Label Changes for:
Votrient (pazopanib) tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Drugs That Raise Gastric pH
- Avoid concomitant use of Votrient with drugs that raise gastric pH. Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2 receptor antagonists. Separate antacid and pazopanib dosing by several hours.
Musculoskeletal and Connective Tissue Disorders
- Arthralgia, muscle spasms
WARNINGS AND PRECAUTIONS
- Thrombotic Microangiopathy - Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) has been reported in clinical trials of Votrient as monotherapy, in combination with bevacizumab, and in combination with topotecan…