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Safety

Otezla® (apremilast) has a proven safety profile1,2
  • Adverse Reactions
    Through Week 16
    Button to view the adverse reactions through week 16 reported in the PALACE 1-3 clinical trials
  • Adverse Reactions
    Through Week 208
    Button to view the adverse reactions reported in the PALACE 1-3 clinical trials through week 208
  • Additional
    Safety
    Button to view additional safety information from the PALACE 1-3 clinical trials
  • Laboratory
    Parameters
    Button to view a table of selected abnormalities in laboratory parameters reported in the PALACE 1-3 clinical trials

THE MOST COMMON 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

 
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
Diarrheaa6 (1.2)8 (1.6)46 (9.3)38 (7.7)
Nauseaa7 (1.4)15 (3.1)37 (7.4)44 (8.9)
Headachea9 (1.8)11 (2.2)24 (4.8)29 (5.9)
Upper respiratory tract infectionb3 (0.6)9 (1.8)3 (0.6)19 (3.9)
Vomitinga2 (0.4)2 (0.4)4 (0.8)16 (3.2)
Nasopharyngitisb1 (0.2)8 (1.6)1 (0.2)13 (2.6)
Upper abdominal painb0 (0.0)1 (0.2)3 (0.6)10 (2.0)
a

Of 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.

b

Of the reported adverse drug reactions, none were serious.

Discontinuation rates due to adverse reactions in the 3 trials1

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

THE MOST COMMON ADVERSE REACTIONS THROUGH WEEK 2082

PALACE 1-3: Adverse reactions in ≥5% of patients on Otezla 30 mg twice daily, any treatment group2

 
Otezla 30 mg BID
Weeks 0 to ≤52 (N = 721)
n (%)
Weeks >52 to ≤104 (N = 520)
n (%)
Weeks >104 to ≤156 (N = 443)
n (%)
Weeks >156 to ≤208 (N = 401)
n (%)
Diarrhea112 (15.5)20 (3.8)12 (2.7)4 (1.0)
Nausea108 (15.0)11 (2.1)10 (2.3)3 (0.7)
Upper respiratory tract infection60 (8.3)27 (5.2)24 (5.4)21 (5.2)
Headache75 (10.4)17 (3.3)12 (2.7)7 (1.7)
Nasopharyngitis41 (5.7)31 (6.0)20 (4.5)26 (6.5)
Vomiting32 (4.4)2 (0.4)2 (0.5)1 (0.2)
Upper abdominal pain23 (3.1)8 (1.5)6 (1.4)1 (0.2)

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

BID, twice daily.

Discontinuation due to adverse reactions occurred at 7.8% during weeks 0 to ≤52, 2.5% during weeks >52 to ≤104, 1.6% during weeks >104 to ≤156, and 1.7% during weeks >156 to ≤2082

ADVERSE REACTIONS OF SPECIAL INTEREST2

PALACE 1-3: Adverse reactions of special interest2

Exposure-adjusted incidence rate/100 patient-yearsa

 
Placebo(168.2 patient-years)
Otezla 30 mg BID (769.0 patient-years)
Major adverse cardiac events
Events0.00.1
Malignancies
Hematologic0.00.0
Skin (excluding melanoma)1.20.5
Solid (including melanoma)0.60.1
Infections
Non-opportunistic serious0.60.5
Opportunistic (systemic)0.60.0
New cases of tuberculosis (TB)b0.00.0
Reactivation of TB0.00.0
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).

b

Patients with a history of active or incompletely treated TB were excluded from the trials. The trials included 32 patients with a history of fully treated TB, a positive PPD or QuantiFERON®, or a history of receiving preventive medication for TB.

BID, twice daily; PPD, purified protein derivative.

The adverse reactions of special interest were generally similar through 208 weeks2

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

PALACE 1-3: Selected marked abnormalities in laboratory parameters2

Icon for a test tube used in clinical laboratory tests

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 ≤24Weeks 0 to ≤24Weeks 0 to ≤52Weeks >52 to ≤104Weeks >104 to ≤156Weeks >156 to ≤208
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)
Chemistry
AST >3x ULN0.2 (1/492)1.4 (7/492)1.3 (9/713)0.4 (2/518)0.5 (2/442)0.2 (1/401)
AST >3x ULN0.4 (2/491)0.4 (2/492)0.6 (4/713)0.2 (1/518)0.7 (3/442)0.5 (2/401)
Bilirubin >1.8x ULN0.00.4 (2/492)0.3 (2/713)0.4 (2/518)0.5 (2/442)0.7 (3/401)
Creatinine >1.7x ULN0.2 (1/492)0.2 (1/492)0.1 (1/713)0.00.00.2 (1/401)
Cholesterol >7.8 mmol/Lc2.0 (10/492)3.5 (17/492)3.8 (27/713)2.3 (12/518)2.9 (13/442)2.5 (10/401)
Urate, male >590 μmol/L; female >480 μmol/Ld2.8 (14/492)3.5 (17/492)3.8 (27/713)3.7 (19/518)4.3 (19/442)6.0 (24/401)
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL0.2 (1/489)0.4 (2/489)0.7 (5/713)0.8 (4/517)1.1 (5/442)1.2 (5/401)
Leukocytes <1.5 x 109/L0.00.00.00.00.00.0
Lymphocytes <0.8 x 109/L3.5 (17/488)3.3 (16/489)3.9 (28/713)2.9 (15/517)3.2 (14/442)2.5 (10/401)
Neutrophils <1.0 x 109/L0.4 (2/488)0.2 (1/489)0.3 (2/713)0.6 (3/517)0.5 (2/442)0.5 (2/401)
Platelets <75 x 109/L0.00.00.00.00.2 (1/441)0.0
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.

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

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Data on file, Celgene Corporation.

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Reference: 1. Data on file, Celgene Corporation.
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