3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

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

Explore the Otezla video library

Dermatology

Otezla Is the Only Oral Therapy with Scalp Data in Its Label2

Learn from Dr. Cather about the STYLE data in patients with moderate to severe plaque psoriasis of the scalp.

Mechanism of Action in Plaque Psoriasis

See how Otezla may work in moderate to severe plaque psoriasis. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.1

Rheumatology

Otezla Is the First & Only FDA-Approved Therapy for Adult Patients with Oral Ulcers Associated with Behçet's Disease3

Learn about the RELIEF clinical trial data.

Mechanism of Action in Psoriatic Arthritis

See how Otezla may work in psoriatic arthritis. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.1

Otezla Is an Oral Treatment Option for Use in Psoriatic Arthritis Patients1

Learn about the PALACE 4 clinical trial data in DMARD-naïve patients.1

Video transcripts

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Mechanism of Action in Psoriatic Arthritis

Otezla Is an Oral Treatment Option for Use in Psoriatic Arthritis Patients1

Otezla, apremilast, is an oral treatment option for first-line systemic use in patients with psoriatic arthritis.1 Please see Important Safety Information within this video and full Prescribing Information on OtezlaPro.com. Otezla is a phosphodiesterase-4 inhibitor indicated for the treatment of adult patients with active psoriatic arthritis.1 And it is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.1 Before we explore the clinical trials for Otezla in patients with psoriatic arthritis,3 let’s look at some important safety information. Cases of severe diarrhea, nausea, and vomiting have been reported with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized.1 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.1 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.1 Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts or behavior, or in patients who develop such symptoms while on Otezla.1 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.1 Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% of patients treated with Otezla reported depression or depressed mood compared to 0.8% treated with placebo. Suicidal ideation and behavior was observed in 0.2% of patients on Otezla, compared to none in placebo-treated patients. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla.1 Body weight loss of 5 to 10% was reported in 10% of patients taking Otezla and in 3.3% of patients taking placebo.1 Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur.1 Concomitant use of Otezla with CYP450 enzyme inducers—such as, rifampin, phenobarbital, carbamazepine, phenytoin—is not recommended.1 Otezla was evaluated in one of the largest global clinical development programs ever conducted in psoriatic arthritis.3 The approval of Otezla was based on the results of 3 multicenter, randomized, placebo-controlled Phase 3 studies: PALACE 1, 2, and 3.1 The efficacy and safety of Otezla were examined in disease-modifying antirheumatic drug, or DMARD, and/or biologic-naïve patients in the PALACE 4 study.2 Let’s focus our attention on PALACE 4 and Otezla in DMARD- and/or biologic-naïve patients.2 All 4 PALACE studies enrolled patients of 18 or more years of age with active psoriatic arthritis, defined as having at least 3 swollen joints and at least 3 tender joints.2,4-6 Patients in PALACE 1, 2, and 3 had active psoriatic arthritis, despite prior or current DMARD therapy.4-6 Only DMARD-naïve patients were allowed in PALACE 4 and the only concomitant therapies allowed were NSAIDs and corticosteroids.2 All 4 studies had a similar design. During the placebo-controlled phase, patients were randomized to receive Otezla 20 mg or 30 mg twice daily or placebo.1,2 The primary endpoint was the percentage of patients achieving an ACR20 response at week 16.1,2 All patients in the placebo group whose tender or swollen joint counts had not improved by at least 20% at week 16 were re-randomized to one of the Otezla treatment groups.1,2 At week 24, patients entered the blinded active-treatment phase, and all remaining placebo patients were re-randomized to active treatment with Otezla.1,2 After 1 year, patients could continue in the long-term open-label extension of the trial. Despite being DMARD-naïve, PALACE 4 patients had considerable disease activity at baseline; the mean duration of disease at baseline was 3.4 years, and the mean disease activity score in 28 joints using C-reactive protein—or DAS28-CRP—was 4.6.2,3 In PALACE 1-3, the mean age was 50 years, the mean duration of psoriatic arthritis at baseline was 7.4 years, and the mean DAS28-CRP was 4.7.3 Significantly more patients on Otezla 30 mg twice daily met the primary endpoint of ACR20 response at week 16 than patients on placebo in all 4 PALACE studies. In PALACE 4, 31% of DMARD-naïve patients on Otezla achieved an ACR20 response at week 16 compared with 16% of patients on placebo.1-6 ACR20 response was captured through 5 years.3 In PALACE 4, the proportion of patients achieving an ACR20 response was 66% at 5 years.3 Consider open-label extension study limitations when interpreting results. The open-label extension is not blinded, not controlled, and includes inherent self-selection bias.3 Of importance to patients with psoriatic arthritis, Otezla has 5-year data on the following manifestations and symptoms. Let’s dive deeper into these data.2 Joint tenderness and swelling are 2 of the main symptoms of psoriatic arthritis.7 At 5 years, the mean percent reduction in tender joint count, or TJC, was -76%3 and the mean percent reduction in swollen joint count, or SJC, was -85%.3 Dactylitis and enthesitis are also distinguishing features of psoriatic arthritis.8 Based on a review of 157 publications on dactylitis and enthesitis in patients with psoriatic arthritis, dactylitis occurs in up to 53% of patients and enthesitis occurs in up to 78% of patients with psoriatic arthritis.9 Of the patients in PALACE 4 with preexisting dactylitis, the percentage of patients whose dactylitis resolved was 39% at week 16 and 95% at 5 years.3 In PALACE 4, of the DMARD-naïve patients with preexisting enthesitis, the percentage of patients who achieved resolution of enthesitis was 35% at week 16 and 71% at 5 years.3 Let’s turn our attention to the safety profile of Otezla. In PALACE 1 to 3, adverse reactions that were reported in at least 2% of patients taking Otezla, that occurred at a frequency of at least 1% higher than that observed in patients taking placebo, for up to 16 weeks after the initial 5-day titration, were: diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, and upper abdominal pain.1 Let’s turn our attention to the safety profile of Otezla. In PALACE 1 to 3, adverse reactions that were reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks after the initial 5-day titration, were: diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, and upper abdominal pain.1 The most common adverse reactions with Otezla were diarrhea, nausea, and headache.3 The majority of diarrhea and nausea generally occurred within the first 2 weeks of treatment and tended to resolve within 4 weeks with continued dosing.2 There have been reports of severe cases of diarrhea, nausea, and vomiting associated with the use of Otezla. In some cases patients were hospitalized. Be sure to monitor patients who are more susceptible to complications of diarrhea or vomiting.1 Overall through week 24, 3.4% of patients taking Otezla discontinued treatment because of any adverse reaction compared with 2.3% of placebo-treated patients.2 The long-term safety profile of Otezla was consistent through 5 years of exposure in the PALACE 4 clinical trial study of DMARD-naïve patients with active psoriatic arthritis.3 When prescribing Otezla, it’s also important to note that Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss and consider pregnancy planning and prevention for females of reproductive potential. Note, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling the phone number or visiting the website listed here. Additionally, there are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition.1 Otezla dosage should be reduced to 30 mg once daily in patients with severe renal impairment, defined by a creatinine clearance (CrCl) of less than 30 mL per minute estimated by the Cockcroft-Gault equation. For initial dosage titration in this group, it is recommended that Otezla be titrated using only the AM schedule and the PM doses be skipped.1 Otezla is an oral treatment for adults with active psoriatic arthritis. It has the first and largest study in DMARD-naïve psoriatic arthritis patients and may be used as a first-line systemic treatment option. Furthermore, it has 5 years of efficacy and safety data available.1,3 For more information about Otezla and its other indications, including the efficacy and safety profile, please refer to the full Prescribing Information on OtezlaPro.com.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc. 2. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57:1253-1263. 3. Data on file, Amgen Inc. 4. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Ann Rheum Dis. 2014;73:1020-1026. 5. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43:1724-1734. 6. Edwards CJ, Blanco FJ, Crowley J, et al. Ann Rheum Dis. 2016;75:1065-1073. 7. Gottlieb A, Korman NJ, Gordon KB, et al. J Am Acad Dermatol. 2008;58:851-864. 8. Mease PJ, Armstrong AW. Drugs. 2014;74:423-441. 9. Sakkas LI, Alexiou I, Simopoulou T, et al. Semin Arthritis Rheum. 2013;43:325-334.

Otezla Is the First and Only FDA-Approved Therapy for Adult Patients with Oral Ulcers Associated with Behçet’s Disease3

Otezla, apremilast, is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. Please see Important Safety Information within this video and full Prescribing Information on OtezlaPro.com. Behçet’s Disease is a rare, chronic, and variable vasculitis that causes inflammation of the arteries and veins across multiple organ systems.1-3 Hallmark characteristics of Behçet’s Disease include aphthous ulcers, commonly occurring in the oral mucosa.1 The clinical manifestations of Behçet’s Disease are heterogeneous and can vary from patient to patient.4 Despite these differences, the majority of patients with Behçet’s Disease frequently experience recurrent oral ulcers as their first manifestation. These can be bothersome and painful.4-8 Other clinical manifestations of Behçet’s Disease include, in decreasing prevalence, genital ulcers, skin lesions, ocular involvement, joint involvement, vascular involvement, neurological involvement, and gastrointestinal involvement.5,8,9 Understanding the many manifestations of Behçet’s Disease can help with diagnosis. The International Study Group or ISG criteria can be used to diagnose Behçet’s Disease by the presence of recurrent oral ulceration plus at least 2 of the following: recurrent genital ulceration, eye lesions, skin lesions, or a positive result on pathergy testing. Otezla is the first and only therapy approved for adult patients with oral ulcers associated with Behçet’s Disease. Otezla is a phosphodiesterase 4 inhibitor indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. It is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. Cases of severe diarrhea, nausea, and vomiting have been reported 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. 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. Treatment with Otezla may be associated with an increase in depression. During the RELIEF trial, 1% of patients treated with Otezla reported depression or depressed mood compared with 1% of patients treated with placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. Patients treated with Otezla may experience weight loss. Body weight loss of >5% was reported in 4.9% of patients treated with Otezla and in 3.9% of patients treated with placebo. 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. Otezla was evaluated in 207 adult patients with active oral ulcers associated with Behçet’s Disease in the Phase 3, multicenter, randomized, placebo-controlled RELIEF study. All patients in the study met the ISG criteria for Behçet’s Disease, had 1 or more prior treatments with non-biologic therapy, had at least 2 oral ulcers at screening and randomization, had at least 3 occurrences of oral ulcers within 12 months prior to randomization, and were candidates for systemic therapy.10,11 Patients were excluded if they had active major organ involvement or prior biologic therapy for oral ulcers associated with Behçet’s Disease.10,11 In this study, patients were randomized 1:1 to receive either Otezla 30 mg twice daily or placebo for the first 12 weeks of the placebo-controlled treatment phase.10 After week 12, all patients received Otezla 30 mg twice daily up to 64 weeks during the active treatment phase.11 Of note, the mean age of patients included in the RELIEF study was 40 years, with a mean duration of Behçet’s Disease of 6.8 years. The mean baseline oral ulcer count was 4.2 for the Otezla arm and 3.9 for the placebo arm. The measures of oral ulcers observed at week 12 included the following: change from baseline in the pain of oral ulcers as measured by visual analog scale scores at week 12; proportion of patients achieving oral ulcer complete response, meaning oral ulcer–free, at week 12; proportion of patients achieving oral ulcer complete response by week 6, and who remained oral ulcer–free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase; and daily average number of oral ulcers during the 12-week placebo-controlled treatment phase. Let’s first look at the effect of Otezla on oral ulcer pain. The change from baseline in oral ulcer pain, as measured by VAS scores, was statistically greater in patients treated with Otezla vs placebo, with a treatment difference of -24.1. Now let’s look at the effect on oral ulcer complete response, characterized by the patients who were oral ulcer–free at week 12. There was a significantly greater proportion of patients achieving oral ulcer complete response at week 12 when treated with Otezla vs placebo, with a treatment difference of 31%. Next, let’s look at maintenance of oral ulcer complete response. 30% of patients taking Otezla who achieved oral ulcer complete response by week 6 remained oral ulcer–free for at least 6 additional weeks during the 12-week phase compared with 5% of patients treated with placebo, which accounts for a significant treatment difference of 25%. Lastly, let’s look at the effect of Otezla on the number of oral ulcers over 12 weeks. Patients taking Otezla experienced a significantly lower daily average number of oral ulcers compared with patients taking placebo. Let’s turn our attention to the safety profile for Otezla. Adverse reactions reported in at least 5% of patients taking Otezla, occurring at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, included: diarrhea, nausea, headache, upper respiratory tract infection, upper abdominal pain, vomiting, back pain, viral upper respiratory tract infection, and arthralgia. Adverse reactions reported in at least 5% of patients taking Otezla, occurring at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, included: diarrhea, nausea, headache, upper respiratory tract infection, upper abdominal pain, vomiting, back pain, viral upper respiratory tract infection, and arthralgia. The majority of patients reporting diarrhea, nausea, and vomiting did so within the first week of treatment, and the events tended to resolve over time.11 Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. It is important to monitor patients who are more susceptible to complications of diarrhea or vomiting.10 During the placebo-controlled period of the study, 2.9% of patients taking Otezla and 4.9% of those taking placebo discontinued treatment due to adverse reactions.10 When prescribing Otezla, it’s also important to note that Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss and consider pregnancy planning and prevention for females of reproductive potential. Note, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling the phone number or visiting the website listed here. Additionally, there are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition. And finally, the dose of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment, as defined by a creatinine clearance of less than 30 mL per minute. Otezla is the first and only approved therapy indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. For more information about Otezla and its other indications, including the efficacy and safety profile, please refer to the full Prescribing Information on OtezlaPro.com.

References: 1. Leonardo NM, McNeil J. Int J Rheumatol. 2015;2015:945262. 2. Zeidan MJ, Saadoun D, Garrido M, et al. Auto Immun Highlights. 2016;7. 3. Koné-Paut I. Pediatr Rheumatol Online J. 2016;14:10. 4. Kokturk A. Patholog Res Int. 2012;2012:690390. 5. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5):901-906. 6. Alpsoy E. J Dermatol. 2016;43(6):620-632. 7. Melikoğlu M, Melikoğlu MA. Acta Reumatol Port. 2014;39(1):46-53. 8. Barnes CG. History and diagnosis. In: Behçet’s Syndrome. 2010. 9. Verity DH, Wallace GR, Vaughan RW, et al. Br J Ophthalmol. 2003;87(9):1175-1183. 10. Otezla [package insert]. Thousand Oaks, CA: Amgen, Inc. 11. Data on file, Amgen Inc.

Multidisciplinary Care

A Real-World Perspective on Joint Care in Dermatology & Rheumatology

Dr. Glick (Dermatologist) and Dr. Sulich (Rheumatologist) discuss case-based insights to recognize and manage psoriatic disease and review data for Otezla, the only oral therapy indicated for moderate to severe plaque psoriasis as well as psoriatic arthritis

Getting Your Patients Started on Otezla

Otezla Prescription Roadmap

Learn how to get started prescribing Otezla for your patients.

Video transcript

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Otezla Prescription Roadmap

Hi, I’m Angelo, a reimbursement specialist who has processed thousands of claims for Otezla. Today, we’ll review the journey of getting your patients started on Otezla. When you and your patient have agreed that Otezla is the right medication, you can send them home with a 2-week Starter Pack while you begin the paperwork for the prescription. It’s also important to let them know that their specialty pharmacy will call to confirm their contact and insurance information. Explain that the call may be from an unfamiliar number, but it is important to answer in order to avoid any processing delays. The first form to complete is the Otezla START Form. As there are 2 versions of this form, the Otezla version and the Specialty Pharmacy version, be sure to check which one your office uses. The Otezla START Form can be downloaded at OtezlaPro.com or obtained from your local field resource manager or representative or from Otezla SupportPlus. Make sure to complete sections 3 through 5 of the START Form. Sections 3 and 4 will cover the relevant clinical and prescribing information, while section 5 includes your signature and NPI number. Each START Form is accompanied by a HIPAA authorization to share health information. This authorization allows your office to share patient medical information related to their condition, treatment, and insurance coverage to help ensure access to Otezla. Once you have completed the START Form, submit it to a specialty pharmacy or the Otezla support program, Otezla SupportPlus. A list of specialty pharmacies with experience handling Otezla prescriptions is available on OtezlaPro.com. You can send the prescription to one of these specialty pharmacies or to a pharmacy of your choice that is not listed here. Getting access to Otezla is a team effort. Your office, the specialty pharmacy, and the health plan all share a common goal of ensuring that appropriate patients receive Otezla for optimal outcomes. This teamwork is especially important for the next part of the prescribing journey, which is requesting and processing prior authorizations. After you have submitted the START Form, the specialty pharmacy or Otezla SupportPlus will conduct a benefits investigation to determine if a prior authorization is needed. If so, your office should obtain and complete the appropriate prior authorization request form for the health plan you are submitting to. The specialty pharmacy may be able to initiate this process but will likely need more information from your office to do so. Submit the prior authorization form by phone, fax, email, or dedicated web portal for the health plan, depending on which method the health plan requires. Make sure you have confirmed all the documentation requirements and have collected the necessary materials. Be sure to include the health plan’s contact information and submission requirements on the Insurance Carrier Contact Sheet when submitting the request. It is important to keep copies of all these documents and note the date the prior authorization request was made, just in case you need to reference these documents in the future. Once you have completed and submitted your prior authorization request, monitor the progress of your request in order to avoid delays in obtaining Otezla access. You should also keep thorough documentation of previous submissions and denials for all your patients. Health plans will often require additional documentation during the prior authorization process, like diagnosis codes or treatment response evidence. If necessary, submit this information in a timely manner. If the prior authorization request is denied you can complete and submit a letter of medical necessity along with any other required documentation to the insurer, Otezla SupportPlus, or the specialty pharmacy. This can be submitted even if Otezla is not on your patient’s formulary. To obtain a letter of medical necessity, you can visit OtezlaPro.com or call Otezla SupportPlus or your local field reimbursement manager. If you have communicated with a specific individual from the health plan, make sure to keep their contact information in the event you need to reach them quickly. While the authorization paperwork is in progress commercially insured patients may be eligible to receive Otezla for no cost through the Otezla Bridge Program. When completing the START Form, be sure to check the “Bridge Rx” option in Section 4. It’s important to let your patients know that the Bridge packs are not the same as receiving coverage for their prescription. Your office must continually work on the authorization and appeal for your patient to continue to receive the Bridge. Once the request for Otezla is approved, the medication is delivered straight to your patient’s door. There are a number of ways throughout the journey to help your patients gain access to Otezla, including the 2-week Starter Pack and Bridge Program we’ve already discussed. The Otezla SupportPlus program is available to help both your office and your patients throughout the entire prescribing process. The program can help with the prior authorization and appeals process, and provide financial assistance, educational information, and trained nurse support.

Otezla SupportPlus also provides financial support for eligible non-commercially insured patients, such as your Medicare and Medicaid patients through the Patient Assistance Program. The application can be downloaded or emailed to you from the resources tab on OtezlaPro.com. Your local field reimbursement manager or sales representatives can also help direct you to any Otezla SupportPlus resources you may need to navigate the access process. Once the maintenance medication is received, eligible commercially insured patients may be able to receive Otezla for free. To be eligible for a $0 co-pay, a patient must be commercially insured, a US resident, and over 18 years of age. Enrollment is for 1 calendar year with automatic re-enrollment at the end of each year. Patients will receive a $0 co-pay card with a unique ID number that must be activated by the patient, by calling Otezla SupportPlus or by visiting the Otezla website. This ID number must be provided to the specialty pharmacy in order to receive benefits. Otezla can also be prescribed via telemedicine. For these prescriptions, signatures on the START Form are not required and a 4-week Starter Pack will be mailed directly to your patient. The Bridge Program is also available for certain eligible patients. For more help with prescribing Otezla via telemedicine, a Telemedicine Prescribing Guide is available on OtezlaPro.com. Thank you for taking the time to review the Otezla prescribing journey with me today. Click any of these buttons to learn more about Otezla.

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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

  • 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
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 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
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients 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

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients 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.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. FDA Approves Otezla® (apremilast) for the treatment of oral ulcers associated with Behcet's Disease. BusinessWire. July 19, 2019. Accessed February 16, 2021.