Oral Ulcers in Behçet’s Disease Treatment | Otezla® (apremilast)
Indications
APPROVED USES Prescription Otezla®/Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis. Read more >
Approved Uses Prescription Otezla®/Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis.
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease. Read less >

Otezla is the

first and
only pill

approved to treat oral ulcers associated with Behçet’s Disease.

In a clinical study, Otezla was proven to treat the oral ulcers associated with Behçet’s Disease

After 12 weeks Otezla reduced oral ulcers and oral ulcer pain
Otezla reduced oral
ulcers
and oral ulcer pain associated with Behçet’s Disease in some people

Missing lively conversations over brunch? Otezla helped people with Behçet’s Disease experience less oral ulcer pain

What are the most common side effects of Otezla?

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. 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. Ask your doctor about potential side effects, and let them know about any side effect that bothers you or doesn’t go away.

Pay as little as $0*

Did you know you may be eligible to pay as little as $0 per month with the Otezla Co-Pay Program? For eligible, commercially insured patients, your co-pay can be applied to deductible, co-insurance, and co-payment,* and is available regardless of your income level.

First-time co-pay card user? Find out more about how it works and how it can help.

No insurance? Learn about other ways you may be able to access Otezla as prescribed.

*For commercially insured patients only. Eligibility criteria and program maximums apply.
See AmgenSupportPlus.com/copay-terms for full Terms and Conditions.

Caregivers of kids and teens under 18 can contact Amgen® SupportPlus at
1-844-4OTEZLA (1-844-468-3952) to complete enrollment, Monday – Friday, 8 AM – 8 PM ET.
Hand holding copay card from Amgen® SupportPlus program
Hand holding copay card from Amgen® SupportPlus program

Frequently asked questions

  • What is Behçet’s Disease?
    Information

    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.

  • How Otezla works for Behçet’s Disease
    Example of PDE4 inhibitor

    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 type of treatment called a phosphodiesterase 4 (PDE4) inhibitor, meaning it works inside cells to reduce PDE4 activity
    • Reducing PDE4 is thought to help reduce inflammation
  • What dosing options are available?

    Otezla is available as a 30 mg twice-daily pill or as a 75 mg Extended-Release once-daily pill.

    Talk to your doctor to explore which formulation is the right option for you.

  • Who can take Otezla Extended-Release Pills?

    Otezla Extended-Release 75 mg pills are approved for:

    • Adult patients with: Plaque psoriasis who are candidates for phototherapy or systemic therapy; or active psoriatic arthritis (PsA) or oral ulcers associated with Behçet’s Disease
    • Pediatric patients 6 years of age and older and weighing at least 110 lbs with: Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis (PsA)

    Otezla Extended-Release pills are not recommended for patients with severe kidney disease.

    Talk to your doctor if you are currently taking Otezla 30 mg twice-daily and are interested in switching your prescription to Otezla Extended-Release once daily.

  • How do I to take my prescription?
    Example of Otezla (apremilast) pill
    • Otezla is a pill offered in a 30 mg twice-daily pill or 75 mg Extended-Release once-daily pill.
    • Take with or without food. Swallow tablets whole and do not crush, split, or chew the pill.
    • Otezla should be stored below 86° F and Otezla Extended-Release should be stored between 68° F and 77° F.
    Your prescription will be delivered right to your door

    Be sure to take as directed by your doctor. Find out more about getting your prescription.

  • Your first week on treatment
    Calendar

    Once your doctor prescribes Otezla or Otezla Extended-Release, you can get started with a titration pack right away: with no blood work or routine lab testing required.§

    Your doctor may send you home with a 14-day treatment initiation pack.** With this, you will slowly increase your treatment dose until you reach the recommended dose. This is known as titration.

    Titration is meant to help reduce the stomach and digestive side effects (nausea and diarrhea) that may occur when starting Otezla.

    Once you have completed your titration pack as instructed by your doctor, you will then continue with either your Otezla 30 mg twice-daily, or Otezla Extended-Release 75 mg once-daily prescription.

    People with severe kidney disease will follow a different schedule for Otezla. Otezla Extended-Release tablets are not recommended for people with severe kidney disease. Be sure to take your medication as directed by your healthcare professional.

    See the titration details on Otezla below:

    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 Or
    75 mg
    Otezla
    Extended-
    Release
    PM 10 mg 20 mg 20 mg 30 mg 30 mg

    When taking Otezla Extended-Release, you may sometimes see part of the tablet in your stool. This is not a cause for concern, this is the outer shell of the tablet. By the time you see it, the medicine inside has already been absorbed by your body.

    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.

    §Otezla Extended-Release once-daily dosing starts after initial titration with Otezla.

    **Treatment initiation pack can be 14-day or 28-day, you should use the pack as instructed by your doctor.

  • What happens if I miss a dose?
    Doctor

    If you miss a dose, contact your healthcare provider to determine the most appropriate next steps.

  • Helpful resources
    Resources

    If you’re interested in learning more, the following resources can help. Each organization has information for people living with Behçet’s Disease:


    American Behçet's Disease Associate logo
    National Organization for Rare Disorders logo
    Vasculitis Foundation logo
Two woman at a brunch gathering

What to expect on Otezla

Find out about managing side effects, seeing results, and more.
A father with his arm around his daughter, both smiling

Get support

Amgen® SupportPlus can help with financial support and insurance coverage for Otezla.

IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR 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.
  • 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/Otezla XR may increase the risk of complications from having severe diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.
  • 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/Otezla XR, 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/Otezla XR.
  • Weight loss. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla/Otezla XR. For children 6 years of age or older, their doctor should monitor their growth (height and weight). If they are not growing or gaining weight as expected, their doctor will decide if they should continue taking Otezla/Otezla XR.

Some medicines may make Otezla/Otezla XR less effective and should not be taken with Otezla/Otezla XR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines.

The most common side effects include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. These are not all the possible side effects with Otezla/Otezla XR. 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 XR.

APPROVED USES

Prescription Otezla® /Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR.

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR 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.