The OTEZLA® international website

This site is intended for healthcare professionals outside the U.S.

NO LABEL-REQUIRED LABORATORY PRESCREENING OR ONGOING MONITORING DURING TREATMENT

Marked laboratory abnormalities were generally infrequent and transient across exposure periods1,2
 
Placebo-controlled period
Cumulative exposure
Weeks 0 to 16
(n = 418), %
Weeks 0 to 16
(n = 832), %
Weeks 0 to 182a
(N = 1,184), %
Placebo OTEZLA
(30 mg BID)
OTEZLA
(30 mg BID)
Chemistry
ALT >3x ULN0.20.11.1
AST >3x ULN0.70.21.5
Bilirubin >1.8x ULN mmol/L0.20.20.6
Total cholesterol >7.8 mmol/Lb2.10.82.4
Hemoglobin A1C >9%0.50.51.0
Hematology
Lymphocytes <0.8 x 109/L mmol/L3.01.13.7
Neutrophils <1.0 x 109/L0.00.00.3
  • No clinically meaningful effects on laboratory parameters were reported during short-or long-term treatment1,2

aPooled data from ESTEEM 1 and ESTEEM 2. Includes all patients who received OTEZLA regardless of when OTEZLA exposure started. OTEZLA exposure is based on each patient’s total exposure to OTEZLA, defined as the time interval between the date of the first dose and the date of the last dose, inclusive.

bDid not have to be drawn when patient was fasting.

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

References:

  1. Papp K, Sobell JM, Shah K, et al. Safety and Tolerability of Apremilast Up to 182 Weeks: Pooled Analyses From Phase 3 Clinical Trials. Presented at: the 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, DC.
  2. Data on file, Amgen Inc.
You are leaving the OTEZLA® (apremilast) website
Do you wish to leave this site?
OTEZLA International Websites
OTEZLA is approved in 54 countries*
  • United States

  • Canada

  • Australia

  • Israel

  • Switzerland

  • New Zealand

  • Austria

  • Belgium

  • Bulgaria

  • Croatia

  • Republic of Cyprus

  • Czech Republic

  • Denmark

  • Estonia

  • Finland

  • France

  • Germany

  • Greece

  • Hungary

  • Ireland

  • Italy

  • Latvia

  • Lithuania

  • Luxembourg

  • Malta

  • Netherlands

  • Poland

  • Portugal

  • Romania

  • Slovakia

  • Slovenia

  • Singapore

  • Spain

  • Sweden

  • United Kingdom

  • Norway

  • Iceland

  • Liechtenstein

  • Russia

  • Japan

  • Hong Kong

  • Kuwait

  • Taiwan

  • UAE

  • South Korea

  • Thailand

  • Lebanon

  • Qatar

  • Argentina

  • Mexico

  • Brazil

  • Malaysia

  • Oman

  • Saudi Arabia

On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).

Effective November 21, 2019, refer to the Amgen's Terms of Use relating to the access of Amgen websites, applications and digital services and Privacy Statement concerning the collection and use of your personal information.

For information collected by Celgene prior to November 21, 2019, refer to Celgene's Terms of Use and Privacy Policy.