Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Clinical Studies Experience in RA
- Cholesterol elevations were observed in some patients treated with Kineret.
- thrombocytopenia, including severe thrombocytopenia (i.e platelet counts <10x109/L)
The following adverse reactions have been identified during postapproval use of Kineret. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- elevations of transaminases
- non-infectious hepatitis