Indications and Usage for Apidra® (insulin glulisine [rDNA origin] injection)
Prescription Apidra® 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® given by subcutaneous injection is usually used with
a longer-acting insulin. When used as a mealtime insulin, Apidra® should be
given within 15 minutes before or within 20 minutes after starting a meal.
Apidra® may be infused subcutaneously by external insulin infusion pumps.
Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection)
Do not use Apidra® during a low blood sugar reaction (hypoglycemia) or if you
are allergic to any of the ingredients in Apidra®.
Do not share needles, insulin pens or syringes with others. Do NOT reuse needles.
You must test your blood sugar levels while using insulin,
such as Apidra®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider.
Any change of insulin should be made cautiously and only under medical supervision.
Apidra® must only be used if the solution is clear and colorless with no particles visible.
Apidra®, when given by injection under the skin, should not be mixed with insulins
other than NPH. Do not mix Apidra® with any insulin when used in the pump or
for intravenous administration.
The most common side effect of insulin, including Apidra®, is low blood
sugar (hypoglycemia), which may be serious. Some people may experience
symptoms such as shaking, sweating, fast heartbeat, and blurred vision. Severe hypoglycemia
may be serious and life threatening. It may cause harm to your heart or brain. Other
possible side effects may include low blood potassium, 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 to insulin, including anaphylactic reactions.
Tell your doctor about other medicines, especially ones commonly called TZDs (thiazolidinediones), and supplements you are taking because they
can change the way insulin works. Before starting Apidra®, tell your doctor
about all your medical conditions including if you have liver or kidney problems,
are pregnant or planning to become pregnant, or are breast-feeding or planning to
breast-feed. If you have heart failure or other heart problems, it may get worse while you take TZDs with Apidra®.
It is important to always follow the instructions provided with your Apidra® prescription for use with an external insulin infusion pump. These instructions may differ from the instructions that accompany your insulin infusion pump. Failure to follow the Apidra® specific instructions may lead to serious side effects.
You must change the infusion set (reservoir, tubing, and catheter), and the Apidra® in the pump reservoir at least every 48 hours. Do not mix Apidra® with any insulin when used in the pump and do not dilute Apidra®.
If the pump or infusion set does not work right or in case of handling errors, you may not get the right amount of insulin. This can cause low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), high amounts of sugar and ketones in your blood (ketosis) or a build-up of acid in your blood because your body is breaking down fat instead of sugar (diabetic ketoacidosis). It is important to have another way to inject Apidra® in case the pump does not work.
Apidra® has not been studied in children with type 2 diabetes or in children younger
than 4 years of age with type 1 diabetes. In a clinical study of children with type
1 diabetes, there was a higher rate of severe symptomatic hypoglycemia in the two
treatment groups (Apidra® or insulin lispro) compared to adult trials with type
Apidra® SoloSTAR® is a disposable prefilled insulin pen. Please talk to
your healthcare provider about proper injection technique and follow instructions
in the Instruction Leaflet that accompanies the pen.
here for Full Prescribing Information for Apidra®.
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only. Your healthcare professional is the single best source of information regarding
your health. Please consult your healthcare professional if you have any questions
about your health or treatment.
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