RYZODEG® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ml

INJECTION, SOLUTION

**4.2 Posology and method of administration** **Posology** Ryzodeg® is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. Ryzodeg® can be administered once or twice daily with the main meal(s). When needed, the patient can change the time of administration as long as Ryzodeg® is dosed with the largest meal when taken once daily. The potency of insulin analogues, including Ryzodeg®, is expressed in units (U). One (1) unit (U) of Ryzodeg® corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart. _Patients with type 2 diabetes mellitus_ In patients with type 2 diabetes mellitus, Ryzodeg® can be administered alone, in combination with oral antidiabetic medicinal products, and in combination with bolus insulin (see Pharmacodynamic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with type 1 diabetes mellitus_ In type 1 diabetes mellitus, Ryzodeg® is combined with short-/rapid-acting insulin at the remaining meals. Ryzodeg® is to be dosed in accordance with the individual patient’s needs. Dose adjustments are recommended to be primarily based on fasting plasma glucose measurements. As with all insulin products adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. _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 Ryzodeg® 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. Ryzodeg® 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. _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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. _Paediatric population:_ Ryzodeg® can be used in adolescents of age 12–17 years. 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **Method of administration** Ryzodeg® is for subcutaneous use only. Ryzodeg® must not be administered intravenously as it may result in severe hypoglycaemia. Ryzodeg® must not be administered intramuscularly as it may change the absorption. Ryzodeg® must not be used in insulin infusion pumps. Ryzodeg® must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 this leaflet (see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.