Apidra - Dosage insulin glulisine

• 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.

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)].

Subcutaneous Injection

• 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)].

Intravenous Administration

• 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.

APIDRA injection, 100 units per mL (U-100), is a clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use APIDRA SoloStar prefilled pen

Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

APIDRA injection, 100 units per mL (U-100), is a clear and colorless solution available as:

Pen needles are not included in the packs.

SoloStar is compatible with all pen needles from Becton Dickinson and Company, Ypsomed, and Owen Mumford.

The APIDRA SoloStar prefilled pen dials in 1-unit increments.

Do not use after the expiration date (see carton and container).

Unopened Vial/SoloStar

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.

Use in an External Insulin Pump

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).

Intravenous Use

Infusion bags in normal saline solution (0.9% Sodium Chloride Injection, USP) are stable at room temperature for 48 hours [see Dosage and Administration (2.2)].