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4 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

  • Otezla is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
  • Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Oral Ulcers in Behçet’s Disease
About Behçet's Disease Oral Ulcers in BD
Oral Ulcers in Behçet’s Disease
Clinical Response of Oral Ulcers Oral Ulcers: Pain Results Oral Ulcers: Complete Response Oral Ulcers: Maintenance of Response Oral Ulcers: Daily Average
Oral Ulcers in Behçet’s Disease
Study Design
Oral Ulcers in Behçet’s Disease
RELIEF Safety Laboratory Parameters
Psoriatic Arthritis
About Psoriatic Arthritis
Psoriatic Arthritis
Overview PALACE 1-3 PALACE 4 FORMOST ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Oligoarticular PsA Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years FOREMOST Safety Tolerability ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Study Design
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Pediatric Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library Real-World Data
Plaque Psoriasis
Overview Mild to Moderate Plaque PsO Moderate to Severe Plaque PsO Pediatric
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
How Otezla Works
Dosing

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA

SEE THE DATA REFERENCES

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1 START TODAY WITHOUT DELAY

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1

 START TODAY WITHOUT DELAY REFERENCES

A small pill with a big history: 1 million+ patients treated globally since 2014 1-3,* PsO SAFETY PsA SAFETY

A small pill with a big history: 1 million+ patients treated globally since 2014 1-3,*

PsO SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=59% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.

SEE HOW OTEZLA MADE A DIFFERENCE FOR
REAL PATIENTS * WITH PLAQUE PSORIASIS

*Real Otezla patients who have been compensated for their time.

  • “Talking to my doctor about a pill was a total game changer.”

    Watch Dallas’s Story

    dallas's story on living with mild to moderate plaque psoriasis

    Meet Dallas – Mild to Moderate Plaque Psoriasis

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    As a football player, Dallas felt embarrassed about his plaque psoriasis and often found himself covering up his skin both on and off the field. He felt that topical treatments didn’t fit his lifestyle, considering them greasy and oily. Recently, he talked to a new doctor about Otezla, a pill that works from the inside out to treat his plaque psoriasis.

  • “I WANT TO ENCOURAGE OTHER PEOPLE NOT TO WAIT.”

    Watch Genine's Story

    Genine's story on living with mild to moderate plaque psoriasis

    Meet Genine – Mild to Moderate Plaque Psoriasis

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    Genine had been struggling with plaque psoriasis on her scalp. She struggled with how it made her look, but also with the topical treatments for it. She realized that the time she spent applying topicals was getting in the way of her life.

    When her doctor prescribed Otezla, she could stop struggling with greasy topicals in her hair. Now, Genine says that she can even wear her hair up without embarrassment.

  • “IT'S IMPORTANT TO BE HONEST WITH YOUR DOCTOR.”

    Watch Rebecca’s Story

    Pat's story on living with moderate to severe plaque psoriasis

    Meet Rebecca – Moderate to Severe Plaque Psoriasis

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    Rebecca’s first symptom of plaque psoriasis was on her face. Her plaque psoriasis was front and center, and it meant that each time it appeared she couldn’t wear makeup. She had to apply a greasy ointment to her face instead.

    Then there was the itching, which was very bothersome. Eventually her doctor recommended Otezla: no needles, no ointments, just a pill.

  • “I LIKE TO TELL MY
    STORY TO HELP
    SOMEBODY ELSE OUT.”

    Watch Kayla’s Story

    Kayla's story on living with moderate to severe plaque psoriasis

    Meet Kayla – Moderate to Severe Plaque Psoriasis

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    Kayla felt like people would look at her differently because of her plaque psoriasis. When she was initially diagnosed, she was scared. Her skin was extremely dry, which would lead to itching and bleeding. At first, she only used topicals as her treatment regimen, but she didn’t like how they were greasy and sticky.

    Kayla’s dermatologist recommended Otezla. She takes one pill in the morning with her breakfast, and one pill in the evening with her dinner. Kayla is grateful that she has Otezla.

  • “I WAS LIKE, ‘OH MY GOSH, IT’S WORKING!’”
     

    Watch Michael’s Story

    Michael's story on living with mild to moderate plaque psoriasis

    Meet Michael – Mild to Moderate Plaque Psoriasis

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    Around 18 years old, Michael noticed his skin was very itchy. He found himself not wanting to socialize and began to isolate himself from his friends. After being diagnosed with plaque psoriasis, he initially treated his plaques with topicals, which he found frustrating to have to apply regularly. He sought out a different treatment option.

    Michael’s dermatologist told him that Otezla looked like it could be a good fit for him. After 4 months of treatment, he began to see his plaques lessen. Michael now keeps a busy schedule with his symptoms well-managed.

  • “I WAS SO EXCITED TO SHARE [MY] PROGRESS.”
     

    Watch Pat’s Story

    Pat's story on living with moderate to severe plaque psoriasis

    Meet Pat – Moderate to Severe Plaque Psoriasis

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    Growing up swimming and surfing, Pat was constantly struggling with his plaques. Pat’s doctor told him that the best way to manage plaque psoriasis was from the inside out, and recommended Otezla.

    Pat was excited about his progress on Otezla from the very first follow-up appointment.

    He still has plaque psoriasis, but feels good about not having to cover up all the time.

Individual results may vary.

SEE HOW OTEZLA ALSO MADE A DIFFERENCE FOR
A REAL PATIENT † WITH PSORIATIC ARTHRITIS

†Real Otezla patient who has been compensated for her time.

  • “FOR THE FIRST TIME IN THEIR LIVES, MY BOYS KNOW WHAT IT’S LIKE TO SEE THEIR MOM LIVING WELL.”

    Watch Cindy’s Story

    Cindy's story on living with psoriatic arthritis

    Meet Cindy – Psoriatic Arthritis

    plusminus

    Cindy has always been confident and outgoing, but when her psoriatic arthritis showed up, the things she loved doing, like playing sports and keeping up with her twin sons, became difficult.

    Cindy buckled down and did some research on which treatment options seemed right for her, which led her to Otezla, a pill that was different from the other treatment options she had tried. Her doctor agreed Otezla was a good fit, and she left her appointment with a Sample Starter Pack that same day.

    Cindy noticed less swelling, tenderness, and pain in her joints after 4 months of taking Otezla. She can now keep up with her twins and feels like a better version of herself.

Individual results may vary.

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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in adult patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of adult patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

INDICATIONS

Otezla is indicated for the treatment of:

  • Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Adult patients with active psoriatic arthritis
  • Adult patients with oral ulcers associated with Behçet’s Disease

Please click here for the full Prescribing Information.