RYZODEG Solution for injection Ref.[50574] Active ingredients: Insulin aspart Insulin degludec

Posology

This medicinal product is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart.

The potency of insulin analogues, including Ryzodeg, is expressed in units. One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.

Ryzodeg is to be dosed in accordance with the individual patient’s needs. Dose-adjustments are recommended to be based on fasting plasma glucose measurements.

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

Patients with type 2 diabetes mellitus

Ryzodeg can be administered once or twice daily with the main meal(s) alone, in combination with oral antidiabetic medicinal products, and in combination with bolus insulin (see section 5.1). When using Ryzodeg once-daily, changing to twice daily should be considered when higher doses are needed, e.g. to avoid hypoglycaemia. Split the dose based on individual patient’s needs and administer with main meals.

Patients with type 1 diabetes mellitus

Ryzodeg can be administered once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals.

Flexibility in dosing time

Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s).

If a dose of this medicinal product is missed, the patient can take the missed dose with the next main meal of that day and thereafter resume the usual dosing schedule. Patients should not take an extra dose to make up for a missed dose.

Initiation

Patients with type 2 diabetes mellitus

The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments.

Patients with type 1 diabetes mellitus

The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements. This medicinal product is to be used once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.

Transfer from other insulin medicinal products

Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted.

Patients with type 2 diabetes mellitus

Patients switching from once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous total daily insulin dose.

Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous total daily insulin dose.

Patients switching from basal/bolus insulin therapy to Ryzodeg will need to convert their dose based on individual needs. In general, patients are initiated on the same number of basal units.

Patients with type 1 diabetes mellitus

The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.

Special populations

Elderly (≥65 years old)

Ryzodeg can be used in the elderly. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).

Renal and hepatic impairment

Ryzodeg can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).

Paediatric population

There is no clinical experience with the use of this medicinal product in children below the age of 2 years.

This medicinal product can be used in adolescents and children from the age of 2 years (see section 5.1). When changing from another insulin regimen to Ryzodeg, dose reduction of total insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see section 4.4).

Ryzodeg should be used with special caution in children 2 to 5 years old because data from the clinical trial indicate that there may be a higher risk for severe hypoglycaemia in children in this age group (see sections 4.4, 4.8 and 5.1).

Method of administration

Subcutaneous use only.

This medicinal product must not be administered intravenously as it may result in severe hypoglycaemia.

This medicinal product must not be administered intramuscularly as it may change the absorption.

This medicinal product must not be used in insulin infusion pumps.

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

Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh. 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).

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).

Ryzodeg 100 units/mL solution for injection in pre-filled pen

Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles. The pre-filled pen delivers 1–80 units in steps of 1 unit.

Ryzodeg 100 units/mL solution for injection in cartridge

Ryzodeg comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.

A specific overdose for insulin cannot be defined. However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin 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 glucose-containing products.
• Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously 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.

30 months.

Ryzodeg 100 units/mL solution for injection in pre-filled pen:

After first opening or carried as a spare, the medicinal product may be stored for a maximum of 4 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C–8°C). Keep the cap on the pen in order to protect from light.

Ryzodeg 100 units/mL solution for injection in cartridge:

After first opening or carried as a spare, the medicinal product may be stored for a maximum of 4 weeks. Do not store above 30°C. Do not refrigerate. Keep the cartridges in the outer carton in order to protect from light.

Ryzodeg 100 units/mL solution for injection in pre-filled pen

Before first use:

Store in a refrigerator (2°C–8°C). Do not freeze.

Keep away from the freezing element.

Keep the cap on the pen in order to protect from light.

Ryzodeg 100 units/mL solution for injection in cartridge

Before first use:

Store in a refrigerator (2°C–8°C). Do not freeze.

Keep away from the freezing element.

Keep the cartridges in the outer carton in order to protect from light.

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

Ryzodeg 100 units/mL solution for injection in pre-filled pen:

3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.

Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.

Not all pack sizes may be marketed.

Ryzodeg 100 units/mL solution for injection in cartridge:

3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.

Pack sizes of 5 and 10 cartridges.

Not all pack sizes may be marketed.

This medicinal product is for use by one person only. It must not be refilled.

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

Ryzodeg 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 waste material should be disposed of in accordance with local requirements.

For detailed instructions for use, see the package leaflet.

Ryzodeg 100 units/mL solution for injection in pre-filled pen:

The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm. It delivers 1–80 units in steps of 1 unit. Detailed instructions accompanying the pre-filled pen must be followed.

Ryzodeg 100 units/mL solution for injection in cartridge:

The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm. Detailed instructions accompanying the delivery system must be followed.