ADMELOG Solution for injection Ref.[10741] Active ingredients: Insulin lispro

2.1 Important Administration Instructions

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Inspect ADMELOG visually before use. It should appear clear and colorless. Do not use ADMELOG if particulate matter or coloration is seen.
• Use ADMELOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
• Do NOT mix ADMELOG with other insulins when administering using a continuous subcutaneous infusion pump.

2.2 Route of Administration

Subcutaneous Injection:

• Administer the dose of ADMELOG within fifteen minutes before a meal or immediately after a meal.
• ADMELOG administered by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin.
• ADMELOG should be administered by subcutaneous injection in the abdominal wall, thigh, upper arm, or buttocks. Rotate injection site within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
• The ADMELOG SoloStar prefilled pen dials in 1-unit increments.

Continuous Subcutaneous Infusion (Insulin Pump):

• Administer ADMELOG by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
• Follow healthcare provider recommendations when setting basal and mealtime infusion rate.
• Do NOT dilute or mix ADMELOG when administering by continuous subcutaneous infusion.
• Change ADMELOG in the pump reservoir at least every 7 days.
• Change the infusion sets and the infusion set insertion site at least every 3 days.
• Do NOT expose ADMELOG in the pump reservoir to temperatures greater than 98.6°F (37°C).
• Use ADMELOG in accordance with the insulin infusion pump systems instructions for use. See the insulin infusion pump system labeling to determine if ADMELOG can be used with the pump system.

Intravenous Administration:

• Dilute ADMELOG to concentrations from 0.1 unit/mL to 1 unit/mL using 0.9% sodium chloride.
• Administer ADMELOG 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, 5.6) and How Supplied/Storage and Handling (16.4)].

2.3 Dosage Information

• Individualize and adjust the dosage of ADMELOG based on route of administration, the individual’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.6, 8.7)].
• If changing patients from another insulin lispro product to ADMELOG, the dose of ADMELOG should be the same as the other insulin lispro product [see Warnings and Precautions (5.2)].

2.4 Dosage Adjustment Due to Drug Interactions

• Dosage adjustment may be needed when ADMELOG is coadministered with certain drugs [see Drug Interactions (7)].
• Dosage adjustment may be needed when switching from another insulin to ADMELOG [see Warnings and Precautions (5.2)].
• Do NOT mix ADMELOG with any other insulin.

Excess insulin administration may cause hypoglycemia and 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 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.

Dispense in the original sealed carton with the enclosed Instructions for Use.

Do not use after the expiration date.

Not in-use (unopened) ADMELOG should be stored in a refrigerator (36°F-46°F [2°C-8°C]), but not in the freezer. Do not use ADMELOG if it has been frozen.

In-use (opened) ADMELOG vials and ADMELOG SoloStar pens should be stored at room temperature (below 86°F [30°C]) and must be used within 28 days or be discarded, even if they still contain ADMELOG. Protect from direct heat and light.

See table below:

Use in an External Insulin Pump

Insulin in the reservoir should be discarded after 7 days. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.

Diluted ADMELOG for Subcutaneous Injection

Diluted ADMELOG may remain in patient use for up to 24 hours when stored in a refrigerator (36°F-46°F [2°C-8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute ADMELOG used in an external insulin pump.

Preparation and Handling

Diluted ADMELOG for Subcutaneous Injection

ADMELOG may be diluted with sterile 0.9% sodium chloride for subcutaneous injection. Diluting one-part ADMELOG to one-part 0.9% sodium chloride will yield a concentration one-half that of ADMELOG (equivalent to U-50).

Admixture for Intravenous Administration

Infusion bags prepared with ADMELOG are stable when stored in a refrigerator (36°F-46°F [2°C-8°C]) for 24 hours or may be used at room temperature for up to 4 hours [see Dosage and Administration (2.2)].