Otezla (apremilast)
An approved treatment for Behcet Disease.
The same compound appears under different names depending on the context. Here is how to identify Apremilast wherever you encounter it, plus the key facts at a glance.
- Generic name
- Apremilast
- Brand name
- Otezla
- Development code
- CC-10004
- Drug class
- Small molecule PDE4 inhibitor
- Manufacturer
- Amgen
- How it's taken
- Apremilast is a tablet taken by mouth.
An oral pill, taken twice daily (Otezla) or once daily (Otezla XR), approved specifically for mouth ulcers in Behcet disease in adults. It works by blocking an enzyme involved in inflammation, reducing the frequency and pain of oral sores.
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Where Apremilast fits
First FDA-approved oral therapy specifically for Behcet's disease-associated oral ulcers. Provides a systemic oral option for patients who need more than topical treatments.
How Apremilast works
Apremilast works by blocking an enzyme called PDE4 that normally breaks down a signaling chemical in immune cells. By stopping this enzyme, the drug allows this chemical to build up, which helps calm down inflammation. Think of it like putting the brakes on immune cells that are overreacting in Behcet disease.
Mechanism: Phosphodiesterase 4 (PDE4) inhibitor that reduces inflammation
Side effects and safety
The most common side effects are diarrhea, nausea, and headache, especially during the first few weeks. Most patients find these improve after 2 weeks of treatment. Watch for mood changes or depression, and tell your doctor immediately if you have thoughts of harming yourself. Serious allergic reactions, including swelling of the face or throat (angioedema) and anaphylaxis, have been reported; stop taking it and get emergency help if they happen. The label also warns that diarrhea, nausea, and vomiting can be severe and have sometimes needed a hospital stay, with a higher risk of complications in people 65 and older or taking medicines that can cause fluid loss or low blood pressure, that weight loss can happen so weight should be checked regularly, and that drugs such as rifampin, carbamazepine, phenytoin, and phenobarbital can make it work less well.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Apremilast
Apremilast is a tablet taken by mouth. You start with a 5-day dose increase schedule using Otezla tablets, then from day 6 take 30 mg twice daily, or 75 mg once daily as the extended-release tablet Otezla XR (not recommended for people with severe kidney problems). It can be taken with or without food. Patients with severe kidney problems take 30 mg once daily instead.
Availability and cost
Only available as the brand-name product.
Oral PDE4 inhibitor originally developed for psoriasis and psoriatic arthritis. Specialty-tier pricing reflects multiple rare and autoimmune indications.
Help paying for Otezla
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients may pay as little as $0 per month with the Otezla Co-Pay Program, regardless of income. Annual maximum applies; not for Medicare or Medicaid.
For: private insurance · source - Bridge or quick-start supply
If your plan requires prior authorization or approval is delayed, you may get Otezla free for up to 12 fills within 12 months while seeking coverage.
For: private insurance · source - Free medicine program
The Amgen Safety Net Foundation may provide Otezla at no cost to eligible patients; income limits apply. Some Medicare patients may qualify.
For: no insurance, Medicare · source - Insurance and case manager help
Amgen SupportPlus representatives help with coverage questions and connect government-insured or uninsured patients to financial support resources.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Free drug is run by the separate Amgen Safety Net Foundation (amgensafetynetfoundation.com). You must have lived in the US 6+ months, meet income limits, and have no insurance (some Medicare patients qualify for certain products). The bridge offer is one-time only.
Clinical trial results
Apremilast was approved by the FDA in 2019 for Behcet disease after showing it significantly reduced oral ulcers compared to placebo. It is currently the only FDA-approved oral medication specifically for oral ulcers in Behcet disease.
Development history
Developed by Celgene (now part of Bristol-Myers Squibb), apremilast was initially studied for psoriasis and other inflammatory conditions before being approved for Behcet disease in 2019, representing the first oral treatment for this rare disease.
Explore Behcet Disease trials
Other Behcet Disease treatments
Common questions about Apremilast
▸What is Apremilast (Otezla)?
An oral pill, taken twice daily (Otezla) or once daily (Otezla XR), approved specifically for mouth ulcers in Behcet disease in adults. It works by blocking an enzyme involved in inflammation, reducing the frequency and pain of oral sores.
▸How does Apremilast work?
Apremilast works by blocking an enzyme called PDE4 that normally breaks down a signaling chemical in immune cells. By stopping this enzyme, the drug allows this chemical to build up, which helps calm down inflammation. Think of it like putting the brakes on immune cells that are overreacting in Behcet disease.
▸What are the side effects of Apremilast?
The most common side effects are diarrhea, nausea, and headache, especially during the first few weeks. Most patients find these improve after 2 weeks of treatment. Watch for mood changes or depression, and tell your doctor immediately if you have thoughts of harming yourself. Serious allergic reactions, including swelling of the face or throat (angioedema) and anaphylaxis, have been reported; stop taking it and get emergency help if they happen. The label also warns that diarrhea, nausea, and vomiting can be severe and have sometimes needed a hospital stay, with a higher risk of complications in people 65 and older or taking medicines that can cause fluid loss or low blood pressure, that weight loss can happen so weight should be checked regularly, and that drugs such as rifampin, carbamazepine, phenytoin, and phenobarbital can make it work less well.
▸How is Apremilast taken?
Apremilast is a tablet taken by mouth. You start with a 5-day dose increase schedule using Otezla tablets, then from day 6 take 30 mg twice daily, or 75 mg once daily as the extended-release tablet Otezla XR (not recommended for people with severe kidney problems). It can be taken with or without food. Patients with severe kidney problems take 30 mg once daily instead.
▸Is Apremilast FDA approved?
Yes, Apremilast (Otezla) is FDA approved (2014) for the treatment of Behcet Disease.
▸How does apremilast work for oral ulcers in Behcet disease?
Apremilast inhibits phosphodiesterase 4 (PDE4), an enzyme involved in inflammatory signaling. By blocking PDE4, it reduces production of inflammatory cytokines that drive the painful oral ulcers characteristic of Behcet disease.
▸Was apremilast originally developed for Behcet disease?
No. Apremilast was first approved as Otezla for psoriasis and psoriatic arthritis. The Behcet disease oral ulcer indication was approved later in 2019, making it the first FDA-approved treatment specifically for this manifestation of Behcet disease.
▸How is apremilast taken?
Treatment starts with a 5-day dose increase using Otezla tablets to reduce stomach and bowel side effects. From day 6 it continues at 30 mg twice daily, or 75 mg once daily with the extended-release tablet Otezla XR.
▸What are the most common side effects?
Diarrhea, nausea, and headache are the most common side effects, particularly during the initial titration period. These often improve over the first few weeks of treatment. Weight loss has also been reported.
▸How does apremilast compare to adalimumab for Behcet disease?
Apremilast is an oral PDE4 inhibitor specifically approved for Behcet oral ulcers, while adalimumab is an injectable TNF inhibitor used off-label for various Behcet manifestations. Apremilast offers the convenience of oral dosing.
▸Is generic apremilast available?
Generic availability may vary by market. The brand name is Otezla, manufactured by Amgen (which acquired the product from Celgene/Bristol Myers Squibb).