HIGHLIGHTS OF PRESCRIBING INFORMATION ... - Sanofi

1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use TOUJEO safely andeffectively. See full PRESCRIBING INFORMATION for TOUJEO .TOUJEO (insulin glargine injection) U-300, for subcutaneous useInitial Approval: 2015 RECENT MAJOR CHANGES Dosage and Administration ( , )3/2018 Warnings and Precautions ( , )3/2018 INDICATIONS AND USAGE TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults withdiabetes mellitus. (1)Limitations of Use:Not recommended for treating diabetic ketoacidosis. (1) DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoringresults and glycemic control goal.

2 ( , , ) Administer subcutaneously once daily at any time during the day, at the same time every day.( ) Rotate injection sites to reduce the risk of lipodystrophy. ( ) Do not dilute or mix with any other insulin or solution. ( ) Closely monitor glucose when changing to TOUJEO and during initial weeks thereafter. ( ) DOSAGE FORMS AND STRENGTHS Injection: 300 units/mL insulin glargine in: mL TOUJEO SoloStar disposable prefilled pen (3) 3 mL TOUJEO Max SoloStar disposable prefilled pen (3) CONTRAINDICATIONS During episodes of hypoglycemia (4) Hypersensitivity to TOUJEO or one of its excipients (4) WARNINGS AND PRECAUTIONS Never sharea TOUJEO SoloStar or TOUJEO Max SoloStar-disposable prefilled pen betweenpatients, even if the needle is changed ( ) Hyperglycemia or hypoglycemia with changes in insulin regimen:Carry out under closemedical supervision.

3 ( ) Hypoglycemia:May be life-threatening. Increase frequency of glucose monitoring with changesto: insulin dosage, coadministered glucose-lowering medications, meal pattern, physicalactivity, and in patients with renal impairment or hepatic impairment or hypoglycemiaunawareness. ( , ) Medication Errors:Accidental mix-ups between insulin products can occur. Instruct patients tocheck insulin labels before injection. ( ) Hypersensitivity reactions:Severe, life-threatening, generalized allergy, including anaphylaxis,can occur. Discontinue TOUJEO, monitor and treat if indicated. ( , ) Hypokalemia:May be life-threatening. Monitor potassium levels in patients at risk of hypoka-lemia and treat if indicated.

4 ( ). Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs):Observefor signs and symptoms of heart failure; consider dosage reduction or discontinuation if heartfailure occurs. ( ) ADVERSE REACTIONS Adverse reactions commonly associated with TOUJEO ( 5%) are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edemaand weight gain. ( , )To report SUSPECTED ADVERSE REACTIONS, contact Sanofi -aventis at 1-800-633-1610 orFDA at 1-800-FDA-1088 DRUG INTERACTIONS Drugs that affect glucose metabolism:Adjustment of insulin dosage may be needed; closelymonitor blood glucose.

5 (7) Antiadrenergic Drugs ( , beta-blockers, clonidine, guanethidine, and reserpine):Signs andsymptoms of hypoglycemia may be reduced or absent. (7) USE IN SPECIFIC POPULATIONS Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to thefetus. ( )See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 03/2018 FULL PRESCRIBING INFORMATION : CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND Dosing Dose in Insulin-Naive Dose in Patients with Either Type 1 or Type 2 Diabetes Already on Administration Instructions3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between or Hypoglycemia with Changes in Insulin and Allergic Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists6 ADVERSE Trials DRUG INTERACTIONS8 USE IN SPECIFIC OVERDOSAGE11 DESCRIPTION12 CLINICAL Mechanism of Pharmacokinetics13 NONCLINICAL Carcinogenesis, Mutagenesis.

6 Impairment of Fertility14 CLINICAL Overview of Clinical Clinical Study in Adult Patients with Type 1 Clinical Studies in Adult Patients with Type 2 Diabetes16 HOW SUPPLIED/STORAGE AND How Storage17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full PRESCRIBING INFORMATION are not listedFULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGETOUJEO is indicated to improve glycemic control in adults with diabetes of Use:TOUJEO is not recommended for the treatment of diabetic DOSAGE AND General Dosing Instructions TOUJEO is available in 2 disposable prefilled pens: TOUJEO SoloStar contains 450 units of TOUJEO U-300. It delivers doses in 1 unitincrements and can deliver up to 80 units in a single injection.

7 TOUJEO Max SoloStar contains 900 units of TOUJEO U-300. It delivers doses in 2 unitincrements and can deliver up to 160 units in a single injection. It is recommended for patientsrequiring at least 20 units per day. Inject TOUJEO subcutaneously once a day into the abdominal area, thigh, or deltoid at the sametime each day. Rotate injection sites within the same region from one injection to the next to reduce the risk oflipodystrophy[see Adverse Reactions ( )]. Individualize and titrate the dosage of TOUJEO based on the individual s metabolic needs, bloodglucose monitoring results, and glycemic control To minimize the risk of hypoglycemia, titrate the dose of TOUJEO no more frequently than every3 to 4 days.

8 Dosage adjustments may be needed with changes in physical activity, changes in meal patterns( , macronutrient content or timing of food intake), changes in renal or hepatic function or duringacute illness to minimize the risk of hypoglycemia or hyperglycemia[see Warnings andPrecautions ( ) and Use in Specific Populations ( , )]. Use TOUJEO with caution in patients with visual impairment who may rely on audible clicks todial their Starting Dose in Insulin-Naive PatientsType 1 Diabetes The recommended starting dose of TOUJEO in insulin-naive patients with type 1 diabetes isapproximately one-third to one-half of the total daily insulin dose. The remainder of the total dailyinsulin dose should be given as a short-acting insulin and divided between each daily meal.

9 Asa general rule, to units of insulin per kilogram of body weight can be used to calculate theinitial total daily insulin dose in insulin-naive patients with type 1 diabetes. The maximum glucose lowering effect of a dose of TOUJEO may take five days to fully manifestand the first TOUJEO dose may be insufficient to cover metabolic needs in the first 24 hours ofuse[see Clinical Pharmacology ( )]. To minimize risks associated with insufficient insulinizationwhen initiating TOUJEO, monitor glucose daily, titrate TOUJEO per instructions, and adjustcoadministered glucose-lowering therapies per standard of 2 Diabetes The recommended starting dose of TOUJEO in insulin-naive patients with type 2 diabetes is per kilogram of body weight once daily.

10 The dosage of other antidiabetic drugs may needto be adjusted when starting TOUJEO to minimize the risk of hypoglycemia[see Warnings andPrecautions ( )]. Starting Dose in Patients with Either Type 1 or Type 2 Diabetes Already on Insulin Therapy To minimize the risk of hypoglycemia when changing patients from a once-daily long-acting orintermediate-acting insulin product to TOUJEO, the starting dose of TOUJEO can be the sameas the once-daily long-acting dose. For patients controlled on LANTUS (insulin glargine, 100units/mL) expect that a higher daily dose of TOUJEO will be needed to maintain the same levelof glycemic control[see Clinical Pharmacology ( ) and Clinical Studies ( )].