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Humalog ® (insulin lispro)
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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); not known (cannot be estimated form the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA system organ classes |
Very common |
Common |
Uncommon |
Rare |
Very rare |
Not known |
Immune system disorders |
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Local allergy |
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X |
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Systemic allergy |
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X |
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Skin and subcutaneous tissue disorders |
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Lipodystrophy |
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X |
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Cutaneous amyloidosis |
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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.
Skin and subcutaneous tissue disorders
Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions
Oedema
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie, or United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk /yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Reference
Humalog 200 Units/ml [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.
Date of Last Review: 22 September 2020
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