Symdeko 4-Week

Symdeko 4-Week is a combination medicine used to treat cystic fibrosis in adults and children who are at least 12 years old.

This medicine is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take Symdeko 4-Week, you may need a medical test to make sure you have this gene mutation.

Symdeko 4-Week may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before you start treatment, tell your doctor about all of your medical conditions, including if you:

• have or have had liver problems.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. You and your doctor should decide if you will take Symdeko while you are pregnant.
• are breastfeeding or planning to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor should decide if you will take Symdeko while you are breastfeeding.

Symdeko may affect the way other medicines work, and vice versa.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because the dose of Symdeko may need to be adjusted when taken with certain medicines.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

• antifungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), posaconazole (Noxafil), voriconazole (Vfend), or fluconazole (Diflucan)
• antibiotics such as telithromycin (Ketek), clarithromycin (Biaxin), or erythromycin (Ery-Tab)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

• Take this medicine exactly as your doctor tells you to take it.
• Take the tablets by mouth only.
• Symdeko consists of 2 different tablets.
  • The yellow tablet is marked with ‘V100’ and contains the medicines tezacaftor and ivacaftor. Take one yellow tablet in the morning.
  • The light blue tablet is marked with ‘V150’ and contains the medicine ivacaftor. Take one light blue tablet in the evening.
• Take the yellow tablet and the light blue tablet about 12 hours apart.
• Always take Symdeko with food that contains fat. Examples of fat-containing foods include eggs, butter, peanut butter, cheese pizza, and whole-milk dairy products such as whole milk, cheese, and yogurt.
• If you miss a dose:
  • and it is six hours or less from the time you usually take the yellow tablet in the morning or the light blue tablet in the evening, take the missed dose with food that contains fat as soon as you can. Then take your next dose at your usual time.
  • and it is more than six hours from the time you usually take the yellow tablet in the morning or the light blue tablet in the evening, do not take the missed dose. Take your next dose at the usual time with food that contains fat.
  • Do not take more than your usual dose to make up for a missed dose.

Applies to ivacaftor/tezacaftor: oral tablet therapy pack

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Dizziness.
• Sinus pain.
• Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ivacaftor / tezacaftor: oral tablet

General

The most commonly reported side effects have included headache, nasopharyngitis, nausea, sinus congestion, and dizziness.[Ref]

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness

Ocular

Frequency not reported: Non-congenital lens opacities

Respiratory

Common (1% to 10%): Sinus congestion

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Distal intestinal obstruction syndrome

Hepatic

Common (1% to 10%): Transaminase elevations

The incidence of maximum transaminase (ALT or AST) elevations to greater than 8 times the upper limit of normal (8 x ULN), greater than 5 x ULN, or greater than 3 x ULN was similar between drug treated and placebo treated patients (0.2%, 1%, 3.4% versus 0.4%, 1%, 3.4%, respectively). A total of 3 patients in clinical trials permanently discontinued therapy due to elevated transaminases (1 drug treated and 2 on placebo). No drug-treated patient experienced a transaminase elevation greater than 3 x ULN associated with elevated total bilirubin greater than 2 x ULN.

Applies to ivacaftor / tezacaftor: oral tablet

General

The most commonly reported side effects have included headache, nasopharyngitis, nausea, sinus congestion, and dizziness.[Ref]

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness

Ocular

Frequency not reported: Non-congenital lens opacities

Respiratory

Common (1% to 10%): Sinus congestion

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Distal intestinal obstruction syndrome

Hepatic

Common (1% to 10%): Transaminase elevations

The incidence of maximum transaminase (ALT or AST) elevations to greater than 8 times the upper limit of normal (8 x ULN), greater than 5 x ULN, or greater than 3 x ULN was similar between drug treated and placebo treated patients (0.2%, 1%, 3.4% versus 0.4%, 1%, 3.4%, respectively). A total of 3 patients in clinical trials permanently discontinued therapy due to elevated transaminases (1 drug treated and 2 on placebo). No drug-treated patient experienced a transaminase elevation greater than 3 x ULN associated with elevated total bilirubin greater than 2 x ULN.

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

Some side effects may not be reported. You may report them to the FDA.

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