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Ondibta is a brand name for Insulin Glargine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Ondibta contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Ondibta should be administered once daily at any time but at the same time each day. The dose regimen (dose and timing) should be individually adjusted.
In patients with type 2 diabetes mellitus, Ondibta can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. 1). Special populations Elderly population (≥ 65 years old) In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Renal impairment In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. 3 Hepatic impairment In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
1). The dose regimen (dose and timing) should be individually adjusted. Children below 2 years of age The safety and efficacy of Ondibta have not been established. No data are available. Switch from other insulins to Ondibta When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Ondibta, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Switch from twice daily NPH insulin to Ondibta To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Ondibta should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Switch from insulin glargine 300 units/ml to Ondibta Ondibta and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Ondibta should reduce their dose by approximately 20%.
During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
4). Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are 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 system organ classes Very common Common Uncommon Rare Very rare Not known Immune system disorders Allergic reactions Metabolism and nutrition disorders Hypoglycaemia Nervous system disorders Dysgeusia Eye disorders Visual impairment Retinopathy Skin and subcutaneous tissue disorders Lipohypertrophy Lipoatrophy Cutaneous amyloidosis Musculoskeletal and connective tissue disorders Myalgia 8 General disorders and administration site conditions Injection site reactions Oedema 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 neuroglycopenia are preceded by signs of adrenergic counter-regulation. 4). 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, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening. 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, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Ondibta is not the insulin of choice for the treatment of diabetic ketoacidosis.
Instead, regular insulin administered intravenously is recommended in such cases. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. ), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis.
There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.
Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Hypoglycaemia The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Due to more sustained basal insulin supply with Ondibta, less nocturnal but more early morning hypoglycaemia can be expected. Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. 4). Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Ondibta.
Method of administration Ondibta is administered subcutaneously. Ondibta should not be administered intravenously. The prolonged duration of action of Ondibta is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Ondibta. 8). 4 Ondibta must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
6).
In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis. Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption.
4). 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 of age) 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 of age) than in adults.
Clinical study safety data are not available for children under 2 years. 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 listed in Appendix V. 9
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. 5). Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
g. g. 5). Intercurrent illness Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Insulin antibodies Insulin administration may cause insulin antibodies to form. 1). Handling of Ondibta pre-filled pen Ondibta 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. Before using Ondibta, the instructions for use included in the package leaflet must be read carefully.
6). Medication errors Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.
Combination of Ondibta with pioglitazone 6 Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Ondibta is considered.
If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in […]