Cerdelga (eliglustat)

Cerdelga (eliglustat) is a prescription medicine used for the long-term treatment of Gaucher disease type 1 (GD1) in adults.

Cerdelga is not used in certain people with Gaucher disease type 1. Your doctor will perform a test to make sure that Cerdelga is right for you.

Cerdelga can affect the way other medicines work and other medicines can affect how Cerdelga works. Using Cerdelga with other medicines or herbal supplements may cause an increased risk of side effects.

Especially tell your doctor if you take:

• St. John’s Wort (Hypericum perforatum)

Or medicine for:

• Fungal infections
• Tuberculosis
• Seizures
• Heart conditions or high blood pressure
• Depression or other mental health problems

If you take any medicines for the conditions listed above, your doctor may need to prescribe a different medicine, change your dose of other medicines, or change your dose of Cerdelga. Tell your doctor about any new medicines before you start taking them.

Avoid eating or drinking grapefruit products while taking Cerdelga. Grapefruit products can increase the amount of Cerdelga in your body.

Cerdelga, used with certain other medicines, may cause changes in the electrical activity of your heart (ECG changes) and irregular heart beat (arrhythmias). Tell your doctor if you have new symptoms such as palpitations, fainting, or dizziness.

The most common side effects of Cerdelga include:

• tiredness,
• headache,
• nausea,
• diarrhea, and
• pain in the arms, legs, back, or stomach (abdomen).

Tell your doctor if you have any side effect that bothers you or that does not go away.  These are not all the possible side effects of Cerdelga.

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

• Take Cerdelga exactly as your doctor tells you to take it.
• Your doctor may change your dose if needed.
• Take Cerdelga capsules whole, preferably with water. Do not open, crush, or dissolve capsules before swallowing.
• Cerdelga can be taken with or without food.
• If you miss a dose of Cerdelga, take the next dose at the usual time. Do not take two doses of Cerdelga at the same time.
• If you take too much Cerdelga, call your doctor or go to the nearest hospital emergency room right away.

It is not known if Cerdelga is safe and effective in children.

Before taking Cerdelga, tell your doctor about all of your medical conditions, including if you:

• have heart problems, including a condition called long QT syndrome
• have a history of a heart attack
• have kidney or liver problems
• are pregnant or planning to become pregnant. It is not known if Cerdelga will harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known if Cerdelga passes into your breast milk. You and your doctor will decide if you should take Cerdelga or breastfeed. You should not do both.

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