APIDRA (insulin glulisine [rdna origin] inj) is indicated to improve glycemic control in adults and children with diabetes mellitus.

Dosage considerations

APIDRA (insulin glulisine [rdna origin] inj) is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of APIDRA (insulin glulisine [rdna origin] inj) has the same glucose-lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, APIDRA (insulin glulisine [rdna origin] inj) has a more rapid onset of action and a shorter duration of action than regular human insulin.

The dosage of APIDRA (insulin glulisine [rdna origin] inj) must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.

The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.

Subcutaneous administration

APIDRA (insulin glulisine [rdna origin] inj) should be given within 15 minutes before a meal or within 20 minutes after starting a meal.

APIDRA (insulin glulisine [rdna origin] inj) given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.

APIDRA (insulin glulisine [rdna origin] inj) should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy [See ADVERSE REACTIONS].

Continuous subcutaneous infusion (insulin pump)

APIDRA (insulin glulisine [rdna origin] inj) may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy [See ADVERSE REACTIONS]. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.

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) .

Physicians and patients should carefully evaluate information on pump use in the APIDRA (insulin glulisine [rdna origin] inj) prescribing information, Patient Information Leaflet, and the pump manufacturer's manual. APIDRA (insulin glulisine [rdna origin] inj) -specific information should be followed for in-use time, frequency of changing infusion sets, or other details specific to APIDRA (insulin glulisine [rdna origin] inj) usage, because APIDRA (insulin glulisine [rdna origin] inj) -specific information may differ from general pump manual instructions.

Based on in vitro studies which have shown loss of the preservative, metacresol and insulin degradation, APIDRA (insulin glulisine [rdna origin] inj) in the reservoir should be changed at least every 48 hours. APIDRA (insulin glulisine [rdna origin] inj) in clinical use should not be exposed to temperatures greater than 98.6° F (37° C). [See WARNINGS AND PRECAUTIONS and HOW SUPPLIED/Storage and Handling].

Intravenous administration

APIDRA (insulin glulisine [rdna origin] inj) can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, APIDRA (insulin glulisine [rdna origin] inj) should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. APIDRA (insulin glulisine [rdna origin] inj) has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.

Dosage Forms And Strengths

APIDRA (insulin glulisine [rdna origin] inj) 100 units per mL (U-100) is available as:

• 10 mL vials
• 3 mL cartridges for use in the OptiClik® Insulin Delivery Device

APIDRA (insulin glulisine [rdna origin] inj) 100 units per mL (U-100) is available as:

10 mL vials..........................NDC 0088-2500-33

3 mL cartridge system*, package of 5..................NDC 0088-2500-52

* Cartridge systems are for use only in OptiClik® (Insulin Delivery Device)

Storage

Do not use after the expiration date.

Unopened Vial/Cartridge System

Unopened APIDRA (insulin glulisine [rdna origin] inj) vials and cartridge systems should be stored in a refrigerator, 36°F-46°F (2°C-8°C). Protect from light. APIDRA (insulin glulisine [rdna origin] inj) should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen.

Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.

Open (In-Use) Vial:

Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 77°F (25°C).

Open (In-Use) Cartridge System

The opened (in-use) cartridge system inserted in OptiClik® should NOT be refrigerated but should be kept below 77°F (25°C) away from direct heat and light. The opened (in-use) cartridge system must be discarded after 28 days. Do not store OptiClik®, with or without cartridge system, in a refrigerator at any time.

Infusion sets

Infusion sets (reservoirs, tubing, and catheters) and the APIDRA (insulin glulisine [rdna origin] inj) in the reservoir should be discarded after 48 hours of use or after exposure to temperatures that exceed 98.6°F (37°C).

Intravenous use

Infusion bags prepared as indicated under DOSAGE AND ADMINISTRATION are stable at room temperature for 48 hours.

Preparation and Handling

After dilution for intravenous use, the solution should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it has become cloudy or contains particles; use only if it is clear and colorless. APIDRA (insulin glulisine [rdna origin] inj) is not compatible with Dextrose solution and Ringers solution and, therefore, cannot be used with these solution fluids. The use of APIDRA (insulin glulisine [rdna origin] inj) with other solutions has not been studied and is, therefore, not recommended.

Cartridge system: If OptiClik® (the Insulin Delivery Device for APIDRA (insulin glulisine [rdna origin] inj) ) malfunctions, APIDRA (insulin glulisine [rdna origin] inj) may be drawn from the cartridge system into a U-100 syringe and injected.

Sanofi-Aventis U.S. LLC Bridgewater, NJ 08807. FDA rev date: 10/24/2008

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