Sarilumab

Refrigerated Storage · New Medicines ·

Unassigned

Refrigerated Storage

Kevzara · Sanofi Genzyme Therapeutics

Sanofi Genzyme Therapeutics
Kevzara
Solution for injection in pre-filled syringe pen, solution for injection in pre-filled syringe pen, 150mg and 200mg

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

Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25 °C.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Sanofi Genzyme in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details

Reduce to 14 days from the day of exposure (but not exceeding the original expiry date)
No
13th June 2018
London MI Service

New Medicines

Kevzara · Giant cell (temporal) arteritis

Information

Kevzara
Licence extension / variation
Genzyme Therapeutics
Sanofi

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fully human antibody to the interleukin-6 receptor (IL-6R)
GCA occurs in 2.2 per 10,000 patient years in the UK [1].
Giant cell (temporal) arteritis
Subcutaneous

Kevzara · Polymyalgia rheumatica

Information

Kevzara
Licence extension / variation
Genzyme Therapeutics
Sanofi

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Fully human antibody to the interleukin-6 receptor (IL-6R)
The annual incidence of the disease in the general population in the UK has been estimated as 84 per 100,000. PMR occurs almost exclusively in people aged above 50 and the mean age of onset is about 73 [1].
Polymyalgia rheumatica
Subcutaneous