XULTOPHY Solution for injection Ref.[50802] Active ingredients: Insulin degludec Insulin degludec and Liraglutide Liraglutide

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Product name and form

Xultophy 100 units/mL + 3.6 mg/mL solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless, isotonic solution.

Qualitative and quantitative composition

1 mL solution contains 100 units insulin degludec* and 3.6 mg liraglutide*.

* Produced in Saccharomyces cerevisiae by recombinant DNA technology.

One pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide.

One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Insulin degludec

Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

Insulin degludec and Liraglutide

Insulin degludec/liraglutide is a combination having complementary mechanisms of action to improve glycaemic control. Insulin degludec is a basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect of insulin degludec with a low day-today variability in insulin action. Liraglutide is a Glucagon-Like Peptide-1 (GLP-1) analogue. Liraglutide action is mediated via a specific interaction with GLP-1 receptors and improves glycaemic control by lowering fasting and postprandial blood glucose.

Liraglutide

Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells. Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration.

List of Excipients

Glycerol
Phenol
Zinc acetate
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a stopper (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polycarbonate and acrylonitrile butadiene styrene.

Pack sizes of 1, 3, 5 and multipack containing 10 (2 packs of 5) pre-filled pens.

Not all pack sizes may be marketed.

Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Marketing authorization dates and numbers

EU/1/14/947/001
EU/1/14/947/002
EU/1/14/947/003
EU/1/14/947/004

Date of first authorisation: 18 September 2014
Date of latest renewal: 08 July 2019

Drugs

Drug Countries
XULTOPHY Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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