Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)
Lantus® is contraindicated in patients hypersensitive to insulin glargine or
one of its excipients.
Warnings and Precautions
Monitor blood glucose in all patients treated with insulin. Insulin regimens should
be modified cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment.
Do not dilute or mix Lantus® 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. Do not administer Lantus® via an
insulin pump or intravenously because severe hypoglycemia can occur. Insulin devices
and needles must not be shared between patients.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®,
and may be life-threatening.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
A reduction in the Lantus® dose may be required in patients with renal or hepatic
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Other adverse reactions commonly associated with Lantus® are injection site
reaction, lipodystrophy, pruritus, and rash.
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.
Important Safety Information for Lantus®
Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure
an accurate dose each time, patients should follow all steps in the Instruction
Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin,
which may affect their blood glucose.
Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)
Lantus® is a long-acting insulin analog indicated to improve glycemic control
in adults and children (6 years and older) with type 1 diabetes mellitus and in
adults with type 2 diabetes mellitus. Lantus® should be administered once a
day at the same time every day.
Important Limitations of Use: Lantus® is not recommended for the treatment of
diabetic ketoacidosis. Use intravenous short-acting insulin instead.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
here for Full Prescribing Information for Lantus®.