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Psoriatic Arthritis

Safety

Safety data from Otezla® (apremilast) clinical trials
 
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ADVERSE REACTIONS THROUGH WEEK 161

PALACE 1-3: Adverse reactions reported in ≥2% of patients on Otezla 30 mg twice daily and ≥1% observed in patients on placebo for up to day 112 (week 16)1,a

 
Placebo
Otezla 30 mg BID
Day 1 to Day 5 (N=495)n (%) Day 6 to Day 112 (N=490)n (%) Day 1 to Day 5(N=497)n (%) Day 6 to Day 112(N=493)n (%)
Adverse reaction
Diarrheab 6 (1.2) 8 (1.6) 46 (9.3) 38 (7.7)
Nauseab 7 (1.4) 15 (3.1) 37 (7.4) 44 (8.9)
Headacheb 9 (1.8) 11 (2.2) 24 (4.8) 29 (5.9)
Upper respiratory tract infectionc 3 (0.6) 9 (1.8) 3 (0.6) 19 (3.9)
Vomitingb 2 (0.4) 2 (0.4) 4 (0.8) 16 (3.2)
Nasopharyngitisc 1 (0.2) 8 (1.6) 1 (0.2) 13 (2.6)
Upper abdominal painc 0 (0.0) 1 (0.2) 3 (0.6) 10 (2.0)
 

aAfter initial 5-day titration. bOf the reported gastrointestinal adverse reactions, 1 patient experienced a serious adverse reaction of nausea and vomiting in Otezla 30 mg twice daily; 1 patient treated with Otezla 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 patient treated with Otezla 30 mg twice daily experienced a serious adverse reaction of headache. cOf the reported adverse drug reactions, none were serious.

Discontinuation rates due to adverse reactions in the 3 trials1

  • Otezla arm 4.6%; placebo arm 1.2%
  • Most common adverse reactions leading to discontinuation: nausea (1.8%), diarrhea (1.8%), and headache (1.2%)

The majority of patients reporting the most common adverse reactions did so within the first 2 weeks, and the events tended to resolve over time with continued dosing1

  • 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 vomiting1
 

BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

Next: Adverse Reactions Through 5 Years

THE MOST COMMON ADVERSE REACTIONS THROUGH 5 YEARS1

Pooled PALACE 1-3: Adverse reactions in ≥5% of patients on Otezla 30 mg BID, any treatment group1

 
Otezla 30 mg BID
Years 0 to ≤1 (N=721)
n (%)		 Years >1 to ≤2 (N=520)
n (%)		 Years >2 to ≤3 (N=443)
n (%)		 Years >3 to ≤4 (N=401)
n (%)		 Years >4 to ≤5 (N=364)
n (%)
Diarrhea 113 (15.7) 20 (3.8) 12 (2.7) 5 (1.2) 2 (0.5)
Nausea 108 (15.0) 11 (2.1) 10 (2.3) 3 (0.7) 1 (0.3)
Headache 75 (10.4) 17 (3.3) 12 (2.7) 8 (2.0) 2 (0.5)
Upper respiratory tract infection 60 (8.3) 27 (5.2) 24 (5.4) 22 (5.5) 21 (5.8)
Nasopharyngitis 41 (5.7) 31 (6.0) 20 (4.5) 27 (6.7) 24 (6.6)
 

Includes all patients who received Otezla during the time interval relative to the start of Otezla administration.


 

PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.

  • The long-term safety profile of Otezla was consistent through 5 years of exposure in the PALACE 1-3 clinical studies of patients with active psoriatic arthritis.

Discontinuation due to adverse reactions occurred at 7.9% during years 0 to ≤1, 2.5% during years >1 to ≤2, 1.6% during years >2 to ≤3, 2.0% during years >3 to ≤4, and 1.4% during years >4 to ≤51

Next: Additional Safety

ADVERSE REACTIONS OF SPECIAL INTEREST1

Pooled PALACE 1-3: Adverse reactions of special interest1

Exposure-adjusted incidence rate/100 patient-yearsa

 
Placebothrough week 16
(145.0 patient-years)
Otezla 30 mg twice dailythrough week 16
(142.6 patient-years)
Otezla 30 mg twice dailythrough year 5
(2196.7 patient-years)
Major adverse cardiac eventsb
Events 0.7 0.0 0.3
Malignancies
Hematologic 0.0 0.0 0.1
Skin (excluding melanoma) 2.1 0.0 0.3
Solid 0.7 0.7 0.5
Infections
Non-opportunistic serious 1.4 0.7 1.1
Opportunistic (systemic) 0.0 0.0 0.1
New cases of tuberculosis (TB)c 0.0 0.0 0.0
Reactivation of TB 0.0 0.0 0.0
a

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). bMajor adverse cardiac events (MACE) were defined as TEAEs of acute or fatal myocardial infarction, stroke or fatal stroke, or sudden cardiac death. cPatients with a history of active or incompletely treated TB were excluded from the trials. The trials included 32 patients with a medical history of TB (including latent TB and pulmonary TB), or a positive tuberculin test.


 

PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TEAEs, treatment-emergent adverse events.

The adverse reactions of special interest were generally similar through 260 weeks1

Next: Laboratory Parameters

The Full Prescribing Information for Otezla has no requirement for routine laboratory monitoring1

PALACE 1-3: Selected marked abnormalities in laboratory parameters2

Laboratory abnormalities reported in the placebo-controlled period and long-term exposure period in patients on Otezla 30 mg twice daily2
Placebo-controlleda
Exposure periodb
Weeks 0 to ≤24 Weeks 0 to ≤24 Weeks 0 to ≤52 Weeks >52 to ≤104 Weeks >104 to ≤156 Weeks >156 to ≤208 Weeks >208 to ≤260
Laboratory parameter Placebo
(N = 495) %, (n/N)		 Otezla 30 mg BID
(N = 497) %, (n/N)		 Otezla 30 mg BID
(N = 721) %, (n/N)		 Otezla 30 mg BID
(N = 520) %, (n/N)		 Otezla 30 mg BID
(N = 443) %, (n/N)		 Otezla 30 mg BID
(N = 401) %, (n/N)		 Otezla 30 mg BID
(N = 364) %, (n/N)
Chemistry
ALT >3x ULN 0.2 (1/492) 1.4 (7/492) 1.3 (9/713) 0.4 (2/518) 0.5 (2/442) 0.2 (1/401) 0.3 (1/363)
AST >3x ULN 0.4 (2/491) 0.4 (2/492) 0.6 (4/713) 0.2 (1/518) 0.7 (3/442) 0.5 (2/401) 0.3 (1/363)
Bilirubin >1.8x ULN 0.0 0.4 (2/492) 0.3 (2/713) 0.4 (2/518) 0.5 (2/442) 0.7 (3/401) 1.1 (4/363)
Creatinine >1.7x ULN 0.2 (1/492) 0.2 (1/492) 0.1 (1/713) 0.0 0.0 0.2 (1/401) 0.3 (1/363)
Cholesterol >7.8 mmol/Lc 2.0 (10/492) 3.5 (17/492) 3.8 (27/713) 2.3 (12/518) 2.9 (13/442) 2.5 (10/401) 2.8 (10/363)
Urate, male >590 μmol/L; female >480 μmol/Ld 2.8 (14/492) 3.5 (17/492) 3.8 (27/713) 3.7 (19/518) 4.3 (19/442) 6.0 (24/401) 3.9 (14/363)
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL 0.2 (1/489) 0.4 (2/489) 0.7 (5/713) 0.8 (4/517) 1.1 (5/442) 1.2 (5/401) 1.4 (5/362)
Leukocytes <1.5 x 109/L 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Lymphocytes <0.8 x 109/L 3.5 (17/488) 3.3 (16/489) 3.9 (28/713) 2.9 (15/517) 3.2 (14/442) 2.5 (10/401) 4.4 (16/362)
Neutrophils <1.0 x 109/L 0.4 (2/488) 0.2 (1/489) 0.3 (2/713) 0.6 (3/517) 0.5 (2/442) 0.5 (2/401) 1.1 (4/362)
Platelets <75 x 109/L 0.0 0.0 0.0 0.0 0.2 (1/441) 0.0 0.6 (2/362)
a

Placebo-controlled period includes all data through week 16 for patients initially assigned to placebo who escaped, and all data through week 24 for all other patients.

b

Otezla-exposure period includes all Otezla-exposure data, regardless of when the Otezla exposure started (week 0, 16, or 24).

c

Did not have to be drawn when the patient was fasting.

d

Urate, male >9.9 mg/dL; female >8.1 mg/dL.

 

ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; ULN, upper limit of normal.

Next: PALACE 4 Safety

THE MOST COMMON ADVERSE REACTIONS THROUGH WEEK 161-3

PALACE 4: Adverse reactions reported in ≥5% of patients through week 162,a

  Number of Patients (%)
Placebo (N=176)
Otezla 30 mg BID (N=175)
Adverse reactions
Any TEAE 71 (40.3) 86 (49.1)
Diarrhea 3 (1.7) 20 (11.4)
Nausea 4 (2.3) 25 (14.3)
Headache 4 (2.3) 14 (8.0)
 

aBefore early escape.

 

BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TEAE, treatment-emergent adverse event.

The majority of diarrhea and nausea adverse reactions were generally reported within
the first 2 weeks of treatment and tended to resolve within 4 weeks with continued dosing3

  • 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 most susceptible to complications of diarrhea or vomiting1

THE MOST COMMON ADVERSE REACTIONS THROUGH 5 YEARS2

PALACE 4: Adverse reactions reported in ≥5% of patients through 5 years, in any patient group2

 
Otezla exposure perioda
Years 0 to ≤1 (N=252)
n (%)		 Years >1 to ≤2 (N=201)
n (%)		 Years >2 to ≤3 (N=163)
n (%)		 Years >3 to ≤4 (N=138)
n (%)		 Years >4 to ≤5 (N=130)
n (%)
Adverse reactions
Nausea 35 (13.9) 4 (2.0) 4 (2.5) 1 (0.7) 0 (0.0)
Diarrhea 28 (11.1) 4 (2.0) 4 (2.5) 0 (0.0) 1 (0.8)
Headache 24 (9.5) 2 (1.0) 1 (0.6) 1 (0.7) 1 (0.8)
Upper respiratory tract infection 15 (6.0) 9 (4.5) 4 (2.5) 6 (4.3) 5 (3.8)
Nasopharyngitis 9 (3.6) 7 (3.5) 7 (4.3) 9 (6.5) 9 (6.9)
 

aIncludes all patients who received Otezla during the time interval relative to the start of Otezla administration.

 

DMARD, disease-modifying antirheumatic drug.

  • The long-term safety profile of Otezla was consistent through 5 years of exposure in the PALACE 4 clinical study of DMARD-naïve patients with active psoriatic arthritis

During the Otezla exposure period, discontinuation due to adverse reactions
occurred at 5.2% for years 0 to ≤1, 3.5% for years >1 to ≤2, 3.1% for years >2 to ≤3,
0.0% for years >3 to ≤4, and 1.5% for years >4 to ≤5


ADVERSE REACTIONS OF SPECIAL INTEREST2

PALACE 4: Adverse reactions of special interest through 5 years2

EXPOSURE-ADJUSTED INCIDENCE RATE/100 PATIENT-YEARSa

 
Placebo
through week 16 (51.3 patient-years)
Otezla 30 mg BID
through week 16 (50.7 patient-years)
Otezla 30 mg BID
through year 5 (792.5 patient-years)
Major adverse cardiac eventsb
Events 0 0 0
Malignancies
Hematologic 0 0 0
Skin (excluding melanoma) 2.0 0 0.5
Solid tumors 0 0 0.3
Infections
Non-opportunistic serious 2.0 2.0 0.6
Opportunistic (systemic) 0 0 0
New cases of TBc 0 0 0
Reactivation of TB 0 0 0
 

aExposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by the patient-years (up to the first event start date for patients reporting the event). bMajor adverse cardiac events were defined as TEAEs of acute or fatal myocardial infarction, stroke or fatal stroke, or sudden cardiac death. cPatients with a history of active or incompletely treated TB were excluded from the trials. No patients in the placebo or Otezla 30 mg BID treatment groups were identified as having potential risks for TB. No cases of reactivation or de novo TB were reported.3


 

TB, tuberculosis.


THE FULL PRESCRIBING INFORMATION FOR OTEZLA HAS NO REQUIREMENT FOR ROUTINE LABORATORY MONITORING1

PALACE 4: Selected marked abnormalities in laboratory parameters2

Otezla exposure perioda
Years
0 to ≤1		 Years
>1 to ≤2		 Years
>2 to ≤3		 Years
>3 to ≤4		 Years
>4 to ≤5
Laboratory parameter Otezla 30 mg BID (N=252)% (n/N) Otezla 30 mg BID (N=201)% (n/N) Otezla 30 mg BID (N=163)% (n/N) Otezla 30 mg BID (N=138)% (n/N) Otezla 30 mg BID (N=130)% (n/N)
Chemistry
ALT >3 x ULN 1.2 (3/246) 1.0 (2/200) 1.9 (3/161) 1.5 (2/137) 0
AST >3 x ULN 1.2 (3/246) 2.0 (4/200) 1.2 (2/161) 1.5 (2/137) 0
Bilirubin >1.8 x ULN 0 0 1.2 (2/161) 0 0
Cholesterol >7.8 mmol/Lb,c 3.3 (8/246) 4.5 (9/200) 4.3 (7/161) 3.6 (5/137) 2.3 (3/130)
Creatinine >1.7 x ULN 0.4 (1/246) 1.0 (2/200) 1.9 (3/161) 1.5 (2/137) 1.5 (2/130)
Urate, male >590 µmol/L;
female >480 µmol/L		 3.7 (9/246) 4.5 (9/200) 2.5 (4/161) 5.1 (7/137) 1.5 (2/130)
Hematology
Hemoglobin, male <10.5 g/dL;
female <8.5 g/dL		 0.8 (2/245) 1.0 (2/199) 0.6 (1/160) 2.2 (3/136) 2.3 (3/129)
Leukocytes <1.5 x 109/L 0 0 0 0 0
Lymphocytes <0.8 x 109/L 1.6 (4/244) 0.5 (1/199) 3.1 (5/160) 0.7 (1/136) 1.6 (2/129)
Neutrophils <1.0 x 109/L 0.8 (2/244) 0 0 0 0.8 (1/129)
Platelets <75 x 109/L 0 0 0 0 0
 

aOtezla exposure period includes all Otezla exposure data, regardless of when the Otezla exposure started. bEquivalent to 302 mg/dL. cDid not have to be drawn when the patient was fasting.


 

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.

Next: ACTIVE Safety

THE MOST COMMON ADVERSE REACTIONS IN BIOLOGIC-NAÏVE PATIENTS1

ACTIVE: The most common adverse reactions (reported in ≥5% of patients)1,2

Placebo-controlled phase (weeks 0-24)a
Cumulative Otezla exposureb
  Placebo
(N=109)		 Otezla 30 mg BID
(N=109)		 Otezla 30 mg BID
(N=206)
Adverse reactions
Diarrheac 11.0%c 14.7%c 16.0%
Nausea 1.8% 8.3% 7.8%
Nasopharyngitis 6.4% 8.3% 7.8%
Headache 3.7% 7.3% 5.8%
Hypertension 6.4% 6.4% 6.3%
Upper respiratory tract infection 10.1% 4.6% 6.8%
 

aIncludes data through week 16 for placebo patients who escaped, and data through week 24 for all other patients. bIncludes all available Otezla exposure data (including data beyond 52 weeks): patients with multiple reports are only counted once. cProtocol-defined characterization of diarrhea of two or more watery or liquid stools/day: placebo (8.3%) and Otezla 30 mg BID (11%).

 

ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; BID, twice daily.

Discontinuations due to any adverse reactions occured at 8.3%
during the Otezla exposure period (N=206)1

Next: Dosing

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

Reference: 1. Data on file, Amgen Inc.

Reference: 1. Data on file, Amgen Inc.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263.

References: 1. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698. 2. Data on file, Amgen Inc.

INDICATIONS & IMPORTANT SAFETY 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.

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 & IMPORTANT SAFETY 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.

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.