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Aiden age 13, with gene mutation F508del/F508del
CF DOESN'T WAIT.
NEITHER DO I.

Since CF is working beneath the surface, your treatment should be, too.

With SYMDEKO, you can target the underlying cause of your CF.

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO.

If you don't know your mutation, talk to your healthcare provider to learn if you have an indicated CF gene mutation.

It is not known if SYMDEKO is safe and effective in children under 12 years of age.

See which mutations SYMDEKO is indicated for

F508del/F508del or
At least one other responsive mutation from the following list:
711+3AG A455E D579G E193K K1060T R117C S945L
2789+5GA A1067T D1152H E831X L206W R347H S977F
3272-26AG D110E D1270N F1052V P67L R352Q
3849+10kbCT D110H E56K F1074L R74W R1070W
F508del/F508del or
At least one other responsive mutation from the following list:
711+3AG E831X
2789+5GA F1052V
3272-26AG F1074L
3849+10kbCT K1060T
A455E L206W
A1067T P67L
D110E R74W
D110H R117C
D579G R347H
D1152H R352Q
D1270N R1070W
E56K S945L
E193K S977F

If you don't know your mutation, talk to your healthcare provider to learn if you have an indicated CF gene mutation.

It is not known if SYMDEKO is safe and effective in children under 12 years of age.

Explore Vertex GPS™: Guidance & Patient Support

Vertex GPS™: Guidance and Patient Support

Vertex GPS™: Guidance & Patient Support provides eligible patients with reimbursement support, potential financial resources, refill reminders, and ongoing product educational resources—all through a dedicated Case Manager.

Learn more at VertexGPS.com

Vertex GPS™: Guidance and Patient Support

Vertex GPS™: Guidance & Patient Support provides eligible patients with reimbursement support, potential financial resources, refill reminders, and ongoing product educational resources—all through a dedicated Case Manager.

Learn more at VertexGPS.com

Important Safety Information

Do not take SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) if you take certain medicines or herbal supplements such as:

  • antibiotics such as rifampin (Rifamate®, Rifater®) or rifabutin (Mycobutin®)
  • seizure medicines such as phenobarbital, carbamazepine (Tegretol®, Carbatrol®, Equetro®) or phenytoin (Dilantin®, Phenytek®)
  • St. John’s wort

Talk to your doctor before taking SYMDEKO if you take any of the medicines or herbal supplements listed above.

Before taking SYMDEKO, 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 SYMDEKO 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 SYMDEKO 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 other medicines may affect how SYMDEKO works.

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.

Especially tell your doctor if you take:
  • antifungal medicines such as ketoconazole (e.g., Nizoral®), itraconazole (e.g., Sporanox®), posaconazole (e.g., Noxafil®), voriconazole (e.g., Vfend®), or fluconazole (e.g., Diflucan®)
  • antibiotics such as telithromycin (e.g., Ketek®), clarithromycin (e.g., Biaxin®), or erythromycin (e.g., Ery-Tab®)

What should I avoid while taking SYMDEKO?

  • SYMDEKO can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how SYMDEKO affects you.
  • Avoid food or drink that contains grapefruit or Seville oranges while you are taking SYMDEKO.

What are the possible side effects of SYMDEKO?

SYMDEKO can cause serious side effects, including:
  • High liver enzymes in the blood have been reported in people treated with SYMDEKO or treated with ivacaftor alone. Your doctor will do blood tests to check your liver:
    • before you start SYMDEKO
    • every 3 months during your first year of taking SYMDEKO
    • every year while you are taking SYMDEKO

    Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

    Call your doctor right away if you have any of the following symptoms of liver problems:
    • pain or discomfort in the upper right stomach (abdominal) area
    • yellowing of your skin or the white part of your eyes
    • loss of appetite
    • nausea or vomiting
    • dark, amber-colored urine

  • Abnormality of the eye lens (cataract) in some children and adolescents treated with SYMDEKO or with ivacaftor alone. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with SYMDEKO to look for cataracts.

The most common side effects of SYMDEKO include headache, nausea, sinus congestion, and dizziness.

These are not all the possible side effects of SYMDEKO. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

For further information, please see full Prescribing Information, including Patient Information.

What is SYMDEKO?

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if SYMDEKO is safe and effective in children under 12 years of age.

What is SYMDEKO?

SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if SYMDEKO is safe and effective in children under 12 years of age.

Click for full safety