TOUJEO- insulin glargine injection, solution TOUJEO MAX- insulin glargine injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

insulin glargine (UNII: 2ZM8CX04RZ) (insulin glargine - UNII:2ZM8CX04RZ)

から入手可能:

Sanofi-Aventis U.S. LLC

INN（国際名）:

insulin glargine

構図:

insulin glargine 300 U in 1 mL

投与経路:

SUBCUTANEOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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:

認証ステータス:

Biologic Licensing Application

製品の特徴

TOUJEO- INSULIN GLARGINE INJECTION, SOLUTION
TOUJEO MAX- INSULIN GLARGINE INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
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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, manufactur