TOUJEO MAX- insulin glargine injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ)

Disponible depuis:

A-S Medication Solutions

Mode d'administration:

SUBCUTANEOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Product: 50090-4177 NDC: 50090-4177-0 3 mL in a SYRINGE / 2 in a CARTON

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

TOUJEO MAX- INSULIN GLARGINE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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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, manufacturer, type, injection site,
or method of admin