OTEZLA:
4 INDICATIONSOtezla^® (apremilast)/Otezla XR^™ (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.Read more

OTEZLA:
4 INDICATIONS

Otezla® (apremilast)/Otezla XR™ (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 XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis.
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis.
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

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: 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.

Otezla has an established safety profile in Behçet’s Disease ¹

RELIEF: ADVERSE REACTIONS

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 12 ¹

RELIEF: Adverse reactions reported in ≥5% of patients on Otezla 30 mg BID and
with at least 1% greater frequency than patients on placebo up to week 12 ¹

Table of adverse reactions reported in Otezla patients

*There were no serious adverse reactions of diarrhea, nausea, or vomiting.

The most commonly reported adverse reactions (≥10%) for Otezla include diarrhea, nausea, headache, and upper respiratory tract infection ¹
Discontinuation of treatment due to adverse reactions during the placebo-controlled period of the study was 2.9% for patients taking Otezla and 4.9% for placebo ¹

THE MAJORITY OF PATIENTS REPORTING DIARRHEA, NAUSEA, AND VOMITING DID SO WITHIN THE FIRST WEEK, AND THE EVENTS TENDED TO RESOLVE OVER TIME ²

Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. Monitor patients who are more susceptible to complications of diarrhea or vomiting ¹

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 68 ^2,3

RELIEF: Adverse reactions reported in >5% of patients
on Otezla 30 mg BID through week 68 ^2,3

Table of demonstrated safety report in Otezla patients

^†The Otezla exposure period includes all Otezla exposure data from the first dose of Otezla, irrespective of when Otezla exposure started (at week 0 or week 12), and includes 4 weeks of follow-up between weeks 64 and 68. ^‡Exposure-adjusted incidence rate/100 patient years is 100 times the number (n) of patients reporting the event divided by patient-years (up to the first event start date for patients reporting the event). ^§Rates were not equal to or greater than 5% during the placebo-controlled period.

Discontinuation of treatment due to adverse reactions during the Otezla exposure period of the study was 11.5% for patients taking Otezla/Otezla 30 mg BID and 3.6% for placebo/Otezla 30 mg BID ³

BID, twice daily; EAIR, exposure-adjusted incidence rate.

Oral Ulcers: Daily Average

Laboratory Parameters

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/OTEZLA XR 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/OTEZLA XR and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/Otezla XR 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/Otezla
XR 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/Otezla XR
dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with Otezla/Otezla XR for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla/Otezla XR. 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 in adult patients, 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/Otezla XR
- 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/Otezla XR-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 adult 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 co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla/Otezla XR efficacy may occur. Concomitant use of Otezla/Otezla XR 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

Advise pregnant women of the potential risk of fetal loss

INDICATIONS

Otezla/Otezla XR 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 XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease

Please click here for the full Prescribing Information.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Hatemi G, Mahr A, Ishigatsubo Y, et al. N Engl J Med. 2019;381(20):1918-1928. 3. Data on file, Amgen, Inc.

Study Design

Study Design

How Otezla Works

Dosing

Otezla has an established safety profile in Behçet’s Disease 1

RELIEF: ADVERSE REACTIONS

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 12 1

RELIEF: Adverse reactions reported in ≥5% of patients on Otezla 30 mg BID and with at least 1% greater frequency than patients on placebo up to week 12 1

THE MAJORITY OF PATIENTS REPORTING DIARRHEA, NAUSEA, AND VOMITING DID SO WITHIN THE FIRST WEEK, AND THE EVENTS TENDED TO RESOLVE OVER TIME 2

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 68 2,3

RELIEF: Adverse reactions reported in >5% of patients on Otezla 30 mg BID through week 68 2,3

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla has an established safety profile in Behçet’s Disease ¹

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 12 ¹

RELIEF: Adverse reactions reported in ≥5% of patients on Otezla 30 mg BID and
with at least 1% greater frequency than patients on placebo up to week 12 ¹

THE MAJORITY OF PATIENTS REPORTING DIARRHEA, NAUSEA, AND VOMITING DID SO WITHIN THE FIRST WEEK, AND THE EVENTS TENDED TO RESOLVE OVER TIME ²

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 68 ^2,3

RELIEF: Adverse reactions reported in >5% of patients
on Otezla 30 mg BID through week 68 ^2,3