viernes, 12 de julio de 2019

SYMDEKO (tezacaftor/ivacaftor and ivacaftor) is now approved for more patients

Now approved: Symdeko for children 6 years and older with cystic fibrosis and certain mutations

Have you heard the latest news about SYMDEKO?
SYMDEKO is now approved for children with cystic fibrosis (CF) as young as 6 years of age with eligible mutations.
Speak with your doctor today and see if SYMDEKO could be right for your child.
See which mutations SYMDEKO is indicated for >
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.
Discover more about SYMDEKO:
Patient StoriesIn our updated SYMDEKO brochureThrough our SYMDEKO studies
Follow us on Facebook >
Find the way forward with
Vertex GPS™: Guidance & Patient Support >
Important Safety Information
Do not take SYMDEKO 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., 
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 includeheadache, 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.

No hay comentarios:

Publicar un comentario