OPTISULIN

What it is

Optisulin is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia. Optisulin is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing. Optisulin is available as a 3 mL cartridge and pre-filled pen, each containing insulin glargine 100 units per mL.

Approved indications

— Type 1 diabetes mellitus in adults and children — Type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia

Dosing overview

Optisulin is given subcutaneously once a day, administered at any time during the day, however, at the same time every day. In a clinical study in insulin-naïve patients with type 2 diabetes, Optisulin was started at a dose of 10.8 ± 4.9 IU (mean ± SD; median dose 10 IU) once daily and subsequently adjusted individually. Optisulin can be safely administered to paediatric patients older than 6 years of age. When patients are transferred from once daily insulin glargine 300 units per mL to once daily Optisulin, the recommended initial Optisulin dose is approximately 80% of the insulin glargine 300 units per mL that is being discontinued. When patients were transferred from twice-daily NPH human insulin to Optisulin once daily at bedtime, the initial dose was usually reduced by approximately 20% compared to total daily IU of NPH human insulin within the first week of treatment and then adjusted based on patient response.

Key safety warnings

Optisulin must not be diluted or mixed with any other insulin or solution and is not intended for intravenous administration. The prolonged duration of activity of insulin glargine is dependent on injection into subcutaneous space. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia. Particular caution including intensified blood glucose monitoring should be exercised in patients who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. The warning symptoms of hypoglycaemia may be changed, be less pronounced, or be absent in certain risk groups such as in patients whose glycaemic control is markedly improved, in elderly patients, where autonomic neuropathy is present, in patients with a long history of diabetes, and in patients receiving concurrent treatment with certain other drugs. Such situations may result in severe hypoglycaemia and possibly loss of consciousness prior to the patient's awareness of hypoglycaemia. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and localised 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. There was a slightly higher rate of injection site pain seen with Optisulin, possibly related to the acidic nature of insulin glargine when compared with NPH insulin. The majority of injection site reactions were mild, with only one subject in each of the Optisulin and NPH treatment groups discontinuing study medication due to injection site adverse events.

Contraindications

Optisulin must not be used in patients hypersensitive to insulin glargine or any of its excipients.

PBS listing

Optisulin is listed on the PBS as injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 pack. There are 2 PBS items with unrestricted restriction. The ex-manufacturer price is A$31.71.

Regulatory history

Optisulin cartridge (ARTG 159295) and Optisulin SoloStar pre-filled pen (ARTG 159302) were both first listed on the ARTG on 2009-11-05. In July 2018, the PBAC recommended unrestricted PBS listing of Optisulin as a biosimilar brand, flagged as equivalent to Lantus SoloStar for substitution at pharmacy level.