Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Otezla?
Otezla contains the active ingredient apremilast. Otezla is used to treat adults with
plaque psoriasis, Psoriatic arthritis, or mouth ulcers associated with Behçet's Disease.
2. What should I know before I take Otezla?
Do not use if you have ever had an allergic reaction to apremilast or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Otezla and affect how it works.
4. How do I take Otezla?
Swallow Otezla tablets whole with a glass of water, either with or without food.
5. What should I know while taking Otezla?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking Otezla.
If you have any questions, ask your doctor, pharmacist or nurse
Keep all your doctor’s appointments so that your progress can be checked.
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Things you should not do
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Do not stop taking this medicine or change the dose without speaking to your doctor.
Do not take Otezla when pregnant or breast feeding.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Otezla
affects you.
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Looking after your medicine
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Store below 30°C.
Keep Otezla in a cool, dry place out of the reach of children.
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6. Are there any side effects?
Common side effects: diarrhoea, nausea, vomiting, stomach pain, indigestion, decrease
in appetite, cough, cold, runny nose, inflammation/infection of the nose, throat,
sinus, or upper respiratory tract, tiredness, difficulty sleeping, headaches, migraines,
and back pain.
Serious side effects: shortness of breath, wheezing or difficulty breathing, swelling
of the face, lips, tongue, or other parts of the body.
Active ingredient:
apremilast
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking Otezla. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Otezla.
Where to find information in this leaflet:
1. Why am I taking Otezla?
Otezla contains the active ingredient apremilast. Otezla is a selective immunosuppressant which helps to reduce inflammation.
Otezla is used
to treat adults with the following conditions:
Plaque psoriasis
Psoriatic arthritis
Mouth ulcers associated with Behçet's disease.
Plaque psoriasis
Plaque psoriasis is 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.
Plaque psoriasis can look different depending on skin tone, people with skin of colour
may have grey or white scaly patches.
Treatment with Otezla can result in a reduction in psoriasis skin plaques, nail and
scalp psoriasis and other signs and symptoms of psoriasis, such as itching, skin pain
or discomfort.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, often accompanied by
psoriasis, an inflammatory disease of the skin.
Treatment with Otezla can result in an improvement in swollen and painful joints,
swollen and painful fingers / toes, signs and symptoms of psoriasis, and can improve
your general physical function.
Behçet's disease
Behçet's disease is a rare type of inflammatory disease which affects many parts of
the body. The most common problem is mouth ulcers.
Treatment with Otezla can result in fewer and less painful mouth ulcers.
How Otezla works
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,
psoriatic arthritis, and Behçet's disease and helps to control the signs and symptoms
of these conditions.
Psoriasis, psoriatic arthritis, and Behçet's disease are usually lifelong conditions.
There is currently no cure. Otezla has been shown to improve the quality of life in
patients with psoriasis, psoriatic arthritis and Behçet's disease. This means that
the impact of your condition on daily activities, relationships and other factors
should be less than it was before.
2. What should I know before I take Otezla?
Warnings
Do not take Otezla if:
You are allergic to apremilast, or any of the ingredients listed at the end of this
leaflet. Symptoms of an allergic reaction may include, rash, itching or hives on the
skin, swelling of the face, lips, tongue, mouth or throat that may lead to difficulty
breathing or swallowing.
You are pregnant or breastfeeding.
Check with your doctor if you:
Have kidney problems
Experience severe diarrhoea, nausea or vomiting.
Have experienced depression or have had suicidal thoughts now or in the past.
Have intolerance to some sugars, Otezla contains lactose (a type of sugar).
Take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
Otezla must not be taken during pregnancy. Check with your doctor if you are pregnant
or intend to become pregnant.
Breastfeeding
Do not breastfeed whilst taking Otezla. Talk to your doctor if you are breastfeeding
or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Otezla and affect how it works.
Medicines that may reduce the effect of Otezla include:
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 how well Otezla works. You may need different amounts of
your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Otezla.
4. How do I take Otezla?
How much to take
Follow the instructions given to you by your doctor or pharmacist carefully. Take
Otezla until your doctor tells you to stop. Your doctor will monitor your progress.
When you first start taking Otezla, you will receive a 'treatment starter pack' which
contains all the doses for the first 14 days of therapy as listed in the table below.
The 'treatment starter pack' is clearly labelled to help you take the correct tablet
at the right time.
Your treatment will start at a lower dose and will gradually be increased over the
first 6 days of treatment.
The starter pack also contains enough tablets for a further 8 days at the daily recommended
dose (days 7 to 14).
After the titration phase is complete the recommended dose of Otezla is 30 mg twice
a day - one 30 mg tablet in the morning and one 30 mg tablet in the evening. This
is a total daily dose of 60 mg.
Once the recommended dose has been reached, you will only get the 30 mg tablet strength
in your prescribed packs.
You will only ever need to go through this stage of gradually increasing your dose
once, even if you re-start treatment following a (longer) break.
If you have severe kidney problems, the recommended daily dose is 30 mg once a day
(morning dose). Your doctor will talk to you about how to increase your dose when
you first start taking Otezla.
When to take Otezla
Take Otezla at about the same time each day, following the instructions provided.
Most people should take one tablet in the morning and one tablet in the evening each
day, approximately 12 hours apart.
Take Otezla until your doctor tells you to stop.
How to take Otezla
Swallow the tablets whole, preferably with water, either with or without food, as
directed by your doctor.
Do not crush, break or chew the tablets.
Take Otezla at about the same time each day, one tablet in the morning and one tablet
in the evening.
If you forget to take Otezla
If you miss a dose of Otezla, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much Otezla
If you think that you have taken too much Otezla, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking Otezla?
Things you should do
Your doctor will monitor your progress while you are taking Otezla. Keep all your
doctor’s appointments so that your progress can be checked.
Tell your doctor if you have experienced depression or have had suicidal thoughts
in the past.
During treatment with Otezla, tell your doctor or nurse if you experience severe diarrhoea,
nausea or vomiting. These side effects are usually noticed at the start of treatment.
Inform your doctor, nurse or pharmacist if you experience these side effects.
Call your doctor straight away if during treatment you:
Feel depressed, have suicidal thoughts, experience other mood changes or notice that
these events have worsened.
Experience any serious side effects listed in the table below.
Remind any doctor, dentist or pharmacist you visit that you are taking Otezla.
Things you should not do
Do not take Otezla when pregnant or breastfeeding.
Do not take Otezla if you are under the age of 18 years. Safety and effectiveness
in children have not been established.
Do not take Otezla after the expiry date printed on the pack or if the packaging shows
signs of tampering.
Do not stop taking this medicine suddenly or change the dose without speaking to your
doctor.
Do not give Otezla to anyone else, even if they have the same condition as you.
Do not take Otezla to treat any other complaints unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Otezla
affects you.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store Otezla below 30°C.
Store it in a cool dry place away from moisture, heat, or sunlight; for example, do
not store it in:
the bathroom or near a sink, or
the car or on windowsills.
Keep it where children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gut and digestion:
diarrhoea; nausea; vomiting; stomach pain; indigestion
decrease in appetite
weight loss
Lungs and upper airway:
cough; cold; runny nose
inflammation/infection of the nose, throat, sinus, or upper respiratory tract
Other:
tiredness; trouble or difficulty sleeping
headaches or migraine headaches
back pain
skin rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Otezla contains
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Active ingredient
(main ingredient)
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apremilast
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
lactose monohydrate
croscarmellose sodium
magnesium stearate (vegetable grade)
polyvinyl alcohol
titanium dioxide
polyethylene glycol
talc
iron oxide red
iron oxide yellow (20 mg and 30 mg tablets only)
iron oxide black (30 mg tablets only)
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Potential allergens
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Contains lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What Otezla looks like
Otezla 10 mg - Pink, diamond shaped film-coated tablet with “APR” engraved on one
side and “10” on the opposite side.
Otezla 20 mg - Brown, diamond shaped film-coated tablet with “APR” engraved on one
side and “20” on the opposite side.
Otezla 30 mg - Beige, diamond shaped film-coated tablet with “APR” engraved on one
side and “30” on the opposite side.
The tablets are provided in blister packs as follows.
Otezla titration starter pack, a folding wallet containing 27 film-coated tablets:
4 × 10 mg tablets, 4 × 20 mg tablets and 19 × 30 mg tablets (AUST R 220424)
Otezla 30 mg standard trade pack contains 56 x 30mg film-coated tablets. (Aust R 220423).
Sponsor
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
This leaflet was prepared in August 2023.