Ryzodeg Dosage/Direction for Use

Posology: Ryzodeg 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 Pharmacology: Pharmacodynamics under Actions). 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 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 Pharmacology: Pharmacokinetics 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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacodynamics under Actions). 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 Precautions).
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 Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
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 Precautions).
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 and cutaneous amyloidosis (see Precautions and Adverse Reactions).
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 (see Special precautions for disposal and other handling under Cautions for Usage).
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.