This page contains a Flash digital edition of a book.
For adults with Type 1 or

Type 2 diabetes1 Next generation basal insulin


(insulin glargine 300 U/ml). Please refer to Summary of Product

Characteristics prior to use of Toujeo. Toujeo Solostar pre-fi lled pens each contain 450 Units of insulin glargine in 1.5 ml of solution for injection, equivalent to 10.91 mg/ml. Indications: Treatment of diabetes mellitus in adults. Administration: Toujeo is administered subcutaneously once daily, at any time of the day, preferably at the same time every day. Do not administer intravenously. Insulin glargine dose regimen (dose and timing) should be individually adjusted. 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, Toujeo can also be given together with other anti-hyperglycaemic medicinal products. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. Dose and timing of other antidiabetic medicines may need to be adjusted. 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. Mixing or diluting Toujeo changes its time/action profi le and mixing causes precipitation. Insulin requirements may be diminished in the elderly or patients with renal or hepatic impairment. The safety and effi cacy of Toujeo have not been established in children and adolescents below 18 years of age. No data are available. Contraindications: Hypersensitivity to insulin glargine or any excipients. Precautions and warnings: 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 unit-to- unit 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%) to reduce the risk of hypoglycaemia. Close metabolic monitoring is recommended

during the switch and in the initial weeks thereafter. Toujeo is not the insulin of choice for treatment of diabetic ketoacidosis. In case of insuffi cient 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. Insulin administration may cause insulin antibodies to form. Rarely, this may necessitate dose adjustment. Particular caution should be exercised, and intensifi ed 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. 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. Pregnancy and lactation: No clinical data on exposed pregnancies from controlled clinical trials are available. A large amount of data on pregnant women (more than 1000 pregnancy outcomes with a medicinal product containing insulin glargine 100 units/ml (Lantus)) indicate no specifi c adverse effects on pregnancy and no specifi c malformative nor feto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity. The use of Toujeo may be considered during pregnancy, if clinically needed. Insulin requirements may decrease during the fi rst trimester and generally increase during the second and third

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to the Sanofi drug safety department on 01483 554242.

SAGB.TJO.15.06.0747d | Date of preparation: August 2015 Reference: 1. Toujeo SmPC.

trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential. It is unknown if insulin glargine is excreted in breast milk. Adverse reactions: Very common: Hypoglycaemia.

threatening. Common: Lipohypertrophy, injection site reactions, including redness, pain, itching, hives, swelling, or

Prolonged or severe hypoglycaemia may be life- infl ammation. Uncommon: Lipoatrophy. Rarely:

Immediate-type allergic reactions; which may be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock and may be life threatening; visual impairment, retinopathy and oedema. Very rare: Dysgeusia, myalgia. Insulin administration may cause insulin antibodies to form and may, in rare cases, necessitate adjustment of the insulin dose. Overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia. Please consult Summary of Product Characteristics for full details of the recognised side effects with Toujeo. NHS price: £33.13 for pack of x3 1.5ml pens. Legal category: POM. MA holder: Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. MA Numbers: SoloStar: 3 Pen pack: EU/1/00/133/034. Full prescribing information is available from: Sanofi , One Onslow Street, Guildford, Surrey, GU1 4YS. Tel: 01483 505515 or the Sanofi Diabetes Care Line 08000 35 25 25. Date of PI Revision: May 2015

Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108