DIRA Safety
KINERET safety profile for patients with DIRA
The safety of KINERET has been established in patients with DIRA1
The safety of KINERET has been established in patients with DIRA1
Adverse events1
- The most common adverse events were upper respiratory tract infections, rash, pyrexia, influenza-like illness, and gastroenteritis
- No patient permanently discontinued KINERET treatment due to adverse events
- There were 16 serious adverse events reported in 4 out of 9 treated patients*
- Overall, the safety profile observed in patients with DIRA treated with KINERET was consistent with the safety profile in NOMID patients
*The most common type of SAE reported (5 events in 2 patients) was infection.
Additional safety information1
- In KINERET-treated DIRA patients, the risk of a disease flare when discontinuing KINERET treatment should be weighed against the potential risk of continued treatment. Do not initiate KINERET in patients with active infections
- Use in combination with TNF-blocking agents is not recommended
- Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported
- The impact of treatment with KINERET on active and/or chronic infections and the development of malignancies is not known
- Live vaccines should not be given concurrently with KINERET
- Neutrophil counts should be assessed prior to initiating KINERET treatment, and while receiving KINERET, monthly for 3 months, and thereafter quarterly for a period up to 1 year