Presentation:

Toujeo SoloStar prefilled pens each contain 450 units of insulin glargine in 1.5ml of solution for injection. Toujeo DoubleStar prefilled pens each contain 900 units of insulin glargine in 3ml of solution for injection. Each 300 units insulin glargine is equivalent to 10.91mg.

Indications:

Treatment of diabetes mellitus in adults.

Administration:

Toujeo is administered subcutaneously, by injection into the abdominal wall, the deltoid or the thigh, once daily, at any time of the day, preferably at the same time every day. The dose regimen (dose and timing) should be adjusted according to individual response. Do not administer intravenously. The dose window shows the number of units of Toujeo to be injected. Both SoloStar and DoubleStar prefilled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen. Before using Toujeo the instructions for use included in the package leaflet must be read carefully. In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. In patients with type 2 diabetes mellitus, recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments. Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Toujeo SoloStar prefilled pen injects a dose between 1-80 units per single injection, in steps of 1 unit, Toujeo DoubleStar prefilled pen injects a dose of 2-160 units per single injection, in steps of 2 units.

Switch from Toujeo SoloStar to Toujeo DoubleStar:

If the patient’s previous dose was an odd number (e.g. 23 units) then the dose must be increased or decreased by 1 unit (e.g. 24 or 22 units). Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day.

Switch between insulin glargine 100 units/ml and Toujeo:

Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable. When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unittounit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels. When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%).

Switching from other basal insulins to Toujeo:

A change of dose and/or timing of the basal insulin and concomitant antihyperglycaemic treatment may be required. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia. Toujeo must not be mixed or diluted with any other insulin or other medicinal products. Close metabolic monitoring is recommended during a switch and in the initial weeks thereafter.

Special populations:

Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment.

Paediatric:

No data available.

Contraindications:

Hypersensitivity to insulin glargine or any excipients.

Precautions and warnings:

Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis.

Hypoglycaemia:

In case of insufficient glucose control or a tendency to hyper/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. Particular caution should be exercised, and intensified blood glucose monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups, potentially resulting in severe hypoglycaemia and loss of consciousness. Risk groups include patients in whom glycaemic control is markedly improved, hypoglycaemia develops gradually, an autonomic neuropathy is present, or who are elderly. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.

Intercurrent illness:

Requires intensified metabolic monitoring and often it is necessary to adjust the insulin dose.

Insulin antibodies:

Administration may cause insulin antibodies to form.

Use with pioglitazone:

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. 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 cardiac symptoms occurs.

Medication errors:

Insulin labels must always be checked before each injection to avoid errors between Toujeo and other insulins. Patients must be instructed to never use a syringe to remove Toujeo from the SoloStar or DoubleStar prefilled pen. A new sterile needle must be attached before each injection. Needles must not be re-used.

Pregnancy and lactation:

There is no data from exposed pregnancies in controlled clinical trials. However, there is a large amount of data on use of insulin glargine 100 units/ml in pregnant women indicating no specific adverse effects on pregnancy and no specific malformative nor feto/ neonatal toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk.

Adverse reactions:

• Very common (≥1/10): Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening.

• Common (≥1/100 to <1/10): Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or inflammation.

• Uncommon (≥1/1,000 to <1/100): Lipoatrophy.

• Rare (≥1/10,000 to <1/1,000): Allergic reactions; which may be associated with generalised skin reactions, angiooedema, bronchospasm, hypotension and shock and may be life threatening; visual impairment, retinopathy and oedema.

• Very rare (<1/10,000): Dysgeusia, myalgia. Overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

• Please consult SmPC for full details of the adverse reactions.

Legal category:

POM.

Marketing Authorisation holder:

Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

Marketing Authorisation Numbers:

EU/1/00/133/033-41.

Further information is available from:

• Sanofi 18 Riverwalk, Citywest Business Campus, Dublin 24 or

• Email: Emedinfo@sanofi-aventis.com

• Tel: (01) 403 5600.

Date of preparation:

July 2019 

 Presentations:

Lantus 100 units/ ml solution for injection in a vial or in a cartridge. Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen. Lantus cartridges and Solostar pre-filled pens each contain 3 ml of solution for injection, equivalent to 300 units insulin glargine. Each vial contains 10 ml of solution for injection, equivalent to 1000 units.

Indications:

Treatment of diabetes mellitus in adults, adolescents and children of 2 years or above.

Dosage and administration:

Lantus is administered subcutaneously once daily, at any time but at the same time each day. Injection sites must be rotated within a given injection area from one injection to the next. Do not administer intravenously. Lantus dosage should be individually adjusted. In type 2 diabetes mellitus, Lantus can also be used in combination with orally active antidiabetic medicinal products. Lantus must not be mixed with other insulins or diluted.

Switch from twice daily NPH insulin to Lantus:

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 Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.

Switch from Toujeo (insulin glargine) 300 units/ml to Lantus:

Lantus and Toujeo 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 Toujeo to a once daily regimen with Lantus should reduce their dose by approximately 20%.

Switching from other insulins to Lantus:

When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, 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). Close metabolic monitoring is recommended during, and for a period after, transition from other insulins to Lantus. Dose adjustments may also be required if the patient’s weight or lifestyle changes, the timing of insulin dose is changed or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia.

Elderly population (≥65 years old), patients with renal or hepatic impairment:

Insulin requirements may be diminished.

Children (<2 years of age):

No data are available.

Contraindications:

Hypersensitivity to insulin glargine or any excipients.

Precautions and warnings:

Lantus is not the insulin of choice for treatment of diabetic ketoacidosis. In case of insufficient glucose control or a tendency to hypo/hyperglycaemic episodes all 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.

Hypoglycaemia:

Particular caution should be exercised, and intensifi ed blood monitoring is advisable for patients in whom hypoglycaemic episodes might be of clinical relevance and in those where dose adjustments may be required. Warning signs of hypoglycaemia may be changed, less pronounced or absent in certain risk groups. The prolonged effect of subcutaneous Lantus may delay recovery from hypoglycaemia. Due to more sustained basal insulin supply with Lantus, less nocturnal but earlier morning hypoglycaemia can be expected.

Intercurrent illness:

Requires intensified metabolic monitoring.

Insulin antibodies:

Administration may cause insulin antibodies to form. Rarely, this may necessitate dose adjustment.

Pioglitazone:

Cases of cardiac failure have been reported, especially in patients with risk factors for development of cardiac heart failure. Patients on this combination should be observed and pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Medication errors:

Insulin labels must always be checked before each injection to avoid errors between Lantus and other insulins. Lantus Solostar is only suitable for subcutaneous injections from its pre-filled pen. Lantus cartridges are only suitable for subcutaneous injections from a reusable pen (JuniorSTAR which delivers Lantus in 0.5 unit dose increments and Autopen 24, AllStar and AllStar PRO which all deliver Lantus in 1 unit dose increments). If administration by syringe is necessary, a vial should be used.

Interactions:

A number of substances affect glucose metabolism and may require dose adjustment of Lantus.

Pregnancy and lactation:

No clinical data on exposed pregnancies from controlled clinical trials are available. A large amount of post-marketing data indicates no specifi c adverse effects of Lantus in pregnancy. Use of Lantus in pregnancy can be considered if clinically needed. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. It is unknown if Lantus is excreted in breast milk.

Reactions:

• Very common (≥1/10): Hypoglycaemia. Prolonged or severe hypoglycaemia may be life-threatening. 

• Common (≥1/100 to <1/10): Lipohypertrophy, injection site reactions.

• Uncommon (≥1/1,000 to <1/100): Lipoatrophy.

• Rare (≥1/10,000 to <1/1,000): Allergic reactions, visual impairment, retinopathy and oedema.

• Very rare (<1/10,000): Dysgeusia, myalgia. Overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

Please consult SmPC for full details of the adverse reactions.

Legal category:

POM.

Marketing Authorisation (MA) holder:

Sanofi  Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

MA Numbers:

• Vial: EU/1/00/134/012,

• Cartridge: EU/1/00/134/006,

• SoloStar: EU/1/00/134/033.

Full prescribing information is available from:

• Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24

• Email: Emedinfo@sanofi-aventis.com

• Tel.: (01) 4035600

Date of preparation:

April 2018

 Presentations:

Apidra 100 Units/ ml solution for injection in a vial each containing 10 ml of solution. Apidra 100 Units/ml solution for injection in a cartridge or in a pre-filled pen each containing 3 ml of solution. Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).

Indications:

Treatment of adults, adolescents and children 6 years or older, with diabetes mellitus, where treatment with insulin is required.

Dosage and administration:

Subcutaneous use:

Apidra cartridges and Solostar are only suitable for subcutaneous injections from a reusable pen and prefilled pen, respectively. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. Apidra should be given by subcutaneous injection (into the abdominal wall, thigh or deltoid) shortly (0-15 min) before or soon after meals or by continuous subcutaneous pump infusion (into the abdominal wall). Apidra must not be mixed with other medicinal products except NPH human insulin. Injection sites and infusion sites within an injection area should be rotated from one injection to the next. The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables. Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites. Care should be taken to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use proper injection techniques.

Intravenous use (Apidra vial only):

Must not be mixed with glucose, Ringer’s solution or with any other insulin and must be administered by a healthcare professional. Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion with the appropriate catheters and reservoirs. When used with a subcutaneous insulin infusion pump, Apidra must not be mixed with diluents or any other insulin. The infusion set and reservoir used with Apidra must be changed at least every 48 hours using aseptic technique. These instructions may differ from general pump manual instructions. It is important that patients follow the Apidra specifi c instructions, be comprehensively instructed on the use of the CSII pump system and must have an alternative insulin delivery system available in case of pump system failure, in order to prevent serious adverse events.

Special Populations:

Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment.

Paediatric:

There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.

Contraindications:

Hypoglycaemia, or hypersensitivity to insulin glulisine or any excipients (such as metacresol).

Precautions and warnings:

Transferring a patient to another type or brand of insulin should be done under strict medical supervision and may result in the need for a change in dose. Concomitant oral antidiabetic treatment may need to be adjusted.

Medication errors:

Insulin label must always be checked before each injection to avoid medication errors between Apidra and other insulins.

Hyperglycaemia:

The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.

Hypoglycaemia:

The time of occurrence of hypoglycaemia depends on the action profi le of the insulins used and may, therefore, change when the treatment regimen is changed. Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. Insulin requirements may be altered during illness or emotional disturbances.

Apidra cartridges should only be used with the following pens:

JuniorSTAR which delivers Apidra in 0.5 unit dose increments and Autopen 24, AllStar and AllStar PRO which all deliver Apidra in 1 unit dose increments.

Apidra in a vial:

Malfunction of the insulin pump, infusion set or handling errors can rapidly lead to hyperglycaemia, ketosis and diabetic ketoacidosis. Interim subcutaneous injections with Apidra may be required.

Apidra SoloStar in a pre-filled pen:

Instructions for use included in the Package leafl et must be read carefully, before administration.

Interactions:

Cases of cardiac failure have been reported when Pioglitazone is used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. A number of substances affect glucose metabolism and may require dose adjustment of Apidra.

Pregnancy and lactation:

Caution should be exercised when prescribing to pregnant women. Careful monitoring of glucose control is essential. It is unknown whether Apidra is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration. Breast-feeding mothers may require adjustments in insulin dose and diet.

Adverse reactions:

• Very common (≥1/10): Hypoglycaemia. Potentially becoming severe and may lead to unconsciousness and/or convulsions and temporary or permanent impairment of brain function or even death.

• Common (≥1/100 to <1/10): Injection site reactions and local hypersensitivity reactions, which are usually transitory and normally disappear during continued treatment.

Please consult SmPC for full details of adverse reactions.

Legal category:

OM (S1B).

MA holder:

Sanofi  Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

MA Numbers:

• Apidra 100 Units/ml solution for injection in a vial: EU/1/04/285/001-004

• Apidra 100 Units/ml solution for injection in a cartridge: EU/1/04/285/005-012

• Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: EU/1/04/285/029-036

Further information is available from:

• Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24

• Email: Emedinfo@sanofi-aventis.com

• Tel.: (01) 4035600

Date of Preparation:

April 2018

 

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