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
|
|
|
Local
allergy
|
|
X
|
|
|
|
|
|
Systemic
allergy
|
|
|
|
X
|
|
|
|
Skin
and subcutaneous tissue disorders
|
|
|
Lipodystrophy
|
|
|
X
|
|
|
|
|
Cutaneous
amyloidosis
|
|
|
|
|
|
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.