OTEZLA

Main information

  • Trade name:
  • OTEZLA TITRATION PACK apremilast tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OTEZLA TITRATION PACK apremilast tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220424
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220424

OTEZLA TITRATION PACK apremilast tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Celgene Pty Ltd

Postal Address

Level 15 / 60 City Road,Southbank, VIC, 3006

Australia

ARTG Start Date

19/03/2015

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. OTEZLA TITRATION PACK apremilast tablet blister pack

Product Type

Composite Pack

Effective date

28/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Otezla is indicated for:- The treatment of signs and symptoms of active psoriatic arthritis in adult patients. - The treatment of adult patients with moderate

to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC-coated Al

24 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

4 x 10 mg plus 4 x 20 mg plus 19 x 30 mg Titration pack

(S4) Prescription Only Medicine

Components

1. Apremilast 20 mg film coated tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Brown, diamond shaped 20 mg film-coated tablet with 'APR' engraved on

one side and '20' on the opposite side

Active Ingredients

apremilast

20 mg

2. Apremilast 10 mg film coated tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, diamond shaped film-coated tablet with APR engraved on one side

and 10 on the opposite side.

Active Ingredients

apremilast

10 mg

3. Apremilast 30 mg film coated tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Beige, diamond shaped 30 mg film-coated tablet with 'APR' engraved on

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:24:54 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

one side and '30' on the opposite side

Active Ingredients

apremilast

30 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 2 of

Produced at 26.11.2017 at 02:24:54 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

OTEZLA

Otezla

®

film coated tablets

apremilast

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Otezla. 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 Otezla against

the benefits this medicine is expected

to 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 Otezla is used

for

Otezla is used to treat adults with the

following conditions:

Moderate to severe plaque

psoriasis (an inflammatory

disease of the skin, which can

cause red, scaly, thick, itchy,

painful patches on your skin, and

can also affect your scalp and

nails)

Psoriatic arthritis (an

inflammatory disease of the

joints, often accompanied by

psoriasis)

Psoriasis and psoriatic arthritis are

usually lifelong conditions and there

is currently no cure. Otezla works by

reducing the activity of a natural

substance in the body's cells called

'phosphodiesterase 4'. This helps

regulate the immune response

associated with psoriasis and

psoriatic arthritis. By regulating the

immune response, Otezla can help to

control the signs and symptoms of

these conditions.

In psoriasis, treatment with Otezla

results in a reduction in psoriatic skin

plaques and other signs and

symptoms of the disease.

In psoriatic arthritis, treatment with

Otezla results in an improvement in

swollen and painful joints, and can

improve your general physical

function.

Otezla has also been shown to

improve the quality of life in patients

with psoriasis or psoriatic arthritis.

This means that the impact of your

condition on daily activities,

relationships and other factors should

be less than it was before.

Ask your doctor if you have any

questions about how Otezla works,

or why this medicine has been

prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

Before you take Otezla

When you must not take it

Do not take Otezla if you have an

allergy to:

Apremilast, the active ingredient

of Otezla

any of the other ingredients of

Otezla listed at the end of this

leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

If you think you may be allergic to

Otezla, ask your doctor for advice.

Do not take Otezla if you are

pregnant or think you may be

pregnant.

Do not breast-feed if you are

taking Otezla.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Follow your doctor's instructions

carefully.

If you have not fully understood

these instructions, ask your doctor

again before taking Otezla.

Tell your doctor if you have or

have had any kidney problems.

Tell your doctor if you are

pregnant, think you may be

pregnant or are planning to have a

baby.

There is little information about the

effects of Otezla in pregnancy. You

should not use Otezla if you are

pregnant. You should not become

pregnant while taking this medicine.

OTEZLA

Tell your doctor before taking this

medicine if you are breast-feeding

or intend to breast-feed.

It is not known whether Otezla

passes into the mother's milk. You

should not use Otezla while breast-

feeding.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have

experienced depression or have

had suicidal thoughts in the past.

During treatment with Otezla, if

you feel depressed, have suicidal

thoughts, other mood changes or

notice that these events have

worsened, tell your doctor as soon

as possible.

During treatment with Otezla, if

you experience severe diarrhoea,

nausea or vomiting, tell you doctor.

Do not take Otezla if you have the

rare hereditary problems of

glucose intolerance, lactose

intolerance or glucose-galactose

malabsorption.

Otezla contains lactose (a type of

sugar).

Do not give this medicine to a child

or adolescent under the age of 18

years.

Safety and effectiveness of Otezla in

children under the age of 18 years

have not been established.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines

or have recently taken any other

medicines, including any medicines

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

In particular, tell your doctor or

pharmacist before taking Otezla if

you are taking any of the following

medicines:

rifampicin, an antibiotic used for

tuberculosis

carbamazepine, phenytoin and

phenobarbitone, medicines used

in the treatment of seizures or

epilepsy

St. John's Wort, a herbal

medicine for mild anxiety and

depression.

These medicines may affect Otezla

or may affect how well it works. You

may need different amounts of these

medicines, or you may need to take

different medicines. Your doctor and

pharmacist have more information on

medicines to be careful with or avoid

while taking Otezla.

How to take Otezla

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

How much to take

Your doctor will tell you how much

Otezla to take and for how long you

will need to take it. Your doctor will

monitor your progress.

When you first start taking

Otezla, you will receive a

treatment initiation pack which

contains all the doses as listed in

the table below.

This pack is clearly labelled to

make sure you take the correct

tablet at the correct time.

Your treatment will start at a

lower dose and will gradually be

increased (also called 'titrated')

over the first 6 days of treatment.

This initiation pack will also

contain enough tablets for another

8 days at the recommended dose

(Days 7 to 14).

The final recommended dose of

Otezla is a 30 mg tablet twice a

day; one 30 mg dose in the

morning and one 30 mg dose in

the evening. This is a total daily

dose of 60 mg.

By the end of Day 6 you will

have reached this recommended

dose.

Once the recommended dose has

been reached, you will only get

the 30 mg tablet strength in your

prescribed packs.

You will only ever go through a

titration stage once, even if you

re-start treatment after a break.

Day 1: total dose - 10 mg

Morning dose

10 mg - pink tablet

Evening Dose

Do not take a dose

Day 2: total dose - 20 mg

Morning dose

10 mg - pink tablet

Evening Dose

10 mg - pink tablet

Day 3: total dose - 30 mg

Morning dose

10 mg - pink tablet

Evening Dose

20 mg - brown tablet

Day 4: total dose - 40 mg

Morning dose

20 mg - brown tablet

Evening Dose

20 mg - brown tablet

Day 5: total dose - 50 mg

Morning dose

20 mg - brown tablet

Evening Dose

30 mg - beige tablet

Day 6 onwards: total dose - 60 mg

Morning dose

30 mg - beige tablet

Evening Dose

30 mg - beige tablet

OTEZLA

If you have severe kidney problems,

the recommended dose of Otezla is

30 mg once a day. Your doctor will

tell you how to gradually increase

(titrate) your dose when you first

start taking Otezla. Your doctor may

advise that you only take the morning

dose shown in the table above, and

that you skip the afternoon or

evening dose.

How to take it

Swallow the tablets whole,

preferably with water, either with

or without food, twice a day as

directed by your doctor.

Do not crush, split or chew the

tablets.

When to take it

Take Otezla at about the same time

each day, one tablet in the morning

and one tablet in the evening.

How long to take it

Your doctor will tell you how long to

continue taking Otezla.

If you forget to take it

Take it as soon as you remember.

If it is close to the time for the next

dose, just skip the missed dose.

Take the next dose at the regular

time. Do not take a double dose to

make up for the dose that you

missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when 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 Otezla.

Do this even if there are no signs of

discomfort or poisoning. Keep the

telephone numbers for these places

handy.

Take the medicine pack with you.

While you are taking

Otezla

Things you must do

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking Otezla.

If you are about to be started on

any new medicine, remind your

doctor, dentist or pharmacist that

you are taking Otezla.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not breast-feed or become

pregnant whilst taking Otezla.

Do not stop taking Otezla or

change the dose without first

checking with your doctor.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not take this medicine to treat

any other complaints unless your

doctor tells you to.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering. In that case,

return it to your pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

Otezla affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Otezla.

Like all medicines, Otezla can have

side effects, although not everybody

gets them and some are uncommon.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Tell your doctor if you notice any

of the following and they worry

you:

diarrhoea; nausea; vomiting;

stomach pain; indigestion;

decrease in appetite

weight decrease

cough; cold; runny nose;

inflammation/infection of the

nose, throat, sinus, or upper

respiratory tract

if you feel tired; if you have

trouble or difficulty sleeping

headaches and migraine

headaches

back pain; joint pain; painful,

swollen joints

increased blood pressure

skin rash

allergic reactions.

The above list mainly includes the

more common side effects of your

medicine.

Tell your doctor immediately if

you notice the following:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body.

Tell your doctor or pharmacist

immediately if any of the side

effects gets worse, or if you notice

any other side effects not listed in

this leaflet.

OTEZLA

After taking Otezla

Storage

Keep your tablets in a dry place

where the temperature stays below

30°C.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, take any unused

Otezla tablets to your pharmacist.

Medicines should not be disposed of

via wastewater or household waste.

These measures will help to protect

the environment.

Product description

What Otezla looks like

Apremilast 10 mg Tablets: Pink,

diamond shaped film-coated tablet

with "APR" engraved on one side

and "10" on the opposite side.

Apremilast 20 mg Tablets: Brown,

diamond shaped film-coated tablet

with "APR" engraved on one side

and "20" on the opposite side.

Apremilast 30 mg Tablets: Beige,

diamond shaped film-coated tablet

with "APR" engraved on one side

and "30" on the opposite side.

The tablets are provided in packs as

follows:

A titration pack that will last for

two weeks.

This pack will contain 4 x 10 mg,

4 x 20 mg and 5 x 30 mg tablets

for the first week and 14 x 30 mg

tablets for the second week.

A four week pack (56 x 30 mg

tablets).

Ingredients

Otezla tablets contain an active

ingredient called apremilast

The other ingredients are:

lactose monohydrate

microcrystalline cellulose

croscarmellose sodium

magnesium stearate.

The film coat contains:

Polyvinyl alcohol, titanium dioxide,

polyethylene glycol, talc, iron oxide

red. In addition, iron oxide yellow (in

20 mg and 30 mg tablets only) and

iron oxide black (in 30 mg tablets

only).

Supplier

Otezla is supplied in Australia by:

Celgene Pty Limited

Level 15, 60 City Road

Southbank VIC 3006

Australia.

Telephone: 1800 CELGENE (1800

235 4363).

This leaflet was updated in

September 2017.

Australian Registration Numbers:

Otezla titration pack AUST R

220424

Otezla 30 mg blister pack AUST R

220423

® = Registered Trademark

(Celgene Version 1.4.0)

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety