Symdeko

Symdeko is a prescription medication used to cystic fibrosis (CF). It comes packaged with a single tablet containing 2 drugs (tezacaftor and ivacaftor) that is taken in the morning, and another single tablet containing only ivacaftor that is taken in the evening.

Symdeko belongs to a group of drugs called cystic fibrosis transmembrane conductance regulator (CFTR) gene modulators. These help to treat CF in patients with the most common mutation, the F508del mutation, or another mutation in the CFTR gene. Tezacaftor increases the amount of normal CFTR protein the body can use, while ivacaftor allows the CFTR protein to work correctly. 

This medication comes in a tablet form that is copackaged with yellow tezacaftor/ivacaftor combination tablets and light blue ivacaftor tablets. The yellow (tezacaftor/ivacaftor combination) tablet is taken in the morning and the light blue (ivacaftor) tablet is taken about 12 hours later, in the evening. Both tablets should be taken with foods that contain fat. 

Common side effects of Symdeko include headache, nausea, sinus congestion ("stuffy nose") and dizziness.

Symdeko can also cause dizziness. Do not drive or operate heavy machinery until you know how Symdeko affects you.

Symdeko is a prescription medication used to treat CF in patients 12 years and older who have the F508del mutation or another type of mutation. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symdeko. See the “Symdeko Precautions” section.

Common side effects of Symdeko include the following:

• Headache
• Nausea
• Sinus congestion ("stuffy nose")
• Dizziness

This is not a complete list of Symdeko side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that use the p-glycoprotein transporter such as digoxin (Lanoxin), loperamide (Imodium), quinidine (Cardioquine, Quinact, Duraquin), vinblastine (Velban), fexofenadine (Allegra), indinavir (Crixivan), colchicine (Colcrys), topotecan (Hycamtin), and paclitaxel (Abraxane, Onxol, Taxol)
• Food or drink containing grapefruit
• Seville oranges

This is not a complete list of Symdeko drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symdeko including the following:

• Increases in certain liver enzymes. High liver enzymes in the blood have been reported with Symdeko. Your doctor can do blood tests to check your live. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems:
  • nausea or vomiting
  • loss of appetite
  • dark, amber-colored (almost brown) urine
  • yellowing of your skin or eyes
  • pain in the upper right part of your stomach
• Abnormalities of the eye lens (cataracts). This occurred in some children and adolescents (teenagers) treated with Symdeko. If your child is taking Symdeko, talk to their healthcare provider about having eye examinations.

Symdeko can cause dizziness. Do not drive or operate heavy machinery until you know how Symdeko affects you.

Do not take Symdeko if you are allergic to Symdeko or to any of its ingredients.

Grapefruit and grapefruit juice may interact with Symdeko and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Symdeko, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Symdeko falls into category B. There are no well-done studies that have been done in humans with Symdeko. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Symdeko crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Symdeko. 

Take Symdeko exactly as prescribed.

Symdeko comes in a tablet form and is taken by mouth twice daily, about 12 hours apart.

Symdeko comes packaged with two different tablets. 

• The yellow tablet is marked with ‘V100’ and contains the medicines tezacaftor and ivacaftor. Take 1 yellow tablet in the morning. 
• The light blue tablet is marked with ‘V150’ and contains the medicine ivacaftor. Take 1 light blue tablet in the evening. 
• Take the yellow tablet and the light blue tablet about 12 hours apart.

Take Symdeko with foods that contains fat such as eggs, butter, peanut butter, cheese pizza, and whole-milk dairy products such as whole milk, cheese, and yogurt.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Symdeko at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• results of your liver blood tests

The recommended dose of Symdeko for the treatment of CF is 1 yellow tablet in the morning with food containing fat and 1 light blue tablet in the evening with food containing fat. These tablets should be taken about 12 hours apart. The yellow tablet contains 2 ingredients: tezacaftor 100 mg and ivacaftor 150 mg. The light blue tablet contains 1 ingredient: ivacaftor 150 mg. 

If you take too much Symdeko, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Symdeko at room temperature between 68 to 77 degrees Fahrenheit. 

Do not use Symdeko after the expiration date on the package. 

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