APREMILAST (Apremilast)

What is this medication?

Apremilast is a phosphodiesterase 4 (PDE4) inhibitor that works to suppress the immune system, which reduces inflammation. Apremilast is used to treat active psoriatic arthritis in adults.Apremilast is also used to treat moderate to severe plaque psoriasis in adults who may also receive phototherapy or other treatments for psoriasis. Apremilast is also used to treat mouth ulcers in adults with Behçet's disease (a disease causing inflammation in blood vessels).

How should I take this medication?

Take apremilast exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. You may take apremilast with or without food. Swallow the tablet whole and do not crush, chew, or break it. Keep track of your body weight while you are taking this medicine, and tell your doctor about any major weight loss. Dosing information Usual Adult Dose for Psoriatic Arthritis: Initial dose:

• Day 1: 10 mg orally once a day (AM)
• Day 2: 10 mg orally twice a day (AM and PM)
• Day 3: 10 mg orally once a day (AM); 20 mg orally once a day (PM)
• Day 4: 20 mg orally twice a day (AM and PM)
• Day 5: 20 mg orally once a day (AM); 30 mg orally once a day (PM)

Maintenance dose: 30 mg orally twice a day (AM and PM) Comments: This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy. Use: Treatment of adult patients with active psoriatic arthritis.

What if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

How should I store this medication?

Store at room temperature away from moisture and heat.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction to apremilast: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have:

• severe diarrhea, nausea, and vomiting;
• unexplained weight loss, or if you lose a lot of weight;
• mood changes, new or worsening depression; or
• thoughts of suicide or hurting yourself.
• Common apremilast side effects may include:
• nausea, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.