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Overview: Symdeko is used to treat cystic fibrosis in people who have certain genetic mutations. It contains two medicines that reduce symptoms of cystic fibrosis by thinning out the mucus that blocks the lungs and the digestive system. Common side effects include headache, nausea, sinus pain and congestion, and dizziness. Before using Symdeko, make sure to tell your health care provider about any other medicines you are taking.

Uses

What is Symdeko used for?

Symdeko (tezacaftor/ivacaftor and ivacaftor) is commonly used to treat an inherited disorder called cystic fibrosis, which is caused by many different types of genetic changes (mutations). Symdeko should only be used for cystic fibrosis that is caused by certain mutations.

Symdeko may also be used for other conditions as determined by your health care provider.

How does Symdeko work (mechanism of action)?

Cystic fibrosis is caused by changes (mutations) in a specific gene called the cystic fibrosis transmembrane conductance regulator (CFTR), which controls the movement of chloride ions and water through the body. In people with cystic fibrosis, chloride ions and water do not move well through the body, causing a thick, sticky mucus that blocks the airways and the digestive system. 

Symdeko contains two different medicines that work together to help CFTR move chloride ions and water through the body more easily. This thins out the mucus and reduces the symptoms of cystic fibrosis.

How is Symdeko supplied (dosage forms)?

Brands and other names

  • Symdeko

Dosage forms and strengths

  • 50 mg/75 mg and 75 mg oral tablets
  • 100 mg/150 mg and 150 mg oral tablets

How should I store Symdeko?

Symdeko should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Symdeko?

The most common side effects of Symdeko are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Nausea
  • Sinus pain and congestion
  • Dizziness

There may be other side effects of Symdeko that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Symdeko?

While less common, the most serious side effects of Symdeko are described below, along with what to do if they happen.

Severe Allergic Reactions. Symdeko may cause allergic reactions, which can be serious. Stop taking Symdeko and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cataracts. Some children have developed changes in the lenses of their eyes (cataracts) while taking Symdeko. It is unclear if Symdeko increases the risk of cataracts. You may need to have your eyes examined while you are taking this medicine. Contact your health care provider if you develop any of the following symptoms of cataracts.

  • Blurry, foggy, or cloudy vision
  • Changes in the way you see color
  • Seeing double

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Symdeko. Keep all appointments for blood tests so that your health care provider can monitor your liver function. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)

Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Symdeko?

Allergies to Ingredients. People who are allergic to any of the following should not take Symdeko.

  • Ivacaftor
  • Symdeko
  • Tezacaftor
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Symdeko.

What should I know about Symdeko before using it?

Do not take Symdeko unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Symdeko with other people, even if they have the same condition as you. It may harm them.

Keep Symdeko out of the reach of children.

Symdeko can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Symdeko affects you.

Symdeko contains two different tablets. One tablet contains tezacaftor/ivacaftor and should be taken in the morning each day. The other tablet only contains ivacaftor and should be taken in the evening each day. Read the label carefully and speak to your pharmacist or another health care provider if you are unsure how to take Symdeko. Swallow the tablets whole.

What should I tell my health care provider before using Symdeko?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Symdeko is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems
  • Liver problems

Other Medicines and Supplements. Symdeko may interact with other medicines and supplements. Before taking Symdeko, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Symdeko could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Symdeko while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Symdeko passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Symdeko while breastfeeding.

How can I get more information about Symdeko?

For more information about Symdeko, you can visit the drugmaker’s website at www.symdeko.com or call them at 877-752-5933.

Interactions

Does Symdeko interact with foods or drinks?

Symdeko should be taken with a meal that contains a fatty food, such as whole milk, yogurt, cheese, eggs, butter, peanut butter, avocado, or cheese pizza. 

You should not eat grapefruit or drink grapefruit juice while taking Symdeko. Grapefruit or grapefruit juice can cause a dangerous increase in the blood levels of Symdeko.

It is unknown if drinking alcohol will affect Symdeko. The risk of dizziness may increase if you drink alcohol while taking Symdeko.

Does Symdeko interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Symdeko.

  • Any medicine for seizures, such as carbamazepine, phenobarbital, or phenytoin
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are medicines used for fungal infections
  • Clarithromycin or erythromycin, which is a medicine used for bacterial infections
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • St. John’s wort, which is a supplement that may be used to treat depression

Many other medicines may alter the blood levels of Symdeko, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Symdeko. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Symdeko?

If you or someone else has used too much Symdeko, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Symdeko?

If you miss a dose and it has been less than six hours since the missed dose, take it as soon as you remember. If it has been more than six hours since the missed dose, skip the missed dose and only take the next dose at the regular scheduled time. Do not take double or extra doses.