RYZODEG

What it is

Ryzodeg 70/30 is a soluble insulin product consisting of insulin degludec (ultra-long acting basal insulin) and insulin aspart (rapid acting mealtime insulin) administered in one injection. The product contains 100 U insulin degludec/insulin aspart per millilitre (70% soluble insulin degludec and 30% soluble insulin aspart). Insulin degludec and insulin aspart are produced by recombinant DNA technology in Saccharomyces cerevisiae. Ryzodeg 70/30 is a ready-to-use, clear, colourless, neutral solution in pre-filled pen or cartridge.

Approved indications

— Use in diabetes mellitus in patients aged 6 years and older.

Dosing overview

Ryzodeg 70/30 can be administered once- or twice-daily with the main meal(s). For adults with type 2 diabetes, the recommended total daily starting dose of Ryzodeg 70/30 is 10 units with meal(s) followed by individual dosage adjustments. For patients with type 1 diabetes, the recommended starting dose of Ryzodeg 70/30 is 60–70% of the total daily insulin requirements. Ryzodeg 70/30 is to be dosed in accordance with individual patients' needs. Pre-meal plasma glucose levels should be used to evaluate the adequacy of the preceding dose.

Key safety warnings

Ryzodeg 70/30 must be taken with a carbohydrate containing meal. Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Ryzodeg 70/30 should be used with special caution in paediatric patients because data from the clinical trial indicate that there may be a higher risk for severe hypoglycaemia. As with other basal insulin products or insulin products with a basal component, the prolonged effect of Ryzodeg 70/30 may delay recovery from hypoglycaemia. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. 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.

Contraindications

Hypersensitivity to insulin degludec, insulin aspart or to any of the excipients.

Regulatory history

Ryzodeg 70/30 FlexTouch and Ryzodeg 70/30 Penfill were first listed on the Australian Register of Therapeutic Goods on 29 November 2017. The TGA approved Ryzodeg 70/30 FlexTouch and Ryzodeg 70/30 Penfill on 24 November 2017, for improving glycaemic control in adult patients with diabetes mellitus requiring basal and prandial insulin. The TGA's evaluation identified advantages over other premixed insulins, such as 24-hour basal coverage and reduced nocturnal hypoglycaemia. This medicinal product is subject to additional monitoring in Australia.