dm+d

126212009

Articles

RMOC Best Value Biologic – Insulin Glargine Toolkit: Consultation running until 24/12/2020

26 November 2020A draft toolkit has been produced on Best value biologic – insulin glargine, on behalf of the RMOC system. Insulin glargine is the first medicine managed…

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…

In use product safety assessment report for insulin glargines

11 November 2019The availability of five insulin glargine products as multiple presentations in the UK market creates a real potential for confusion in the prescribing, dispensing, and…

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…
Search Articles

Refrigerated Storage

LantusSanofi

Sanofi
Lantus
Solution for injection. 100 units/mL. Vials, cartridges and pre-filled pen (SoloStar)

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

Vials
Unopened vials are not to be stored above 8°C. Storage of unopened vials or in-use vials above the recommended 8°C reduces shelf life to 28 days. The vial can be stored back in the refrigerator (2-8°C) or at temperatures not exceeding 25°C for 5 ml vials and 30°C for 10ml vials.

Cartridges
If unopened cartridges are stored above 8°C they have a reduced shelf life of 28 days and may be stored back in the refrigerator (2-8°C) or at room temperature below 30°C. In-use cartridges in the pen device should be stored at room temperature not exceeding 30°C and must be discarded 28 days after opening. The pen cap must be put back on the pen after each injection to protect from light.

SoloStar
If unused SoloStar pens are stored between 8°C to 30°C they have a reduced shelf life of 28 days. After first use, a SoloStar pen should continue to be stored at room temperature not exceeding 30°C for a maximum of 28 days. The pen cap must be put back on the SoloStar pen after each injection to protect from light.

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

If exposed to temperatures as described above, reduce the expiry date to 28 days from the date of excursion.
See above

Pen products should be kept inside the box with the pen lids on to protect them from light. Do not freeze them or keep them near the freezer compartment of the refrigerator. The products should be protected from light.

12 October 2020
London MI Service

ToujeoSanofi

Sanofi
Toujeo
Injection, 300 units/ml, pre-filled disposable injection

In the event of an inadvertent temperature excursion the following data may be used:
Shelf life after first use of the pen
The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light.

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

6 weeks when exposed to conditions described above
No when exposed to conditions described above

Do not freeze.

12 October 2020
London MI Service

AbasaglarEli Lilly

Eli Lilly
Abasaglar
100 units/ml solution for injection in cartridge and pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce expiry to 28 days for temperature excursions described above
See above
20 May 2019
London Medicines Information service

Lactation Safety Information

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

New Medicines

Toujeo Type 1 and 2 diabetes mellitus in children and adolescents

Information

Toujeo
Licence extension / variation
Sanofi
Sanofi

Development and Regulatory status

Launched
Launched
Launched
November 2019
Nov 19Approved in the UK. Pack sizes and prices - 3 x 1.5ml SoloStar pre-filled pen=£33.13, 3 x 3ml DoubleStar pre-filled pen=£66.26 [9,10].
Nov 19Approved in US [8].
Oct 19Recommended for EU approval by CHMP - the amended indication is "Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years" [5].

Category

U300 is a new formulation based on the insulin glargine molecule but has flatter and more prolonged pharmacokinetic/dynamic profile than Lantus and offers the benefit of a smaller volume of subcutaneous injection vs Lantus.
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 in children and adolescents
Subcutaneous injection

Trial or other data

May 20PIII EDITION JUNIOR RCT (n=463) found similar reductions in HbA1c at week 26 (-0.40% for both, non-inferiority demonstrated). Incidence of severe or documented hypoglycaemia were similar. Incidence of any hyperglycaemia with ketosis was 6.4% for glargine 300 vs 11.8% for glargine 100 [11].
Nov 19Topline data from the EDITION JUNIOR PIII trial (NCT02735044) show that it reached its primary endpoint of comparable reduction (to insulin glargine 100 Units/mL) in blood sugar over 6m and similar risk of hypoglycemia. The change From baseline in HbA1c to Month 6 was -0.399 % with Toujeo and -0.402% with Lantus (95% CI; -0.172 to 0.179 with non-inferiority demonstrated if the upper bound of the two-sided 95% confidence interval for the difference in the mean change in HbA1c from baseline to month 6 was <0.3%.). The % of pts with FPG of 7.2 mmol/L without symptomatic Hypoglycemia within last 3 Months was 9.44% in the Toujeo gp and 7.39% with Lantus. [6,7]
May 18Recruitment in PIII study (NCT02735044) is complete [2].
Mar 16PIII study to compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c) starts (NCT02735044). 450 children aged 6 to 17 years will be recruited in the UK, Eastern & Western Europe, North & South America, Asia and Africa. Collection of primary outcome data due to complete May 18 [1,2].