This is a well established
safety profile

Kineret safety and tolerability

The safety profile of Kineret has been well established in several placebo- controlled, randomised trials, as well as clinical use following its first marketing authorisation in 2001.1

In clinical studies, the most frequently reported adverse reactions associated with Kineret have been injection site reactions (ISRs), mostly reported as mild to moderate. ISRs typically appear within 2 weeks of starting treatment and disappear within 4-6 weeks.1 Other common adverse events with Kineret include headache, neutropenia, thrombocytopenia, serious infections, and increased serum levels of cholesterol.1

The short half-life of 4 to 6 hours for Kineret allows for flexible dosing.2

TOTAL WORLDWIDE EXPOSURE TO KINERET3
>170 000
PATIENT YEARS

The favorable tolerability profile of Kineret is further supported by the following:

  • Low discontinuation rates were observed in placebo-controlled studies with Kineret.1
  • Kineret can be used in very young children (from 8 months of age), except for the treatment of RA and COVID-19.1

How to manage injection site reactions (ISRs)

Around 70% of patients report ISRs when they start taking Kineret. The reactions are usually mild to moderate and take the form of redness, bruising, inflammation, pain, or discomfort at the injection site. ISRs typically appear within 2 weeks of starting Kineret and disappear within 4-6 weeks. ISRs are unlikely to occur if they have not appeared in the first month of treatment.1

For a more comfortable injection, the syringe can be taken out of the refrigerator 30 minutes before the injection to allow it to warm to room temperature. The pre- filled syringe can also be held gently in one hand, warming it for a few minutes. Kineret must not be warmed in any other way (for example, in a microwave or in hot water).1

The best places to inject Kineret are1

Rotate the injection site. Do not inject into skin that is tender, red, bruised, or hard. Avoid scars or stretch marks. Do not inject close to a vein.4

Other suggestions for alleviating the signs and symptoms of ISRs include:

  • Using topical glucocorticoids and antihistamines after the injection.1
  • Cooling the injection site with an ice pack before and after injecting.1
risk management plan

Safety monitoring

Sobi is committed to monitor the possible risks for adverse events with Kineret treatment. The risks are collected and assessed in a Risk Management Plan (RMP) which also provides information on how to minimise the risks.

The identified safety concerns with Kineret, as outlined in the RMP, comprise ISRs, immunogenicity, serious infections, neutropenia, allergic conditions, and hepatic disorders. Potential risks include malignancies, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), medication errors including reuse of syringes, and pulmonary events such as interstitial lung disease, pulmonary hypertension, and alveolar proteinosis.3

You are asked to report any adverse events in accordance with local regulations.

Kineret Q&A

How is Kineret administered?
  • Kineret is given in a pre-filled syringe containing 100 mg of anakinra per 0.67 ml (150 mg/ml).1
  • Kineret is given as a subcutaneous injection.1
  • Dosage depends on indication. In children, the dose is determined depending on body weight. Please refer to current SmPC.
How should Kineret be stored?
  • Kineret should be stored in a refrigerator between 2°C and 8°C.1
  • Kineret should not be frozen or shaken.1
  • Kineret should be kept in its original carton and away from light.1

References

  • Swedish Orphan Biovitrum AB (publ). Kineret summary of product characteristics [SmPC]. Latest version available from: https:// www.ema.europa.eu/en/documents/product-information/kineret-epar-product-information_en.pdf
  • Kineret-H-C-363-II-0056 : EPAR - Assessment Report - Variation. Available at: https://www.ema.europa.eu/en/documents/variation- report/kineret-h-c-363-ii-0056-epar-assessment-report-variation_en.pdf
  • EU Risk Management Plan for Kineret (anakinra), Table 21. Available at: https://www.ema.europa.eu/en/documents/rmp/kineret- epar-risk-management-plan_en.pdf
  • Kineret US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103950s5189lbl.pdf