Insulin lispro

Insulin lispro
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

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Overview

Insulin lispro is an insulin analog that is FDA approved for the {{{indicationType}}} of improve glycemic control in adults and children with diabetes mellitus. Common adverse reactions include injection site reaction, hypoglycemia, hypokalemia, lipodystrophy.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosage Considerations

When given subcutaneously, insulin lispro has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of insulin lispro must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.
The total daily insulin requirement may vary and is usually between 0.5 to 1 unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Subcutaneous Administration

Insulin lispro should be given within 15 minutes before a meal or immediately after a meal.
Insulin lispro given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
Insulin lispro administered by subcutaneous injection should be given in the abdominal wall, thigh, upper arm, or buttocks. Injection sites should be rotated within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy.

Continuous Subcutaneous Infusion (Insulin Pump)

Insulin lispro may be administered by continuous subcutaneous infusion by an external insulin pump. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. Change the insulin lispro in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days.
The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant variability among patients, approximately 50% of the total dose is usually given as meal-related boluses of insulin lispro and the remainder is given as a basal infusion. Insulin lispro is recommended for use in pump systems suitable for insulin infusion such as MiniMed, Disetronic, and other equivalent pumps.

Intravenous Administration

Insulin lispro can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Insulin lispro should be used at concentrations from 0.1 unit/mL to 1.0 unit/mL in infusion systems containing 0.9% sodium chloride.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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Off-Label Use and Dosage (Pediatric)

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Contraindications

Insulin lispro is contraindicated:

During episodes of hypoglycemia
In patients who are hypersensitive to insulin lispro or to any of its excipients.

Warnings

Dose Adjustment and Monitoring

Glucose monitoring is essential for patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose. Concomitant oral antidiabetic treatment may need to be adjusted.
As with all insulin preparations, the time course of action for insulin lispro may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages.

Hypoglycemia

Hypoglycemia is the most common adverse effect associated with insulins, including insulin lispro. The risk of hypoglycemia increases with tighter glycemic control. Patients must be educated to recognize and manage hypoglycemia. Hypoglycemia can happen suddenly and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life-threatening or cause death.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia.
As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia.

Hypersensitivity and Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including insulin lispro.

Hypokalemia

All insulin products, including insulin lispro, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations and patients receiving intravenously administered insulin).

Renal or Hepatic Impairment

Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.

Mixing of Insulins

Insulin lispro for subcutaneous injection should not be mixed with insulin preparations other than NPH insulin. If insulin lispro is mixed with NPH insulin, insulin lispro should be drawn into the syringe first. Injection should occur immediately after mixing.
Do not mix insulin lispro with other insulins for use in an external subcutaneous infusion pump.

Subcutaneous Insulin Infusion Pumps

When used in an external insulin pump for subcutaneous infusion, insulin lispro should not be diluted or mixed with any other insulin. Change the insulin lispro in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days. Insulin lispro should not be exposed to temperatures greater than 98.6°F (37°C).
Malfunction of the insulin pump or infusion set or insulin degradation can rapidly lead to hyperglycemia and ketosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with insulin lispro may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Drug Interactions

Some medications may alter insulin requirements and the risk for hypoglycemia or hyperglycemia.

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including , and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.