Ryzodeg SC Injection 100 IU/ml

Uses

Insulin degludec (a long-acting human insulin analog) and insulin aspart (a rapid-acting human insulin analog) used to improve glycemic control in patients 1 year of age and older with diabetes mellitus

Ryzodeg SC Injection 100 IU/ml is also used to associated treatment for these conditions: Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

How Ryzodeg SC Injection 100 IU/ml works

Insulin detemir binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signalling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism.

Dosage

Ryzodeg SC Injection 100 IU/ml dosage

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

This 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.

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 is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.

This 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 this insulin is dosed with the largest meal when taken once daily.

In patients with type 2 diabetes mellitus this insulin can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin.

In type 1 diabetes mellitus, this insulin is combined with short-/rapid-acting insulin at the remaining meals.

Side Effects

Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain

Toxicity

Observe for signs and symptoms of hypoglycemia, hypokalemia, and fluid retention and heart failure with concomitant use of Thiazolidinediones. Pregnancy Category C

Precaution

Hypoglycaemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.

Hyperglycaemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.

Eye disorder: Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.

Avoidance of accidental mix-ups: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between this and other insulin products.

Older patients (> 65 years old): Insulin Degludec & Insulin Aspart Premixed can be used in older patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.

Paediatric population: This Insulin has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been investigated in children and adolescents.

Interaction

There are no known drug interactions and none well documented.

Elimination Route

In patients with type 1 diabetes, after 8 days of once daily subcutaneous dosing with 0.4 U/kg, maximum degludec concentrations of 4472 pmol/L were attained at a median of 9 hours (tmax). After the first dose of, median onset of appearance was around one hour. The glucose lowering effect lasted at least 42 hours after the last of 8 once-daily injections. Insulin degludec concentration reach steady state levels after 3-4 days.

Half Life

The half-life after subcutaneous administration is determined primarily by the rate of absorption from the subcutaneous tissue. On average, the half-life at steady state is approximately 25 hours independent of dose.

Clearance

The mean apparent clearance of insulin degludec is 0.03 L/kg (2.1 L/h in 70 kg individual) after single subcutaneous dose of 0.4 units/kg.

Pregnancy & Breastfeeding use

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.

Contraindication

Hypersensitivity to the active substances or to any of the excipients.

Special Warning

Renal and hepatic impairment: This insulin can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.

Innovators Monograph

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