Apremilast

• While taking apremilast you must see your rheumatologist regularly to make sure the treatment is working and to minimise any possible side effects.
• If you are worried about any possible side effects, you should contact your rheumatologist as soon as possible.
• Tell any other doctors, dentists and pharmacists who treat you that you are taking apremilast.
• Do not breastfeed or become pregnant while taking apremilast. If you are planning to become pregnant you should discuss this with your doctor.

Treatment with apremilast can improve the signs and symptoms of psoriasis. In psoriatic arthritis it can also improve your general physical function by reducing the swelling and pain in the inflamed joints. Apremilast can reduce the number of ulcers associated with Behçet's disease.

Apremilast is taken by mouth in tablet form.

Sometimes when you start apremilast tablets, you may feel sick, get indigestion, diarrhoea and/or vomiting. To help prevent the risk of these side effects, your doctor will start you on a lower dose that will gradually be increased (also called “titrated”) over the first 6 days of treatment. 

After the titration period, the usual dose is 30mg twice daily: one 30mg tablet in the morning and one 30mg tablet in the evening.

How to take apremilast

The tablets should be swallowed whole with water, not chewed or broken. They can be taken with or without food.

Do not crush or split the tablets.

Apremilast may be used with other arthritis medicines including:

• other Disease Modifying Anti-Rheumatic Drugs (DMARDs) such as methotrexate;
• steroid medicines such as prednisolone or cortisone injections into the joint;
• anti-inflammatory medicines (NSAIDs) such as naproxen (Naprosyn) or ibuprofen (Brufen, Nurofen);
• simple pain medicines such as paracetamol.

There are separate information sheets for the medicines mentioned above.

Take your apremilast at the same time each day, one tablet in the morning and one in the evening.

If you have severe kidney problems, your doctor may tell you to only take apremilast once a day, in the morning.

How long to take apremilast

Your doctor will tell you how long to continue taking your apremilast tablets. Do not stop taking your treatment unless advised by your doctor or unless side effects develop.

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.

You might experience side effects with your treatment. Tell your doctor if you are concerned about possible side effects.

Most common possible side effects

Tell your doctor or pharmacist immediately if any of side effects you experience get worse, or if you notice any side effects not listed in this leaflet.

• The most common side effects that may occur when taking apremilast are those affecting the stomach and bowel. These side effects can include bowel discomfort, loss of appetite, nausea (feeling sick), indigestion, vomiting and diarrhoea. 
• These side effects may occur within the first 2 weeks of starting apremilast but oftem resolve within 4 weeks. Speak to your rheumatologist about how to best manage these side effects if they occur.
• Starting apremilast with a lower dose in the 'Starter pack' helps to reduce the chance of these side effects.
• Other common side effects with apremilast include weight loss, tiredness or difficulty sleeping, cough, cold or runny nose, headaches, increased blood pressure and back pain.
• Depression, mood changes and suicidal behavior may occur, and this should be discussed with your doctor if you experience such changes in mood.
• Tell your doctor if you have rare hereditary problems to some sugars (e.g., galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption). Apremilast contains lactose (a type of sugar). Tell your doctor if you have lactose intolerance.

• Allergic reactions may occur with apremilast. Seek medical attention immediately if you become short of breath, suffer wheezing or have difficulty breathing, or if you have swelling of the face, lips, tongue or other parts of the body.
• Tell your doctor or pharmacist immediately if any of the side effects you experience get worse, or if you notice any side effects not listed in this leaflet.

• Apremilast can interact with other medicines. You should tell your doctor (including your general practitioner, rheumatologist and others) about all medicines you are taking or plan to take. This includes over-the-counter or herbal/naturopathic medicines. You should also mention your treatment when you see other health professionals.
• In particular, apremilast can interfere with:
  • rifampicin, an antibiotic for tuberculosis and certain other antibiotics such as erythromycin or clarithromycin
  • some medicines used to treat seizures or epilepsy, such as carbamazepine, phenytoin and phenobarbitone
  • St John’s Wort, a herbal medicine for mild anxiety and depression.

These medicines can affect apremilast or may affect how well it works. You may need to change the dose of these medicines while you take apremilast.

• Apremilast should not be taken during pregnancy or when breastfeeding.
• If you are a woman of childbearing age, you should use effective contraception while taking apremilast.
• If you are planning to become pregnant, discuss this with your doctor.

• Store apremilast in a cool, dry place, away from direct heat and light (e.g. not in the bathroom).
• Keep all medicines out of reach of children.

Disposal

• If your doctor tells you to stop taking your medicine, or if the expiry date has passed, return any unused apremilast tablets to your pharmacy.
• Do not dispose of apremilast tablets via wastewater or household waste.