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

Posology

Xultophy is given once daily by subcutaneous administration. Xultophy can be administered at any time of the day, preferably at the same time of the day.

Xultophy is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule. A minimum of 8 hours between injections should always be ensured. This also applies when administration at the same time of the day is not possible.

Xultophy is administered as dose steps. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. The pre-filled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step. The maximum daily dose of Xultophy is 50 dose steps (50 units insulin degludec and 1.8 mg liraglutide). The dose counter on the pen shows the number of dose steps.

Add-on to oral glucose-lowering medicinal products

The recommended starting dose of Xultophy is 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide).

Xultophy can be added to existing oral antidiabetic treatment. When Xultophy is added to sulfonylurea therapy, a reduction in the dose of sulfonylurea should be considered (see section 4.4).

Transfer from GLP-1 receptor agonist

Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy. When transferring from a GLP-1 receptor agonist, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 5.1). The recommended starting dose should not be exceeded. If transferring from a long-acting GLP-1 receptor agonist (e.g. onceweekly dosing), the prolonged action should be considered. Treatment with Xultophy should be initiated at the moment the next dose of the long-acting GLP-1 receptor agonist would have been taken. Close glucose monitoring is recommended during the transfer and in the following weeks.

Transfer from any insulin regimen that includes a basal insulin component

Therapy with other insulin regimens should be discontinued prior to initiation of Xultophy. When transferring from any other insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1). The recommended starting dose should not be exceeded, but may be reduced to avoid hypoglycaemia in selected cases. Close glucose monitoring is recommended during the transfer and in the following weeks.

Special populations

Elderly patients (≥65 years old)

Xultophy can be used in elderly patients. Glucose monitoring is to be intensified and the dose adjusted on an individual basis.

Renal impairment

When Xultophy is used in patients with mild, moderate or severe renal impairment, glucose monitoring is to be intensified and the dose adjusted on an individual basis. Xultophy cannot be recommended for use in patients with end-stage renal disease (see sections 5.1 and 5.2).

Hepatic impairment

Xultophy can be used in patients with mild or moderate hepatic impairment. Glucose monitoring is to be intensified and the dose adjusted on an individual basis. Due to the liraglutide component, Xultophy is not recommended for use in patients with severe hepatic impairment (see section 5.2).

Paediatric population

There is no relevant use of Xultophy in the paediatric population.

Method of administration

Xultophy is for subcutaneous use only. Xultophy must not be administered intravenously or intramuscularly.

Xultophy is administered subcutaneously by injection in the thigh, the upper arm or the abdomen. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8). For further instructions on administration, see section 6.6.

Xultophy must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).

Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).

Limited data are available with regard to overdose of Xultophy.

Hypoglycaemia may develop if a patient is dosed with more Xultophy than required:

• Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the patient always carries sugar-containing products
• Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon given intramuscularly, subcutaneously or intranasally by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.

2 years.

After first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C. The medicinal product should be discarded 21 days after first opening

Before first opening: Store in a refrigerator (2°C-8°C). Keep away from the freezing element. Do not freeze. Keep the cap on the pre-filled pen in order to protect from light.

After first opening: Store at a maximum of 30°C or store in a refrigerator (2°C-8°C). Do not freeze. Keep the cap on the pre-filled pen in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

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.

The pre-filled pen is designed to be used with NovoTwist or NovoFine injection needles up to a length of 8 mm and as thin as 32G.

The pre-filled pen is for use by one person only.

Xultophy must not be used if the solution does not appear clear and colourless.

Xultophy which has been frozen must not be used.

A new needle must always be attached before each use. Needles must not be re-used. The patient should discard the needle after each injection.

In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

For detailed instructions for use, see the package leaflet.