Close window icon

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.
Read less
Resource Center
Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Oral Ulcers in Behçet’s Disease
Resource Center
About Behçet's Disease Oral Ulcers in BD
Oral Ulcers in Behçet’s Disease
Resource Center
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
Resource Center
Oral Ulcers in Behçet’s Disease
Resource Center
RELIEF Safety Laboratory Parameters
Psoriatic Arthritis
Resource Center
About Psoriatic Arthritis
Psoriatic Arthritis
Resource Center
Overview PALACE 1-3 PALACE 4 FORMOST ACTIVE
Psoriatic Arthritis
Resource Center
Overview ACR20 Response Oligoarticular PsA Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Resource Center
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years FOREMOST Safety ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Resource Center
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Resource Center
Overview ADVANCE ESTEEM SPROUT STYLE DISCREET LIBERATE
Plaque Psoriasis
Resource Center
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
Resource Center
Overview Adverse Reactions Through Week 16 Pediatric: Adverse Reactions Adverse Reactions Weeks 16 to 32 Adverse Reactions Through 5 Years Adverse Events of Special Interest Laboratory Parameters
Resource Center
Resources Overview Downloadable Resources Patient Profiles Billing and Coding Video Hub FAQs
Resource Center
Start Today Co-Pay and Patient Support Coverage
Resource Center
Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Resource Center
Mechanism of Disease (MOD) Otezla MOA
Resource Center
PATIENT PROFILES

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
REFERENCES

*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.

JUMP TO:

OTEZLA PATIENT PROFILES

Your patients may be ready for an oral systemic therapy—keep an eye out for patients like these in your practice

Plaque Psoriasis

  • Emily, hypothetical patient with plaque psoriasis of the scalp

    Emily PLAQUE PSORIASIS PATIENT WITH SCALP INVOLVEMENT

    48 years old

    Account Manager

  • Chris, hypothetical mild plaque psoriasis patient who is ready for an oral medication

    CHRIS HAS DIFFICULTY WITH TOPICAL TREATMENT

    40 years old

    Electrician

  • Ivan, hypothetical patient with plaque psoriasis on nails

    IVAN STRUGGLES WITH BOTH PLAQUE PSORIASIS
    AND PSORIATIC ARTHRITIS

    37 years old

    Teacher and Coach

Psoriatic Arthritis

  • Fred, hypothetical patient with joint tenderness from psoriatic arthritis

    FREDSTRUGGLING WITH JOINT TENDERNESS DESPITE
    TREATMENT WITH AN NSAID

    34 years old

  • Paula, hypothetical patient with psoriatic arthritis

    PAULA PsA AND STRUGGLES WITH LOSS OF PHYSICAL
    FUNCTION ASSOCIATED WITH TENDER AND
    SWOLLEN JOINTS

    51 years old

Oral Ulcers in Behçet’s Disease

  • Joseph, hypothetical patient with oral ulcers in Behçet's disease

    JOSEPH RECURRENT ORAL ULCERS

    37 years old

    Chef

 

BID, twice daily; BMI, body mass index; BSA, body surface area; CASPAR, Classification of Psoriatic Arthritis; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count.

Accordion icon

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. Aldredge LM, Higham RC. JDNA. 2018;10(4):189-197. 2. Kaplan D, Hetherington J, Lucas J, et al. J Dermatolog Treat. 2022;33(6):2844-2852. 3. Blakely K, Gooderham M. Psoriasis (Auckl). 2016;6:33-40. 4. Wilson FC, Icen M, Crowson CS, et al. Arthritis Rheum. 2009;61(2):233-239. 5. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide. Accessed February 1, 2024. 6. Kimmel GW, Lebwohl M. Psoriasis: overview and diagnosis. In: Bhutani T, Liao W, Nakamura M, eds. Evidence-based Psoriasis: Diagnosis and Treatment. Springer; 2018:1-6. 7. Barnes CG. History and diagnosis. In: Yazici Y, Yazici H, eds. Behçet’s Syndrome. Springer; 2010:7-33. 8. Alpsoy E, Akman A. Therapy. 2016;3(1):139-151. 9. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5):901-906.