Dear Healthcare Professional Letter on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra)
10.06.2015
Swedish Orphan Biovitrum (Sobi) has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) sent a letter to healthcare professionals on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra).
Summary
- Sobi has received complaints on the product due to particles of a solid material to be present on the needle surface of pre-filled syringes of Kineret.
- The actual number of received complaints is small in comparison to the number of manufactured and distributed syringes.
- These syringes and needles have been analysed and the discovered material on the needle happens to be anakinra, the active protein substance in Kineret.
- If present, this solid material is visible on the needle when the protective rubber cap is removed before administration of the injection. Further analyses have revealed the maintenance of the entire syringe and protective rubber cap, demonstrating that the sterility has not been impaired.
- Sobi has yet to establish the main cause and the investigation is in the course.
- No serious adverse events have been reported in relation to complaints on the product Kineret. The benefit/risk ratio for Kineret remains positive.
- Syringes, including needles, should be thoroughly examined before use. Syringes having solid material particles on the outer needle surface should not be used. Syringes not having such changes may be used. however, all unused syringes (affected or not with the solid material) from the affected package may be returned to the pharmacy by a standard procedure and Sobi will replace them.
Further information
16 complaints on the product have been received in the past few months. There were no serious adverse events and no reports indicating an increased risk of other events related to these complaints.
By the end of the quality investigation and until further resolving of this safety issue, patients, doctors and nurses should not use the affected syringes. This safety issue concerns Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe that has not been marketed in Croatia.
Kineret is indicated in adult patients to treat signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate, in individuals with inadequate response to methotrexate.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
