País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
insulin glargine (UNII: 2ZM8CX04RZ) (insulin glargine - UNII:2ZM8CX04RZ)
Sanofi-Aventis U.S. LLC
insulin glargine
insulin glargine 300 U in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. Limitations of Use: TOUJEO is not recommended for the treatment of diabetic ketoacidosis. TOUJEO is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.3)] . - In patients with hypersensitivity to insulin glargine or any excipients in TOUJEO [see Warnings and Precautions (5.5)] . Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day. Overall, the effects of insulin glargine did not generally differ from those obser
TOUJEO U-300 (insulin glargine) injection 300 units/mL is a clear and colorless solution and is available as: Needles are not included in the packs of TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen. BD (such as BD Ultra-Fine® ), Ypsomed (such as Clickfine® ) or Owen Mumford (such as Unifine® Pentips® ) needles‡ can be used in conjunction with TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen and are sold separately. A new sterile needle must be attached before each injection. TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Dispense in the original sealed carton with the enclosed Instructions for Use. TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen should not be stored in the freezer and should not be allowed to freeze. Discard TOUJEO prefilled pen if it has been frozen. Protect TOUJEO SoloStar/TOUJEO Max SoloStar from direct heat and light. Storage conditions are summarized in the following table:
Biologic Licensing Application
TOUJEO- INSULIN GLARGINE INJECTION, SOLUTION TOUJEO MAX- INSULIN GLARGINE INJECTION, SOLUTION SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOUJEO U-300 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOUJEO U-300. TOUJEO U-300 (INSULIN GLARGINE) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. (1) Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis. (1) DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. (2.1, 2.2, 2.3) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day. (2.1) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (2.1) Do not dilute or mix with any other insulin or solution. (2.1) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to switch to TOUJEO from other insulins (2.3, 2.4) Closely monitor glucose when changing switching to TOUJEO and during initial weeks thereafter. (2.4) DOSAGE FORMS AND STRENGTHS Injection: 300 units/mL (U-300) insulin glargine in: 1.5 mL TOUJEO SoloStar single-patient-use prefilled pen (3) 3 mL TOUJEO Max SoloStar single-patient-use prefilled pen (3) CONTRAINDICATIONS During episodes of hypoglycemia (4) Hypersensitivity to insulin glargine or any excipients in TOUJEO (4) WARNINGS AND PRECAUTIONS _Never share_ a TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen between patients, even if the needle is changed. (5.1) _Hyperglycemia or hypoglycemia with changes in insulin regimen:_ Make changes to a patient's insulin regimen (e.g., insulin strength, manufactur Llegiu el document complet