Label Changes for:
Promacta (eltrombopag) Tablets
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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.
- 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.
- 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
- swelling of the stomach area (abdomen)
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 marrow changes…section deleted.
- Abnormal liver functions…section added.
WARNINGS AND PRECAUTIONS
- Thrombotic/Thromboembolic Complications
High platelet counts and higher chance for blood clots
- You may have a higher chance of getting a blood clot if your platelet count is too high during treatment with Promacta but blood clots can occur with normal or even low platelet counts. You may have severe complications or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Promacta if your platelet counts get too high. Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg.