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Patient Information Leaflets (PILs)

Apremilast

 

What are the aims of this leaflet?

This leaflet has been written to help you understand more about Apremilast. It tells you what it is, how it works, how it is used to treat skin conditions, and where you can find out more about it.

What is Apremilast and how does it work?

Apremilast is an oral medication which works by inhibiting (stops it from working as it usually does) an enzyme known as phosphodiesterase inhibitor (PDE4). PDE4 controls the inflammation process in the skin. Reducing or controlling the inflammation in the skin can lead to improvement of symptoms in people with psoriasis.

What skin conditions are treated with Apremilast?

Apremilast is used to treat moderate to severe psoriasis in adults whose condition has not responded to other medication, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet-A light), or when these treatments are not suitable or cause side effects. Apremilast is also used in the treatment of psoriatic arthritis.

Will Apremilast cure my skin condition?

No treatment currently can cure psoriasis, but Apremilast may control the signs and symptoms of psoriasis.

How should I take Apremilast?

Apremilast should be prescribed by a specialist experienced in the treatment of psoriasis. The tablet should be taken every morning and every evening, approximately 12 hours apart. The tablet can be taken with or without food and should be swallowed whole.

What dose should I take?

The recommended dose is 30 mg twice daily. However, to reduce possible stomach and gut symptoms an initial lower dose will be given which will be increased gradually over the first week.

How long will I need to take Apremilast before I see an effect?

The greatest improvement will be seen in the first 16 weeks of treatment. If no improvement is seen in this period the doctor may decide to change your treatment.

What are the common side effects of Apremilast?

Like all medications, Apremilast may cause side effects. The most common are diarrhoea, decreased appetite, nausea, headache, insomnia, tiredness, muscle pain and respiratory infections.

What are the rare side effects of Apremilast?

Depression

Apremilast may increase the risk of depression. Therefore, the risks and benefits of taking Apremilast should be carefully considered particularly for patients with a history of depression, suicidal thoughts or behavior problems. You should tell your doctor if you experience any changes in mood or behavior or any suicidal thoughts.

Weight Loss

Weight loss of 5-10% of body weight was reported in 1 in 10 patients treated with Apremilast in clinical studies. While taking Apremilast your weight may be monitored.  If unexplained weight loss occurs then the doctor may discontinue Apremilast.

How will I be monitored for the side effects of Apremilast treatment? 

Your progress will be monitored at regular clinic reviews. There is usually no need for regular blood tests while on Apremilast but your Dermatologist may choose to perform blood tests periodically.

Can I have immunisations (vaccinations) whilst on Apremilast?

While there is limited information about this at present, experts agree that live vaccines should not be given whilst taking Apremilast. For information on live vaccines see information leaflet on immunisations and vaccinations.

Does Apremilast affect fertility or pregnancy?

Apremilast has not been studied in pregnant woman or nursing mothers, so its effects on unborn babies and children remains unknown.

It is recommended that Apremilast is not taken if pregnant or planning to have a baby. It is also recommended that Apremilast is not taken while breastfeeding.

It is important that an effective method of contraception is used while taking Apremilast.

May I drink alcohol while taking Apremilast?

Apremilast does not interact with alcohol. However, as alcohol can make psoriasis worse, excess alcohol intake should be avoided and the current recommended limits of alcohol intake should be followed.

Can I take other medicines at the same time as Apremilast?

Most medications can be taken safely with Apremilast. Some may cause an interaction so it is important to inform the doctor or pharmacist before taking any new prescriptions, over the counter medication and/or supplements including herbal medicines.

The use of medicines called cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin, St John’s wort) with Apremilast is not recommended as they can decrease the effect of Apremilast.

The doctor should be informed if you have any allergies; especially if you are lactose intolerant as Apremilast may not be suitable for you as it contains lactose.

Where can I get more information about Apremilast?

This information leaflet does not list all the potential side effects of Apremilast. To find out more about this medication please speak to your dermatologist, specialist nurse or pharmacist.

For more details, you may look at the drug information sheet, which comes as an insert with your prescription for Apremilast:

Or visit these websites:

https://www.nice.org.uk/guidance/ta368

https://www.otezla.com/

https://www.drugs.com/cdi/apremilast.html

For details of source materials used please contact the Clinical Standards Unit (clinicalstandards@bad.org.uk).

This leaflet aims to provide accurate information about the subject and is a consensus of the views held by representatives of the British Association of Dermatologists: individual patient circumstances may differ, which might alter both the advice and course of therapy given to you by your doctor.

This leaflet has been assessed for readability by the British Association of Dermatologists’ Patient Information Lay Review Panel

BRITISH ASSOCIATION OF DERMATOLOGISTS
PATIENT INFORMATION LEAFLET
PRODUCED NOVEMBER 2017
REVIEW DATE NOVEMBER 2020

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