Approved Uses Otezla® (apremilast) is a prescription medicine used to treat adult patients with:

  • Plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
  • Active psoriatic arthritis.
  • Oral ulcers associated with Behçet’s Disease.

Otezla is the first and only FDA-approved pill for oral ulcers associated with Behçet’s Disease

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

In some people, after just 12 weeks, Otezla was proven to:

  • Help reduce oral ulcers
  • Help reduce oral ulcer pain

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Common side effects of Otezla

Otezla was studied among 207 adults with oral ulcers associated with Behçet’s Disease.

The table below shows the most commonly reported side effects from people taking Otezla 30 mg twice daily, compared to those taking placebo (sugar pill).

*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.

These are not all the possible side effects of Otezla. Tell your doctor about any side effect that bothers you or does not go away.

If you are experiencing side effects, please consult your doctor.

For more information, please see Important Safety Information to the right of this page.

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Ask your rheumatologist if Otezla is right for you

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Inflammation in Behçet’s Disease

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Although the exact role of inflammation in Behcet's Disease is unknown, it may play a part.

Behçet’s Disease is associated with inflammation inside the body. Lab research has shown that an enzyme called phosphodiesterase 4 (PDE4), located inside cells, contributes to the inflammation.

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How does Otezla work?

The exact way Otezla works in people with Behçet’s Disease isn’t completely understood, but here’s what we do know:

  • Otezla is a type of pill called a “PDE4 inhibitor”—meaning it works inside inflammatory cells to reduce PDE4 activity
  • Reducing PDE4 activity is thought to help reduce inflammation

Taking Otezla

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Otezla is the first and only FDA-approved treatment for oral ulcers associated with Behçet’s Disease

Otezla is a pill taken by mouth every day—once in the morning, and once at night. For example, you can take Otezla with breakfast and dinner each day, or when you wake up and when you go to bed at night. (On your first day, you only take one pill.) For people with severe kidney disease, Otezla is one pill a day.

  • Be sure to take Otezla as directed by your doctor
  • You can take Otezla with or without food. But don’t crush, split, or chew the pill

When you first start treatment, you’ll see you have a 5-day titration period, which means that you’ll gradually increase your dose over your first 5 days until you reach the recommended dose. People with severe kidney disease will follow a different schedule for their titration period.

 

This titration period is meant to help reduce the gastrointestinal symptoms related to initial treatment with Otezla.

Did you know?

Your Otezla prescription will be sent right to your doorstep each month. Questions? Call 1-844-4OTEZLA and ask about delivery from a specialty pharmacy.

What is Behçet’s Disease?

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Behçet’s Disease is a chronic inflammatory disease that can produce a variety of symptoms.

Because symptoms of Behçet’s Disease appear differently for different people, it can often be hard for doctors to diagnose.

One of the main symptoms associated with Behçet’s Disease is oral ulcers. Oral ulcers are usually painful, and can interfere with everyday functions like eating, drinking, and speaking.

Otezla is only approved to treat the oral ulcers associated with Behçet’s Disease, but there are other symptoms to be aware of. These can include genital ulcers, eye inflammation, skin lesions, joint pain, blood vessel inflammation, brain inflammation, and digestive tract ulcers.

Did you know almost all people diagnosed with Behçet’s Disease will experience oral ulcers?

Often, they’re the first symptoms people notice.

More resources

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Want more information about Behçet’s Disease?

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

You can learn more by visiting their websites:

 

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Savings and cost support

Commercially insured patients can get Otezla for $0 per month with the Otezla $0 Co-Pay* Card.

 

ENROLL NOW

  • If you are uninsured or underinsured, Otezla SupportPlus™ can put you in touch with the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Otezla and other Amgen medicines at no cost
  • If you have Medicare or Medicaid coverage, our team of Insurance Solutions Specialists can assist you with any questions you may have about your plan. Our team is knowledgeable in Medicaid and can also review the Medicare Part D plan phases to help you understand what you can anticipate.
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For all Otezla savings and support questions:

Call 1-844-4OTEZLA (1-844-468-3952), Monday – Friday AM to 8 PM, ET

*Summary of Terms and Conditions

It is important that every patient read and understand the full Otezla® Co-Pay Card Terms and Conditions. The following summary is not a substitute for reviewing the Terms and Conditions in their entirety.

As further described below, in general:

  • The Otezla Co-Pay Card is open to patients with commercial insurance, regardless of financial need. The program is not valid for patients whose Otezla® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. (See ELIGIBILITY section below.)

With the Otezla Co-Pay Card, a commercially insured patient who meets eligibility criteria can receive one of the following two offers when filling their Otezla prescription:

  • If the patient’s health plan does not cover Otezla® (apremilast) or requires a prior authorization, a patient can receive Otezla free for up to twelve (12) prescription fills within twelve (12) months from the date of the first prescription filled under the Bridge to Commercial Coverage Offer. (See PROGRAM DETAILS section below.)
  • If Otezla is approved by the patient’s health plan, a patient can pay as little as a $0 co-pay per month for their Otezla monthly out-of-pocket costs. Monthly out-of-pocket costs include co-payment, co-insurance, and deductible out-of-pocket costs. Amgen will pay the remaining eligible out-of-pocket costs on behalf of the patient until the Amgen payments have reached either the Maximum Program Benefit or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed this limit. (See PROGRAM DETAILS section below.)
  • The Otezla Co-Pay Card provides support up to the Maximum Program Benefit or Patient Total Program Benefit. If a patient’s commercial insurance plan imposes different or additional requirements on patients who receive Otezla Co-Pay Card benefits, Amgen has the right to reduce or eliminate those benefits. Whether you are eligible to receive the Maximum Program Benefit or Patient Total Program Benefit is determined by the type of plan coverage you have. Please ask your Otezla SupportPlus™ representative to help you understand eligibility for the Otezla Co-Pay Card, and whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit, or your Patient Total Program Benefit amount, by calling 1-844-4OTEZLA (1-844-468-3952). (See PROGRAM BENEFITS section below.)

Click here to see the Otezla $0 Co-Pay Card Full Terms and Conditions.

Otezla® Co-Pay Card Terms and Conditions

I. ELIGIBILITY

Eligibility Criteria: Subject to program limitations and terms and conditions, the Otezla Co-Pay Card is open to patients who have an Otezla prescription and who have commercial or private insurance, including plans available through state and federal healthcare exchanges. This program helps eligible patients cover out-of-pocket costs related to Otezla, up to program limits. There is no income requirement to participate in this program.

This offer is not valid for patients whose Otezla prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for Otezla or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of an Otezla prescription.

II. PROGRAM BENEFITS

The Otezla Co-Pay Card helps provide out-of-pocket support to eligible patients for their Otezla prescription up to program limits. With the Otezla Co-Pay Card, a commercially insured patient who meets eligibility criteria can receive one of two offers when filling their Otezla prescription: the Bridge Offer or the Co-Pay Card Offer. Patients can participate in one offer at a time. See PROGRAM DETAILS for full description.

The Otezla Co-Pay Card offer does not cover out-of-pocket costs for any patient whose selected coverage option under their commercial insurance plan does not apply Otezla Co-Pay Card payments to satisfy the patient’s co-payment, deductible, or co-insurance for Otezla. Patients with these plan limitations are not eligible for the Otezla Co-Pay Card but may be eligible for other needs-based assistance provided by Amgen. These programs are often referred to as accumulator adjustment programs. If you believe your commercial insurance plan may have such limitations, please contact Otezla SupportPlus at 1-844-4OTEZLA (1-844-468-3952).

The Otezla Co-Pay Card also may provide a reduced benefit amount, unilaterally determined by Amgen in its sole discretion, to satisfy the out-of-pocket cost-sharing requirement for any patient whose plan or plan agent (including, but not limited to, a Pharmacy Benefit Manager [PBM]) requires enrollment in the Otezla Co-Pay Card as a condition of the plan or PBM waiving some or all of an otherwise applicable patient out-of-pocket cost-sharing amount. These programs are often referred to as co-pay maximizer programs. If you believe your commercial insurance plan may have such limitations, please contact Otezla SupportPlus at 1-844-4OTEZLA (1-844-468-3952). Health plans, specialty pharmacies, and Pharmacy Benefit Managers (individually and collectively “Plan Administrators”) are prohibited from enrolling patients in the Otezla Co-Pay Card. Plan Administrators are prohibited from assisting patients with enrollment in the Otezla Co-Pay Card. The patient, or his/her legal representative, must personally enroll in the Otezla Co-Pay in order to be eligible for program benefits.

If at any time a patient begins receiving prescription drug coverage under any state or government program (including but not limited to Medicare, Medicaid, TRICARE, Department of Defense, or Veteran Affairs programs), the patient will no longer be able to use this card and they must contact Otezla SupportPlus at 1-844-4OTEZLA (1-844-468-3952) (Monday through Friday, from 8AM-8PM ET) to stop their participation in this program.

Patients may not seek reimbursement for the value received from the Otezla Co-Pay Card from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure regarding your participation in the Otezla Co-Pay Card of your insurance carrier or Pharmacy Benefit Manager. Restrictions may apply. Offer is subject to change or discontinuation without notice. This is not health insurance.

III. PROGRAM DETAILS

With the Otezla Co-Pay Card, a commercially insured patient who meets eligibility criteria can receive one of the following two offers when filling their Otezla prescription:

Bridge to Commercial Coverage Offer

  • If the patient’s health plan does not cover Otezla (apremilast) or requires a prior authorization, a patient can receive Otezla free for up to 3 prescription fills over 90 days (whichever occurs first) from the date of the first prescription filled under the Bridge Offer, while pursuing approval from their health plan.

Co-Pay Offer

  • If Otezla is approved by the patient’s health plan, a patient can pay as little as a $0 co-pay per month for their Otezla monthly out-of-pocket costs.
  • For all eligible patients, the Otezla Co-Pay Card offers:
    • A program benefit that covers the patient’s eligible out-of-pocket prescription costs for Otezla (co-pay, deductible, or co-insurance) on behalf of the patient, up to a Maximum Program Benefit determined by the program per calendar year.
    • Otezla patients can pay $0 out of pocket at the first fill and at every refill, and Amgen will pay on behalf of the patient the remaining eligible out-of-pocket prescription costs (up to the Patient Total Program Benefit described below; Otezla patients are responsible for all amounts that exceed this limit).
  • Maximum Program Benefit, Patient Total Program Benefit and Benefits May Change, End, or Vary: The program provides up to a Maximum Program Benefit of assistance to reduce a patient’s out-of-pocket prescription costs that Amgen will provide per patient for each calendar year, which must be applied to the Otezla patient’s out-of-pocket costs (co-pay, deductible, or co-insurance). Patient Total Program Benefit amounts are unilaterally determined by Amgen in its sole discretion and will not exceed the Maximum Program Benefit. The Patient Total Program Benefit may be less than the Maximum Program Benefit, depending on the terms of a patient’s prescription drug plan, and may vary among individual patients covered by different plans, based on factors determined solely by Amgen, to ensure all programs funds are used for the benefit of the patient. Each patient is responsible for costs above the Patient Total Program Benefit amounts. Please ask your Otezla SupportPlus representative to help you understand whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit or your Patient Total Program Benefit amount by calling 1-844-4OTEZLA (1-844-468-3952) and selecting option 1. Participating patients are solely responsible for updating Amgen with changes to their prescription health insurance including, but not limited to, initiation of insurance provided by the government, the addition of any coverage terms that do not apply Otezla Co-Pay Card benefits to reduce a patient’s out-of-pocket costs, such as accumulator adjustment benefit design or a co-pay maximization program. Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility. By accepting payments from Amgen made on behalf of participating patients, participating PBMs and Plans likewise are responsible for providing Amgen with accurate information regarding patient eligibility.
  • Patients may use the card every time they fill their Otezla prescription. Benefits reset each calendar year. Enrollment in the program is for 12 months. Patients may participate in the program for 12 months, or continue in the program after that, provided s/he continues to meet all of the program’s eligibility requirements during participation in the program, and with program enrollment renewal every 12 months. Patients can enroll/re-enroll by calling 1-844-4OTEZLA (1-844-468-3952).
 

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Important Safety Information

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.

APPROVED USES

Otezla® (apremilast) is a prescription medicine used to treat adult patients with:

  • Plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
  • Active psoriatic arthritis.
  • Oral ulcers associated with Behçet’s Disease.
Important Safety Information

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.

 

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