NOW APPROVED for people with cystic fibrosis (CF) age 6 years and older with eligible mutations.
SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 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.
If you don't know your mutation, talk to your healthcare provider to learn
if you have an indicated CF
It is not known if SYMDEKO is safe and effective in children under 6 years of age.
Check Your Eligibility
Neither CF gene mutation you entered is eligible for SYMDEKO.
Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.
Hide the list of eligible mutations. -One of the CF gene mutations you entered is not eligible for SYMDEKO.
Please note, if you only have one copy of the F508del mutation, your second CF gene mutation must also be eligible for SYMDEKO.
Talk with your healthcare provider to discuss your CF care plan and treatment options that may be right for you.
Hide the list of eligible mutations. -Based on the information entered, you may be potentially eligible for SYMDEKO.
Talk with your healthcare provider to see if SYMDEKO is right for you.
Hide the list of eligible mutations. -Here is some information about SYMDEKO that may be helpful:
Get to Know Vertex GPS™: Guidance & Patient Support
Vertex GPS offers eligible patients ongoing one-on-one support, right from the start of treatment. Patient Support Specialists can help you navigate questions about insurance, reimbursement, and potential co-pay assistance. You can even get tips for your Vertex treatment and resources that may help you stay on track. No matter where you’re headed, Vertex GPS is with you along the way.
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.
- 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?
- 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 age 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.
What is SYMDEKO?
SYMDEKO is a prescription medicine use for the treatment of cystic fibrosis (CF) in patients age 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.
