Update on Insuman®
January 10, 2017
End of temporary shortage supply of Insulin human - INSUMAN® BASAL, COMB 25 – suspension for injection in 3 mL cartridges and prefilled pens
In November 2015 Sanofi provided notification of the lack of availability of Insuman® Basal and Comb 25.
In agreement with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency, Sanofi would like to confirm the resolution of the market shortage of Insuman® (recombinant human insulin) in the United Kingdom.
The cause of the shortage was the limited manufacturing capacity at the Sanofi manufacturing site.
The presentations concerned are:
- Insuman® Basal 100 IU/mL suspension for injection in a cartridge
- Insuman® Comb 25 100 IU/mL suspension for injection in a cartridge
- Insuman® Basal Solostar® 100 IU/mL suspension for injection in a pre-filled pen
- Insuman® Comb 25 Solostar® 100 IU/mL suspension for injection in a pre-filled pen
Normal production resumed in September 2016. Stocks in the different distribution centers, hospitals and pharmacies are currently being replenished and will be back to normal by the end of March 2017.
Further information - implications for patients
The re-conversion of patients initially treated with Insuman®, who were switched to an alternative insulin and who would like to come back to Insuman®, should be performed under the supervision of a Healthcare Professional and with close monitoring of blood glucose levels. Patients may need to be trained again in the use of the Insuman delivery device that is specific to each device manufacturer.
Call for reporting
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
The following should be reported:
- all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason.
- all suspected ADRs associated with new drugs and vaccines identified by the black triangle
Reports can also be made to the Sanofi UK Pharmacovigilance department at:Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 01483 554242, Fax: 01483 554806, Email: email@example.com
Company contact point
Should you have any question or require additional information, please call Medical Information at Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK - Tel: 0845 372 7101, Email: firstname.lastname@example.org. For questions relating to order of product: Sanofi Customer Services – 0800 854 430, (9am – 5.15pm Monday-Thursday, 9am – 4pm Friday).
January 2017 - SAGB.INA.16.12.1119b