Symdeko

Generic name: Ivacaftor And Tezacaftor
Drug class: CFTR combinations

Usage of Symdeko

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.

Symdeko side effects

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.

Before taking Symdeko

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.

Relate drugs

How to use Symdeko

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.

Warnings

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..

What other drugs will affect Symdeko

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.

Disclaimer

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