impairment, refer to Table 2.

Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C), but exposure of tezacaftor and ivacaftor is expected to be higher than in patients with moderate hepatic impairment. Therefore, SYMDEKO should be used with caution at an adjusted dose after weighing the risks and benefits of treatment in these patients [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

Table 2: Dosing Recommendations for Patients with Hepatic Impairment
Hepatic Impairment Morning Evening
Patients Age 6 to <12 Years Weighing <30kg Patients Age 6 to <12 Years Weighing ≥30 kg and Patients Age ≥12 Years All Patients
Mild (Child-Pugh Class A) No dose adjustment No dose adjustment No dose adjustment
Moderate (Child-Pugh Class B) One tablet of tezacaftor 50 mg/ivacaftor 75 mg once daily One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily No ivacaftor dose
Severe (Child-Pugh Class C) One tablet of tezacaftor 50 mg/ivacaftor 75 mg once daily
(or less frequently)
One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
(or less frequently)

Dose Adjustment for Patients Taking Drugs that are CYP3A Inhibitors

The dosing regimen of SYMDEKO should be adjusted when co-administered with moderate and strong CYP3A inhibitors.

When co-administered with moderate CYP3A inhibitors (e.g., fluconazole, erythromycin), the dosing regimen should be adjusted as in Table 3 [see Drug Interactions (7.2), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

Table 3: Dosing Schedule for Concomitant Use of SYMDEKO with Moderate CYP3A Inhibitors
Day 1 Day 2 Day 3 Day 4*
*
Continue dosing with tezacaftor/ivacaftor or ivacaftor tablets on alternate days.
Patients Age 6 to <12 Years Weighing <30 kg
Morning
Tezacaftor 50 mg/ivacaftor 75 mg tablet - -
Ivacaftor 75 mg tablet - -
Evening
Ivacaftor 75 mg tablet - - - -
Patients Age 6 to <12 Years Weighing ≥30 kg and Patients Age ≥12 Years
Morning
Tezacaftor 100 mg/ivacaftor 150 mg tablet - -
Ivacaftor 150 mg tablet - -
Evening
Ivacaftor 150 mg tablet - - - -

When co-administered with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin), the dosing regimen should be adjusted as in Table 4 [see Drug Interactions (7.2), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

Table 4: Dosing Schedule for Concomitant Use of SYMDEKO with Strong CYP3A Inhibitors
Day 1 Day 2 and Day 3 Day 4*
*
Continue dosing with tezacaftor/ivacaftor tablets twice a week, taken approximately 3 to 4 days apart.
The evening dose of ivacaftor should not be taken on any day.
Patients Age 6 to <12 Years Weighing <30 kg
Morning
Tezacaftor 50 mg/ivacaftor 75 mg tablet -
Evening
Ivacaftor 75 mg tablet - - -
Patients Age 6 to <12 Years Weighing ≥30 kg and Patients Age ≥12 Years
Morning
Tezacaftor 100 mg/ivacaftor 150 mg tablet -
Evening
Ivacaftor 150 mg tablet - - -

Food or drink containing grapefruit should be avoided during treatment with SYMDEKO [see Drug Interactions (7.2) and Patient Counseling Information (17)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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