Medical Editor: John P. Cunha, DO, FACOEP
What Is Cerdelga?
Cerdelga (eliglustat) is a small molecule inhibitor of glucosylceramide synthase used for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
What Are Side Effects of Cerdelga?
Common side effects of Cerdelga include:
- joint pain
- headache or migraine
- mouth and throat pain
- back pain
- pain in the extremities, and
- abdominal pain
Dosage for Cerdelga
The recommended dosage of CerdelgA is 84 mg twice daily in CYP2D6 EMs and IMs. The recommended dosage in CYP2D6 PMs is 84 mg once daily.
What Drugs, Substances, or Supplements Interact with Cerdelga?
Cerdelga may interact with drugs that inhibit CYP2D6 and CYP3A. Tell your doctor all medications and supplements you use. During pregnancy, Cerdelga should be used only if prescribed.
Cerdelga During Pregnancy and Breastfeeding
It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Cerdelga (eliglustat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions to CERDELGA (occurring in ≥10% of the 126 GD1 patients treated with CERDELGA across Trials 1 and 2 were fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.
The adverse reaction profile of CERDELGA is based on two controlled studies, Trials 1 and 2 [see Clinical Studies]. Table 3 presents the profile from the 9-month double-blind, randomized, placebo-controlled trial of 40 treatment-naive patients (Trial 1). Patients were between the ages of 16 and 63 on the date of the first dose of study drug, and included 20 males and 20 females.
Table 3: Adverse Reactions Occurring in ≥10% of Treatment-Naive GD1 Patients and More Frequently than Placebo (Trial 1)
|Arthralgia||9 (45)||2 (10)|
|Headache||8 (40)||6 (30)|
|Migraine||2 (10)||0 (0)|
|Flatulence||2 (10)||1 (5)|
|Nausea||2 (10)||1 (5)|
|Oropharyngeal pain||2 (10)||1 (5)|
Table 4 presents the profile from the 12-month open-label, randomized, imiglucerase-controlled trial of 159 treated patients switching from enzyme replacement therapy (ERT) (Trial 2). Patients were between the ages of 18 and 69 on the date of the first dose of CERDELGA, and included 87 females and 72 males.
Table 4: Adverse Reactions Occurring in ≥5% of GD1 Patients Switching from Enzyme Replacement Therapy to CERDELGA and More Frequently than Imiglucerase (Trial 2)*
|Fatigue||15 (14)||1 (2)|
|Headache||14 (13)||1 (2)|
|Nausea||13 (12)||0 (0)|
|Diarrhea||13 (12)||2 (4)|
|Back pain||13 (12)||3 (6)|
|Pain in extremity||12 (11)||1 (2)|
|Upper abdominal pain||11 (10)||0 (0)|
|Dizziness||9 (8)||0 (0)|
|Asthenia||9 (8)||0 (0)|
|Cough||7 (7)||2 (4)|
|Dyspepsia||7 (7)||1 (2)|
|Gastroesophageal reflux disease||7 (7)||0 (0)|
|Constipation||5 (5)||0 (0)|
|Palpitations||5 (5)||0 (0)|
|Rash||5 (5)||0 (0)|
|* Trial 2 was not designed to support comparative claims for CERDELGA for the adverse reactions reported in this table.|
In a separate uncontrolled study, with up to 4 years of treatment in 26 naive GD1 patients, the types and incidences of adverse reactions were similar to Trials 1 and 2.
Read the entire FDA prescribing information for Cerdelga (Eiglustat Capsules)
© Cerdelga Patient Information is supplied by Cerner Multum, Inc. and Cerdelga Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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