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Cerdelga

eliglustat
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease

Cerdelga (eliglustat) is a medication that belongs to a drug class known as glucosylceramide synthase inhibitors. This medication is FDA-approved as long-term treatment for certain adults with a rare genetic condition called Gaucher disease type 1 (GD1). Cerdelga (eliglustat) is a capsule that's taken by mouth. Side effects can include fatigue, headache, and nausea.

Reviewed by:
reviewer
Jenny Zhang, PharmD, BCOP
reviewer
Cydnee Ng, PharmD
Last reviewed on December 21, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageContraindicationsAlternativesLatest newsReferencesPricesMedicare
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What is Cerdelga (eliglustat)?

What is Cerdelga (eliglustat) used for?

How Cerdelga (eliglustat) works

People with Gaucher disease type 1 (GD1) have higher levels of a fatty substance called glucosylceramide (GL-1). As a result, GL-1 builds up in certain organs, like your spleen, liver, and bones, which can lead to serious symptoms and complications of GD1.

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor. It blocks your body from making GL-1. This lowers the amount of GL-1 in the body, which helps lower GL-1 buildup in your spleen, liver, and other organs.

Are you looking for information on miglustat (Zavesca) instead?

Drug Facts

Common BrandsCerdelga
Drug ClassGlucosylceramide synthase inhibitor
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Cerdelga (eliglustat)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Fatigue (14%)
  • Headache (13%)
  • Nausea (12%)
  • Diarrhea (12%)
  • Back pain (12%)
  • Pain in arm or leg (11%)
  • Upper stomach pain (10%)

Other Side Effects

  • Dizziness
  • Weakness
  • Cough
  • Indigestion or acid reflux
  • Constipation
  • Pounding heart (palpitations)
  • Rash

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Abnormal heart rhythm: abnormally fast heart rate, racing or pounding heart, fainting, dizziness

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Cerdelga (eliglustat)

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Pros

First-choice treatment option in most adults with GD1

Can take with or without food

Taken by mouth, so it doesn’t require an IV or port like enzyme replacement therapy (ERT)

More convenient than ERT since you don't need frequent trips to the infusion center

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Cons

Requires genetic testing before you start treatment

Has many drug interactions (such as with certain antidepressants, antibiotics, and anti-seizure medications)

Might not be able to use if you have certain liver, kidney, or heart problems because of the risk for serious side effects

Not for use in children because it hasn’t been studied

pharmacist-tips

Pharmacist tips for Cerdelga (eliglustat)

pharmacist

  • Take Cerdelga (eliglustat) with or without food.

    • Swallow Cerdelga (eliglustat) capsules whole, preferably with water. Don't open, crush, or dissolve the capsules because it might affect how the medication works. Let your provider know if you have trouble swallowing pills to see what other options you have.

      • Avoid grapefruit and grapefruit juice while you're taking Cerdelga (eliglustat). Grapefruit can raise the amount of medication that your body absorbs, which means that your risk for side effects is greater.

        • Tell your providers and pharmacists about all the medications and supplements you take so they can check for drug interactions with Cerdelga (eliglustat). These interactions can either make Cerdelga (eliglustat) work less well or raise your risk for side effects (e.g., heart rhythm problems). You might need some of your doses adjusted or stop some medications altogether to keep you safe.

          • Tell your provider if you have heart, kidney, or liver problems. These health conditions might worsen or raise your risk for side effects. In some cases, your provider might need to change your Cerdelga (eliglustat) dose or stop the medication altogether.

            faqs

            Frequently asked questions about Cerdelga (eliglustat)

            Is Cerdelga (eliglustat) FDA approved?
            Yes, the FDA approved Cerdelga (eliglustat) in August 2014. It's a medication that's taken by mouth and is approved for the long-term treatment of Gaucher disease type 1 (GD1) in certain adults.
            Who makes Cerdelga (eliglustat)?
            The manufacturer of the brand-name medication Cerdelga is Genzyme Corporation.
            What is the difference between Cerdelga (eliglustat) and Cerezyme (imiglucerase)?
            Cerdelga (eliglustat) and Cerezyme (imiglucerase) are both first-choice treatment options for people with Gaucher disease type 1 (GD1), a genetic condition that causes a buildup of a fatty substance called GL-1 in the body. Cerdelga is a capsule that's taken by mouth every day. It helps lower the amount of GL-1 that your body makes so that Gl-1 can't build up. On the other hand, Cerezyme is given as an infusion into your veins (intravenously or IV) roughly every 2 weeks, typically at a treatment center. It's considered an enzyme replacement therapy (ERT); it replaces the missing enzyme (protein) in your body that helps break down GL-1 appropriately. Talk to your provider to see which of these two treatment options is right for you.
            What is the difference between Cerdelga (eliglustat) and miglustat (Zavesca)?
            Cerdelga (eliglustat) and miglustat (Zavesca) work similarly to treat adults with Gaucher disease type 1 (GD1). They both block the body from making a fatty substance to help lessen toxic buildup in the organs. But Cerdelga (eliglustat) is considered a first-choice treatment option for GD1, whereas miglustat (Zavesca) isn't. The two medications both come as capsules that are taken by mouth, but miglustat (Zavesca) is typically taken more often during the day than Cerdelga (eliglustat). Cerdelga (eliglustat) appears to be less likely to cause side effects than miglustat (Zavesca). Speak with your provider to discuss which medication best fits your needs.
            Why does Cerdelga (eliglustat) dosing depend on my genetic makeup?
            Your genetic makeup determines how well Cerdelga (eliglustat) gets broken down (metabolized) in your body. In people who can't metabolize Cerdelga (eliglustat) well, the medication can build up in your body and raise your risk for side effects, especially serious heart rhythm problems. Because of this, you might need to take Cerdelga (eliglustat) less often to prevent these side effects from happening. Before you start this medication, you must do genetic testing so your provider can find the right dose for you. Discuss with your provider about what your genetic test results mean for you.
            Is Cerdelga (eliglustat) safe during pregnancy?
            It's not clear whether Cerdelga (eliglustat) is safe to take during pregnancy. There's not enough information about how the medication can affect you or your unborn baby if you take it while pregnant. Animal studies suggest that Cerdelga (eliglustat) can lead to birth defects. Keep in mind that there can be serious complications, such as a higher risk for miscarriage (pregnancy loss), if GD1 symptoms aren't controlled before or during pregnancy. Pregnancy can also worsen GD1 symptoms. Talk with your provider about the risks and benefits of taking Cerdelga (eliglustat) if you're pregnant or if you think you might become pregnant.
            Is Cerdelga (eliglustat) safe to take while breastfeeding?
            It's not known whether Cerdelga (eliglustat) can be found in breast milk, affect your milk supply, or harm your breastfed baby. But in animal studies, it was found in the milk of lactating rats, so it's possible that the medication can be passed along in human milk. Discuss with your provider about the risks and benefits of taking Cerdelga (eliglustat) if you’re breastfeeding.
            How do people get Gaucher disease?
            Gaucher disease is a rare genetic condition that causes toxic buildup of a fatty substance in certain organs of the body. This condition is caused by abnormal changes (mutations) in a specific section of your DNA. These abnormal changes are inherited (passed down) to you from one or both of your parents.
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            What are the risks and warnings for Cerdelga (eliglustat)?

            Cerdelga (eliglustat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Heart rhythm problems

            • Risk factors: History of heart problems | Taking certain antiarrhythmics (medications for an irregular heartbeat)

              Extremely high levels of Cerdelga (eliglustat) in the body can affect the way the heart beats and raise the risk for heart rhythm problems (arrhythmias). These heart rhythm problems can be serious and potentially life-threatening.

              The levels of Cerdelga (eliglustat) you have in your body depend on how well your body can break down the medication. And how well your body breaks down the medication can depend on your genetic makeup and any medications you take that can interact with Cerdelga (eliglustat).

              Tell your provider and pharmacist about your full medical history and all the medications you take. They can check your risk for heart rhythm problems with Cerdelga (eliglustat) treatment. You might need dose adjustments or an alternative treatment option. Avoid Cerdelga (eliglustat) if you have heart problems or if you take certain medications to control your heart rate, like amiodarone (Pacerone) and sotalol (Betapace).

              Seek medical help right away if you experience an abnormally fast heartbeat, fainting, or dizziness while you're taking Cerdelga (eliglustat).

              dosage

              Cerdelga (eliglustat) dosage forms

              Typical dosing for Cerdelga (eliglustat)

              In general, the typical dose is 84 mg by mouth once or twice daily, with or without food.

              Dosing is based on your genetic makeup and how well your body can break down Cerdelga (eliglustat). Because of this, you'll need to do genetic testing before you start this medication so your provider can prescribe the appropriate dose for you.

              The dose will also depend on whether you have liver problems or whether you're taking other medications that can interact with Cerdelga (eliglustat).

              contraindications-icon

              Cerdelga (eliglustat) contraindications

              Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Cerdelga (eliglustat) will not be safe for you to take.

              • Taking certain medications that interact with Cerdelga (eliglustat), depending on your genetic makeup

              • Certain liver problems, depending on your genetic makeup

              alternatives

              What are alternatives to Cerdelga (eliglustat)?

              There are a number of medications that your doctor can prescribe in place of Cerdelga (eliglustat). Compare a few possible alternatives below.
              Cerdelga (eliglustat)
              Used for:
              View Prices
              Miglustat (Zavesca)
              Used for:

              • Mild to moderate type 1 Gaucher disease in adults

              View Prices
              Cerezyme (imiglucerase)
              Used for:

              • Type 1 Gaucher disease in adults and children 2 years of age or older

              View Prices

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              References

              Best studies we found

              American Heart Association. (2022). What is an arrhythmia?

              Balwani, M., et al. (2016). Recommendations for the use of eliglustat in the treatment of adults with Gaucher disease type 1 in the United States. Molecular Genetics and Metabolism.

              Canadian Agency for Drugs and Technologies in Health. (2017). Appendix 8: Summary of drug interactions. Clinical Review Report: Eliglustat (Cerdelga): (Sanofi Genzyme): Indication: Gaucher Disease Type 1.

              View All References (8)

              Drug Approval Package. (n.d.). Cerdelga (eliglustat) capsules. U.S. Food and Drug Administration.

              Genzyme Corporation. (2023). Cerdelga- eliglustat capsule [package insert]. DailyMed.

              Kane, M., et al. (2020). Eliglustat therapy and CYP2D6 genotype. Medical Genetic Summaries.

              Kishnani, P. S., et al. (2022). Screening, patient identification, evaluation, and treatment in patients with Gaucher disease: Results from a Delphi consensus. Molecular Genetics and Metabolism.

              National Gaucher Foundation. (n.d.). Enzyme replacement therapy.

              National Gaucher Foundation. (n.d.). What is Gaucher disease?

              National Organization for Rare Diseases. (2020). Gaucher disease.

              U.S. Food and Drug Administration. (2021). Grapefruit juice and some drugs don’t mix.

              GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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