Otezla (apremilast) is a medication that's taken by mouth to treat psoriasis, psoriatic arthritis, and mouth sores from Behçet’s disease in adults. It belongs to the drug class called phosphodiesterase-4 (PDE-4) inhibitors. You must start the medication at a low dose and slowly go up because it can cause a lot of nausea and diarrhea as side effects. Generic versions of apremilast have been FDA-approved, but they likely won't be available on the market until at least 2028.
Active psoriatic arthritis
Plaque psoriasis
Mouth sores from Behçet’s disease
Otezla (apremilast) is a phosphodiesterase-4 (PDE-4) inhibitor. It blocks a protein called PDE-4 that plays a role in causing inflammation in your body. This helps to lower inflammation.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Taken by mouth
Works well to treat psoriatic arthritis, plaque psoriasis, and mouth sores due to Behçet's disease
Dose adjustment available for people with severe kidney problems
Dosing schedule can be confusing in the beginning
Might not be a good option for people with a history of depression or suicidal behavior
Not well-studied in children
Interacts with some medications, such as certain seizure medications
When you first start Otezla (apremilast), you'll use a starter pack that will help you slowly raise your dose. This helps your body get used to the medication and lessen your risk for nausea, vomiting, and diarrhea. Make sure you follow the dosing instructions for each day. Ask your provider or pharmacist if you have questions.
You can take Otezla (apremilast) with or without food. Swallow the tablets whole; don't crush, split, or chew them.
Let your provider know if you're having a lot of nausea, vomiting, or diarrhea. Your provider might pause your treatment with Otezla (apremilast) or lower your dose.
Make sure your provider has a list of all the medications you're taking. Some medications interact with Otezla (apremilast) and aren't recommended to be taken together.
Talk to your providers about family planning and let them know if you become pregnant while you're taking Otezla (apremilast). Though unclear, there might be a risk of harm to unborn babies if the medication is taken during pregnancy.
Otezla (apremilast) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Rarely, Otezla (apremilast) can cause a serious allergic reaction. Stop taking the medication and get medical attention right away if you experience hives; trouble breathing; or swelling in your lips, tongue, or throat.
Risk factors: Older adults | Taking diuretics (water pills)
Nausea, vomiting, and diarrhea are common side effects when you first start Otezla (apremilast). While these side effects should go away with time, they can be severe and lead to dehydration (low fluids in the body). Older adults and people taking medications that remove fluid from the body (e.g., diuretics) are at a higher risk for dehydration. Let your provider know if you're having a lot of nausea, vomiting, or diarrhea. Your provider might lower your dose or pause treatment.
Risk factors: History of depression or suicidal thoughts or behavior
Some people who took Otezla (apremilast) reported having depression or feeling depressed. Before you start Otezla (apremilast), let your provider know if you have a history of depression or have had suicidal thoughts. Contact your provider right away if you or your loved ones notice any changes in your behavior or mood.
Monitor your weight closely while you're taking Otezla (apremilast). In clinical studies, up to 12% of people who took Otezla (apremilast) had unexplained weight loss. Contact your provider if you notice that you've lost an unusual amount of weight during treatment.
Taking certain medications with Otezla (apremilast) can affect the amount of Otezla (apremilast) in your body. It isn't recommended to take Otezla (apremilast) with certain medications, such as rifampin (Rifadin), phenobarbital, carbamazepine (Tegretol), and phenytoin (Dilantin). These medications can make Otezla (apremilast) levels in the body too low, which might make it work less well for you. Talk to your provider before you start any new medications and supplements while you're taking Otezla (apremilast).
To lower your risk of stomach-related side effects, your provider will start you at a low dose and slowly raise it up over 5 days. The typical dosing schedule is outlined below.
Day 1: 10 mg by mouth in morning
Day 2: 10 mg in the morning and 10 mg in the evening
Day 3: 10 mg in the morning and 20 mg in the evening
Day 4: 20 mg in the morning and 20 mg in the evening
Day 5: 20 mg in the morning and 30 mg in the evening
Day 6 and beyond: 30 mg twice daily
Your dose might differ if you have kidney problems.
Active psoriatic arthritis
Plaque psoriasis
Mouth sores from Behçet’s disease
Rheumatoid arthritis (RA) in adults
Psoriatic arthritis (PsA) in adults and children ages 2 years and older
Eczema (atopic dermatitis) in adults and children ages 12 years and older
Ulcerative colitis (UC) in adults
Crohn's disease (CD) in adults
Ankylosing spondylitis (AS) in adults
Non-radiographic axial spondyloarthritis (nr-axSpA) in adults
Polyarticular juvenile idiopathic arthritis (pJIA) in adults and children ages 2 years and older
Moderate-to-severe rheumatoid arthritis (RA) in adults
Psoriatic arthritis (PsA) in adults
Ankylosing spondylitis (AS) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe polyarticular juvenile idiopathic arthritis (pJIA) in children ages 2 years and older - immediate-release tablets and liquid only
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Amgen. (2019). Amgen completes acquisition of Otezla® (apremilast). PRNewswire.
Amgen. (2023). Amgen wins patent appeal on Otezla® (apremilast). PRNewswire.
Amgen Inc. (2024). Otezla- apremilast tablet, film coated; apremilast kit [package insert]. DailyMed.
Kavanaugh, A., et al. (2019). Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis. Arthritis Research and Therapy.
Li, H., et al. (2018). Phosphodiesterase-4 inhibitors for the treatment of inflammatory diseases. Frontiers in Pharmacology.
Padda, I. S., et al. (2023). Apremilast. StatPearls.
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