Cerdelga

The recommended dose depends on liver function, specifically how well the CYP2D6 enzyme works to metabolize (break down) medications. This will be determined by a blood test that will be done before you start treatment.

The recommended dose for intermediate and extensive CYP2D6 metabolizers is 84 mg taken by mouth 2 times a day.

The recommended dose of poor CYP2D6 metabolizers is 1 capsule taken by mouth, once daily.

This medication works best if it is taken at the same time each day.

Swallow the capsules whole with water. Do not crush, dissolve or chew the capsules. This medication may be taken with food or on an empty stomach. Do not drink grapefruit juice while taking this medication as it can cause increased blood levels of eliglustat.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each hard gelatin capsule, with a blue-green opaque cap and white opaque body, imprinted with "GZ02C" in black, contains 84 mg of eliglustat as eliglustat tartrate (hemitartrate salt). Nonmedicinal ingredients: glyceryl behenate/glycerol dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose; capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and indigotine (E132); printing ink: shellac glaze, black iron oxide (E172), propylene glycol and ammonium hydroxide 28%.

Do not take this medication if you:

• are allergic to eliglustat or any ingredients of the medication

• have a galactose intolerance, glucose-galactose malabsorption, or Lapp lactase deficiency

• are taking certain other medications which may result in a serious drug interaction with eliglustat (see you doctor or pharmacist for details)

  • bupropion

  • cimetidine

  • cinacalcet

  • clarithromycin

  • diltiazem

  • duloxetine

  • fluoxetine

  • fluvoxamine

  • idelalisib

  • mirabegron

  • nefazodone

  • nelfinavir

  • paroxetine

  • quinidine

  • terbinafine

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation

• diarrhea

• dizziness

• dry mouth

• fatigue

• gas

• headache

• heartburn

• low energy

• nausea

• stomach pain

• tremor

• trouble swallowing

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal heart rhythms (such as fast or slow heart rate, palpitations), fainting or seizures

• pain in the arms, legs or back

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of several types of abnormal heart rhythm including QT prolongation, and should not be used in combination with eliglustat. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female

• are older than 65 years of age

• have a family history of sudden cardiac death

• have a history of heart disease or abnormal heart rhythms

• have a slow heart rate

• have congenital prolongation of the QT interval

• have diabetes

• have had a stroke

• have low potassium, magnesium, or calcium levels

• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney Function: Eliglustat is not recommended for people with moderate to severe kidney disease or decreased kidney function. This medication has not been studied for use by people with decreased kidney function.

Liver function: The safety and effectiveness of having decreased liver function and using eliglustat have not been determined. This medication is not recommended for people with liver disease or decreased liver function.****

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if eliglustat passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between eliglustat and any of the following:

• abiraterone

• alfuzosin

• aliskiren

• amantadine

• antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, flecainide, quinidine, procainamide, propafenone)

• anticancer medications (e.g., daunorubicin, etoposide, irinotecan, methotrexate, paclitaxel, vincristine)

• antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)

• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• aprepitant

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• B-2 agonists (e.g., formoterol, indacaterol, salmeterol, vilanterol)

• bosentan

• brentuximab

• buprenorphine

• bupropion

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• carvedilol

• cinacalcet

• chloral hydrate

• chloroquine

• colchicine

• conivaptan

• corticosteroids (e.g., dexamethasone, hydrocortisone)

• cyclosporine

• dabigatran

• darifenacin

• deferasirox

• dextromethorphan

• digoxin

• domperidone

• donepezil

• edoxaban

• enzalutamide

• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)

• everolimus

• fingolimod

• galantamine

• "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)

• grapefruit juice

• H2 receptor blockers (e.g., famotidine, ranitidine)

• hepatitis C antivirals (e.g., asunaprevir, ledipasvir, simeprevir,)

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• hydroxychloroquine

• indapamide

• ivabradine

• lithium

• loperamide

• lumacaftor

• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)

• maprotiline

• methadone

• metoclopramide

• metronidazole

• mifepristone

• mirabegron

• mirtazapine

• modafinil

• nadolol

• naloxegol

• nefazodone

• octreotide

• pentamidine

• phenobarbital

• primaquine

• probucol

• protein kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)

• prucalopride

• rifabutin

• rifampin

• romidepsin

• quinine

• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)

• St. John's wort

• seizure medications (e.g., carbamazepine, lomitapide, oxcarbazepine, phenytoin, primidone)

• serotonin norepinephrine reuptake inhibitors (SNRIs: e.g., desvenlafaxine, duloxetine, venlafaxine)

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)

• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)

• silodosin

• siltuximab

• sirolimus

• solifenacin

• sotalol

• "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)

• sulfamethoxazole

• tacrolimus

• tamoxifen

• terbinafine

• tetrabenazine

• tizanadine

• tocilizumab

• tolterodine

• tolvaptan

• trazodone

• trimethoprim

• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)

• vardenafil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Cerdelga