Humalog ® (insulin lispro)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Humalog Summary of Product Characteristics (SmPC)

Humalog 200 Units/ml (insulin lispro): Undesirable effects

Summary of the safety profile of Humalog 200 Units/ml KwikPen (insulin lispro)

Summary of safety profile

Hypoglycaemia is the most frequent adverse reaction of insulin lispro 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.

Tabulated list of adverse reactions

The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA system organ classes

Very common

Common

Uncommon

Rare

Very rare

Immune system disorders

Local allergy


X




Systemic allergy




X


Skin and subcutaneous tissue disorders

Lipodystrophy



X





Description of selected adverse reactions

Local allergy

Local allergy in patients is common). 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

Systemic allergy, which is rare 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

Lipodystrophy at the injection site is uncommon.

Oedema

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

Reference

Humalog 200 Units/ml [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.

Date of Last Review: December 26, 2018

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