Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
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and reduced <strong>insulin</strong> metabolism, similar to observations found with other <strong>insulin</strong>s (see ACTION<br />
AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Careful glucose<br />
monitoring and dose adjustments of <strong>insulin</strong> or <strong>insulin</strong> analogues including APIDRA may be<br />
necessary in patients with hepatic or renal dysfunction.<br />
Transferring Patients from Other Insulins<br />
Any change of <strong>insulin</strong> should be made cautiously and only under medical supervision. Changes<br />
in <strong>insulin</strong> strength, timing of administration, manufacturer, type (e.g., regular, NPH, or <strong>insulin</strong><br />
analogs), species (animal, human), or method of manufacture (recombinant DNA versus animalsource<br />
<strong>insulin</strong>) may result in the need for a change in dosage. Concomitant oral antidiabetic<br />
treatment may need to be adjusted.<br />
Special Populations<br />
Pregnant Women:<br />
There are no well-controlled clinical studies of the use of APIDRA in pregnant women. Animal<br />
reproduction studies have not revealed any differences between APIDRA and human <strong>insulin</strong><br />
regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see<br />
Part II: TOXICOLOGY, Reproduction toxicity).<br />
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic<br />
control before conception and during pregnancy. Insulin requirements may decrease during the<br />
first trimester and generally increase during the second and third trimesters. Immediately after<br />
delivery, <strong>insulin</strong> requirements decline rapidly.<br />
Careful monitoring of glucose control is essential.<br />
Patients with diabetes must inform their doctor if they are pregnant or are contemplating<br />
pregnancy.<br />
Nursing Women:<br />
It is unknown whether APIDRA is excreted in human milk. Many drugs including human<br />
<strong>insulin</strong>, are excreted in human milk. There are no adequate and well-controlled studies in nursing<br />
women. For this reason, caution should be exercised when APIDRA is administered to a nursing<br />
woman. Lactating women may require adjustments in <strong>insulin</strong> dose and diet (see Part II:<br />
TOXICOLOGY, Reproduction toxicity).<br />
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