Symdeko contains a combination of ivacaftor and tezacaftor and is used to treat cystic fibrosis in adults and children who are at least 6 years old.

Symdeko is for use only in patients with a specific gene mutation related to cystic fibrosis.

Before you take Symdeko, you may need a medical test to make sure you have this gene mutation.

Before taking Symdeko , tell your doctor if you:

• are pregnant or plan to become pregnant. It is not known if ivacaftor and tezacaftor 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 ivacaftor and tezacaftor passes into your breast milk. You and your doctor should decide if you will take Symdeko while you are breastfeeding.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together..

Before taking this medicine

You should not use Symdeko if you are allergic to ivacaftor or tezacaftor.

Some medicines can cause unwanted or dangerous effects when used with Symdeko. Your doctor may change your treatment plan if you also use:

• St. John's wort;

• seizure medicine - carbamazepine, phenobarbital, phenytoin; or

• tuberculosis medicine - rifabutin, rifampin.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Symdeko is not approved for use by anyone younger than 6years old.

Take Symdeko exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Symdeko is supplied as two separate daily tablets. A yellow tablet is taken in the morning and a blue tablet is taken 12 hours later. Follow your doctor's dosing instructions very carefully.

Always take this medicine with food that contains fat, such as butter, peanut butter, whole milk, cheese, yogurt, or cheese pizza. Follow your doctor's dosing instructions very carefully.

You will need frequent blood tests to check your liver function. Your blood pressure may also need to be checked often.

A child using this medicine may need frequent eye exams to check for cataracts.

Store at room temperature away from moisture and heat. Keep each tablet in its daily blister strip until you are ready to take your dose.

Usual Adult Dose for Cystic Fibrosis:

Adults and pediatric patients age 12 years and older or pediatric patients age 6 to less than 12 years weighing 30 kg or more: one tablet (containing tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one tablet (containing ivacaftor 150 mg) in the evening, approximately 12 hours apart.

-Tablets should be taken with fat-containing food

Comments:
-Tablets should be taken with fat-containing foods; examples include those prepared with butter or oils, those containing eggs, cheeses, nuts, whole milk, or meats.
-When the genotype is not known, an FDA-cleared cystic fibrosis (CF) mutation test should be used to detect the presence of a CF transmembrane conductance regulator (CFTR) mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Use: For the treatment of patients with cystic fibrosis who are homozygous for the F508del mutation or who have at least 1 mutation in the CFTR gene that is responsive to this combination drug based on in vitro data and/or clinical evidence.

Usual Pediatric Dose for Cystic Fibrosis:

Pediatric patients age 6 to less than 12 years weighing less than 30 kg: one tablet (containing tezacaftor 50 mg/ivacaftor 75 mg) in the morning and one tablet (containing ivacaftor 75 mg) in the evening, approximately 12 hours apart.

-Tablets should be taken with fat-containing food

Comments:
-Tablets should be taken with fat-containing foods; examples include those prepared with butter or oils, those containing eggs, cheeses, nuts, whole milk, or meats.
-When the genotype is not known, an FDA-cleared cystic fibrosis (CF) mutation test should be used to detect the presence of a CF transmembrane conductance regulator (CFTR) mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Use: For the treatment of patients with cystic fibrosis who are homozygous for the F508del mutation or who have at least 1 mutation in the CFTR gene that is responsive to this combination drug based on in vitro data and/or clinical evidence.

You should not use Symdeko if you are allergic to ivacaftor or tezacaftor.

Some medicines can cause unwanted or dangerous effects when used with Symdeko. Your doctor may change your treatment plan if you also use:

• St. John's wort;

• seizure medicine - carbamazepine, phenobarbital, phenytoin; or

• tuberculosis medicine - rifabutin, rifampin.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Symdeko is not approved for use by anyone younger than 6years old.

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

Be sure to take a missed dose with a food that contains fat.

If you miss doses or stop taking Symdeko for more than 1 week, call your doctor before you start taking the medicine again. You may need a different dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Grapefruit and Seville oranges may interact with ivacaftor and tezacaftor and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

Get emergency medical help if you have signs of an allergic reaction to Symdeko: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision problems; or

• liver problems - loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common Symdeko side effects may include:

• stuffy nose;

• dizziness;

• nausea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Your doctor may adjust your Symdeko dose if you also use other medicines, especially:

• an antibiotic - clarithromycin, erythromycin, telithromycin; or

• antifungal medicine - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole.

This list is not complete. Other drugs may interact with ivacaftor and tezacaftor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.