DIRA Safety

KINERET safety profile for patients with DIRA

The safety of KINERET has been established in patients with DIRA1

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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
View preparation and administration information