See FDA-approved patient labeling.

Instructions for all patients

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Refer patients to the APIDRA (insulin glulisine [rdna origin] inj) Patient Information Leaflet for additional information.

Women with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.

Accidental mix-ups between APIDRA (insulin glulisine [rdna origin] inj) and other insulins, particularly long-acting insulins, have been reported. To avoid medication errors between APIDRA (insulin glulisine [rdna origin] inj) and other insulins, patients should be instructed to always check the insulin label before each injection.

For patients using continuous subcutaneous insulin pumps

Patients using external pump infusion therapy should be trained appropriately.

The following insulin pumps^† have been used in APIDRA (insulin glulisine [rdna origin] inj) clinical trials conducted by sanofi-aventis, the manufacturer of APIDRA (insulin glulisine [rdna origin] inj) :

• Disetronic® H-Tron® plus V100 and D-Tron® with Disetronic catheters (Rapid™, Rapid C™, Rapid D™, and Tender™)
• MiniMed® Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate QR™, and Quick-set™).

Before using a different insulin pump with APIDRA (insulin glulisine [rdna origin] inj) , read the pump label to make sure the pump has been evaluated with APIDRA (insulin glulisine [rdna origin] inj) .

To minimize insulin degradation, infusion set occlusion, and loss of the preservative (metacresol), the infusion sets (reservoir, tubing, and catheter) and the APIDRA (insulin glulisine [rdna origin] inj) in the reservoir should be replaced every 48 hours and a new infusion site should be selected. The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat. Insulin exposed to temperatures higher than 98.6°F (37°C) should be discarded. Infusion sites that are erythematous, pruritic, or thickened should be reported to the healthcare professional, and a new site selected because continued infusion may increase the skin reaction or alter the absorption of APIDRA (insulin glulisine [rdna origin] inj) .

Pump or infusion set malfunctions or insulin degradation can lead to rapid hyperglycemia and ketosis. This is especially pertinent for rapid-acting insulin analogs that are more rapidly absorbed through skin and have a shorter duration of action. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Problems include pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Less commonly, hypoglycemia from pump malfunction may occur. If these problems cannot be promptly corrected, patients should resume therapy with subcutaneous insulin injection and contact their healthcare professional. [See DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and HOW SUPPLIED/Storage and Handling].

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.