Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen

INSULIN LISPRO PROTAMINE AND INSULIN LISPRO INJECTABLE SUSPENSION MIX75/25 KWIKPEN — insulin lispro injection, suspension
Eli Lilly and Company

1 INDICATIONS AND USAGE

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is indicated to improve glycemic control in patients with diabetes mellitus.

Limitations of Use:

The proportions of rapid-acting and intermediate-acting insulins in Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Always check insulin labels before administration [see Warnings and Precautions (5.4)].
  • Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature.
  • To resuspend KwikPen, gently roll the KwikPen at least 10 times and then carefully invert the Kwikpen at least 10 times until the suspension appears uniformly white and cloudy. Inject immediately.
  • Inspect Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 visually before use. Do not use if discoloration or particulate matter is seen.
  • Administer Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks.
  • Rotate the injection site within the same region 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) and 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 Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen dials in 1 unit increments.
  • Use Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
  • Do not administer Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 intravenously, intramuscularly or by a continuous subcutaneous insulin infusion pump.
  • Do not mix Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 with any other insulins or diluents.

2.2 Dosage Information

  • Individualize and adjust the dosage of Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal.
  • Inject Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 subcutaneously within 15 minutes before a meal.
  • Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack)
  • 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)].
  • Dosage adjustment may be needed when switching from another insulin to Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25.

2.3 Dosage Adjustment Due to Drug Interactions

  • Dosage adjustment may be needed when Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is coadministered with certain drugs [see Drug Interactions (7)].

3 DOSAGE FORMS AND STRENGTHS

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 100 units per mL (U-100) is 75% insulin lispro protamine and 25% insulin lispro, a white and cloudy suspension available as:

  • 3 mL single-patient-use KwikPen (prefilled)

4 CONTRAINDICATIONS

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is contraindicated:

  • during episodes of hypoglycemia [see Warnings and Precautions (5.3)]
  • in patients who have had hypersensitivity reactions to Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 or to any of its excipients. [see Warnings and Precautions (5.5)]

5 WARNINGS AND PRECAUTIONS

5.1 Never Share an Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen Between Patients

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPens must never be shared between patients, even if the needle is changed. 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 an 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 all insulin therapies, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. Severe hypoglycemia can cause seizures, may lead to unconsciousness, 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 Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 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 co-administered 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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