Insunova Adverse Reactions

Serious: As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect. It may occur if the insulin dose is too high in relation to the insulin requirement. Symptoms of hypoglycaemia can be caused by the release of adrenaline or by an inadequate supply of glucose to the brain. Mild nocturnal hypoglycaemia may cause restless sleep, nightmares, or a cold sweat that awakens patient at night. With severe hypoglycaemia, lack of sufficient glucose to the brain may cause slurred speech, impaired concentration, confusion, seizures, coma and irreversible brain damage and death.
Common: Symptoms resulting from release of an adrenaline are common manifestations of mild to moderate hypoglycaemia. They include cold sweats, anxiety, shakiness, hunger, rapid heartbeat, headache, and nervousness. Weight gain is common when taking insulin.
Less Common: Anaphylactic reactions and lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area. Oedema may occur upon initiation of insulin therapy. These symptoms are usually a transitory nature.
Insunova-G: Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
The following related adverse reactions from clinical investigations are listed as follows by system organ class and in order of decreasing incidence: Very Commonly (≥1/10): Metabolism and Nutrition Disorders: Hypoglycaemia.
Commonly (≥1/100 to <1/10): Skin and Subcutaneous Tissue Disorders: Lipohypertrophy.
General Disorders and Administration Site Conditions: Injection site reactions.
Uncommonly (≥1/1000 to <1/100): Skin and Subcutaneous Tissue Disorders: Lipoatrophy.
Rarely (≥1/10,000 to <1/1000): Immune System Disorders: Allergic reactions.
Eye Disorders: Visual impairment, retinopathy.
General Disorders and Administration Site Conditions: Oedema.
Very Rarely (<1/10,000): Nervous System Disorders: Dysgeusia.
Musculoskeletal and Connective Tissue Disorders: Myalgia.
Metabolism and Nutrition Disorders: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life threatening. In many patients, the signs and symptoms of neuroglycopaenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Immune System Disorders: Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angiooedema, bronchospasm, hypotension and shock and may be life threatening. Insulin administration may cause insulin antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper-or hypoglycaemia.
Eye Disorders: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensive insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Skin and Subcutaneous Tissue Disorders: As with any insulin therapy, lipodystrophy 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.
General Disorders and Administration Site Conditions: Injection site reactions include redness, pain, itching, hives, swelling or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Paediatric Population: In general, the safety profile for children and adolescents (18 years) is similar to the safety profile for adults. The adverse reaction reports received from post-marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (18 years) than in adults. No safety data from clinical studies are available in children <6 years. In a clinical study done by Biocon the adverse events were similar in nature, frequency and severity as compared to the reference product.
Hypoglycaemic events were the most common adverse events in both the treatment groups. Apart from hypoglycaemia, pyrexia was the next most common adverse event with 3 events in each study arm. Retinal adverse events reported in this study were comparable between the treatment groups. The abnormalities in the laboratory parameters were comparable between the 2 study arms and all of them were considered not clinically significant. Antibodies against Biocon's insulin glargine were observed with the same frequency as compared to the reference product.