Eliglustat, Oral

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KEY POINTS

• This medicine is taken by mouth to treat the symptoms of Gaucher's disease. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: glucosylceramide synthase inhibitor

Generic and brand names: eliglustat, oral; Cerdelga

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of Gaucher's disease.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Heart disease, heart attack, slow or irregular heartbeat
• Kidney or liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Take each dose at the same time each day. Do not take more or less or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the capsules whole. Do not break, crush, or chew them. Take each dose with a full glass of water.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: dizziness, slow heartbeat, nausea, vomiting.

What should I watch out for?

You may need blood tests or other tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast, pounding, or irregular heartbeat; fainting; severe dizziness.

Other: Diarrhea; constipation; heartburn; nausea; headache; mild dizziness; tiredness; weakness; cough; mild rash; pain in the arms, legs, back, joints, or stomach.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Alzheimer's disease medicines such as donepezil (Aricept) and galantamine (Razadyne)
• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), terbinafine (Lamisil), and voriconazole (Vfend)
• Antihistamines such as diphenhydramine (Benadryl) and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), perphenazine, pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), ezogabine (Potiga), felbamate (Felbatol), fosphenytoin (Cerebyx), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), simeprevir (Olysio), and sofosbuvir/velpatasvir (Epclusa)
• Apomorphine (Apokyn)
• Atomoxetine (Strattera)
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Zyban)
• Cancer medicines such as abiraterone (Zytiga), afatinib (Gilotrif), arsenic trioxide (Trisenox), bicalutamide (Casodex), bosutinib (Bosulif), brentuximab (Adcetris), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), goserelin (Zoladex), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), lenvatinib (Lenvima), leuprolide (Lupron), mitotane (Lysodren), nilotinib (Tasigna), osimertinib (Tagrisso), panobinostat (Farydak), pazopanib (Votrient), sunitinib (Sutent), tamoxifen, topotecan (Hycamtin), vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lovastatin (Altoprev)
• Cinacalcet (Sensipar)
• Cisapride
• Colchicine (Colcrys)
• Corticosteroids such as dexamethasone and hydrocortisone (A-Hydrocort, Cortef)
• Cystic fibrosis medicines such as lumacaftor/ivacaftor (Orkambi) and ivacaftor (Kalydeco)
• Darifenacin (Enablex)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Fingolimod (Gilenya)
• Heart medicines such as aliskiren (Tekturna), amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, indapamide, ivabradine (Corlanor), metoprolol (Lopressor, Toprol), nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Loperamide (Imodium)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or treat stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as budesonide/formoterol (Symbicort), fluticasone/salmeterol (Advair), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), indacaterol (Arcapta), mometasone/formoterol (Dulera), olodaterol (Striverdi Respimat), and salmeterol (Serevent)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), and rivaroxaban (Xarelto)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Mirabegron (Myrbetriq)
• Modafinil (Provigil)
• Naloxegol (Movantik)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), granisetron (Sancuso), netupitant/palonosetron (Akynzeo), ondansetron (Zofran), prochlorperazine (Compro), promethazine, and rolapitant (Varubi)
• Octreotide (Sandostatin)
• Olanzapine (Zyprexa)
• Pain medicines such as buprenorphine (Buprenex, Butrans), codeine, methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• St. John’s wort
• Tetrabenazine (Xenazine)
• Vardenafil (Levitra, Staxyn)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.