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Glyxambi▼ gets approval for use in Scotland

Glyxambi▼, for Type 2 diabetes from Boehringer Ingelheim

The Scottish Medicines Consortium (SMC) have approved Boehringer Ingelheim's medicine containing empagliflozin and linagliptin, brand name Glyxambi▼, for the treatment of adults aged 18 years and older with type 2 diabetes mellitus:
  • to improve glycaemic control (blood sugar) when metformin and/or sulphonylurea and one of the components of Glyxambi do not provide adequate glycaemic control
  • When already being treated with the free combination of empagliflozin and linagliptin
In patients for whom this combination is appropriate, Glyxambi offers a single tablet at a lower cost per dose compared with the individual components.

You can follow developments with Glyxambi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Glyxambi (source EMA)
Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels. It contains two active substances, empagliflozin and linagliptin.

Glyxambi is used in the following groups:
  • patients whose blood glucose levels are not controlled well enough by a combination of one of Glyxambi’s active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea);
  • patients who are already taking empagliflozin and linagliptin as separate tablets
Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood. The two active substances in Glyxambi work in different ways to lower glucose levels:

Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine. By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood. Empagliflozin has been authorised in the European Union (EU) as Jardiance since 2014.

Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Linagliptin has been authorised in the EU as Trajenta since 2011.
Together, these actions reduce blood glucose levels and help to control type 2 diabetes.

Glyxambi was first made available in the EU in 2016. It is manufactured by Boehringer Ingelheim.

Sources
European Medicines Agency website page for Glyxambi
Accessed 13/08/19
Links available in External Resources

SMC information on Glyxambi

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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