Toujeo

Toujeo

insulin glargine

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Concise Prescribing Info
Contents
Insulin glargine
Indications/Uses
DM in adults, adolescents & childn from age 6 yr.
Dosage/Direction for Use
SC Administer in the abdominal wall, deltoid or thigh. Individualized dose. Administer once daily at any time of the day, preferably at the same time every day. When needed, can be administered up to 3 hr before or after usual time of administration. Initiation Patient w/ type 1 DM Use once daily w/ meal-time insulin & requires individual dose adjustments, type 2 DM Initially 0.2 u/kg daily followed by individual dose adjustments.
Contraindications
Special Precautions
For SC use only. Do not administer IV. Do not use in insulin infusion pumps. Not the insulin of choice for treatment of diabetic ketoacidosis. Review adherence to prescribed treatment regimen, inj sites, proper inj technique & all other relevant factors prior to considering dose adjustment in case of insufficient glucose control or tendency to hyper- or hypoglycaemic episodes. Perform continuous rotation of inj site to reduce risk of developing lipodystrophy & cutaneous amyloidosis. Monitor blood glucose after change in inj site & consider dose adjustment of antidiabetics. Risk of hypoglycaemia. Caution in patients in whom hypoglycaemic episodes might be of clinical relevance (eg, patients w/ significant stenosis of coronary arteries or of blood vessels supplying brain as well as in patients w/ proliferative retinopathy, particularly if not treated w/ photocoagulation); patients w/ diminished warning symptoms of hypoglycaemia (eg, patients in whom glycaemic control is markedly improved, in whom hypoglycaemia develops gradually, elderly, after transfer from animal to human insulin, in whom an autonomic neuropathy is present, w/ long history of DM, suffering from psychiatric illness, receiving concurrent treatment w/ certain other medicinal products). Closely monitor patients & dose adjustment may be necessary in case of factors increasing susceptibility to hypoglycaemia eg, change in inj area; improved insulin sensitivity (eg, by removal of stress factors); unaccustomed, increased or prolonged physical activity; intercurrent illness (eg, vomiting, diarrhoea); inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders (eg, in hypothyroidism & anterior pituitary or adrenocortical insufficiency); concomitant treatment w/ certain other medicinal products. Caution when switching between insulin glargine 100 u/mL & Toujeo; another type or brand of insulins & Toujeo. Intercurrent illness requires intensified metabolic monitoring. May cause insulin Abs to form. Observe for signs & symptoms of heart failure, wt gain & oedema when used in combination w/ pioglitazone; discontinue pioglitazone if any deterioration in cardiac symptoms occurs. Always check insulin label before each inj to avoid medication errors between Toujeo & other insulins. Insulin requirements may be diminished in patients w/ renal or hepatic impairment. May impair ability to concentrate & react as a result of hypoglycaemia, hyperglycaemia, or visual impairment which may constitute risk when driving a car or using machines. Insulin dose may need to be changed during pregnancy & after giving birth. Carefully control diabetes for the health of baby. Change in insulin dose & diet might be needed during breast-feeding. Not to be used in childn <6 yr. Elderly ≥65 yr.
Adverse Reactions
Hypoglycaemia. Lipohypertrophy; inj site reactions.
Drug Interactions
Blood glucose-lowering effect may be enhanced & susceptibility to hypoglycaemia increased w/ antihyperglycaemics, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulfonamide antibiotics. Blood glucose-lowering effect may be reduced w/ corticosteroids, danazol, diazoxide, diuretics, glucagon, INH, oestrogens & progestogens, phenothiazine derivatives, somatropin, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotics (eg, clozapine & olanzapine) & PIs. Blood glucose-lowering effect may either be potentiated or weakened w/ β-blockers, clonidine, lithium salts or alcohol. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. Signs of adrenergic counter-regulation may be reduced or absent w/ sympatholytics eg, β-blockers, clonidine, guanethidine & reserpine.
MIMS Class
Insulin Preparations
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Form
Toujeo soln for inj 300 u/mL
Packing/Price
1.5 mL x 5 × 1's (P7,002.5/box, P1,400.5/soln for inj)