March 19, 2014

Promacta (eltrombopag) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

February 2014

Summary View1

BOXED WARNING
 
WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C
  • In patients with chronic hepatitis C, PROMACTA® in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)].
WARNINGS AND PRECAUTIONS
 
5.1 Hepatic Decompensation in Patients With Chronic Hepatitis C
  • Moved from 5.2 to 5.1 and revised to include the risk of hepatic decompensation.…In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. In two controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, ascites and encephalopathy occurred more frequently on the arm receiving PROMACTA plus antivirals treatment (7%) than the placebo plus antivirals arm (4%). Patients with low albumin levels (<3.5 g/dL) or Model for End-Stage Liver Disease (MELD) score =10 at baseline had a greater risk for hepatic decompensation on the arm receiving PROMACTA plus antivirals 124 treatment. Discontinue PROMACTA if antiviral therapy is discontinued.
5.2 Hepatotoxicity
  • Moved from 5.1 to 5.2 and revised…PROMACTA can cause liver enzyme elevations [see Adverse Reactions (6.1)]. Measure serum ALT, AST, and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. PROMACTA inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia….
5.3 Bone Marrow Reticulin Formulation …section removed.
 
5.5 Laboratory Monitoring…section removed.
 
ADVERSE REACTIONS
  • Hepatic Decompensation in Patients With Chronic Hepatitis C [see Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
  • Clinical Trial data added
17 PATIENT COUNSELING INFORMATION
  • confusion
  • swelling of the stomach area (abdomen)
MEDICATION GUIDE

What is the most important information I should know about PROMACTA?

  • Liver problems. If you have chronic hepatitis C virus, and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems.

“What is the most important information I should know about PROMACTA?”

  • Bone marow changes…section deleted.
  • Abnorman liver functions…section added.

Source FDA

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