Cerdelga

Package leaflet: Information for the patient

Cerdelga 21 mg hard capsules, 84 mg hard capsules

eliglustat

Medicinal product subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Cerdelga is and what it is used for
2. What you need to know before taking Cerdelga
3. How to take Cerdelga
4. Possible side effects
5. How to store Cerdelga
6. Contents of the pack and other information

1. What Cerdelga is and what it is used for

Cerdelga contains the active substance eliglustat and is used for the long-term treatment of adult patients and children aged 6 years and older who weigh at least 15 kg with type 1 Gaucher disease.
When used in children, Cerdelga is indicated for those children whose disease is controlled with enzyme replacement therapy. Your doctor will determine whether Cerdelga is suitable for you or your child before starting treatment, using a simple laboratory test.
Type 1 Gaucher disease is a rare inherited condition in which a substance called glucosylceramide is not effectively broken down by the body. As a result, glucosylceramide accumulates in the spleen, liver, and bones, preventing these organs from functioning properly. Cerdelga contains the active ingredient eliglustat, which reduces the production of glucosylceramide, thereby preventing its accumulation and helping the affected organs to function better.
The medicine is broken down by the body at different speeds in different people. Therefore, the amount of medicine in the blood may vary between different patients, which may influence how a patient responds. Cerdelga should be used in patients whose bodies break down the medicine at a normal rate (known as intermediate metabolizers and extensive metabolizers) or at a slow rate (known as poor metabolizers).
Type 1 Gaucher disease is a chronic condition, and you must continue taking the medicine as prescribed by your doctor to achieve maximum benefit.

2. What you need to know before taking Cerdelga

Do not take Cerdelga

• If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
• If you are an intermediate or extensive metabolizer (you metabolize Cerdelga at an intermediate or high rate) and are taking medicines known as strong or moderate CYP2D6 inhibitors (for example, quinidine and terbinafine) in combination with strong or moderate CYP3A inhibitors (for example, erythromycin and itraconazole). The combination of these medicines interferes with the body's ability to break down Cerdelga, which may lead to higher levels of the active substance in the blood (for a complete list of medicines, see section “Other medicines and Cerdelga”).
• If you are a poor metabolizer (you metabolize Cerdelga slowly) and are taking medicines known as strong CYP3A inhibitors (for example, itraconazole). These types of medicines interfere with the body's ability to metabolize Cerdelga, which may result in higher levels of the active substance in the blood (for a complete list of medicines, see section “Other medicines and Cerdelga”).
• If you are an extensive metabolizer (you metabolize Cerdelga rapidly) and have severely impaired liver function.
• If you are an extensive metabolizer (you metabolize Cerdelga rapidly) and have mildly or moderately impaired liver function and are simultaneously taking a strong or moderate CYP2D6 inhibitor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cerdelga if:

• You are currently receiving or are about to start treatment with any of the medicines listed in the section “Other medicines and Cerdelga”.
• You have had a heart attack or heart failure.
• You have a slow heart rate.
• You have an irregular or abnormal heartbeat, including a condition called long QT syndrome.
• You have other heart problems.
• You are taking antiarrhythmic medicines (used to treat irregular heartbeat) such as quinidine, amiodarone, or sotalol.
• You are an extensive metabolizer (you metabolize Cerdelga rapidly) and have moderately impaired liver function.
• You are an intermediate or poor metabolizer (you metabolize Cerdelga at an intermediate or slow rate) and have impaired liver function of any degree.
• You are an intermediate or poor metabolizer (you metabolize Cerdelga at an intermediate or slow rate) and have impaired kidney function.
• You are a patient with end-stage renal disease.

Children and adolescents
Cerdelga must not be used in children under 6 years of age or weighing less than 15 kg.
Other medicines and Cerdelga
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Medicines that must not be taken together with Cerdelga
Cerdelga must not be taken with certain types of medicines. These medicines may interfere
with the body's ability to break down Cerdelga, resulting in higher levels of Cerdelga in the blood. These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors. There are many medicines in these categories, and depending on how your body metabolizes Cerdelga, the effects may vary from person to person. You must discuss these medicines with your doctor before starting Cerdelga. Your doctor will determine which medicines you can take based on how quickly your body metabolizes eliglustat.
Medicines that may increase the level of Cerdelga in the blood, such as:

• paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide – antidepressants (used to treat depression)
• dronedarone, quinidine, verapamil – antiarrhythmics (used to treat irregular heartbeat)
• ciprofloxacin, clarithromycin, erythromycin, telithromycin – antibiotics (used to treat infections)
• terbinafine, itraconazole, fluconazole, posaconazole, voriconazole – antifungals (used to treat fungal infections)
• mirabegron – used to treat overactive bladder
• cinacalcet – calcimimetic (used in some dialysis patients and certain types of cancer)
• atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir – antiretrovirals (used to treat HIV)
• cobicistat – used to boost the effects of antiretrovirals (used to treat HIV)
• aprepitant – antiemetic (used to reduce vomiting)
• diltiazem – antihypertensive (used to increase blood flow and decrease heart rate)
• conivaptan – diuretic (used to increase low sodium levels in the blood)
• boceprevir, telaprevir – antivirals (used to treat hepatitis C)
• imatinib – anticancer (used to treat cancer)
• amlodipine, ranolazine – used to treat angina pectoris
• cilostazol – used to treat cramp-like pain in the legs when walking caused by insufficient blood flow to the legs
• isoniazid – used to treat tuberculosis
• cimetidine, ranitidine – antacids (used to treat indigestion)
• goldenseal (also known as Hydrastis canadensis) – an over-the-counter herbal preparation used to aid digestion.

Medicines that may decrease the level of Cerdelga in the blood:

• rifampicin, rifabutin – antibiotics (used to treat infections)
• carbamazepine, phenobarbital, phenytoin – antiepileptics (used to treat epilepsy and seizures)
• St. John’s wort (also known as Hypericum perforatum) – an over-the-counter herbal preparation used to treat depression and other conditions

Cerdelga may increase blood levels of the following medicines:

• dabigatran – anticoagulant (used to thin the blood)
• phenytoin – antiepileptic (used to treat epilepsy and seizures)
• nortriptyline, amitriptyline, imipramine, desipramine – antidepressants (used to treat depression)
• phenothiazines – antipsychotics (used to treat schizophrenia and psychosis)
• digoxin – used to treat heart failure and atrial fibrillation
• colchicine – used to treat gout
• metoprolol – used to reduce blood pressure and/or heart rate
• dextromethorphan – cough medicine
• atomoxetine – used to treat attention deficit hyperactivity disorder (ADHD)
• pravastatin – used to lower cholesterol and prevent heart disease

Cerdelga with food and drink
Avoid consuming grapefruit or grapefruit juice, as they may increase the level of Cerdelga in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor, who will discuss with you whether you should take this medicine during pregnancy.
The active substance in this medicine has been shown to pass into breast milk in animals in trace amounts. Breastfeeding is not recommended during treatment with this medicine. Inform your doctor if you are breastfeeding.
There are no known effects on fertility at normal doses.
Driving and using machines
Cerdelga may affect the ability to drive and use machines in patients who experience dizziness after administration.
Cerdelga contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Cerdelga

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Cerdelga is available in two different strengths. The hard capsules containing 84 mg of eliglustat are blue-green and white, and the hard capsules containing 21 mg of eliglustat are completely white.
When giving this medicine to your child, make sure they are taking the correct dose.
Cerdelga must be taken orally by children who can swallow the capsule whole.
Cerdelga hard capsules must be swallowed whole with water at the same time each day. It may be taken with or without food. Those taking the medicine twice daily should take one dose in the morning and one dose in the evening.
Do not open, crush, dissolve, or chew the hard capsule before swallowing it. If you are unable to swallow the capsule whole, inform your doctor.
Mixing the capsule contents (eliglustat powder) with food or drink has not been studied.

Recommended dose for adults
If you are an intermediate metabolizer or an extensive metabolizer:
Swallow one 84 mg capsule whole twice daily with water. The capsules may be taken with or without food. Take one capsule in the morning and one capsule in the evening.

If you are a poor metabolizer:
Swallow one 84 mg capsule whole once daily with water. The capsules may be taken with or without food. Take one capsule at the same time each day.

Do not open, crush, dissolve, or chew the capsules before swallowing them. If you cannot swallow the capsules whole, discuss this with your doctor.

Recommended dose for children
The amount of this medicine your child should take depends on their body weight and how they metabolize the medicine. Your doctor will determine this before starting treatment.

Continue taking Cerdelga every day for the period indicated by your doctor.
How to dispense the 21 mg hard capsules
Break the film covering the capsule using your thumb or index finger and push the capsule out.

How to remove the blister pack from the holder for the 84 mg hard capsules
Pressing with your thumb and index finger on one end of the holder (1), gently pull out the blister pack to open the holder (2).
If you take more Cerdelga than you should
If you take more capsules than prescribed, contact your doctor immediately. You may experience dizziness accompanied by loss of balance, slow heartbeat, nausea, vomiting, and faintness.
If you forget to take Cerdelga
Take the next capsule at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Cerdelga
Do not stop treatment with Cerdelga without informing your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• Headache
• Dizziness
• Taste disturbance (dysgeusia)
• Palpitations
• Sore throat
• Cough
• Heartburn (dyspepsia)
• Stomach ache (upper abdominal pain)
• Diarrhoea
• Malaise (nausea)
• Constipation
• Abdominal pain
• Acid reflux disease (gastroesophageal reflux disease)
• Swelling (abdominal distension)
• Inflammation of the stomach (gastritis)
• Difficulty swallowing (dysphagia)
• Vomiting
• Dry mouth
• Gas (flatulence)
• Dry skin
• Hives (urticaria)
• Joint pain (arthralgia)
• Pain in arms, legs or back
• Tiredness (fatigue)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cerdelga

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, container, and blister pack after "EXP / Scad.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cerdelga contains
The active substance is eliglustat (as tartrate).
Cerdelga 21 mg hard capsule:
Each hard capsule contains 21 mg of eliglustat.
The other components are:

• In the capsule: microcrystalline cellulose (E460), monohydrate lactose (see section 2 "Cerdelga contains lactose"), hypromellose 15 mPa.S, 2910 and glycerol dibehenate.
• In the capsule coating: gelatin (E441), potassium aluminum silicate (E555), titanium dioxide (E171).
• In the printing ink: shellac, black iron oxide (E172), propylene glycol (E1520) and concentrated ammonia solution (E527).

Cerdelga 84 mg hard capsule:
Each hard capsule contains 84 mg of eliglustat.
The other components are:

• In the capsule: microcrystalline cellulose (E460), monohydrate lactose (see section 2 "Cerdelga contains lactose"), hypromellose and glycerol dibehenate.
• In the capsule coating: gelatin (E441), potassium aluminum silicate (E555), titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132).
• In the printing ink: shellac, black iron oxide (E172), propylene glycol (E1520) and concentrated ammonia solution (E527).

Description of the appearance of Cerdelga and contents of the pack
Cerdelga 21 mg hard capsule:
Cerdelga 21 mg hard capsules have an opaque white cap and a pearly white body, with the imprint “GZ04” in black ink on the capsule.
Pack: 56 hard capsules in 4 blisters of 14 capsules each.

Cerdelga 84 mg hard capsule:
Cerdelga 84 mg hard capsules have a pearly blue-green opaque cap and an opaque pearly white body, with the imprint “GZ02” in black ink on the capsule.
Packs: 14 hard capsules in 1 blister pack, 56 hard capsules in 4 blister packs of 14 capsules each, or 196 hard capsules in 14 blister packs of 14 capsules each.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sanofi BV
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Manufacturer
Cerdelga 21 mg hard capsule
Patheon France
40 Boulevard de Champaret
Bourgoin Jallieu
France

Cerdelga 84 mg hard capsule
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
Sanofi Winthrop Industrie
1 rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc cedex
France
Genzyme Ireland Ltd
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien/Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt.
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf.: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
International tel: +49 69 305 70 13

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: +43 1 80185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
From abroad: +33 1 57 63 23 23

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 201 200 300

Italia
Sanofi S.r.l.
Tel: 800 536 389

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.