Label Changes for:
Apidra (insulin glulisine [rDNA origin]) injection
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.10 Inclusion of drug class labeling ... Fluid retention and heart failure with concomitant use of PPAR-gamma agonists Thiazolidinediones (TZDs)
5 WARNINGS AND PRECAUTIONS
5.7 Subcutaneous insulin infusion pumps
- When used in an external insulin pump for subcutaneous infusion, APIDRA should not be diluted or mixed with any other insulin. APIDRA in the reservoir must be changed at least every 48 hours. APIDRA should not be exposed to temperatures greater than 98.6°F (37°C). Malfunction of the insulin pump or infusion set or handling errors or insulin degradation can rapidly lead to hyperglycemia, ketosis and diabetic ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis or diabetic ketoacidosis is necessary. Interim subcutaneous injections with APIDRA may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available. [See Dosage and Administration (2.3), How Supplied/Storage and Handling (16), and Patient Counseling Information (17.2)].
17 PATIENT COUNSELING INFORMATION
17.2 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 clinical trials conducted by sanofiaventis, the manufacturer of APIDRA:
- 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, read the pump label to make sure the pump has been evaluated with APIDRA.
- To minimize insulin degradation, infusion set occlusion, and loss of the preservative (metacresol), the infusion sets (reservoir, tubing, and catheter) and the APIDRA in the reservoir must be replaced ........... If these problems cannot be promptly corrected, patients should resume therapy with subcutaneous insulin injection and contact their healthcare professional. Patients administering APIDRA by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure. [See Dosage and Administration (2.3), Warnings and Precautions (5.7), and How Supplied/Storage and Handling (16)].