Otezla

Uses

What is Otezla® (apremilast) used for?

Otezla® 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.

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

How should I take Otezla® (apremilast)?

Take Otezla® 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.

How do I store Otezla® (apremilast)?

Otezla® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Otezla® in the bathroom or the freezer. There may be different brands of Otezla® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Otezla® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Otezla® (apremilast)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Otezla® or other medications.
• You have any other illnesses, disorders, or medical conditions.

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)
• 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.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Otezla® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Otezla®. Otezla® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Otezla® (apremilast)?

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
• Thoughts of suicide or hurting yourself

Common side effects may include:

• Nausea, diarrhea
• Headache
• Cold symptoms such as stuffy nose, sneezing, sore throat

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Otezla® (apremilast)?

Otezla® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Otezla® (apremilast)?

Otezla® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Otezla® (apremilast)?

Otezla® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Otezla® (apremilast).

What is the dose of Otezla® (apremilast) for an adult?

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)

What is the dose of Otezla® (apremilast) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Otezla® (apremilast) available?

Otezla® is available in the following dosage forms and strengths:

• Tablet, film coated: apremilast 10.0mg; apremilast 20.0mg; apremilast 30.0mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Otezla®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

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