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FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
Date:2/26/2009

es C]) until first use. Once in use, it should be kept at room temperature, as long as it remains below 86 degrees F [30 degrees C], away from direct heat or light, and can be used for up to 28 days.

IMPORTANT SAFETY INFORMATION FOR APIDRA(R)

Prescription Apidra(R) is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control. Apidra(R) should normally be used with a longer-acting insulin. Apidra(R) may also be infused subcutaneously by external insulin infusion pumps. Do not use Apidra(R) during a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine.

OptiClik(R) is a reusable insulin delivery device for use with a 3-mL Apidra(R) cartridge (U-100). Needles, OptiClik(R) and cartridge systems must not be shared.

Apidra(R) SoloSTAR(R) is a prefilled disposable insulin pen. Needles and the

SoloSTAR(R) pen must not be shared.

Apidra(R) differs from regular human insulin by its rapid onset and shorter duration of action. When used as a mealtime insulin, Apidra(R) should be given within 15 minutes before or within 20 minutes after starting a meal. Due to the short duration of action of Apidra(R), patients also require a longer-acting insulin or insulin infusion pump therapy. Any change of insulin should be made cautiously and only under medical supervision. Tell your doctor about all other medicines and supplements you are taking. Glucose monitoring is recommended for all patients with diabetes.

Possible side effects may include low blood sugar; injection site reactions, such as changes in fat tissue at the injection site; and allergic reactions, such as itching and rash. Less common, but potentially more serious or life-threatening, is generalized allergy
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