ADMELOG: Insulin Lispro Injection 100 units per mL (U-100) is available as:
Dosage Unit Package Size NDC #
10 mL multiple-dose vials Carton of 1 0024-5924-10
3 mL multiple-dose vials Carton of 1 0024-5926-05
3 mL single patient use SoloStar prefilled pen Carton of 5 0024-5925-05
Each prefilled SoloStar pen is for use by a single patient. ADMELOG SoloStar pen must never be shared between patients, even if the needle is changed. Patients using ADMELOG vials must never share needles or syringes with another person.
The ADMELOG SoloStar prefilled pen dials in 1-unit increments.
16.2 Storage and Handling
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:
ADMELOG Not In-Use (Unopened)
Room Temperature (Below 86°F [30°C]) Not In-Use (Unopened)
Refrigerated (36°F-46°F [2°C-8°C]) In-Use (Opened)
Room Temperature (Below 86°F [30°C])
10 mL multiple-dose vial 28 days Until expiration date 28 days
3 mL multiple-dose vial 28 days Until expiration date 28 days
3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days
Do not refrigerate.
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.These highlights do not include all the information needed to use ADMELOG safely and effectively. See full prescribing information for ADMELOG®.
ADMELOG (insulin lispro injection), for subcutaneous or intravenous use
Initial U.S. Approval: 1996
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 11/2019
Warnings and Precautions (5.2) 11/2019
INDICATIONS AND USAGE
ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for important administration instructions. (2.1, 2.2, 2.3, 2.4)
Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (2.2)
Subcutaneous injection (2.2):
Administer ADMELOG by subcutaneous injection in the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal.
Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
Continuous subcutaneous infusion (Insulin Pump) (2.2):
Administer ADMELOG by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY after dilution and under medical supervision. (2.2)
The dosage of ADMELOG must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) is available as: (3)
10 mL multiple-dose vials
3 mL multiple-dose vials
3 mL single-patient-use SoloStar® prefilled pens
Do not use during episodes of hypoglycemia. (4)
Do not use in patients with hypersensitivity to insulin lispro or any of the excipients. (4)
WARNINGS AND PRECAUTIONS
Never share an ADMELOG SoloStar disposable prefilled pen or syringe between patients, even if the needle is changed. (5.1)
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. (5.2)
Hypoglycemia: May be life-threatening. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. (5.3, 6, 7, 8.6, 8.7)
Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (5.4)
Hypersensitivity Reactions: Severe, life-threatening, generalized allergic, including anaphylaxis can occur. Discontinue ADMELOG, monitor and treat if indicated. (5.5)
Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.6)
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. (5.7)
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer ADMELOG by subcutaneous injection if pump malfunction occurs. (5.8)
Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. (7.1, 7.2, 7.3)
Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. (5.3, 7.4)
USE IN SPECIFIC POPULATIONS
Pediatrics: Safety and effectiveness not established in pediatric patients <3 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.