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.
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