Important Safety Information
Otezla® (apremilast) is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis.
Otezla is a prescription medicine approved for the treatment of adult patients with 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 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 having 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.
Side effects of Otezla include diarrhea, nausea, vomiting, upper respiratory tract infection, runny nose, sneezing, or congestion, abdominal pain, 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. Otezla has not been studied in pregnant women or in women who are breastfeeding.
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 Full Prescribing Information.