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Cerdelga

Generic Name: eliglustat (el-i-GLOO-stat)
Brand Name: Cerdelga

Cerdelga is used for:

Treating type I Gaucher disease in certain patients.

Cerdelga is a glucosylceramide synthase inhibitor. It works by reducing the formation of certain substances in the body (glucosylceramide-based glycosphingolipids). This helps to relieve some of the blood, liver, spleen, and other organ problems caused by type I Gaucher disease.

Do NOT use Cerdelga if:

  • you are allergic to any ingredient in Cerdelga
  • you have certain heart problems (eg, heart block, heart failure, long QT syndrome, slow heartbeat) or have had a recent heart attack
  • you have liver problems or moderate to severe kidney problems
  • you are taking amiodarone, carbamazepine, disopyramide, dofetilide, dronedarone, ibutilide, phenobarbital, phenytoin, procainamide, quinidine, rifampin, sotalol, or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cerdelga:

Some medical conditions may interact with Cerdelga. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems
  • if you have a history of heart problems
  • if you are being treated with or have recently been treated with imiglucerase, taliglucerase alfa, or velaglucerase alfa

Some MEDICINES MAY INTERACT with Cerdelga. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol because the risk of a certain type of irregular heartbeat (prolonged QT interval) may be increased
  • Azole antifungals (eg, fluconazole, ketoconazole), paroxetine, ranitidine, or terbinafine because they may increase the risk of Cerdelga's side effects
  • Carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Cerdelga's effectiveness
  • Colchicine, dabigatran, digoxin, metoprolol, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Cerdelga

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cerdelga may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cerdelga:

Use Cerdelga as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Cerdelga comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Cerdelga refilled.
  • Swallow Cerdelga whole. Do not crush, dissolve, or open before swallowing.
  • Take Cerdelga by mouth with water, with or without food.
  • Do not eat grapefruit or drink grapefruit juice while you use Cerdelga.
  • Take Cerdelga on a regular schedule to get the most benefit from it. Taking Cerdelga at the same times each day will help you remember to take it.
  • If you miss a dose of Cerdelga, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cerdelga.

Important safety information:

  • Tell your doctor or dentist that you take Cerdelga before you receive any medical or dental care, emergency care, or surgery.
  • You may need to have your genes tested before starting Cerdelga. Talk with your doctor.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cerdelga while you are pregnant. It is not known if Cerdelga is excreted in breast milk. Do not breast-feed while taking Cerdelga.

Possible side effects of Cerdelga:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; gas; headache; joint pain; mouth or throat irritation; nausea; pain in the arms or legs; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; fainting; fast or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cerdelga:

Store Cerdelga at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cerdelga out of the reach of children and away from pets.

General information:

  • If you have any questions about Cerdelga, please talk with your doctor, pharmacist, or other health care provider.
  • Cerdelga is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Cerdelga or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cerdelga. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Cerdelga. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Cerdelga.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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