NovoMix 30 FlexPen Adverse Reactions

Summary of the Safety Profile: Adverse drug reactions observed in patients using biphasic insulin aspart 30 are mainly due to the pharmacologic effect of insulin.
The most frequently reported adverse reaction during treatment is hypoglycemia. The frequencies of hypoglycemia vary with patient population, dose regimens and level of glycemic control (see Description of Selected Adverse Reactions as follows).
At the beginning of the insulin treatment, refraction anomalies, edema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of transitory nature.
Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic control decreases the risk of progression of diabetic retinopathy.
List of Adverse Reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention: 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).
Immune System Disorders: Uncommon: Urticaria, rash, eruptions. Very Rare: Anaphylactic reactions*.
Metabolism and Nutrition Disorders: Very Common: Hypoglycemia*.
Nervous System Disorders: Rare: Peripheral neuropathy (painful neuropathy).
Eye Disorders: Uncommon: Refraction disorders, diabetic retinopathy.
Skin and Subcutaneous Tissue Disorders: Uncommon: Lipodystrophy*.
General Disorders and Administration Site Conditions: Uncommon: Injection site reactions, edema.
*See Description of Selected Adverse Reactions as follows.
Description of Selected Adverse Reactions: Anaphylactic Reactions: The occurrence of generalized hypersensitivity reactions (including generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life-threatening.
Hypoglycemia: The most frequently reported adverse reaction is hypoglycemia. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
The symptoms of hypoglycemia 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.
In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens and level of glycemic control. During clinical trials, the overall rates of hypoglycemia did not differ between patients treated with insulin aspart compared to human insulin.
Lipodystrophy: Lipodystrophy is reported as uncommon. Lipodystrophy may occur at the injection site.