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).

Some people have thoughts about suicide while taking apremilast. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

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.

Store at room temperature away from moisture and heat.

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

You should not use apremilast if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• kidney disease; or

• depression or suicidal thoughts or actions.

Some people have thoughts about suicide while taking apremilast. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Apremilast may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of apremilast on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Apremilast is not approved for use by anyone younger than 18 years old.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with apremilast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.