PROTAPHANE

What it is

Protaphane is a suspension containing 100 international units isophane insulin (rys) per mL. Insulin (rys) is produced by recombinant DNA technology using Saccharomyces cerevisiae. Protaphane is a suspension for injection that appears cloudy, white and aqueous.

Approved indications

— Treatment of insulin-requiring diabetes.

Dosing overview

Dosage is individual and determined by the physician in accordance with the needs of the patient. The average range of total daily insulin requirement for maintenance therapy in type 1 diabetes lies between 0.5 and 1.0 IU/kg/day. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg/day, but can be much lower during the period of partial remission. Initial dosages for type 2 diabetes are often lower, for example 0.3 to 0.6 IU/kg/day, and should be adjusted slowly until optimum glycaemic control is reached. The physician determines whether one or more daily injections are necessary, and Protaphane is usually given once or twice daily. Insulin is usually administered subcutaneously by injection in the abdominal wall, the thigh, the gluteal region or the deltoid region.

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 come on gradually over a period of hours or days and include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased urination, thirst and loss of appetite as well as acetone breath. In type 1 diabetes, untreated hyperglycaemic events lead to diabetic ketoacidosis which is potentially lethal. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Concomitant illness, especially infections and conditions with fever, usually increases the patient's insulin requirements. Under certain circumstances such as insufficient food intake or increased physical activity, the daily dose administered to the patient may represent an overdose leading to hypoglycaemia. Hypoglycaemia is a frequently occurring undesirable effect of insulin therapy occurring if the insulin dose is too high in relation to the insulin requirement. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, nervousness or tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, temporary vision changes, headache, nausea and palpitations. 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

Protaphane is contraindicated in hypoglycaemia, hypersensitivity to insulin or any of the excipients, and should not be administered intravenously.

Regulatory history

Protaphane was first registered on the ARTG on 28 April 2011 in three presentations: Protaphane InnoLet human insulin (rys) 100 IU/mL injection multidose cartridge (ARTG 169633), Protaphane Penfill human insulin (rys) 100 IU/mL injection multidose cartridge (ARTG 169635), and Protaphane human insulin (rys) 100 IU/mL injection multidose vial (ARTG 169637).