NOVOMIX

What it is

NovoMix 30 and NovoMix 50 are white suspensions for subcutaneous injection consisting, respectively, of 30% soluble insulin aspart and 70% protamine-crystallised insulin aspart, and 50% soluble insulin aspart and 50% protamine-crystallised insulin aspart. These are biphasic insulin preparations which produce insulin plasma profiles similar to premixed biphasic human insulin, apart from the initial faster absorption of the soluble component. Insulin aspart is a rapid-acting analogue of human insulin that rapidly lowers blood glucose.

Approved indications

— Treatment of diabetes mellitus.

Dosing overview

The dosage of NovoMix is determined by the physician according to the patient's individual needs. The individual insulin requirement is usually between 0.5 and 1.0 Units/kg/day in adults and children. The daily insulin requirement may be fully or partially supplied with NovoMix products. The recommended starting dose of NovoMix products in combination with metformin is 0.2 Units/kg/day and should be adjusted depending on individual requirements based on blood glucose response. Insulin aspart products are administered by subcutaneous injection in the abdominal wall, the thigh, the deltoid region or the gluteal region. The duration of action of NovoMix 30 is up to 24 hours. The duration of action of NovoMix 50 is up to 16 hours.

Key safety warnings

Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. The first symptoms of hyperglycaemia usually develop gradually, over a period of hours or days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst and loss of appetite as well as acetone breath. Untreated hyperglycaemic events may be life threatening. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia is the most frequently reported adverse reaction. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. 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. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.

Contraindications

NovoMix is contraindicated in hypoglycaemia and hypersensitivity to insulin aspart or any of the excipients. NovoMix products should never be administered intravenously.

Regulatory history

NovoMix 50 FlexPen was first listed on the ARTG on 10 May 2007. NovoMix 30 Penfill and NovoMix 30 FlexPen were first listed on the ARTG on 5 June 2008.