Insulin glargine 300 units/mL.
- Toujeo Solostar pre-filled disposable pen injector contains 1.5 mL solution for injection.
- Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
- Treatment of diabetes in individuals 6 years of age and older.
For the latest PBS indications for glargine 300 please see
- Insulin glargine 300 units/mL is a basal insulin for once daily subcutaneous administration at any time of the day, (preferably at the same time every day) without regard to food.
- Toujeo should be injected subcutaneously in the abdominal wall, the deltoid, or the thigh. It should never be administered intravenously.
- Before first use: the pen must be stored at room temperature at least 1 hour before use. After use it should be kept at room temperature (below30°C).
- Individuals who forget a dose: If an individual forgets a dose who, glucose levels should be monitored frequently. Double dose to make up for a forgotten dose should not occur.
- Hepatic impairment: In severe hepatic impairment, insulin requirements maybe diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Careful glucose monitoring and dose adjustments of insulin, including Toujeo, may be necessary. (Diabetes Medscheck, annual cycle of care, referral to appropriate health care professional)
- Renal impairment: Insulin requirements maybe diminished due to reduced insulin metabolism. Careful glucose monitoring and dose adjustments of insulin, including Toujeo, maybe necessary. Diabetes Medscheck, annual cycle of care, referral to appropriate health care professional)
- Elderly In the elderly, progressive deterioration of renal function may lead to steady decrease in insulin requirements. Careful glucose monitoring and dose adjustments of insulin, including Toujeo, maybe necessary in the elderly.
- Toujeo can be used from the age of 6 years.
- Hypersensitivity to glargine or any active ingredient
- Insulin glargine 100 units/mL and insulin glargine 300 units/mL are not bioequivalent.
- Do not mix or dilute Toujeo. Insulin glargine 300 units/mL must not be mixed with any other insulin products. Mixing changes, the time/ action profile of insulin glargine 300units/mL and causes precipitation.
- Insulin glargine 300 units/mL and insulin glargine 100 units/mL injection both contain the same active ingredient, insulin glargine, and therefore should not be used together.
- Switching between insulin glargine 100 units/mL and insulin glargine 300 units/mL.
- Insulin glargine 100 units/mL and insulin glargine 300 units/mL are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/mL to insulin glargine 300 units/mL, the dose should be adjusted on a unit-to-unit basis based on the current total daily dose of insulin glargine 100 units/mL. In clinical studies adults may require approximately 10-18% more Toujeo than insulin glargine 100 units/mL to achieve target ranges. Children may require approximately 8% more Toujeo than insulin glargine 100 units/mL to achieve target ranges for plasma glucose levels.
- When switching from insulin glargine 300 units/mL to insulin glargine 100 units/mL, the dose should be reduced (approximatelyby10-18%in adults and 8%in children) to reduce the risk of hypoglycaemia.
- Close metabolic monitoring is recommended during any switch and in the initial weeks thereafter.
- Storage: Do not put Toujeo next to the freezer compartment or a freezer pack. Do not allow the insulin to freeze, discard if frozen.
- Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. These include (but are not restricted to) change in the injection area improved insulin sensitivity (e.g., by removal of stress factors, weight loss); unaccustomed, increased, or prolonged physical activity. intercurrent illness (e.g., vomiting, diarrhoea); inadequate food intake; missed meals; and alcohol consumption.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
Note: Diabetes MedsCheck with counselling that hypoglycaemia is part of the side effect profile. Referral for blood glucose monitoring. If hypoglycaemia is happening regularly consider referral to healthcare team for adjustment of dose.
- Eyes. A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. As with all insulin regimens, intensification of insulin therapy with abrupt improvement in glycaemic management maybe associated with temporary visual impairment or worsening of diabetic retinopathy. However, long-term improved glycaemic management decreases the risk of progression of diabetic retinopathy.
Note: Diabetes MedsCheck with referral to healthcare if suspected.
- Injection site and allergic reactions. As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation.
Note: Diabetes MedsCheck with counselling on side effect profile and referral to healthcare team to establish correct injection.
- 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, angioedema, bronchospasm, hypotension, and shock, and maybe life threatening.
Note: Diabetes MedsCheck with counselling on side effect profile and referral to hospital for immediate treatment if suspected.
After subcutaneous injection of insulin glargine 300 units/mL, the insulin serum concentrations indicated a slower and more prolonged absorption resulting in an even flatter time concentration profile for up to 36 hours in comparison to insulin glargine 100 units/mL. Concentrations were consistent with the time profile of the pharmacodynamic activity of insulin glargine 300 units/mL. Steady-state level within the therapeutic range is reached after 3-4 days of daily insulin glargine 300 units/mL administration.
After subcutaneous injection of insulin glargine patients, it is rapidly metabolized at the carboxyl terminus of the beta chain with formation of two active metabolites M1 (21A-Glyinsulin) and M2 (21A-Glydes 30B-Thr insulin). In plasma, the principal circulating compound is the metabolite M1.
The half-life after subcutaneous administration of insulin glargine 300 units/mL is determined by the rate of absorption from the subcutaneous tissue. The half-life of Toujeo after subcutaneous injection is 18-19 hours independent of dose.