dm+d

Unassigned

Refrigerated Storage

KevzaraSanofi Genzyme Therapeutics

Sanofi Genzyme Therapeutics
Kevzara
solution for injection in pre-filled pen or syringe (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.
Contact Sanofi Genzyme in cases where additional stability data is required. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 14 days if exposed to the conditions above
If exposed to the conditions above, can return to the fridge or store outside of the fridge at <25°C
11 October 2021
London MI Service

Lactation Safety Information

No published evidence of use during breastfeeding
Drug properties suggest negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract. Adverse effects in the infant would be unlikely
Theoretically, absorption may be increased slightly in the neonatal period due to increased gastrointestinal permeability
Can be used during breastfeeding for patients with COVID-19
Live vaccination does not need to be withheld, unless exposure also occurred during pregnancy
As a precaution, monitor the infant for adequate feeding, fever, frequent infections, diarrhoea, or unusual behaviour
30 November 2021

New Medicines

KevzaraGiant cell (temporal) arteritis

Information

Kevzara
Licence extension / variation
Sanofi Genzyme
Sanofi

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 20Removed from company pipeline, and no longer in planned filings. Assume development discontinued [8].

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

KevzaraPolymyalgia rheumatica

Information

Kevzara
Licence extension / variation
Sanofi Genzyme
Sanofi

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 20Removed from Sanofi pipeline and no longer in planned filings. Assume development discontinued [5].

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