Basalog One

Basalog One Adverse Reactions

insulin glargine




Full Prescribing Info
Adverse Reactions
In a clinical study done by Biocon, the adverse events for Basalog One were found to be similar in nature, frequency and severity as compared to the reference product (Lantus).
The following data for adverse events is summarized from the publicly available information of Lantus.
Summary of the safety profile: Hypoglycaemia (very common), 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 (see Precautions).
Tabulated list of adverse reactions: The following related adverse reactions from clinical investigations are listed as follows 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: 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 counterregulation and its symptoms.
Immune System Disorders: Immediate-type allergic reactions to insulin glargine are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio oedema, bronchospasm, hypotension and shock, and may be life threatening.
Insulin glargine administration may cause insulin glargine 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.
Immunogenicity Comparison: In Studies MYL-GAI-3001 and MYL-GAI-3002, the immunogenicity profiles were comparable between the Basalog One and Lantus groups. No clinically relevant differences were seen for % SB for ADA or cross-reactive insulin antibody at any post-baseline visits. The incidences of ADA (total ADA) and cross-reactive insulin antibody were also comparable between the 2 treatment groups. No clinically relevant differences were found at any post-baseline visits. The incidence of patients meeting the criteria for the presence of potential neutralizing antibodies was very similar between the 2 groups, as was the incidence of anti-HCP antibodies.
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 of 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 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.
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 glargine may cause sodium retention and oedema particularly if previously 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 the national reporting system.
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