*Estimates of patients treated reflect global data since launch (Apr 2014-Aug 2022; US=approximately 60% of
data). Calculations based on observed drug utilization
parameters and number of units distributed. Utilization patterns change over time to best represent current
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® (APREMILAST) DOSING SCHEDULE: PLAQUE PSORIASIS, PSORIATIC ARTHRITIS, AND ORAL ULCERS ASSOCIATED WITH BEHÇET’S DISEASE
Otezla is an oral medication 1
DON’T WAIT—PATIENTS CAN START TODAY WITH A 5-DAY TITRATION PERIOD AND NO INITIAL OR ROUTINE LAB MONITORING1
After an initial 5-day titration period, the maintenance dosage of Otezla is 30 mg twice daily 1
Titration of Otezla is intended to reduce the gastrointestinal symptoms associated with initiation of therapy 1
Otezla can be administered without regard to meals 1
Patients should not crush, split, or chew the tablet 1
The dose of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment 1,*
For initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above and the PM doses be skipped 1
From day 6 on, the dose of Otezla is 30 mg once daily 1
With twice-daily dosing, Otezla can be taken once in the morning and once in the evening, as part of your patients’ daily routine 1
*Creatinine clearance (CLcr) <30 mL/min estimated by the Cockcroft-Gault equation.
THE MAJORITY OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS REPORTING NAUSEA AND DIARRHEA DID SO WITHIN THE FIRST 2 WEEKS; THE EVENTS TENDED TO RESOLVE OVER TIME WITH CONTINUED DOSING 2-4
Diarrhea and nausea are among the most common adverse reactions in plaque psoriasis patients taking Otezla. The overall rates of nausea at week 16 were 7% in placebo and 17% in patients with moderate to severe plaque psoriasis taking Otezla 30 mg BID. The overall rates of diarrhea at week 16 were 6% in placebo and 17% in patients with moderate to severe plaque psoriasis taking Otezla 30 mg BID 1
†Patients who experienced diarrhea or nausea during multiple time intervals were counted at the period that it was reported. 2
START YOUR NEXT APPROPRIATE PATIENT ON OTEZLA TODAY WITH A SAMPLE TITRATION PACK FROM YOUR OFFICE
Start your appropriate patients on Otezla right away
Provide the 14-day Starter Pack to patients before they leave the office or prescribe the 28-day Starter Pack through their specialty pharmacy of choice.
While you are giving your patient the starter pack, setting expectations and discussing compliance may help improve your patient’s outcome 5
Side effects can happen with a new treatment—let your patients know what to expect 1,5
Encourage an open dialogue: Patients should not stop or alter their treatment routine without first consulting their healthcare provider 5,6
The Otezla clinical trials demonstrated efficacy at week 16 and over time 2,4
Remind your patients that even if their symptoms are improving, that does not mean their condition is cured. Psoriatic disease is chronic, and they should continue to take Otezla as prescribed 5,7
Preparing patients with the right information can help with patient adherence and alleviate some challenges you face as their healthcare provider 5
IN PATIENTS WITH ALL SEVERITIES OF PLAQUE PSORIASIS AND ACTIVE PSORIATIC ARTHRITIS, OTEZLA IS THE ONLY ORAL THERAPY THAT PATIENTS CAN START TODAY WITH NO INITIAL OR ONGOING LAB MONITORING
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
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.
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. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 4. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 5. Yélamos O, Ros S, Puig L. Psoriasis (Auckl). 2015;5:109-115. 6. Hugtenburg JG, Timmers L, Elders PJM, et al. Patient Prefer Adherence. 2013;7:675-682. 7. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. psoriasis.org/the-pocket-guide. Accessed December 8, 2022.