This is a well established safety profile

Kineret is widely considered to be a well-tolerated treatment. 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 2002.¹

¨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 elimination half-life of 4 to 6 hours for Kineret allows for prompt dose adjustments or discontinuation if required.¹

The favourable 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 (aged 8 months to 2 years), except for the treatment of RA and COVID-19.¹
• Kineret is not contraindicated in patients with comorbidities such as infection, type 2 diabetes, COPD or pneumonia.¹
• In Still’s disease, treatment with Kineret can have a steroid-sparing effect.¹

For more information on the safety and tolerability of Kineret in its approved indications, see the respective pages on each indication 

This is how to manage ISRs

The most common adverse event associated with Kineret is injection site reaction, mostly reported as mild to moderate. ISRs typically appear within two weeks of starting treatment and disappear within 4-6 weeks.¹

The reactions are usually mild to moderate and take the form of redness, bruising, inflammation, pain, or discomfort in the area where the needle pricks the skin. Skin reactions are unlikely to occur if they have not appeared in the first month of treatment. Around 70% of patients report ISRs when they start taking Kineret.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

Do not inject into skin that is tender, red, bruised, or hard. Avoid scars or stretch marks. Do not inject close to a vein.¹⁵

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

• Rotating injection sites1, leaving at least an inch between injection sites.
• Cooling the injection site with an ice pack before and after injecting.¹

Safety monitoring

Sobi is committed to monitoring the possible risks for adverse events or safety 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 risks with Kineret, as outlined in the RMP, comprise ISRs, immunogenicity, serious infections, neutropenia, allergic conditions, and hepatic disorders. Potential risks include malignancies, macrophage activation syndrome, 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.