Otezla was studied compared to placebo (sugar pill) among 207 adults with oral ulcers in Behçet’s Disease. The most common side effects were:
| Most common side effects (up to week 12)* | Otezla (104 people) | Placebo (103 people) |
|---|---|---|
| Diarrhea | 41% | 20% |
| Nausea | 19% | 11% |
| Headache | 14% | 11% |
| Upper respiratory tract infection | 12% | 5% |
| *The titration period was days 1-5, during which the dose was gradually increased until the recommended dose of 30 mg twice daily was reached. | ||
All medications come with some risk of side effects, and Otezla is no different. These side effects usually occur during the first few weeks of treatment and tend to go away as you keep taking it.
These are not all the possible side effects of Otezla. Ask your doctor about potential side effects, and let them know about any side effect that bothers you or doesn’t go away.
The Otezla Co-Pay Program may help eligible patients with commercial insurance (usually self-purchased or through an employer) lower their out-of-pocket costs for Otezla.
First time using a co-pay card? Find out more about how it can help you.
No insurance? Learn about other ways to access Otezla.
Behçet’s Disease is a rare inflammatory disease that can affect multiple parts of your body. The symptoms of Behçet’s Disease are different for different people, so it can be hard for doctors to diagnose. There is no cure for Behçet’s Disease, but it can be managed with medication. Otezla is the only pill approved to treat oral ulcers in Behçet’s Disease.
Oral ulcers are one of the main symptoms of Behçet’s Disease.
They are usually painful and can interfere with everyday activities like
eating, drinking, and speaking. A few other Behçet’s Disease symptoms to
watch out for with your doctor are genital ulcers, eye inflammation,
skin lesions, joint pain, blood vessel inflammation, brain inflammation,
and digestive tract ulcers.
It’s believed that Behçet’s Disease has to do with inflammation inside the body.
Exactly how Otezla works in people with Behçet’s Disease isn’t completely understood, but here’s what we do know:
Otezla is a pill that you take twice a day—in the morning and at night. For example, you can take it with breakfast and dinner every day, or after you brush your teeth. For people with severe kidney disease, Otezla is one pill a day.
You can take Otezla with or without food. Do not crush, split, or chew the pill. Otezla should be stored below 86° F.
Be sure to take Otezla as directed by your doctor. Find out more about getting your prescription.
When you start Otezla, you will slowly increase your dose over the first 5 days of treatment until you reach the recommended dose. This is known as a titration. People with severe kidney disease will follow a different schedule.
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 & Beyond |
|
|---|---|---|---|---|---|---|
| AM | 10 mg | 10 mg | 10 mg | 20 mg | 20 mg | 30 mg |
| PM | - | 10 mg | 20 mg | 20 mg | 30 mg | 30 mg |
Titration is meant to help reduce the stomach and digestive side effects (nausea and diarrhea) that may occur when starting Otezla.
Talk to your doctor about any side effects that bother you or do not go away. They may be able to suggest ways to manage them.
If you do miss a dose, talk to your doctor about when you should take your next one. Don’t double up on your dose. It’s important to take Otezla as it was prescribed by your doctor.
If you’re interested in learning more, the following resources can help. Each organization has information for people living with Behçet’s Disease:
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 for Otezla.
Otezla® (apremilast) is a prescription medicine used to treat adult patients with:
You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla.