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Symdeko Generic Name & Formulations
Legal Class
Rx
General Description
Tezacaftor, ivacaftor 50mg/75mg, 100mg/150mg; with ivacaftor 75mg, 150mg; tabs.
Pharmacological Class
Cystic fibrosis transmembrane conductance regulator (CFTR) corrector + CFTR potentiator.
How Supplied
Tabs—56 (4x14)
Manufacturer
Generic Availability
NO
Symdeko Indications
Indications
Treatment of cystic fibrosis (CF) in patients ≥6yrs who are homozygous for the F508del mutation or have ≥1 mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor.
Symdeko Dosage and Administration
Adults and Children
<6yrs: not established. Swallow whole. Take with fat-containing food (eg, eggs, cheeses, nuts, whole milk, meats). 6–<12yrs (weighing <30kg): 1 tab (50mg/75mg) in the AM and 1 tab (75mg) in the PM, approx. 12hrs apart; 6–<12yrs (weighing ≥30kg) or ≥12yrs: 1 tab (100mg/150mg) in the AM and 1 tab (150mg) in the PM, approx. 12hrs apart. Concomitant moderate CYP3A inhibitors (6–<12yrs [weighing <30kg]): alternate 1 tab (50mg/75mg) in the AM or 1 tab (75mg) in the AM every other day; (6–<12yrs [weighing ≥30kg]) or ≥12yrs: alternate 1 tab (100mg/150mg) in the AM or 1 tab (150mg) in the AM every other day. Concomitant strong CYP3A inhibitors (6–<12yrs [weighing <30kg]): 1 tab (50mg/75mg) in the AM twice weekly, approx. 3–4 days apart; (6–<12yrs [weighing ≥30kg]) or ≥12yrs: 1 tab (100mg/150mg) in the AM twice weekly, approx. 3–4 days apart. Moderate hepatic impairment (6–<12yrs [weighing <30kg]): 1 tab (50mg/75mg) once daily, or less frequently if severe; (6–<12yrs [weighing ≥30kg]) or ≥12yrs: 1 tab (100mg/150mg) once daily, or less frequently if severe.
Symdeko Contraindications
Not Applicable
Symdeko Boxed Warnings
Not Applicable
Symdeko Warnings/Precautions
Warnings/Precautions
If genotype is unknown, use an FDA-cleared CF mutation test to detect the presence of the CFTR mutation followed by bi-directional sequencing verification. Assess ALT/AST and bilirubin levels prior to initiating therapy, every 3 months during the first year of treatment, and annually thereafter. History of transaminase elevations; consider more frequent monitoring. Interrupt dosing and monitor closely if ALT/AST >5×ULN or ALT/AST >3×ULN with bilirubin elevations >2×ULN; after resolution, consider restarting. Perform baseline and follow-up eye exams. Severe hepatic impairment. Severe renal impairment or ESRD. Pregnancy. Nursing mothers.
Symdeko Pharmacokinetics
See Literature
Symdeko Interactions
Interactions
Potentiated by strong (eg, ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin, and clarithromycin) or moderate (eg, fluconazole, erythromycin) CYP3A inhibitors; adjust dose (see Adults and Children). Avoid food or drink containing grapefruit or Seville oranges. Antagonized by strong CYP3A inducers (eg, rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, St. John’s wort); use not recommended. Caution with concomitant digoxin or other P-gp substrates with a narrow therapeutic index (eg, cyclosporine, everolimus, sirolimus, tacrolimus); monitor.
Symdeko Adverse Reactions
Adverse Reactions
Headache, nausea, sinus congestion, dizziness; transaminase elevations, non-congenital lens opacities/cataracts.
Symdeko Clinical Trials
See Literature
Symdeko Note
Not Applicable
Symdeko Patient Counseling
See Literature
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