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IMPORTANT SAFETY INFORMATION FOR LANTUS®

LANTUS® is indicated for once-daily subcutaneous administration, at the same time each day, for the treatment of adult and pediatric patients (6 years and older) with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

LANTUS® SoloSTAR® is a disposable insulin delivery device. Needles and the SoloSTAR® pen must not be shared.

LANTUS® MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner.

LANTUS® is contraindicated in patients hypersensitive to insulin glargine or the excipients.

Hypoglycemia is the most common adverse effect of insulin, including LANTUS®. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin type and/or regimen should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may need to be adjusted.

Other adverse events commonly associated with LANTUS® include the following: lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions.

In clinical studies in adult patients there was a higher incidence of treatment-emergent injection-site pain (2.7% LANTUS® vs 0.7% NPH). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.

Please click here for full prescribing information.

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US.GLA.07.07.085     Last Update: August 2007

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