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The U.S. Food and Drug Administration (FDA) has approved Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor.
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)
Symdeko consists of 2 different tablets. The yellow tablet is marked with ‘V100’ and contains the medicines tezacaftor and ivacaftor. Take one yellow tablet in the morning. The light blue tablet is marked with ‘V150’ and contains the medicine ivacaftor. Take one light blue tablet in the evening. Take the yellow tablet and the light blue tablet about 12 hours apart.
Always take Symdeko with food that contains fat. Foods like egg, butter, peanut butter, cheese, pizza, and whole-milk dairy products such as whole milk, cheese, and yogurt. If you miss a dose and it is six hours or less from the time you usually take the yellow tablet in the morning or the light blue tablet in the evening, take the missed dose with food that contains fat as soon as you can. Then take your next dose at your usual time and it is more than six hours from the time you usually take the yellow tablet in the morning or the light blue tablet in the evening, do not take the missed dose. Take your next dose at the usual time with food that contains fat. Do not take more than usual dose to make up for a missed dose.
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. It can cause serious side effects, including: high liver enzymes in the blood.
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 treated with ivacaftor alone. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment to look for cataracts. The most common side effects include: headache, nausea, sinus congestion and dizziness.
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