Cerdelga (eliglustat) reduces the formation of a certain protein in the body in people with type 1 Gaucher disease.
Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.
Cerdelga is used to treat mild to moderate type 1 Gaucher disease in adults. Eliglustat is used only if a specific liver enzyme (2D6) in your body breaks down or metabolizes drugs at a certain rate.
Cerdelga may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, it is not a cure for this condition.
Important information
You should not use Cerdelga if you have severe liver disease.
TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some drugs can raise or lower your blood levels of eliglustat, which may cause side effects or make Cerdelga less effective. This medicine can also affect blood levels of certain other drugs, making them less effective or increasing side effects.
Before taking this medicine
Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of eliglustat, which may cause side effects or make Cerdelga less effective. Eliglustat can also affect blood levels of certain other drugs, making them less effective or increasing side effects.
Your doctor may need to change your treatment plan if you use any of the following drugs:
You should not use Cerdelga if you are allergic to eliglustat, or if you have severe liver disease.
To make sure this medicine is safe for you, tell your doctor if you have:
FDA pregnancy category C. It is not known whether Cerdelga will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether eliglustat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medication to anyone under 18 years old without medical advice.
How should I take Cerdelga?
Take Cerdelga exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Your doctor will perform a genotype blood test to make sure Cerdelga is the right treatment for you.
If you switched to Cerdelga from another enzyme replacement medicine, wait at least 24 hours after your last dose of the other medicine before you start taking Cerdelga.
Cerdelga is usually taken 1 or 2 times per day, based on the results of your genotype test. Follow your doctor"s dosing instructions very carefully.
Take this medicine with a full glass of water.
You may take Cerdelga with or without food. Take the medicine at the same time each day.
Do not crush, open, or dissolve the capsule. Swallow it whole.
Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Use Cerdelga regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat.
Cerdelga dosing information
Usual Adult Dose for Gaucher Disease:
CYP450 2D6 Extensive metabolizers (EMs) and Intermediate Metabolizers (IMs): 84 mg orally twice a day
CYP450 2D6 Poor Metabolizers (PMs): 84 mg orally once a day
EMs and IMs taking strong or moderate CYP450 2D6 inhibitors: 84 mg orally once a day
EMs taking strong or moderate CYP450 3A inhibitors: 84 mg orally once a day
Comments: It is recommended to establish the CYP450 2D6 genotype of each patient using an FDA-cleared test before starting treatment.
Use: Long-term treatment of patients with Gaucher disease type 1 who are CYP450 2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers.
What happens if I miss a dose?
If you miss a dose of Cerdelga, skip the missed dose and only take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Cerdelga?
Avoid taking an herbal supplement containing St. John"s wort at the same time you are taking Cerdelga.
Grapefruit and grapefruit juice may interact with eliglustat and lead to unwanted side effects. Avoid the use of grapefruit products while taking Cerdelga.
Cerdelga side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Cerdelga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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headache with chest pain;
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a light-headed feeling, like you might pass out; or
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pounding heartbeats or fluttering in your chest.
Common Cerdelga side effects may include:
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diarrhea, nausea, stomach pain;
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headache;
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back pain; or
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pain in your arms or legs.
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.
See also: Side effects (in more detail)
What other drugs will affect Cerdelga?
Many drugs can interact with eliglustat. Not all possible interactions are listed here. TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE, and any you start or stop using during treatment with Cerdelga, especially:
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anagrelide;
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droperidol;
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methadone;
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ondansetron;
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an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;
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cancer medicine - arsenic trioxide, vandetanib;
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an antidepressant - citalopram, escitalopram;
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anti-malaria medication - chloroquine, halofantrine;
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heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or
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medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, pimozide, thioridazine.
This list is not complete and many other drugs can interact with eliglustat. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
