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SYMDEKO is for people with cystic fibrosis (CF) aged 12 years and older with 2 copies of the F508del-CFTR mutation, or with at least 1 mutation in the CF gene that is responsive to treatment with SYMDEKO. It is not known if SYMDEKO is safe and effective in patients younger than 12 years.

Learn about SYMDEKO safety and side effects. Download the SYMDEKO Safety Overview

What are the possible side effects of SYMDEKO?

SYMDEKO can cause serious side effects, including:

liver

High liver enzymes in the blood have been reported in some patients treated with SYMDEKO or treated with ivacaftor alone.

To monitor this, 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

cataracts

Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with SYMDEKO or treated 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.

person

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

Headache
Headache

15% of people who took SYMDEKO

13% of people who took placebo

Nausea
Nausea

9% of people who took SYMDEKO

7% of people who took placebo

Sinus Congestion
Sinus Congestion

4% of people who took SYMDEKO

2% of people who took placebo

Nausea
Dizziness

4% of people who took SYMDEKO

2% of people who took placebo

The most common side effect information is based on what was reported in 2 different studies where a total of 334 people took SYMDEKO and 343 people took placebo.

Additional safety information from clinical studies

Respiratory events (breathing problems) were monitored

Respiratory events such as chest tightness and difficulty breathing were experienced by:

  • 11.3% of people who took SYMDEKO
  • 14.7% of people who took placebo

People who stopped treatment due to side effects

A percentage of people dropped out of the study due to side effects:

  • 1.6% of people who took SYMDEKO

  • 2.0% of people who took placebo

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.

Considerations before starting SYMDEKO

Before you start SYMDEKO, there are some important things you should discuss with your healthcare provider. This includes your medical history and the medicines you take.

Do not take SYMDEKO if you take certain medicines or herbal supplements such as:

Antibiotics
rifampin (Rifamate®, Rifater®) or rifabutin (Mycobutin®)
Seizure medicines
phenobarbital, carbamazepine (Tegretol®, Carbatrol®, Equetro®), or phenytoin (Dilantin®, Phenytek®)
Herbal supplements
St. John’s wort

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

Before taking SYMDEKO, tell your doctor about all of your medical conditions, including if you:

Liver
Have or have had liver problems
Liver
Have kidney problems
Liver
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
Liver
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 of the medicines you take, including prescription and non-prescription 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
ketoconazole (Nizoral®), itraconazole (Sporanox®), posaconazole (Noxafil®), voriconazole (Vfend®), fluconazole (Diflucan®)
Antibiotics
telithromycin (Ketek®), clarithromycin (Biaxin®), erythromycin (Ery-Tab®)

SYMDEKO is not known to interact with some medicines, including:

Certain oral contraceptives
eg, ethinyl estradiol/norethindrone
Certain antibiotics
eg, ciprofloxacin

Remember, it’s important to know the medicines you take. Keep a list to show your doctor and pharmacist when you get a new medicine.

AvoidAvoid food or drink that contains grapefruit or Seville oranges while you are taking SYMDEKO.

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