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Safety in Lactation: Insulins

23 September 2020Exogenous insulin is excreted into breast milk, including that from insulin analogues. Insulin in breast milk is thought to be necessary for intestinal maturation of…

Insulin preparations: RMOC recommendations of safety considerations for formulary decision making

22 June 2018At its meeting on 18th April 2018 the Regional Medicines Optimisation Committee (RMOC) (Midlands and East) reviewed issues pertaining to safety considerations when adopting any…
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Refrigerated Storage

NovoRapidNovo Nordisk

Novo Nordisk
NovoRapid
Injections (vials, penfills and pen), 100units/ml

The manufacturer does not hold stability data in addition to that provided in the Summary of Product Characteristics (SPC).

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

21 July 2020
London MI Service

FiaspNovo Nordisk Limited 

Novo Nordisk Limited 
Fiasp
100 units/mL solution for injection in pre-filled pen/cartridge/vial

The manufacturer does not hold stability data in addition to that provided in the Summary of Product Characteristics (SPC).

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

21 July 2020
London MI Service

Lactation Safety Information

Yes
Likely to be degraded in infant's GI tract
Short-acting recombinant human insulin
11 September 2020

New Medicines

Trurapi (UK), Insulin aspart Sanofi (EU)Type 1 and 2 diabetes mellitus

Information

Trurapi (UK), Insulin aspart Sanofi (EU)
Biosimilar
Sanofi
Sanofi

Development and Regulatory status

Launched
Approved (Licensed)
Phase III Clinical Trials
June 2021
Jun 21Launched in the UK. Price of 100iu/ml: 5 x 3ml cartridges=£19.82, and 5 x 3ml SoloStar pre-filled pen=£21.42 [9].
Jan 21MHRA grants a licence to Insulin aspart Sanofi, now known in the UK by the brand name Trurapi [10].
Jun 20Insulin aspart Sanofi is a biosimilar medicinal product. It is highly similar to the reference product NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. Data show that Insulin aspart Sanofi has comparable quality, safety and efficacy to NovoRapid (insulin aspart) [8].
Jun 20Approved in EU [8].
Apr 20Recommended for EU approval by CHMP - the full indication is "for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above." [7]
Jul 19Is now pre-registration in the EU [5].
Mar 18EU filing planned for 2019; US submission strategy under evaluation [2].

Category

A rapid acting insulin
Currently, 3.8 million people in the UK are diagnosed with diabetes. Up to 1 million people have type 2 diabetes that is yet to be diagnosed, so the total is estimated to be 4.7 million people at present. This represents 7% of the UK population (1 in every 15 people) having diabetes (diagnosed and undiagnosed). 10% have type 1 diabetes [3]. Incidence is increasing by about 4% each year, particularly in children under five, with a 5% increase each year in this age group [4].
Type 1 and 2 diabetes mellitus
Subcutaneous injection

Trial or other data

Dec 18PIII GEMELLI 1 no longer recruiting; study completion date Jan 2019 [6].
Aug 17PIII GEMELLI 1 trial to compare the efficacy of insulin aspart with NovoLog®/NovoRapid® in 580 patients in the US with diabetes (type I or type II diabetes mellitus), also using insulin glargine starts (NCT03211858). Primary outcome is change in glycated hemoglobin (HbA1c); collection of these data are expected to complete Jul 18 [1].

Evidence based evaluations

KixelleType 1 and 2 diabetes mellitus

Information

Kixelle
Biosimilar
Mylan UK
Viatris

Development and Regulatory status

Licensed but not launched
Licensed but not launched
None
Mar 21Viatris has yet to decide in which countries it will launch and when [4].
Feb 21Now licensed in EU and UK [3].
Dec 20EU positive opinion for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Kixelle will be available as a solution for injection (100 units/ml) [2].

Category

A rapid acting insulin
Currently, 3.8 million people in the UK are diagnosed with diabetes. Up to 1 million people have type 2 diabetes that is yet to be diagnosed, so the total is estimated to be 4.7 million people at present. This represents 7% of the UK population (1 in every 15 people) having diabetes (diagnosed and undiagnosed). 10% have type 1 diabetes [1].
Type 1 and 2 diabetes mellitus
Subcutaneous injection

Trial or other data

Dec 20Kixelle is a biosimilar medicinal product. It is highly similar to the reference product NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. Data show that Kixelle has comparable quality, safety and efficacy to NovoRapid [2].