ArticlesRefrigerated StorageLactation Safety InformationNew Medicines ·


Refrigerated Storage

KineretSwedish Orphan Biovitrum

Swedish Orphan Biovitrum
100 mg solution for injection in a pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:

For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at a temperature not above 25 °C. At the end of this period, the product must not be put back in the refrigerator and must be disposed of.

Please also refer to the manufacturer’s product literature for recommended storage information at

Contact Swedish Orphan Biovitrum Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.


Yes - see above.
No - see above.
19 November 2020
London MI Service

Lactation Safety Information

Recombinant human interleukin-1 receptor antagonist - IL-1Ra

Recombinant human interleukin-1 receptor antagonist - IL-1Ra
See summary
Normal component of breast-milk
Only very limited anecdotal evidence of safety which indicates no effects in a breastfed infant
If clinically indicated monitor infant for signs of neutropenia, which is common in therapeutic use in adults
15 September 2019

New Medicines

KineretFamilial Mediterranean fever (FMF)


Licence extension / variation
SOBI (Swedish Orphan Biovitrum)
SOBI (Swedish Orphan Biovitrum)

Development and Regulatory status

May 2020
May 20Approved in the EU [3].
Mar 20CHMP positive opinion recommending approval of a new indication for the treatment of FMF in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above [2].


A recombinant non-glycosylated human interleukin-1 receptor antagonist expressed in Escherichia coli
Familial Mediterranean fever mainly affects specific racial groups originating from around the eastern Mediterranean Sea. These include Arabs, Armenians, Italians (mild form), Jews and Turks. In these groups, 1 in 25 to 1 in 2000 people are affected. By comparison, in west Europeans, the prevalence is 2.5 per 100,000 (1 in 40,000) people [1].
Familial Mediterranean fever (FMF)