SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

A regimen of a tezacaftor/ivacaftor tablet taken in the morning and an ivacaftor tablet taken in the evening, approximately 12 hours apart1

  • SYMDEKO should always be taken with fat-containing food to ensure adequate absorption. 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

  • Patients should continue taking their other CF therapies as prescribed

 
  • PATIENTS AGE 6 THROUGH 11 YEARS, WEIGHING <30KG
  • PATIENTS AGE 6 THROUGH 11 YEARS, WEIGHING ≥30KG
  • PATIENTS AGE 12 YEARS AND OLDER
 
RECOMMENDED DOSE
Tezacaftor 50 mg
Ivacaftor 75 mg
Ivacaftor 75 mg
Tezacaftor 100 mg
Ivacaftor 150 mg
Ivacaftor 150 mg

TABLETS ARE NOT ACTUAL SIZE.

 

RECOMMENDED DOSE ADJUSTMENTS

 
 

DOSING FOR HEPATIC IMPAIRMENTa

SEVERE HEPATIC IMPAIRMENT
(Child-Pugh Class C)b
USE WITH CAUTION
OR LESS FREQUENTLYc

TEZACAFTOR/IVACAFTOR DOSE

NO IVACAFTOR DOSE

MODERATE HEPATIC IMPAIRMENT
(Child-Pugh Class B)

TEZACAFTOR/IVACAFTOR DOSE

NO IVACAFTOR DOSE

 

DOSING FOR CONCOMITANT USE WITH CYP3A INDUCERS OR INHIBITORSd

STRONG CYP3A INDUCERS
CONCOMITANT USE
NOT RECOMMENDED
CONCOMITANT USE
NOT RECOMMENDED
STRONG CYP3A INHIBITORS
APPROXIMATELY 3-4 DAYS
APART (twice a week)

TEZACAFTOR/IVACAFTOR DOSE

NO IVACAFTOR DOSE

MODERATE CYP3A INHIBITORS
ALTERNATE TABLETS
EVERY DAYe
DAY 1

TEZACAFTOR/
IVACAFTOR DOSE

DAY 2

IVACAFTOR DOSE

NO IVACAFTOR DOSE

  1. aNo dose adjustments are necessary for mild hepatic impairment.1
  2. bStudies have not been conducted in patients with severe hepatic impairment.1
  3. cUse with caution at an adjusted dose after weighing the risks and benefits of treatment.1
  4. dNo dose adjustment necessary for mild/moderate CYP3A inducers or mild CYP3A inhibitors.1
  5. eContinue to alternate tablets every day.1
  • SYMDEKO has not been studied in patients with moderate or severe renal impairment or in patients with end-stage renal disease. No dose adjustment is recommended for mild and moderate renal impairment. Caution is recommended in patients with severe renal impairment or end-stage renal disease

  • Food or drink containing grapefruit or Seville oranges should be avoided during treatment with SYMDEKO

  • The safety and efficacy of SYMDEKO in patients with CF younger than 6 years of age have not been studied

Missed Dose1

  • 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

SYMDEKO should always be taken with fat-containing foods to ensure adequate absorption1

Examples of Fat-Containing Foods1

Fat-containing foods help the body absorb SYMDEKO. A typical CF diet will satisfy this requirement. When counseling patients, the list below provides examples of a variety of fat-containing foods to take with SYMDEKO.
  • Almonds
  • Avocado
  • Cheese pizza
  • Deli ham
  • Eggs
  • Granola
  • Hummus
  • Nuts
  • Peanut butter
  • Roasted peanuts
  • Salmon
  • Trail mix with nuts
  • Tuna
  • Whole milk
  • Whole-milk cheese
  • Whole-milk yogurt

Child-Pugh Classification System2

Factor Units 1 Point 2 Points 3 Points
Serum bilirubin
µmol/L
mg/dL
<34
<2.0
34-51
2.0-3.0
>51
>3.0
Serum albumin g/dL >3.5 3.0-3.5 <3.0
Prothrombin time Seconds prolonged INR
0-4
<1.7
4-6
1.7-2.3
>6
>2.3
Ascites N/A None Easily controlled Poorly controlled
Hepatic encephalopathy N/A None Minimal Advanced
  • The Child-Pugh classification system is used to assess the severity of liver disease. The Child-Pugh Score is calculated by adding the scores of the 5 factors listed above. The patient receives a score of 1, 2, or 3 for each factor, which are added together to get the total Child-Pugh Score

  • According to this system, there are 3 levels of hepatic impairment—mild (Class A, score 5 or 6), moderate (Class B, score 7 to 9), and severe (Class C, score 10-15)

INR, international normalized ratio; N/A, not applicable.