ADMELOG

ADMELOG- insulin lispro injection, solution
Sanofi-Aventis U.S. LLC

1 INDICATIONS AND USAGE

ADMELOG is 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.

2 DOSAGE AND ADMINISTRATION

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

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.

3 DOSAGE FORMS AND STRENGTHS

Insulin lispro injection 100 units per mL (U-100) is available as:

  • 10 mL multiple-dose vials
  • 3 mL multiple-dose vials
  • 3 mL single patient use SoloStar prefilled pens

4 CONTRAINDICATIONS

ADMELOG is contraindicated:

  • during episodes of hypoglycemia.
  • in patients who are hypersensitive to insulin lispro or to any of the excipients.

5 WARNINGS AND PRECAUTIONS

5.1 Never Share an ADMELOG SoloStar Pen or Syringe Between Patients

ADMELOG SoloStar prefilled 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. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction associated with insulins, including ADMELOG.

Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulin preparations, the glucose lowering effect time course of ADMELOG may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [see Clinical Pharmacology (12.2)]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to coadministered medication [see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].

Risk Mitigation Strategies for Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

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