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4 INDICATIONSOtezla® (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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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

*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.

Don't wait words

TREAT PLAQUE PSORIASIS SYSTEMICALLY
FROM THE START 1

Otezla is the first and only oral medication
approved across all severities of plaque
psoriasis and active psoriatic arthritis

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5 YEARS OF SAFETY

Review the established safety profile in plaque psoriasis 2,*

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5 YEARS OF EFFICACY

Explore data across severities and manifestations, including 5-year data in moderate to severe plaque psoriasis 1,2,*

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START OTEZLA TODAY

No initial or ongoing lab monitoring 1

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VIEW OTEZLA COVERAGE

Help patients start and stay on Otezla

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Plaque psoriasis on darker skin tone

Plaque psoriasis is a chronic systemic disease that may benefit from a systemic therapy 3

Data from Otezla® (apremilast)

Otezla has real-world data highlighting the impact of delaying systemic therapy

*Patients with moderate to severe plaque psoriasis in the ESTEEM clinical trials could be treated through 5 years.

CONSIDER OTEZLA TO TREAT FROM WITHIN 1

Otezla is the only oral therapy for all severities of plaque psoriasis, and active psoriatic arthritis that your patients can start today without delay

Otezla® (apremilast) is an oral therapy that can be started without delay

Otezla® (apremilast) is an oral therapy that can be started without delay

5 years of data on Otezla® (apremilast)

A SAFETY PROFILE YOU’VE
COME TO TRUST 1,2

The safety profile for Otezla was studied in 7 clinical trials across mild to moderate and moderate to severe plaque psoriasis 1-5,‡

Otezla® (apremilast) patients worldwide

1 MILLION +

PATIENTS TREATED WITH OTEZLA WORLDWIDE 2,6,§

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COULD YOUR PLAQUE PSORIASIS PATIENTS BENEFIT FROM TREATMENT WITH OTEZLA?

Patients with moderate to severe plaque psoriasis in the ESTEEM clinical trials could be treated through 5 years. The 7 clinical trials for plaque psoriasis include ADVANCE, ESTEEM 1 & 2, SPROUT, STYLE, LIBERATE, and DISCREET. §Estimates of patients treated reflect global data since launch (Apr 2014-March 2024; 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.

OTEZLA HAS THE BEST COMMERCIAL COVERAGE OF ALL BRANDED ORAL THERAPIES FOR
PLAQUE PSORIASIS, AS MEASURED BY THE PERCENTAGE OF COMMERCIAL LIVES COVERED.
2,**,††,‡‡

Inclusion on formulary does not imply superior clinical efficacy or safety.

Commercial insurance coverage for Otezla® (apremilast)

Commercial insurance coverage for Otezla® (apremilast)

**Covered includes Covered, Covered (PA/ST), Preferred and Preferred (PA/ST) as defined by Managed Markets Insights and Technology (MMIT) data. ††Number of commercially insured plaque psoriasis lives provided is obtained from MMIT for health plans in the US. Data as of March 2024. ‡‡This calculation excludes Department of Defense (DoD) TRICARE, Department of Veteran Affairs (VA), and Indian Health Service (IHS) government plans. §§Number of commercially insured plaque psoriasis and active psoriatic arthritis lives provided is obtained from MMIT for health plans in the US. Data as of June 2023.

OTEZLA CAN BE THE NEXT STEP WHEN TOPICALS AREN’T ENOUGH.

BSA, body surface area; PA, prior authorization; ST, step therapy; TB, tuberculosis.

 

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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

Please click here for the full Prescribing Information.

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

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide/ Accessed August 1, 2024. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Fiorillo L, Becker E, de Lucas R, et al. J Am Acad Dermatol. 2024;90(6):1232-1239. 6. Otezla® (apremilast) FDA approval letter. March 21, 2014.