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
- seizure medicines such as phenobarbital, carbamazepine (Tegretol®,
Equetro®), or phenytoin (Dilantin®,
- St. John’s wort
Talk to your doctor before taking SYMDEKO if you take any of the medicines or herbal
Before taking SYMDEKO, tell your doctor about all of your medical conditions, including
- 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
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
milk. You and your doctor should decide if you will take SYMDEKO while you are
SYMDEKO may affect the way other medicines work, and other medicines may affect how
Tell your doctor about all the medicines you take, including
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®),
Sporanox®), posaconazole (e.g., Noxafil®),
voriconazole (e.g., Vfend®),
or fluconazole (e.g., Diflucan®)
- antibiotics such as telithromycin (e.g., Ketek®), clarithromycin
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
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
SYMDEKO or treated with ivacaftor alone. Your doctor will do blood tests to check
- 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
in your blood in the past.
Call your doctor right away if you have any of the following symptoms of liver
- 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
with SYMDEKO or with ivacaftor alone. If you are a child or adolescent, your doctor
eye examinations before and during treatment with SYMDEKO to look for cataracts
The most common side effects of SYMDEKO include headache, nausea, sinus
These are not all the possible side effects of SYMDEKO. Call your doctor for medical
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
What is SYMDEKO?
SYMDEKO is a prescription medicine used for
treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies
F508del mutation, or who have at least one mutation in the CF gene that is responsive to
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 6 years of age.