InsulTM Glargine is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
Dosage & Administration
InsulTM Glargine is a recombinant human insulin analogue. Its potency is approximately the same as human insulin. It exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. InsulTM Glargine may be administered at any time during the day. InsulTM Glargine should be administered subcutaneously once a day at the same time every day. InsulTM Glargine is not intended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. The desired blood glucose levels as well as the doses and timing of antidiabetes medications must be determined individually. Blood glucose monitoring is recommended for all patients with diabetes. The prolonged duration of activity of InsulTM Glargine is dependent on injection into subcutaneous space. As with all insulins, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from one injection to the next. In clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for all insulins, the rate of absorption, and consequently the onset and
duration of action, may be affected by exercise and other variables. InsulTM Glargine is not the insulin of choice for the treatment of diabetes ketoacidosis. Intravenous short-acting insulin is the preferred treatment.
InsulTM Glargine can be safely administered to pediatric patients > 6 years of age. Administration to pediatric patients < 6 years has not been studied. Based on the results of a study in pediatric patients, the dose recommendation for changeover to InsulTM Glargine is the same as described for adults in Dosage & Administration, Changeover to InsulTM Glargine.
Initiation of InsulTM Glargine Therapy
In a clinical study with insulin native patients with type 2 diabetes already treated with oral antidiabetic drugs, InsulTM Glargine was started at an average dose of 10 IU once daily, and subsequently adjusted according to the patient\'s need to a total daily dose ranging from 2 to 100 IU.
Concomitant illness, especially infections and feverish conditions, usually increases the patient\'s insulin requirement. Renal or hepatic impairment may reduce insulin requirement. Adjustment of the dosage may also be necessary if patients change physical activity or their usual diet. Dosage adjustment may be necessary when transferring patients from one insulin preparation to another.
Hypoglycemia is the most common adverse effect of insulin, including InsulTM Glargine . 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 should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogues), species (animal, human), or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage. Concomitant oral antidiabetes treatment may need to be adjusted. InsulTM Glargine is not intended for intravenous administration. The prolonged duration of activity of insulin glargine is dependent on injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. InsulTM Glargine must not be diluted or mixed with any other insulin or solution. If InsulTM Glargine is diluted or mixed, the solution may become cloudy, and the pharmacokinetic/pharmacodynamic profile (e.g., onset of action, time to peak effect) of InsulTM Glargine and/or the mixed insulin may be altered in an unpredictable manner. When InsulTM Glargine and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and time to maximum effect for regular human insulin was observed. The total bioavailability of the mixture was also slightly decreased compared to separate injections of InsulTM Glargine and regular human insulin. The relevance of these observations in dogs to humans is not known. As with all insulin preparations, the time course of InsulTM Glargine action may vary in different individuals or at different times in the same individual and the rate of absorption is dependent on blood supply, temperature, and physical activity. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.Hypoglycemia â€” As with all insulin preparations, hypoglycemic reactions may be associated with the administration of InsulTM Glargine. Rapid changes in serum glucose concentrations may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control.Renal Impairment â€” The requirements for insulin may be reduced in patients with renal impairment. Hepatic Impairment â€” Although impaired hepatic function does not affect the absorption or disposition of InsulTMGlargine, careful glucose monitoring and dose adjustments of insulin, including InsulTM Glargine, may be necessary.
Pregnancy and Lactation
There are no well-controlled clinical studies of the use of insulin glargine in pregnant women. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in such patients. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is unknown whether insulin glargine is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when InsulTM Glargine is administered to a nursing woman. Lactating women may require adjustments in insulin dose and diet.