Otezla

Generic Name: apremilast (a PRE mi last)
Brand Names: Otezla

What is Otezla?

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 the symptoms of active psoriatic arthritis in adults.

Otezla can relieve tenderness and swelling in and around the joints, but this medicine is not a cure for psoriatic arthritis.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

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:

  • a history of depression or suicidal thoughts or actions;

  • kidney disease;

  • if you take seizure medication (such as carbamazepine, phenobarbital, phenytoin); or

  • if you take medicine to treat HIV/AIDS or tuberculosis.

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

FDA pregnancy category C. It is not known whether Otezla will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether apremilast passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

How should I take Otezla?

Take Impavido exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose or dosing schedule to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Otezla with or without food.

Do not crush, chew, or break an Otezla tablet. Swallow it whole.

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.

What happens if I miss a dose?

Otezla 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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Otezla?

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

Otezla side effects

Get emergency medical help if you have any of these 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:

  • 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; or

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Otezla?

Other drugs may interact with apremilast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Otezla.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this Otezla only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-04-11, 2:07:34 PM.

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