Generic name: insulin glulisine 100[iU] in 1mL
Dosage form: injection, solution
Medically reviewed on January 3, 2019.
Important Administration Instructions
- Always check insulin label before administration [see Warnings and Precautions (5.4)].
- Inspect visually for particulate matter and discoloration. Only use APIDRA if the solution appears clear and colorless.
- Train patients on proper use and injection technique before initiating APIDRA [see Warnings and Precautions (5.1)].
- Use APIDRA SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
- APIDRA may be administered by subcutaneous injection, by continuous subcutaneous infusion (insulin pump), or intravenously [see Dosage and Administration (2.2)].
- DO NOT administer APIDRA intramuscularly.
Dosing and Administration Instructions
General Dosing Instructions
- Individualize and adjust the dosage of APIDRA based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal.
- Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2, 5.3), Drug Interactions (7), Use in Specific Populations (8.6, 8.7)].
- Inject APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
- Administer APIDRA by subcutaneous injection in the abdominal wall, thigh, or upper arm. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
- APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.
- The APIDRA SoloStar prefilled pen dials in 1-unit increments.
- Do not mix APIDRA for subcutaneous injection with insulin preparations other than NPH insulin. If APIDRA is mixed with NPH insulin, draw APIDRA into the syringe first and inject immediately after mixing.
Continuous Subcutaneous Infusion (Insulin Pump)
- Administer APIDRA by continuous subcutaneous infusion in the abdominal wall.
- Rotate infusion sites within the same region to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
- Do not dilute or mix insulins in external insulin pumps.
- 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 sanofi-aventis, 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.
- Use APIDRA in accordance with the insulin infusion pump systems instructions for use.
- Change APIDRA in the reservoir and the infusion sets at least every 48 hours.
- Do not expose APIDRA to temperatures greater than 98.6°F (37°C) [see How Supplied/Storage and Handling (16.2)].
- Patients administering APIDRA by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure [see Warnings and Precautions (5.8)].
- Administer APIDRA intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.5)].
- Dilute APIDRA to concentrations from 0.05 unit/mL to 1 unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) infusion bags.
- APIDRA is stable at room temperature for 48 hours only in normal saline solution (0.9% Sodium Chloride Injection, USP).
- APIDRA is not compatible with Dextrose solution and Ringers solution.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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