INSULIN GLARGINE injection, solution INSULIN GLARGINE SOLOSTAR- insulin glargine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sanofi-Aventis Deutschland GmbH

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Insulin glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use Insulin glargine is not recommended for the treatment of diabetic ketoacidosis. Insulin glargine is contraindicated: - during episodes of hypoglycemia [see Warnings and Precautions (5.3)] - in patients with hypersensitivity to Insulin glargine or one of its excipients [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 g

Product summary:

Insulin glargine injection is supplied as a clear solution containing 100 units per mL (U-100) available in: The insulin glargine SoloStar prefilled pen dials in 1-unit increments. Needles are not included in the packs. BD Ultra-Fine ® needles 1 to be used in conjunction with SoloStar prefilled pens are sold separately and are manufactured by BD. Dispense in the original sealed carton with the enclosed Instructions for Use. Insulin glargine should not be stored in the freezer and should not be allowed to freeze. Discard Insulin glargine if it has been frozen. Protect Insulin glargine from direct heat and light. Storage conditions are summarized in the following table.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INSULIN GLARGINE- INSULIN GLARGINE INJECTION, SOLUTION
INSULIN GLARGINE SOLOSTAR- INSULIN GLARGINE INJECTION, SOLUTION
SANOFI-AVENTIS DEUTSCHLAND GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN GLARGINE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INSULIN
GLARGINE.
INSULIN GLARGINE INJECTION, FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Insulin glargine is a long-acting human insulin analog indicated to
improve glycemic control in adults and
pediatric patients with type 1 diabetes mellitus and in adults with
type 2 diabetes mellitus. ( 1)
Limitations of Use
Not recommended for treating diabetic ketoacidosis. ( 1)
DOSAGE AND ADMINISTRATION
Individualize dosage based on metabolic needs, blood glucose
monitoring, glycemic control, type of
diabetes, and prior insulin use. ( 2.1, 2.3, 2.4)
Administer subcutaneously into the abdominal area, thigh, or deltoid
once daily at any time of day, but
at the same time every day. ( 2.1)
Do not dilute or mix with any other insulin or solution. ( 2.1)
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis. ( 2.2)
Closely monitor glucose when changing to Insulin glargine and during
initial weeks thereafter. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) available as:
10 mL multiple-dose vial ( 3)
3 mL single-patient-use SoloStar prefilled pen ( 3)
CONTRAINDICATIONS
During episodes of hypoglycemia ( 4)
Hypersensitivity to Insulin glargine or one of its excipients ( 4)
WARNINGS AND PRECAUTIONS
_Never share_ an Insulin glargine SoloStar 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 administration) under
close medical supervision with increased frequency of blood glucose
monitoring. ( 5.2)
_Hypoglycemia_