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Symdeko

Generic Name: ivacaftor/tezacaftor and ivacaftor
Dosage Form: Tablets
Date of Approval: February 12, 2018
Company: Vertex Pharmaceuticals Incorporated

Treatment for: Cystic Fibrosis

FDA Approves Symdeko

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.

Patient Information

Read this Patient Information carefully before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Symdeko?

  • Symdeko is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 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 this medicine is safe and effective in children under 12 years of age.

Who should not take Symdeko?

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

Before you start treatment, 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 this medicine 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 this medicine 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 vice versa.

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.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take:

  • antifungal medicines such as ketoconazole (Nizoral), itraconazole (Sporanox), posaconazole (Noxafil), voriconazole (Vfend), or fluconazole (Diflucan)
  • antibiotics such as telithromycin (Ketek), clarithromycin (Biaxin), or erythromycin (Ery-Tab)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Symdeko?

  • Take this medicine exactly as your doctor tells you to take it.
  • Take the tablets by mouth only.
  • 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. Examples of fat-containing foods include eggs, 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 your usual dose to make up for a missed dose.

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.

Symdeko side effects

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 treatment
    • every three months during your first year of treatment
    • every year during treatment
    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 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
  • dizziness

These are not all the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Symdeko?

  • Store the tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Do not use the tablets after the expiration date on the package.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Symdeko.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information that is written for health professionals.

What are the ingredients?

ivacaftor/tezacaftor tablets:

Active ingredients: ivacaftor and tezacaftor

Inactive ingredients: hypromellose acetate succinate, sodium lauryl sulfate, hypromellose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, HPMC/hypromellose 2910, hydroxypropyl cellulose, titanium dioxide, talc, and iron oxide yellow.

ivacaftor tablets:

Active ingredients: ivacaftor

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, titanium dioxide, ammonium hydroxide, iron oxide black, propylene glycol, and shellac.

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