HUMULIN

What it is

HUMULIN is available in three presentations: HUMULIN R (regular–neutral–soluble human insulin of recombinant DNA origin), HUMULIN NPH (isophane human insulin of recombinant DNA origin), and HUMULIN 30/70 (a mixture consisting of 30% regular human insulin and 70% isophane human insulin of recombinant DNA origin). HUMULIN is chemically, physically, biologically and immunologically equivalent to pancreatic human insulin.

Approved indications

— Treatment of insulin-dependent diabetic patients.

Dosing overview

The dosage should be determined by the physician according to the requirements of the patient. HUMULIN R is a short-acting insulin which may be administered by subcutaneous, intramuscular or intravenous injection. HUMULIN NPH and HUMULIN 30/70 should only be administered by subcutaneous or intramuscular injection. A mixture of HUMULIN R and NPH is usually administered as a twice-daily regimen, while HUMULIN NPH may be given as a single daily dose before breakfast. Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen, with injection sites rotated so that the same site is not used more frequently than once a month to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.

Key safety warnings

Any change in an insulin regimen should be made cautiously and only under medical supervision with increased frequency of glucose monitoring, as changes in strength, brand, type, species or method of manufacture may result in the need for a change in dosage. Insulin requirements may be increased during illness or emotional disturbances, and in the event of infectious diseases the insulin requirements increase, requiring the patient to consult their physician to prevent dangerous complications. Patients whose glycaemic control is greatly improved may lose some or all of the warning symptoms of hypoglycaemia and should be advised accordingly. Thiazolidinediones in combination with insulin are associated with an increased risk of oedema and heart failure, especially in patients with underlying cardiac disease. Patients who receive insulin containing protamine have an increased risk of severe reactions simulating anaphylaxis when protamine is used to reverse systemic heparinisation after cardiac catheterisation. Hypoglycaemia is the most frequent undesirable effect of insulin therapy, and severe hypoglycaemia may lead to loss of consciousness and, in extreme cases, death. Local allergy including pruritus, rash, erythema and induration occasionally occurs as redness, swelling and itching at the site of insulin injection, usually resolving in a few days to a few weeks. Systemic allergy, less common but potentially more serious, is a generalised allergy to insulin that may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse or sweating, with severe cases potentially being life-threatening.

Contraindications

HUMULIN R, HUMULIN NPH and HUMULIN 30/70 are contraindicated in hypoglycaemia. Human insulin is contraindicated in patients with hypersensitivity to human insulin or any of its excipients unless used as part of a desensitisation program. HUMULIN NPH and 30/70 vials should not be administered by the intravenous route. HUMULIN R, NPH and 30/70 cartridges should not be administered by the intramuscular or intravenous route.

Regulatory history

HUMULIN R and HUMULIN NPH vials were first approved on 5 September 1991. HUMULIN R, HUMULIN NPH and HUMULIN 30/70 cartridges were first listed on 12 May 1992, along with HUMULIN 30/70 vials.