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Otezla® (apremilast) For Healthcare Professionals
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3 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 adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Read less

Read less

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: 920,000+ patients treated globally since 2014 1.2,* PsO SAFETY PsA SAFETY

A small pill with a big history: 920,000+ patients treated globally since 2014 1.2,*

PsO SAFETY PsA SAFETY REFERENCES & FOOTNOTE

Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=57% 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
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For any adult patient with plaque psoriasis or active PsA, Otezla is the only therapy that patients can start today with no initial or ongoing lab monitoring. 1

PsO

Plaque
Psoriasis

PsA

Psoriatic
Arthritis

BD

Oral Ulcers in
Behçet’s Disease

Couple taking a selfie in the woods with their dog during sunset

CHOOSE 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

*Eligibility criteria and program maximums apply. Click here for full Terms and Conditions.

5 years of data on Otezla® (apremilast)

A SAFETY PROFILE YOU’VE COME TO TRUST 1-3

The safety profile for Otezla was studied in 6 clinical trials in both mild to moderate and moderate to severe plaque psoriasis, and 6 clinical trials in active PsA 1,2,4,5,§

920,000+ patients treated with Otezla® (apremilast)

920,000+

PATIENTS TREATED WITH
OTEZLA WORLDWIDE 2,6,**

Patients with moderate to severe plaque psoriasis in the ESTEEM clinical trials could be treated through 5 years. Patients with active PsA in the PALACE 1-4 trials could be treated through 5 years. The 6 clinical trials for plaque psoriasis include ADVANCE, ESTEEM 1 & 2, STYLE, LIBERATE, and DISCREET. §The 6 clinical trials for active PsA include PALACE 1, PALACE 2, PALACE 3, PALACE 4, FOREMOST, and ACTIVE. **Estimates of patients treated reflect global data since launch (Apr 2014- Sept 2023; US=57% 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.

Insurance coverage for commercially insured Otezla® (apremilast) patients with PsO

Insurance coverage for commercially insured Otezla® (apremilast) patients with PsO

††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 (VHA), 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. †††86% of commercially insured patients have access to Otezla with no step edits after trying topicals for plaque psoriasis. ‡‡‡Includes DMARD and bio-step.

BSA, body surface area; DMARD, disease-modifying antirheumatic drug; MOA, mechanism of action; PA, prior authorization; ST, step therapy; TB, tuberculosis.

 

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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla 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

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla 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 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 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 patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • 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 patients with mild to moderate plaque psoriasis was consistent with the safety profile previously 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® (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 adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of 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. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Nash P, Ohson K, Walsh J, et al; ACTIVE Investigators. Ann Rheum Dis. 2018;77(5):690-698. 6. Otezla® (apremilast) FDA approval letter. March 21, 2014.