Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Summary of the safety profile
Hypoglycaemia, the most frequent adverse reactionof insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.

Tabulated list of adverse reactions
The following related adverse reactions from clinical studies were listed below 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 from the available data).

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

MedDRA Organ          Very common                Common             Uncommon              Rare                  Not known system classes
Metabolism and        Hypoglycaemia                                                                             Hyperglycaemia nutrition                                                                                                       (potentially disorders                                                                                                       leading to Diabetic ketoacidosis (1) )
Skin and                                      Injection site                              Lipodystrophy         Cutaneous reactions subcutaneous                                                                                                    amyloidosis Local tissue disorders                              hypersensitivity reactions
General                                                             Systemic disorders and                                                       hypersensitivity administration                                                      reactions site conditions

1)
Apidra 100 Units/ml solution for injection in a vial: Most of the cases were related to handling errors or pump system failure when Apidra was used with CSII.


Description of selected adverse reactions
Metabolism and nutrition disorders
Symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.

Apidra 100 Units/ml solution for injection in a vial
Cases of hyperglycaemia have been reported with Apidra when used with CSII (see section 4.4) that has led to Diabetic Ketoacidosis (DKA); most of the cases were related to handling errors or pump system failure. The patient should always follow the Apidra specific instructions and always have access to alternative insulin delivery system in case of pump system failure.

Skin and subcutaneous tissue disorders
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and normally they disappear during continued treatment.
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 (see section 4.4).
General disorders and administration site conditions
Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form at https://sideeffects.health.gov.il/.