HUMALOG

What it is

HUMALOG U200 KwikPen contains insulin lispro (rbe), an aqueous solution of insulin lispro (a recombinant DNA origin insulin analogue). It is available as a clear, colourless solution for subcutaneous administration in a concentration of 200 units/mL in a 3 mL prefilled insulin delivery device. It has a very quick onset of action and a short duration of activity.

Approved indications

— Treatment of patients with Type 1 (IDDM) and Type 2 (NIDDM) diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Dosing overview

HUMALOG U200 can be given immediately (up to 15 minutes before a meal), or when necessary, soon after meals (within 20 minutes of the start of the meal). It is anticipated the same dose of HUMALOG U200 to HUMALOG 100 units/mL will be required. HUMALOG U200 should be reserved for the treatment of patients with diabetes requiring daily doses of more than 20 units of rapid-acting insulin. In patients with Type 2 diabetes HUMALOG U200 may be administered in combination therapy with oral sulfonylurea agents.

Key safety warnings

All insulins, including HUMALOG U200, lower blood glucose levels and may cause hypoglycaemia. Patients should be educated about the symptoms of hypoglycaemia (e.g., hunger, anxiety, sweating, tachycardia, confusion, etc.), and the risk factors for hypoglycaemia (e.g., reduced carbohydrate intake, exercise, oral hypoglycaemic agents, alcohol). The ability to concentrate and to react may be impaired as a result of hypoglycaemia, in particular recurrent hypoglycaemia, which may constitute a risk in situations where these abilities are of special importance (e.g., driving a car or operating machinery). Use of dosages which are inadequate or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal. 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. Thiazolidinediones (TZDs) in combination with insulin are associated with an increased risk of oedema and heart failure; especially in patients with underlying cardiac disease.

Contraindications

Hypoglycaemia. Hypersensitivity to insulin lispro or one of its excipients.

PBS listing

HUMALOG U200 is listed on the PBS as injections (human analogue), pre-filled pen, 200 units per mL, 3 mL, 5 with one PBS item and unrestricted restriction, at an ex-manufacturer price of A$45.78.

Regulatory history

HUMALOG U200 KwikPen (ARTG 226893) was first listed on 9 November 2015. In November 2017, the PBAC recommended listing of the new strength of insulin lispro HUMALOG U200 for the treatment of type 1 and 2 diabetes mellitus on a cost minimisation basis per unit of insulin with insulin lispro HUMALOG U100.