Important Safety Information
Otezla® (apremilast) is a prescription medicine used to treat adult patients with:
- Plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
- Active psoriatic arthritis.
- Oral ulcers associated with Behçet’s Disease.
IMPORTANT SAFETY INFORMATION
You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.
Otezla can cause allergic reactions, sometimes severe. Stop using Otezla and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla appears to increase the risk of complications from having severe diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.
Otezla is associated with an increase in depression. In clinical studies, some patients reported depression, or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla.
Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla.
Some medicines may make Otezla less effective and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines.
The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. These are not all the possible side effects with Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.
Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
Please click here for the Full Prescribing Information.