Details for: CERDELGA
Company: SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02463261 | CERDELGA | ELIGLUSTAT (ELIGLUSTAT TARTRATE) | 84 MG | CAPSULE | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CERDELGA is a medicine used for treating adult patients with Gaucher disease type 1. CERDELGA is not used in certain people with Gaucher disease type 1. Your doctor will perform a test to make sure that CERDELGA is right for you. This test will tell how quickly your body breaks down (metabolizes) CERDELGA. It will also determine if and how you can use this medicine.
If your body metabolizes CERDELGA at a regular speed, you are an extensive metabolizer.
If your body metabolizes CERDELGA at a slower speed, you are an intermediate metabolizer.
If your body metabolizes CERDELGA at a very slow speed, you are a poor metabolizer.
What it does
Gaucher disease type 1 is caused by not having the normal amount of an enzyme called acid βglucosidase. This enzyme’s job is to break down a lipid, or fatty substance, in your body called glucosylceramide. Because the level of this enzyme is lower in people with Gaucher disease, the lipid builds up in your body. The lipid build up can damage your organs, especially your liver and spleen. CERDELGA decreases the production of glucosylceramide which prevents its buildup. This helps the organs affected by Gaucher disease to work better.
Gaucher disease type 1 is a lifelong condition. You must continue to take CERDELGA as prescribed by your healthcare professional.
When it should not be used
Do not use CERDELGA if you:
- are allergic to eliglustat tartrate or any of the other ingredients of CERDELGA
- have one of the following rare hereditary conditions, because lactose is a non-medicinal ingredient in CERDELGA:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
- are an extensive or intermediate metabolizer, and
- you are taking a combination of other medicines called strong or moderate CYP2D6 inhibitors with strong or moderate CYP3A inhibitors. The combination of these types of medicine will affect how you respond to CERDELGA.
- are an intermediate or poor metabolizer, and
- you are taking medicines that are strong CYP3A inhibitors. Medicines of this type will affect how you respond to CERDELGA, or
- you have liver problems.
- are an extensive metabolizer and you also have one of the following:
- moderate to severe liver problems, or
- mild liver problems and you are taking a strong or moderate CYP2D6 inhibitor, or
- mild liver problems and you are taking a strong CYP3A inhibitor
Examples of strong or moderate CYP2D6 inhibitors are paroxetine, fluoxetine, quinidine, bupropion or terbinafine, duloxetine, moclobemide, mirabegron, cinacalcet and dronedarone.
Examples of moderate CYP3A inhibitors are cobicistat, indinavir, fluconazole, erythromycin, ciprofloxacin, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib and cimetidine.
Examples of strong CYP3A inhibitors are ketoconazole, clarithromycin, itraconazole, lopinavir, ritanovir, saquinavir, cobicistat, indinavir, telaprevir, tipranavir, posaconazole, voriconazole, conivaptan and boceprevir.
What the medicinal ingredient is
eliglustat tartrate
What the non-medicinal ingredients are
ammonium hydroxide, black iron oxide (E172), gelatin, glyceryl behenate/glycerol dibehenate, hypromellose, indigotine (E132), lactose monohydrate, microcrystalline cellulose, propylene glycol, shellac glaze, titanium dioxide (E171) and yellow iron oxide (E172).
What dosage form it comes in
Capsules; 84 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CERDELGA. Talk about any health conditions or problems you may have, including if you:
- Are currently taking, or are about to start taking any of the medicines described in section ‘The following may interact with CERDELGA’.
- Have heart problems.
- Have a history of a heart attack.
- Have a family history of sudden cardiac death before age 50 years.
- Have a history of fainting (syncope).
- Have an irregular or abnormal heart beat, including a heart condition called long QT syndrome.
- Have kidney or liver problems.
- Have an eating disorder.
- Have low blood levels of potassium, magnesium, or calcium.
- Are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
- Are pregnant, think that you may be pregnant or are planning to become pregnant. You must talk to your healthcare professional about whether you can take CERDELGA while you are pregnant.
- Are breast-feeding or planning to breastfeed. It is not known if CERDELGA passes into your breast milk. You and your healthcare professional will decide if you should take CERDELGA or breastfeed. You should not do both.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with CERDELGA: CERDELGA must not be used with certain types of medicines. Some medicines can interfere with your body’s ability to break down CERDELGA, resulting in higher levels of CERDELGA in your blood. These medicines are known as strong, moderate or weak CYP2D6 inhibitors and strong, moderate, or weak CYP3Ainhibitors. Other medicines and herbs can also interact with CERDELGA.
Especially tell your healthcare professional if you take:
- St. John’s wort (Hypericum perforatum), an herbal medicine used to treat depression.
- Goldenseal, an herbal medicine used to treat the common cold.
- Medicine to treat fungal infections (such as ketoconazole, fluconazole, terbinafine, itraconazole, posaconazole, voriconazole, amphotericin B)
- Medicine to treat bacterial infections (such as clarithromycin, erythromycin, ciprofloxacin, moxifloxacin, levofloxacin, telithromycin, tacrolimus)
- Medicine to treat malaria (such as quinine, chloroquine)
- Medicine to treat HIV infection and AIDS (such as cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, atazanavir, darunavir, fosamprenavir)
- Medicine to treat Hepatitis C infection (boceprevir)
- Medicine to treat tuberculosis (such as rifampin, isoniazid, rifabutin)
- Medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin)
- Medicine for heart conditions or high blood pressure (such as quinidine, dronedarone, diltiazem, verapamil, amlopidine, digoxin, metoprolol)
- Medicine to treat depression or other mental health problems (such as paroxetine, fluoxetine, bupropion, duloxetine, moclobemide, fluvoxamine, perphenazine, chlorpromazine, pimozide, haloperidol, droperidol, risperidone, ziprasidone, citalopram, venlafaxine, nortriptyline, amitriptyline, imipramine, desipramine, maprotiline, atomoxetine)
- Medicine to treat overactive bladder (such as mirabegron)
- Opioids (such as methadone)
- Domperidone, often used to increase milk supply in women who are breastfeeding
- Medicine to prevent nausea and vomiting (such as ondansetron, aprepitant)
- Medicine to treat cancer (imatinib, sunitinib, nilotinib, vandetanib, vorinostat)
- Medicine to treat breathing problems like asthma (such as salmeterol, formoterol)
- Diuretics or “water pills”
- Medicine to treat low levels of sodium in the blood (such as conivaptan)
- Medicine to treat problems with the parathyroid gland (such as cinacalcet)
- Medicine to treat gout (such as colchicine)
- Medicine to treat cough (such as dextromethorphan)
- Medicine to prevent stroke (such as dabigatran)
- Medicine to treat high cholesterol levels (such as pravastatin)
- Laxatives and enemas
- High dose corticosteroids used to treat inflammation and reduce the activity of the immune system
- Medicine used to treat ulcers (cimetidine, ranitidine)
- Medicine to treat heartburn and acid reflux (such as proton pump inhibitors)
If you take any medicines for the conditions listed above, your healthcare professional may need to prescribe a different medicine, change your dose of the other medicines, or change your dose of CERDELGA. Tell your healthcare professional about any new medicines before you start taking them.
Do not eat grapefruit or drink grapefruit juice since it may increase the level of CERDELGA in your blood.
Proper use of this medication
How to take CERDELGA:
- Always take CERDELGA exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Continue taking CERDELGA every day for as long as your healthcare professional tells you.
- CERDELGA can be taken with or without food.
- Take CERDELGA at the same time each day.
- Swallow CERDELGA whole with water. Do not open, crush, dissolve, or chew the capsule. If you cannot swallow the capsule whole, tell your healthcare professional.
Usual Dose
Your healthcare professional will decide on the dose that is right for you. It may be either one or two CERDELGA capsules per day. This will be based on any other medicines you may be taking and blood tests to determine:
- the type of metabolizer you are (how quickly your body breaks down CERDELGA), and
- if you have kidney or liver problems.
Overdose
Symptoms of taking too much CERDELGA may include dizziness with loss of balance, slow heart rate, nausea, vomiting and light-headedness.
Missed Dose
If you miss a dose take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking CERDELGA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- tiredness, sleepiness or drowsiness, low energy
- headache
- dizziness
- fainting
- nausea, diarrhea, gas, indigestion, constipation, stomach pain
- dry mouth, trouble swallowing
- tremor
- pain in the arms, legs or back
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Frequent | |||
| Changes in the electrical activity
of your heart (ECG changes): palpitations, irregular heartbeat, dizziness, fainting |
✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Keep out of reach and sight of children.
Store at 20°C to 25°C with excursions permitted between 15o C and 30o C.
Do not use this medicine after the expiry date which is stated on the carton, sleeve and blister after ‘EXP’. The expiry date refers to the last day of that month.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about CERDELGA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.genzyme.ca, or by calling 1-877-220-8918.
This leaflet was prepared by Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
Date of Revision: December 6, 2018