Label Changes for:
Invega (paliperidone) Extended-Release Tablets
Changes have been made to the CONTRAINDICATIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- RISPERDAL/RISPERDAL CONSTA/INVEGA(s) is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL/RISPERDAL CONSTA/ INVEGA(s) formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.