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®,
®), or phenytoin (Dilantin®, Phenytek®)
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
baby. You and your doctor should decide if you will take SYMDEKO while you are
are breastfeeding or planning to breastfeed. It is not known if SYMDEKO passes into
breast milk. You and your doctor should decide if you will take SYMDEKO while you
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
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®),
®), 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
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
enzymes 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
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
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.
SYMDEKO is a prescription medicine use for
the treatment of cystic fibrosis (CF) in patients
aged 6 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 6 years of age.
People with CF pictured may or may not be taking SYMDEKO.
SYMDEKO is manufactured for Vertex Pharmaceuticals Incorporated.
SYMDEKO, the SYMDEKO logo, Vertex, and the Vertex triangle logo are registered
trademarks of Vertex Pharmaceuticals Incorporated.
Vertex GPS is a trademark of Vertex Pharmaceuticals Incorporated.
All other trademarks referenced herein are the properties of their respective