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Generic Name

Drug Description

Presentation

Indications

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. HUMALOG, HUMALOG Pen or HUMALOG KwikPen is also indicated for the initial stabilisation of diabetes mellitus.

Adult Dosage

The dosage should be determined by the physician, according to the requirement of the patient.

HUMALOG may be given shortly before meals. When necessary, HUMALOG can be given soon after meals.

HUMALOG preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump and may, although not recommended, also be given by intramuscular injection. If necessary, HUMALOG may also be administered intravenously, for example, for the control of blood glucose levels during ketoacidosis, acute illnesses, or during intraoperative and postoperative periods.

Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.

When administered subcutaneously, care should be taken when injecting HUMALOG, HUMALOG Pen or HUMALOG KwikPen to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use the proper injection techniques.

HUMALOG, HUMALOG Pen or HUMALOG KwikPen takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a HUMALOG injection (or, in the case of administration by continuous subcutaneous infusion, a HUMALOG bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. As with all insulin preparations, the duration of action of HUMALOG, HUMALOG Pen or HUMALOG KwikPen is dependent on dose, site of injection, blood supply, temperature, and physical activity.

HUMALOG can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.

Use of HUMALOG in an insulin infusion pump:

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions that accompany the infusion pump. Use the correct reservoir and catheter for the pump. Change the infusion set every 48 hours. Use aseptic technique when inserting the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion. A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your health care professional. When used with an insulin infusion pump, HUMALOG should not be mixed with any other insulin.

Intravenous administration of insulin:

Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring of the blood glucose levels is required.

Infusion systems at concentrations from 0.1U/ml to 1.0U/ml insulin lispro in 0.9% sodium chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed before starting the infusion to the patient.

Child Dosage

Contra Indications

Hypersensitivity to insulin lispro or to any of the excipients.

Hypoglycaemia.

Special Precautions

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, lente, etc), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/fasting glucose control.

Vials: The shorter-acting HUMALOG should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just before the injection should be on advice of the physician. However, a consistent routine must be followed.

Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, or medications such as beta-blockers.

A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.

The 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.

Insulin requirements may be reduced in the presence of renal impairment. Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.

Insulin requirements may be increased during illness or emotional disturbances.

Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.

If the 40U/ml vial is the product normally prescribed, do not take insulin from a 100U/ml cartridge using a 40U/ml syringe.

HUMALOG should only be used in children in preference to soluble insulin when a fast action of insulin might be beneficial. For example, in the timing of the injection in relation to meals.

Interactions

Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta₂ stimulants (such as ritodrine, salbutamol, terbutaline).

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide, or alcohol.

The physician should be consulted when using other medications in addition to HUMALOG, HUMALOG Pen or HUMALOG KwikPen.

Adverse Reactions

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors, e.g., a patient's level of diet and exercise.

Local allergy in patients is common (1/100 to <1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. Systemic allergy, which is rare (1/10,000 to <1/1,000) but potentially more serious, is a generalised allergy to insulin. It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be life-threatening.

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

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