CERDELGA

Main information

  • Trade name:
  • CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218172
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218172

CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

13/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PCTFE (Aclar)/AI

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

56 capsules

(S4) Prescription Only Medicine

Components

1. CERDELGA eliglustat (as tartrate) 84 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Pearl blue-green opaque cap and pearl white opaque body capsules with

GZ02 printed in black on the capsule.

Active Ingredients

eliglustat tartrate

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:23:51 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Cerdelga

®

eliglustat

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Cerdelga. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Cerdelga

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Cerdelga is used

for

Cerdelga contains the active

substance eliglustat. It belongs to a

group of medicines that decrease the

production of a substance called

glucosylceramide in the body.

Cerdelga is used for the long term

treatment of adult patients with

Gaucher disease type 1.

Gaucher disease type 1 is a rare,

inherited condition in which a

substance called glucosylceramide

builds up in the cells of your spleen,

liver and bones.

The build-up can prevent these

organs from working properly.

Cerdelga decreases the production of

glucosylceramide, preventing its

build-up. In turn this helps your

affected organs to work better.

Some people's bodies break down

this medicine faster than others. As a

result the amount of this medicine in

the blood can differ between patients

which could affect how you will

respond. Cerdelga is meant to be

used in patients whose body breaks

down this medicine at normal speed

(known as intermediate metaboliser

and extensive metaboliser) or slow

speed (known as poor metaboliser).

Your doctor will determine if

Cerdelga is suitable for you before

you start taking it, using a simple

laboratory test.

Gaucher disease type 1 is a lifelong

condition and you must continue to

take Cerdelga as prescribed by your

doctor to gain the maximum benefit

from your medicine.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

This medicine is available only with

a doctor's prescription.

There is not enough information to

recommend the use of this medicine

for children under the age of 18

years.

Before you take it

When you must not take it

Do not take Cerdelga if you:

are allergic to eliglustat or any of

the other ingredients listed at the

end of this leaflet.

Some symptoms of an allergic

reaction include skin rash, hives,

itching, shortness of breath or

swelling of the face, lips or

tongue, which may cause

difficulty in swallowing or

breathing.

are being treated with any

medicines other than Cerdelga

until after you have consulted

with your doctor. Certain

medicines can interfere with your

body's ability to breakdown

Cerdelga and this can result in

higher levels of Cerdelga than

needed in your body (see the

section 'Taking other medicines'

for an expanded list of

medicines).

Do not give Cerdelga to a child

under the age of 18 years.

Safety and effectiveness in children

have not been established.

Do not take it after the expiry date

(exp) printed on the pack or if the

packaging is torn or shows signs of

tampering.

If it has expired or is damaged return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to any other

medicines, foods, preservatives or

dyes.

Tell your doctor immediately if

you:

are currently treated or about to

start treatment with any of the

medicines listed in section

'Taking other medicines'

have had a heart attack or heart

failure

have a slow heart rate

CERDELGA

have an irregular, or abnormal

heart beat, including a heart

condition called long QT

syndrome

have any other heart problems

are taking an antiarrhythmic

medicine (for irregular heart

beats) like quinidine, amiodarone,

sotalol.

If you are unsure about whether you

should take Cerdelga with your

current medicines, check with your

doctor or pharmacist.

Tell your doctor if you are or

intend to become pregnant.

Your doctor will discuss with you the

risks and benefits involved.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

It is unknown if Cerdelga enters

breast milk. Breast-feeding is not

recommended during treatment with

this medicine.

If you have not told your doctor

about any of the above, tell him/

her before you take Cerdelga.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Medicines that must not be taken

in combination with each other

and Cerdelga:

Cerdelga must not be used with

certain type of medicines. These

medicines can interfere with your

body's ability to break down

Cerdelga and this can result in higher

levels of Cerdelga in your 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 breaks down

Cerdelga the effects may differ from

person to person. Please speak to

your doctor about these medicines

before you start taking Cerdelga.

Your doctor will determine which

medicines you can use based on how

fast your body breaks down

Cerdelga.

Some medicines may increase the

level of Cerdelga in the blood:

paroxetine, fluoxetine,

duloxetine, bupropion,

moclobemide - antidepressants

used to treat depression

quinidine, dronedarone,

verapamil - antiarrhythmics used

to treat irregular heartbeat

clarithromycin, erythromycin,

ciprofloxacin - antibiotics used to

treat infections

terbinafine, itraconazole,

fluconazole, posaconazole,

voriconazole - antifungals used to

treat fungal infections

mirabegron - used to treat

overactive bladders

cinacalcet - calcimimetic used in

some dialysis patients and

specific cancers

atazanavir, darunavir,

fosamprenavir, indinavir,

lopinavir, ritonavir, saquinavir,

telaprevir, tipranavir -

antiretrovirals used to treat HIV

cobicistat - used to improve 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

boceprevir - antiviral used to treat

Hepatitis C

imatinib - anticancer used to treat

cancer

amlopidine - used to treat angina

pectoris

cilostazol - used to treat cramp-

like pain in your legs when you

walk caused by insufficient blood

supply in your legs

Some medicines may decrease the

level of Cerdelga in the blood:

rifampicin, rifabutin - antibiotics

used to treat infections

carbamazepine, phenobarbital,

phenytoin - anti-epileptics used to

treat epilepsy and seizures

St. John's wort - a herbal

preparation obtained without a

prescription, used to treat

depression and other conditions

(also known as Hypericum

perforatum).

Cerdelga may increase the level of

the following types of medicines in

the blood:

dabigatran - anticoagulant used to

thin the blood

phenytoin - anti-epileptic used to

treat epilepsy and seizures

nortryptyline, amitriptyline,

imipramine - 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 lower blood

pressure and/or reduce heart rate

dextromethorphan - cough

medicine

atomoxetine - used to treat

attention deficit hyperactivity

disorder (ADHD)

pravastatin - used to lower

cholesterol and prevent heart

disease

These medicines will be affected by

Cerdelga or may affect how Cerdelga

works. You may need different

amounts of your medicines, or take

different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

Cerdelga.

CERDELGA

How to take it

Follow all directions given to you

by your doctor or pharmacist

carefully and always take this

medicine exactly as your doctor or

pharmacist has told you.

How much to take

If you are an intermediate

metaboliser or extensive

metaboliser:

Swallow one 84 mg capsule whole

twice per day. Take one capsule in

the morning and one capsule at night.

If you are a poor metaboliser:

Swallow one 84 mg capsule whole

once per day. Take the capsule at the

same time every day.

Your doctor may have prescribed a

different dose.

Ask your doctor or pharmacist if

you are unsure of the correct dose

for you.

How to take it

It may be taken with or without

food.

Swallow the capsules whole with a

full glass of water.

Do not open, crush, dissolve, or

chew capsule before swallowing. If

you cannot swallow the capsule

whole, tell your doctor.

Avoid grapefruit or grapefruit

products since grapefruit may

increase the level of Cerdelga in

your blood.

When to take it

Take Cerdelga at about the same

time each morning and night.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it

Continue taking your medicine for

as long as your doctor or

pharmacist tells you.

The medicine helps control your

condition, but it does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

If there is still a long time to go

before your next dose, take it as soon

as you remember, and then go back

to taking it as you would normally.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much Cerdelga. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include: dizziness marked by loss of

balance, slow heart rate, nausea,

vomiting and light-headedness.

While you are taking it

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking Cerdelga.

Remember to provide your

Cerdelga Patient Card to any

health care professional when

seeking treatment.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Cerdelga.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking Cerdelga.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor or pharmacist immediately.

Things you must not do

Do not take more than the

recommended dose unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop taking Cerdelga, or

lower the dosage, without checking

with your doctor.

Do not start taking any new

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop without

consulting your doctor or

pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

Cerdelga affects you.

Side effects

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. Your doctor or pharmacist has

weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

CERDELGA

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Cerdelga.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

headache

feeling sick (nausea)

diarrhoea

stomach pain

wind (flatulence)

joint pain

tiredness (fatigue)

These are the more common side

effects of Cerdelga.

In clinical studies, a small number of

patients fainted. All of these patients

had risk factors for fainting. Please

tell your doctor immediately if you

are feeling faint or you have fainted.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some people.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After taking it

Storage

Keep your capsules in the pack

until it is time to take them.

If you take the capsules out of the

pack they may not keep well.

Keep the medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom or near a

sink. Do not leave it in the car on

hot days or on window sills.

Keep it where children cannot reach

Disposal

If your doctor or pharmacist tells

you to stop taking Cerdelga or the

expiry date has passed, ask your

pharmacist what to do with any

capsules that are left over.

Return any unused medicine to

your pharmacist.

Product description

What it looks like

Cerdelga capsules have a pearl blue-

green opaque cap and a pearl white

opaque body with "GZ02" printed in

black on the capsule.

Each carton contains 56 hard

capsules in 4 blister wallets of 14

capsules each.

Ingredients

Active ingredient:

Each capsule contains 84 mg of the

active ingredient, eliglustat (as

tartrate).

Inactive ingredients:

Lactose, microcrystalline cellulose,

hypromellose, glycerol dibehenate.

The ingredients of the capsule shell

are: gelatin, candurin silver fine

(E555 and E171), iron oxide yellow

(E172) and indigo carmine (E132).

The ingredients of the printing ink

are: shellac glaze, iron oxide black

(E172), propylene glycol and

ammonium hydroxide.

Supplier

Cerdelga

is supplied in Australia

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

= Registered Trademark

This leaflet was prepared in February

2015.

AUST R 218172

cer-ccds1-cmiv1-17feb15

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