Ryzodeg FlexTouch Dosage/Direction for Use

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.
In patients with type 2 diabetes mellitus, Ryzodeg can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin (see Pharmacological properties: Pharmacodynamic properties under Actions).
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 meal-time 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-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 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 elderly patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacological properties: Pharmacokinetic properties under Actions).
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 Pharmacological properties: Pharmacokinetic properties under Actions).
Pediatric population: The safety and efficacy of Ryzodeg in children and adolescents below 18 years of age have not been established. Currently available data are described in Pharmacokinetic properties under Actions, but no recommendation on a posology can be made.
Method of administration: Ryzodeg is for subcutaneous use only.
Ryzodeg must not be administered intravenously as it may result in severe hypoglycemia.
Ryzodeg must not be administered intramuscularly as it may change the absorption.
Ryzodeg must not be used in insulin infusion pumps.
Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
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.