Otezla
Otezla (apremilast) is a tablet that's taken by mouth. It's used to treat plaque psoriasis, psoriatic arthritis, and mouth sores from Behçet’s disease. This medication belongs to the drug class called phosphodiesterase-4 (PDE-4) inhibitors. You usually start Otezla (apremilast) at a low dose. Then, the dose is slowly raised over 5 days to lower the risk of side effects like nausea and diarrhea. This medication is available as a brand-name medication. Generic versions of apremilast likely won't be available until at least 2028.
What is Otezla (apremilast)?
What is Otezla (apremilast) used for?
Active psoriatic arthritis in adults
Moderate-to-severe plaque psoriasis in people age 6 years and older weighing at least 44 lbs
Mouth sores from Behçet’s disease in adults
How Otezla (apremilast) works
Otezla (apremilast) is a phosphodiesterase-4 (PDE-4) inhibitor. It works by blocking a protein in the body called PDE-4. This protein plays a role in causing inflammation in your body. Blocking PDE-4 is thought to help lower inflammation.
Drug Facts
More on Otezla (apremilast) essentials
What are the side effects of Otezla (apremilast)?
Common Side Effects
- Diarrhea (17%)
- Nausea (17%)
- Upper respiratory tract infection (e.g., common cold; 9%)
- Headache (6%)
Other Side Effects
- Vomiting
- Stomach pain
- Indigestion
- Lower appetite
- Tiredness
Serious Side Effects
- Depression
- Suicidal thoughts or behavior
- Severe allergic reaction: hives; trouble breathing; swelling of the lips, tongue, or throat
Source: DailyMed
More on Otezla (apremilast) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Headache
- Loss of appetite with weight loss
- Nausea
- Vomiting
Pros and cons of Otezla (apremilast)
Pros
Taken by mouth
Can take with or without food
Dose adjustment available for people with severe kidney problems
Cons
Dosing schedule can be confusing in the beginning
Common to have nausea or diarrhea in the beginning
Might not be a good option for people who've had depression or suicidal behavior
Pharmacist tips for Otezla (apremilast)
You can take Otezla (apremilast) with or without food. Swallow the tablets whole. Don't crush, split, or chew them.
When you first start Otezla (apremilast), you might use a starter pack to slowly raise your dose. This helps your body get used to the medication and can lessen your chance of nausea, vomiting, and diarrhea. Carefully follow the dosing instructions for each day. Ask your prescriber or pharmacist if you have any questions.
If you vomit or have diarrhea while taking Otezla (apremilast), make sure to drink plenty of fluids so you don't get dehydrated. Tell your prescriber if these side effects happen a lot or bother you a lot, though. They might lower your dose or pause your treatment to help.
Give your care team a list of all the medications you take. Some, like carbamazepine (Tegretol), interact with Otezla (apremilast). These drug interactions can make Otezla (apremilast) not work as well. Your care team can help make sure your medications are safe to take together.
Talk to your prescriber about family planning, and tell them if you become pregnant while taking Otezla (apremilast). It's not clear if the medication can harm an unborn baby if taken during pregnancy, but there might be a risk. Your prescriber can help go through the risks and benefits of treatment.
Frequently asked questions about Otezla (apremilast)
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What are the risks and warnings for Otezla (apremilast)?
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.
Allergic reaction
Rarely, Otezla (apremilast) can cause a serious allergic reaction. Stop taking the medication and get medical help right away if you have an allergic reaction. Look out for hives; trouble breathing; or swelling in your lips, tongue, or throat.
Diarrhea, nausea, and vomiting
Risk factors: Older adults | Taking diuretics (water pills) | Taking medications that can dehydrate you or cause low blood pressure
Nausea, vomiting, and diarrhea are common when you first start taking Otezla (apremilast). These side effects should get better and go away with time. But they can be severe and sometimes lead to dehydration (when your body loses too much fluid). Older adults and people taking medications that remove fluid from the body or lower blood pressure are at risk of dehydration.
Tell your care team if you have a lot of nausea, vomiting, or diarrhea while taking Otezla (apremilast). Your prescriber might lower your dose or pause your treatment.
Depression
Risk factors: History of depression | History of suicidal thoughts or behavior
Some people who took Otezla (apremilast) reported having depression or feeling depressed. Before starting this medication, let your prescriber know if you've ever had depression or suicidal thoughts. They can help weigh the risks and benefits of taking Otezla (apremilast).
During treatment, watch for any unusual changes in your behavior or mood. Call your prescriber if you or someone close to you notices this. If you have suicidal thoughts or actions, call 911 right away.
Possible weight loss
Tell your prescriber if you notice you're losing weight while taking Otezla (apremilast). In studies, 12% of adults with plaque psoriasis lost weight while taking this medication. This has also happened in children who took Otezla (apremilast). Talk to the prescriber if you're worried about this possible side effect.
Drug interactions
Talk to your prescriber before starting any new medications or supplements while taking Otezla (apremilast). Some medications can lower the amount of Otezla (apremilast) in the body. These medications include rifampin (Rifadin), phenobarbital, carbamazepine (Tegretol), and phenytoin (Dilantin), among others. They can make Otezla (apremilast) work less well. So, it's not recommended to take them with Otezla (apremilast).
Otezla (apremilast) dosage forms
Typical dosing for Otezla (apremilast)
Usually, you start the medication at a low dose. Your prescriber will slowly raise it up over 5 days. This helps lower your risk of stomach-related side effects. The recommended dosing schedules are outlined below.
Adults (and children with psoriasis who are 6 years and older weighing 110 lbs or more)
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 in the morning and 30 mg in the evening
Children with psoriasis who are 6 years and older weighing 44 lbs to less than 110 lbs
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 and beyond: 20 mg in the morning and 20 mg in the evening
Your dose might differ if you have kidney problems.
More on Otezla (apremilast) dosage forms
What are alternatives to Otezla (apremilast)?
Active psoriatic arthritis in adults
Moderate-to-severe plaque psoriasis in people age 6 years and older weighing at least 44 lbs
Mouth sores from Behçet’s disease in adults
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 course juvenile idiopathic arthritis (pcJIA) in children 2 years and older - immediate-release tablets and liquid only
What is the latest news about Otezla (apremilast)?
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References
Best studies we foundAmgen. (2023). Amgen wins patent appeal on Otezla® (apremilast). PRNewswire.
Amgen Inc. (2024). Otezla- apremilast tablet, film coated; apremilast kit [package insert]. DailyMed.
Hatemi, G., et al. (2019). Trial of apremilast for oral ulcers in Behçet’s syndrome. The New England Journal of Medicine.
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.
UpToDate. (n.d.). Cytochrome P450 3A (including 3A4) inhibitors and inducers.
Young, M., et al. (2016). Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease. Journal of the American Association of Nurse Practitioners.
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