Otezla

Generic name: apremilast (a PRE mi last)
Brand name: Otezla
Drug class: Antirheumatics

Otezla (apremilast) inhibits an enzyme within your immune system that can affect certain cells and contribute to inflammation in the body.

Otezla is used to treat active psoriatic arthritis in adults.

Otezla is also used to treat moderate to severe plaque psoriasis in adults who may also receive phototherapy or other treatments for psoriasis.

Otezla is also used to treat mouth ulcers in adults with Behçet's disease (a disease causing inflammation in blood vessels).

Warnings

When using Otezla your weight should be monitored regularly. Any unexplained or significant weight loss should be reported to your health care provider.

Contact your healthcare provider if you experience severe diarrhea, nausea, or vomiting.

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

Before taking this medicine

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

To make sure Otezla 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 Otezla. 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.

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

How should I take Otezla?

Take Otezla 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 Otezla 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.

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 happens 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.

What happens if I overdose?

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

What to avoid

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

Otezla side effects

Get emergency medical help if you have signs of an allergic reaction to Otezla: 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 Otezla 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.

What other drugs will affect Otezla?

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.