Otezla
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Otezla Prescribing Information
Indications and Usage (OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with:
Pediatric patients 6 years of age and older with:
In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 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 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/OTEZLA XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. | 08/2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and Administration (To reduce the risk of gastrointestinal symptoms, titrate to recommended dosage as follows:
Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease The recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.
Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque Psoriasis The recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is:
The initial titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.
Patients treated with OTEZLA 30 mg twice daily may be switched to OTEZLA XR 75 mg once daily the day following the last dose of OTEZLA 30 mg. Patients treated with OTEZLA XR 75 mg once daily may be switched to OTEZLA 30 mg twice daily the day following the last dose of OTEZLA XR 75 mg. Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease For initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)] .OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)] .Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis For initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)] .
| 08/2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of:
Adult patients with:
- Active psoriatic arthritis ()
1.1 Psoriatic ArthritisOTEZLA 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. - Plaque psoriasis who are candidates for phototherapy or systemic therapy ()
1.2 Plaque PsoriasisOTEZLA/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. - Oral ulcers associated with Behçet's Disease ()
1.3 Oral Ulcers Associated with Behçet's DiseaseOTEZLA/OTEZLA XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Pediatric patients 6 years of age and older with:
- Active psoriatic arthritis ()
1.1 Psoriatic ArthritisOTEZLA 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. - Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy ()
1.2 Plaque PsoriasisOTEZLA/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.
In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg.
To reduce the risk of gastrointestinal symptoms, titrate to recommended dosage as follows:
- Adults with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease
- See for the initial titration schedule. Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily (
Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage TitrationOTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD)2.1 Recommended Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's DiseaseAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseThe recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage TitrationOTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QDPediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque PsoriasisThe recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally
- For pediatric patients who weigh from 20 kg to less than 50 kg:OTEZLA 20 mg twice daily taken orally
The initial titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 2. Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR
Maintenance DosageBody Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg OTEZLA 20 mg BID
- See
- Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis
- See for the initial titration schedule (
Table 2. Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR
Maintenance DosageBody Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg OTEZLA 20 mg BID )2.1 Recommended Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's DiseaseAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseThe recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage TitrationOTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QDPediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque PsoriasisThe recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally
- For pediatric patients who weigh from 20 kg to less than 50 kg:OTEZLA 20 mg twice daily taken orally
The initial titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 2. Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR
Maintenance DosageBody Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg OTEZLA 20 mg BID - For patients weighing 50 kg or more: Recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily ()
2.1 Recommended Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's DiseaseAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseThe recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage TitrationOTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QDPediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque PsoriasisThe recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally
- For pediatric patients who weigh from 20 kg to less than 50 kg:OTEZLA 20 mg twice daily taken orally
The initial titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 2. Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR
Maintenance DosageBody Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg OTEZLA 20 mg BID - For patients weighing 20 kg to less than 50 kg: Recommended maintenance dosage is OTEZLA 20 mg twice daily ()
2.1 Recommended Dosage in Adult and Pediatric Patients with Psoriatic Arthritis, Plaque Psoriasis, and Behçet's DiseaseAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseThe recommended initial dosage titration from Day 1 to Day 5 is shown in Table 1. Following the 5-day titration with OTEZLA, the recommended maintenance dosage is OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally starting on Day 6. This titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 1. Dosage Titration Schedule for Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease OTEZLA Dosage TitrationOTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR Maintenance Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QDPediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis Moderate to Severe Plaque PsoriasisThe recommended dosage for pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis is based on body weight. Following the appropriate initial titration schedule shown in Table 2, the recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg twice daily or OTEZLA XR 75 mg once daily taken orally
- For pediatric patients who weigh from 20 kg to less than 50 kg:OTEZLA 20 mg twice daily taken orally
The initial titration is intended to reduce the gastrointestinal symptoms associated with initial therapy.Table 2. Dosage Titration Schedule for Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis OTEZLA Dosage Titration OTEZLA tablets should be used for the initial titration regardless of whether OTEZLA or OTEZLA XR will be used for the maintenance dosage.OTEZLA/OTEZLA XR
Maintenance DosageBody Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM BID = twice daily; QD = once daily50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg OTEZLA 30 mg BID OR
OTEZLA XR 75 mg QD20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg OTEZLA 20 mg BID
- See
- Dosage in Patients with Severe Renal Impairment:
- Adult Patients: For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses. Recommended maintenance dosage is OTEZLA 30 mg once daily ()
2.3 Dosage Adjustment in Adult and Pediatric Patients with Severe Renal ImpairmentAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseFor initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque PsoriasisFor initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg once daily taken orally
- For pediatric patients who weigh 20 kg to less than 50 kg:OTEZLA 20 mg once daily taken orally
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]. - Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis: For initial dosage titration, titrate using only morning schedule for appropriate body weight category in Table 2 and skip afternoon doses ()
2.3 Dosage Adjustment in Adult and Pediatric Patients with Severe Renal ImpairmentAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseFor initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque PsoriasisFor initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg once daily taken orally
- For pediatric patients who weigh 20 kg to less than 50 kg:OTEZLA 20 mg once daily taken orally
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].- For patients weighing 50 kg or more: Recommended maintenance dosage is OTEZLA 30 mg once daily ()
2.3 Dosage Adjustment in Adult and Pediatric Patients with Severe Renal ImpairmentAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseFor initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque PsoriasisFor initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg once daily taken orally
- For pediatric patients who weigh 20 kg to less than 50 kg:OTEZLA 20 mg once daily taken orally
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]. - For patients weighing 20 kg to less than 50 kg: Recommended maintenance dosage is OTEZLA 20 mg once daily ()
2.3 Dosage Adjustment in Adult and Pediatric Patients with Severe Renal ImpairmentAdult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's DiseaseFor initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque PsoriasisFor initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg once daily taken orally
- For pediatric patients who weigh 20 kg to less than 50 kg:OTEZLA 20 mg once daily taken orally
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].
OTEZLA is available as diamond shaped, film-coated tablets in the following dosage strengths:
- 10-mg pink tablet engraved with "APR" on one side and "10" on the other side
- 20-mg brown tablet engraved with "APR" on one side and "20" on the other side
- 30-mg beige tablet engraved with "APR" on one side and "30" on the other side
OTEZLA XR is available as 75 mg round, biconvex, pink, film-coated extended-release tablets with "APR 75" printed in black on one side and a hole or indentation on either side of the tablet, which may or may not be visible.
Severe Renal Impairment
: Increased systemic exposure of OTEZLA has been observed. For adults and for pediatric patients weighing 50 kg or more, reduce dosage to OTEZLA 30 mg once daily. For pediatric patients weighing 20 kg to less than 50 kg, reduce dosage to OTEZLA 20 mg once daily (Adult Patients with Psoriatic Arthritis, Plaque Psoriasis, or Behçet's Disease
For initial dosage titration in adult patients with severe renal impairment (creatinine clearance [CLcr] of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 1 and skip the PM doses. The recommended maintenance dosage in this group is OTEZLA 30 mg once daily
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
.OTEZLA XR is not recommended for adult patients with severe renal impairment; the appropriate dosage for these patients has not been determined
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
.Pediatric Patients 6 Years of Age and Older and Weighing at Least 20 kg with Psoriatic Arthritis or Moderate to Severe Plaque Psoriasis
For initial dosage titration in pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment (CLcr of less than 30 mL per minute estimated by the Cockcroft–Gault equation), titrate OTEZLA using only the AM schedule listed in Table 2 for the appropriate body weight category and skip the PM doses. The recommended maintenance dosage is:
- For pediatric patients who weigh at least 50 kg:OTEZLA 30 mg once daily taken orally
- For pediatric patients who weigh 20 kg to less than 50 kg:OTEZLA 20 mg once daily taken orally
OTEZLA XR is not recommended for pediatric patients with severe renal impairment; the appropriate dosage for these patients has not been determined
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]
.OTEZLA pharmacokinetics were characterized in adult subjects with mild, moderate, and severe renal impairment as defined by a creatinine clearance of 60-89, 30-59, and less than 30 mL per minute, respectively, by the Cockcroft–Gault equation. No dosage adjustment is needed in patients with mild or moderate renal impairment. In adult patients with severe renal impairment, reduce the maintenance dosage to OTEZLA 30 mg once daily. In pediatric patients 6 years of age and older and weighing at least 20 kg with psoriatic arthritis or moderate to severe plaque psoriasis and severe renal impairment, reduce the maintenance dosage to OTEZLA 30 mg once daily for pediatric patients weighing at least 50 kg and to OTEZLA 20 mg once daily for pediatric patients weighing 20 kg to less than 50 kg
[see Dosage and Administration (2.3)and Clinical Pharmacology (12.3)]
.The pharmacokinetics of OTEZLA XR has not been evaluated in patients with renal impairment. In patients with severe renal impairment, it is recommended that OTEZLA be used instead of OTEZLA XR
[see Dosage and Administration (2.3)and Clinical Pharmacology (12.3)]
.OTEZLA/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
[see , see
]
.Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Psoriatic Arthritis Clinical Trials
OTEZLA was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3) of similar design in adult subjects with active psoriatic arthritis
[see Clinical Studies (14.1)]
. Across the three trials, there were 1493 subjects randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days[see Dosage and Administration (2.1)]
. Placebo subjects whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA subjects remained on their initial treatment. Subjects ranged in age from 18 to 83 years, with an overall median age of 51 years.The majority of the most common adverse reactions presented in Table 3 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of subjects with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for subjects taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated subjects.
| Placebo | OTEZLA 30 mg BIDBID = twice daily. | |||
|---|---|---|---|---|
| Adverse Reactions | Day 1 to 5 (N = 495) n (%)n (%) indicates number of subjects and percent. | Day 6 to Day 112 (N = 490) n (%) | Day 1 to 5 (N = 497) n (%) | Day 6 to Day 112 (N = 493) n (%) |
| DiarrheaOf the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in OTEZLA 30 mg twice daily; 1 subject treated with OTEZLA 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 subject treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction of headache. | 6 (1.2) | 8 (1.6) | 46 (9.3) | 38 (7.7) |
| Nausea | 7 (1.4) | 15 (3.1) | 37 (7.4) | 44 (8.9) |
| Headache | 9 (1.8) | 11 (2.2) | 24 (4.8) | 29 (5.9) |
| Upper respiratory tract infectionOf the reported adverse drug reactions none were serious. | 3 (0.6) | 9 (1.8) | 3 (0.6) | 19 (3.9) |
| Vomiting | 2 (0.4) | 2 (0.4) | 4 (0.8) | 16 (3.2) |
| Nasopharyngitis | 1 (0.2) | 8 (1.6) | 1 (0.2) | 13 (2.6) |
| Abdominal pain upper | 0 (0.0) | 1 (0.2) | 3 (0.6) | 10 (2.0) |
Moderate to Severe Plaque Psoriasis Clinical Trials
Adverse Reactions from Clinical Trials in Adults
The safety of OTEZLA was assessed in 1426 subjects in three randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days
[see Dosage and Administration (2.1)]
. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions (see Table 4). The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with plaque psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects.
| Adverse Reactions | Placebo (N = 506) n (%) | OTEZLA 30 mg BIDBID = twice daily.(N = 920) n (%) |
|---|---|---|
| Diarrhea | 32 (6) | 160 (17) |
| Nausea | 35 (7) | 155 (17) |
| Upper respiratory tract infection | 31 (6) | 84 (9) |
| Tension headache | 21 (4) | 75 (8) |
| Headache | 19 (4) | 55 (6) |
| Abdominal painTwo subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain. | 11 (2) | 39 (4) |
| Vomiting | 8 (2) | 35 (4) |
| Fatigue | 9 (2) | 29 (3) |
| Dyspepsia | 6 (1) | 29 (3) |
| Decreased appetite | 5 (1) | 26 (3) |
| Insomnia | 4 (1) | 21 (2) |
| Back pain | 4 (1) | 20 (2) |
| Migraine | 5 (1) | 19 (2) |
| Frequent bowel movements | 1 (0) | 17 (2) |
| Depression | 2 (0) | 12 (1) |
| Bronchitis | 2 (0) | 12 (1) |
| Tooth abscess | 0 (0) | 10 (1) |
| Folliculitis | 0 (0) | 9 (1) |
| Sinus headache | 0 (0) | 9 (1) |
Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA.
OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-3) in adults with moderate to severe plaque psoriasis of the scalp
[see Clinical Studies (14.2)]
. A total of 302 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. The most commonly reported adverse reactions that occurred at a higher rate in the OTEZLA group than in the placebo group were: diarrhea (31% vs. 11%), nausea (22% vs. 6%), headache (12% vs. 5%), and vomiting (6% vs. 2%). The proportion of subjects who discontinued treatment because of any adverse reaction during the 16-week placebo-controlled period of the trial was 6% for subjects who received OTEZLA 30 mg twice daily and 3% for subjects who received placebo. Gastrointestinal adverse reactions that led to discontinuation of treatment were diarrhea (3% vs. 0%), nausea (1.5% vs. 1%), and vomiting (1.5% vs. 0%) in the OTEZLA group compared to placebo.OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-5) in adults with moderate to severe plaque psoriasis of the genital area
[see Clinical Studies (14.2)]
. A total of 289 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Overall, the safety profile observed in the OTEZLA group during the placebo-controlled phase was consistent with the safety profile previously established in adult subjects with moderate to severe plaque psoriasis.Adverse Reactions from Clinical Trials in Pediatric Subjects 6 to 17 Years of Age
OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-6) in pediatric subjects 6 to 17 years of age with moderate to severe plaque psoriasis
[see Clinical Studies (14.3)]
. A total of 245 subjects were randomized to receive OTEZLA (163 subjects, at a dosage of 20 mg twice daily or 30 mg twice daily, based on body weight) or placebo (82 subjects) twice daily during the 16-week placebo-controlled phase of the trial. The trial also included a 36-week extension phase during which all subjects received OTEZLA 20 mg or 30 mg twice daily. Overall, the safety profile observed in pediatric subjects treated with OTEZLA during the study was consistent with the safety profile established in adult subjects with moderate to severe plaque psoriasis.Mild to Moderate Plaque Psoriasis Clinical Trial in Adults
OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (PSOR-4) in adult subjects with mild to moderate plaque psoriasis
[see Clinical Studies (14.4)]
. A total of 595 subjects were randomized to receive OTEZLA 30 mg twice daily (297 subjects) or placebo twice daily (298 subjects) during the placebo-controlled phase of the trial. The trial also included an open label extension phase during which all subjects received OTEZLA 30 mg twice daily. Overall, the safety profile observed in the OTEZLA group during the placebo-controlled phase was consistent with the safety profile previously established in adult subjects with moderate to severe plaque psoriasis.Behçet's Disease Clinical Trials
OTEZLA was evaluated in a Phase 3, multicenter, randomized, placebo-controlled trial (BCT-002) in adult subjects with Behçet's Disease (BD) with active oral ulcers
[see Clinical Studies (14.5)]
. A total of 207 subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days[see Dosage and Administration (2.1)]
. After Week 12, all subjects received treatment with OTEZLA 30 mg twice daily. Subjects ranged in age from 19 to 72, with a mean age of 40 years.Diarrhea, nausea, headache, and upper respiratory tract infection were the most commonly reported adverse reactions (see Table 5). The proportion of subjects with BD who discontinued treatment due to any adverse reaction during the placebo-controlled period of the trial, was 2.9% for subjects treated with OTEZLA 30 mg twice daily and 4.9% for placebo-treated subjects.
| Adverse Reactions | Placebo (N = 103) n (%) | OTEZLA 30 mg twice daily (N = 104) n (%) |
|---|---|---|
| DiarrheaThere were no serious adverse reactions of diarrhea, nausea or vomiting. | 21 (20.4) | 43 (41.3) |
| Nausea | 11 (10.7) | 20 (19.2) |
| Headache | 11 (10.7) | 15 (14.4) |
| Upper respiratory tract infection | 5 (4.9) | 12 (11.5) |
| Abdominal pain upper | 2 (1.9) | 9 (8.7) |
| Vomiting | 2 (1.9) | 9 (8.7) |
| Back pain | 6 (5.8) | 8 (7.7) |
| Viral upper respiratory tract infection | 5 (4.9) | 7 (6.7) |
| Arthralgia | 3 (2.9) | 6 (5.8) |
Other adverse reactions reported in subjects on OTEZLA in psoriatic arthritis, plaque psoriasis, and Behçet's Disease clinical trials are
:- Gastrointestinal Disorders: Gastroesophageal reflux disease
- Immune System Disorders: Hypersensitivity
- Investigations: Weight decrease
- Metabolism and Nutrition Disorders: Decreased appetite1 subject treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction.
- Nervous System Disorders: Migraine
- Respiratory, Thoracic, and Mediastinal Disorders: Cough
- Skin and Subcutaneous Tissue Disorders: Rash
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