Otezla

The active ingredient in Otezla, apremilast, is a phosphodiesterase-4 (PDE-4) inhibitor. It works to slow down or stop certain conditions that happen because of an overactive immune system. In general, it works to lower inflammation in the body by increasing the level of cAMP (cyclic adenosine monophosphate), which is a messenger system in our bodies.

Follow all directions and drug information given by your doctor and read the Full Prescribing Information and FDA-approved product labeling, patient information, instructions for use, and Medication Guide before using Otezla.

Your medication will come with a starter guide and packet. Make sure you read it all and follow the instructions provided unless otherwise directed by your healthcare provider. You can decide if you would like to take Otezla with or without food. However, do not chew, break, or split the tablets; take them whole. If you have any mild symptoms, talk to your doctor, and they may lower your dosage.

If you miss a dose of Otezla, take the missed dose immediately after you remember. However, if it is closer to the time of your next dose, skip this dose and take your next dose at your normal time.

The most common side effects of Otezla seen in clinical trials as compared to placebo include:

• Diarrhea or severe diarrhea
• Upper respiratory tract infection
• Nausea
• Tension headache
• Weight loss
• Back pain

Rarely, Otezla may cause some serious side effects, including:

• Depression
• This could include suicidal thoughts.
• Monitor for signs of depression, especially worsening symptoms or general mood changes. Receive medical help when necessary.
• Serious, life-threatening allergic reactions, including anaphylaxis.
• Symptoms of anaphylaxis may include hives (raised red patches on your skin), swelling of your face, lips, tongue, or throat, and trouble breathing.
• Seek immediate medical attention if you experience any symptoms of a severe allergic reaction.

These are not all of the possible adverse effects of Otezla. You should always seek medical advice from a healthcare professional for any questions or concerns about your medical condition or treatment. You should also read all the patient and drug information, including your Medication Guide that comes with Otezla. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before starting Otezla, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney disease
• A pregnancy, plan to become pregnant or are breastfeeding
• Mood disorders, such as depression.
• A hypersensitivity or have had an allergic reaction to any ingredient in Otezla.

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Known hypersensitivity to apremilast or to any of the excipients in the

formulation

Otezla (apremilast), a medication used to treat psoriasis, psoriatic arthritis, and Behçet’s disease, can take several weeks to a few months to show noticeable improvements, depending on the condition being treated.

When Otezla is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Strong cytochrome P450 enzyme inducers (examples: phenobarbital, rifampin, carbamazepine, phenytoin, St. John’s wort). These may change the levels of Otezla in your body.

Otezla (apremilast) is available in the following doses:

10 mg tablets

20 mg tablets

30 mg tablets

Store Otezla below 30°C (86°F) out of the reach of children.

Otezla is manufactured by Amgen, inc.

Currently, there is no generic available for Otezla in the United States.

To stop using Otezla, it's important to consult with your healthcare provider for a safe discontinuation plan. Stopping abruptly may cause a worsening of your symptoms.

Talk to your healthcare provider if you become pregnant or plan on becoming pregnant while you're taking Otezla. Though unclear, there might be a risk of harm to unborn babies if the medication is taken during pregnancy.

It is unknown if this medication passes into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.