"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
APIDRA is indicated to improve glycemic control in adults and children with diabetes mellitus.
DOSAGE AND ADMINISTRATION
APIDRA is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of APIDRA has the same glucose-lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, APIDRA has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of APIDRA 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.
APIDRA should be given within 15 minutes before a meal or within 20 minutes after starting a meal.
APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.
APIDRA 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 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 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.
Physicians and patients should carefully evaluate information on pump use in the APIDRA prescribing information, Patient Information Leaflet, and the pump manufacturer's manual. APIDRA-specific information should be followed for in-use time, frequency of changing infusion sets, or other details specific to APIDRA usage, because APIDRA-specific information may differ from general pump manual instructions. Failure to follow APIDRA-specific instructions may lead to serious adverse events.
Patients administering APIDRA by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure.
Based on in vitro studies which have shown loss of the preservative, metacresol and insulin degradation, APIDRA in the reservoir should be changed at least every 48 hours. APIDRA should not be exposed to temperatures greater than 98.6°F (37°C). In clinical use, the infusion sets and the APIDRA in the reservoir must be changed at least every 48 hours [See WARNINGS AND PRECAUTIONS and HOW SUPPLIED/Storage and Handling].
APIDRA 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 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 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 100 units per mL (U-100) is available as:
- 10 mL vials
- 3 mL SoloStar prefilled pen
Storage And Handling
APIDRA 100 units per mL (U-100) is available as:
10 mL vials NDC 0088-2500-33
3 mL SoloStar prefilled pen, package of 5 NDC 0088-2502-05
Pen needles are not included in the packs.
Solostar is compatible with all pen needles from Becton Dickinson and Company, Ypsomed and Owen Mumford.
Do not use after the expiration date (see carton and container).
Unopened APIDRA vials and SoloStar should be stored in a refrigerator, 36°F-46°F (2°C-8°C). Protect from light. APIDRA should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/SoloStar 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) SoloStar prefilled pen
The opened (in-use) SoloStar should NOT be refrigerated but should be kept below 77°F (25°C) away from direct heat and light. The opened (in-use) SoloStar kept at room temperature must be discarded after 28 days.
Infusion sets (reservoirs, tubing, and catheters) and the APIDRA in the reservoir must be discarded after 48 hours of use or after exposure to temperatures that exceed 98.6°F (37°C).
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 is not compatible with Dextrose solution and Ringers solution and, therefore, cannot be used with these solution fluids. The use of APIDRA with other solutions has not been studied and is, therefore, not recommended.
sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A Sanofi Company. Date of revision: 05/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/2/2014
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