Insulin Lispro (Lexi-Drugs)

Pronunciation

(IN soo lin LYE sproe)

Brand Names: US

Admelog; Admelog SoloStar; HumaLOG; HumaLOG Junior KwikPen; HumaLOG KwikPen

Brand Names: Canada

HumaLOG; HumaLOG KwikPen

Pharmacologic Category

Insulin, Rapid-Acting

Dosing: Adult

Note: Insulin lispro is a rapid-acting insulin analog. Insulin requirements vary dramatically between patients and dictate frequent monitoring and close medical supervision. When switching between insulin lispro products (eg, Humalog, Admelog), continue with the same insulin dose.

Diabetes mellitus, type 1: SubQ:

Note: Insulin lispro must be used concomitantly with intermediate- or long-acting insulin (ie, multiple daily injection regimen) or in a continuous subcutaneous infusion pump. The total daily doses (TDD) presented below are expressed as the total units/kg/day of all insulin formulations combined.

General insulin dosing:

Initial TDD: ~0.4 to 0.5 units/kg/day (AACE/ACE [Handelsman] 2015]; ADA 2018); conservative initial doses of 0.2 to 0.4 units/kg/day may be considered to avoid the potential for hypoglycemia; higher initial doses may be required in patients who are obese, sedentary, or presenting with ketoacidosis (AACE/ACE [Handelsman 2015]; ADA 2018).

Usual TDD maintenance range: 0.4 to 1 units/kg/day in divided doses (ADA 2018)

Division of TDD (multiple daily injections):

Basal insulin: Generally, 40% to 50% of the TDD is given as basal insulin (intermediate- or long-acting) in 1 to 2 daily injections (AACE/ACE [Handelsman 2015]; ADA 2018).

Prandial insulin: The remaining portion (ie, 50% to 60%) of the TDD is then divided and administered before or at mealtimes (depending on the formulation) as a rapid-acting (eg, lispro, aspart, glulisine, insulin for inhalation) or short-acting (regular) insulin (AACE/ACE [Handelsman 2015]; ADA 2018).

Dosage adjustment: Dosage must be titrated to achieve glucose control and avoid hypoglycemia. Adjust dose to maintain premeal and bedtime glucose in target range. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component.

Diabetes mellitus, type 2 (ADA 2018): SubQ:

Initial: 4 units or 0.1 unit/kg or 10% of the basal insulin dose; insulin lispro (ie, a rapid acting insulin) is administered before the largest meal of the day and is usually given in addition to a regimen that includes basal insulin (ie, a long-acting insulin such as glargine, degludec, or detemir; or an intermediate-acting insulin such as NPH) and metformin +/- other noninsulin agents. Consider reducing the basal insulin dose if HbA1c is <8% when initiating prandial insulin.

Dosage adjustment:

To reach self-monitoring glucose target: Adjust dose by 10% to 15% or 1 to 2 units; may adjust at weekly or twice-weekly intervals.

For hypoglycemia: If no clear reason for hypoglycemia, decrease dose by 2 to 4 units or by 10% to 20%.

HbA1c still not controlled despite titrations to reach glycemic targets: One option is to advance to ‘basal-bolus’ (ie, insulin lispro administered before ≥2 meals per day) in addition to basal insulin and usually given in addition to metformin +/- other noninsulin agent.

Patients with diabetes receiving enteral feedings (ADA 2018): Note: TDD of insulin is divided into a basal component (intermediate- or long-acting insulin) and nutritional and correctional components (regular insulin or rapid-acting insulins).

Nutritional/correctional component: SubQ: 1 unit of insulin lispro per 10 to 15 g of carbohydrate plus correctional insulin lispro (as needed for hyperglycemia) administered every 4 hours or prior to each bolus feeding.

Patients with diabetes undergoing surgery and using CSII pump (ADA 2018): On the morning of surgery or procedure, give 60% to 80% of the usual dose of pump “basal” insulin (rapid- or short-acting insulins) dose.

Diabetic ketoacidosis, mild-to-moderate (off-label use): SubQ: Initial: 0.3 units/kg, followed by 0.1 units/kg every hour until blood glucose <250 mg/dL, then decrease to 0.05 units/kg/hour until resolution of ketoacidosis (Umpierrez 2004). Also, refer to institution-specific protocols where appropriate.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment may be needed as insulin requirements may be reduced due to changes in insulin clearance or metabolism.

Dosing: Hepatic Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment may be needed as insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Pediatric

Insulin lispro is a rapid-acting insulin analog which is normally administered SubQ as a premeal component of the insulin regimen or as a continuous SubQ infusion and should be used with intermediate- or long-acting insulin. When compared to insulin regular, insulin lispro has a more rapid onset and shorter duration of activity. In carefully controlled clinical settings with close medical supervision and monitoring of blood glucose and potassium, insulin lispro may also be administered IV in some situations; insulin requirements vary dramatically between patients and dictate frequent monitoring and close medical supervision. See Insulin Regular for additional information.

General insulin dosing:

Type 1 diabetes mellitus: Children and Adolescents: Note: Multiple daily doses or continuous subcutaneous infusions guided by blood glucose monitoring are the standard of diabetes care. Combinations of insulin formulations are commonly used. The daily doses presented below are expressed as the total units/kg/day of all insulin formulations combined.

Initial dose: SubQ: 0.2-0.6 units/kg/day in divided doses. Conservative initial doses of 0.2-0.4 units/kg/day are often recommended to avoid the potential for hypoglycemia. Regular insulin may be the only insulin formulation used initially.

Usual maintenance range: SubQ: 0.5-1 unit/kg/day in divided doses. An estimate of anticipated needs may be based on body weight and/or activity factors as follows:

Nonobese: 0.4-0.6 units/kg/day

Obese: 0.8-1.2 units/kg/day

Pubescent Children and Adolescents: During puberty, requirements may substantially increase to >1 unit/kg/day and in some cases up to 2 units/kg/day (IDF/ISPAD, 2011)

Adjustment of dose: Dosage must be titrated to achieve glucose control and avoid hypoglycemia. Adjust dose to maintain premeal and bedtime glucose in target range. Since combinations of agents are frequently used, dosage adjustment must address the individual component of the insulin regimen which most directly influences the blood glucose value in question, based on the known onset and duration of the insulin component.

Continuous SubQ insulin infusion (insulin pump): A combination of a “basal” continuous insulin infusion rate with preprogrammed, premeal bolus doses which are patient controlled. When converting from multiple daily SubQ doses of maintenance insulin, it is advisable to reduce the basal rate to less than the equivalent of the total daily units of longer-acting insulin (eg, NPH); divide the total number of units by 24 to get the basal rate in units/hour. Do not include the total units of regular insulin or other rapid-acting insulin formulations in this calculation. The same premeal regular insulin dosage may be used.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; insulin requirements are reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling; insulin requirements may be reduced due to changes in insulin clearance or metabolism; monitor blood glucose closely.

Use: Labeled Indications

Diabetes mellitus, types 1 and 2: Treatment of type 1 diabetes mellitus and type 2 diabetes mellitus to improve glycemic control

Use: Off-Label: Adult

  Diabetic ketoacidosis (mild-to-moderate)Level of Evidence [B, G]

Data from a prospective, randomized open trial in a limited number of patients with uncomplicated diabetic ketoacidosis comparing the use of subcutaneous insulin lispro to a standard low-dose IV infusion protocol of regular insulin supports the use of insulin lispro in the treatment of mild-to-moderate diabetic ketoacidosis Ref. Additional trials may be necessary to further define the role of insulin lispro in the management of this condition.

Based on a consensus statement from the American Diabetic Association for the treatment of patients with hyperglycemic crises in adult patients with diabetes, the use of rapid-acting insulin analogues (eg, insulin lispro) is an effective alternative to intravenous regular insulin in the management of mild to moderate diabetic ketoacidosis.

  Gestational diabetes mellitusLevel of Evidence [B, G]

Data from a randomized, active-controlled, open-label trial, comparing the metabolic and immunologic effects of insulin lispro and regular human insulin in gestational diabetic women demonstrated similar anti-insulin antibody levels, mean fasting and postprandial glucose concentrations, and HbA1c between groups; however, the insulin lispro group had lower areas under the curve for glucose, insulin, C-peptide, and fewer hypoglycemic episodes than the group treated with regular human insulin Ref.

Based on the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin for the management of gestational diabetes mellitus and the American Diabetes Association Standards of Medical Care in Diabetes, insulin may be used to treat GDM when nutrition and exercise therapy are not effective. The Endocrine Society Clinical Practice Guideline on Diabetes and Pregnancy as well as ACOG recommend the use of rapid-acting insulin analogs lispro and aspart in preference to regular insulin in pregnant patients with diabetes Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Diabetes Mellitus:

American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE), “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm- 2018 Executive Summary,” January 2018

American Diabetes Association, “Standards of Medical Care in Diabetes – 2018,” January 2018

Diabetes Canada, “Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada,” 2018

Endocrine Society, “Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline,” 2016

Administration: IV

IV administration: Use only if solution is clear and colorless; do not use if solution contains particulate matter or is colored. Insulin lispro U-100 may be administered IV with close monitoring of blood glucose and serum potassium; appropriate medical supervision is required. Do not administer insulin lispro U-200 (200 units/mL) IV. Do not administer insulin mixtures IV.

IV infusions: To minimize insulin adsorption to IV tubing: At low concentrations and flow rates, insulin lispro has been shown to adsorb to PVC IV bags and tubing (Ling 1999). Therefore, flush the IV tubing with a priming infusion of 20 mL from the insulin infusion, whenever a new IV tubing set is added to the insulin infusion container (SCCM [Jacobi 2012; Thompson 2012]).

Note: Also refer to institution-specific protocols where appropriate.

Because of insulin adsorption to IV tubing or infusion bags, the actual amount of insulin being administered via IV infusion could be substantially less than the apparent amount. Therefore, adjustment of the IV infusion rate should be based on effect and not solely on the apparent insulin dose. The apparent dose may be used as a starting point for determining the subsequent SubQ dosing regimen (Moghissi 2009); however, the transition to SubQ administration requires continuous medical supervision, frequent monitoring of blood glucose, and careful adjustment of therapy. Transition to a protocol-driven basal/bolus insulin regimen should begin prior to stopping the IV infusion in order to avoid significant loss of glucose control (Jacobi 2012; Moghissi 2009).

Administration: Injectable Detail

 pH: 7-7.8

Administration: Subcutaneous

Use only if solution is clear and colorless; do not use if solution contains particulate matter or is colored. Insulin lispro should be administered within 15 minutes before or immediately after a meal. Cold injections should be avoided. SubQ administration is usually made into the thighs, arms, buttocks, or abdomen; rotate injection sites within the same region to avoid lipodystrophy.

Admelog: Do not mix with any other insulin. For Admelog SoloStar pen, prime the needle before each injection with 2 units of insulin. Once injected, hold the SoloStar device in the skin for a count of 10 after the dose dial has returned to 0 units before removing the needle to ensure the full dose has been administered.

Humalog: Do not dilute or mix other insulins with insulin lispro contained in a cartridge or prefilled pen. Do not mix insulin lispro U-200 with any other insulin. May mix insulin lispro U-100 (eg, 100 units/mL) from a vial only with insulin NPH (do not mix with other types of insulin); insulin lispro should be drawn into syringe first; perform injection immediately. Kwikpens are designed to dial doses in 1-unit increments (U-100 or U-200 pens) or in 0.5-unit increments (Junior KwikPen). Do not perform dose conversion when using Humalog KwikPen devices; the dose window shows the number of units to be delivered and no conversion is needed. Do not transfer insulin lispro U-200 KwikPen to a syringe for administration. For Humalog KwikPen, prime the needle before each injection with 2 units of insulin. Once injected, hold the KwikPen device in the skin for a count of 5 after the dose dial has returned to 0 units before removing the needle to ensure the full dose has been administered.

Administration: Other

CSII administration: Use only if solution is clear and colorless; do not use if solution contains particulate matter or is colored. Only administer insulin lispro U-100 (eg, 100 units/mL) via CSII; do not administer insulin lispro U-200 (eg, 200 units/mL) in a CSII pump. Patients should be trained in the proper use of their external insulin pump and in intensive insulin therapy. Infusion sets and infusion set insertion sites should be changed every 3 days; rotate infusion sites. Insulin in reservoir should be changed at least every 7 days. Do not dilute or mix other insulins with insulin lispro U-100 (eg, 100 units/mL) contained in an external insulin pump.

Administration: Pediatric

Parenteral:

SubQ: Administration is usually made into the subcutaneous fat of the thighs, arms, buttocks, or abdomen, with sites rotated; cold injections should be avoided. Administer 15 minutes before meals or immediately after. May be mixed in the same syringe with NPH insulin. When mixing insulin lispro with NPH insulin, lispro should be drawn into the syringe first; administer immediately after mixing.

Continuous SubQ insulin infusion (Insulin pump): Do not use if solution is viscous or cloudy; use only if clear and colorless. Patients should be trained in the proper use of their external insulin pump and in intensive insulin therapy. Infusion sets and infusion set insertion sites should be changed every 3 days; rotate infusion sites. Insulin in reservoir should be changed every 7 days. Do not dilute or mix other insulin formulations with insulin lispro contained in an external insulin pump.

IV: Do not use if solution is viscous or cloudy; use only if clear and colorless. Further dilute with NS. May be administered IV with close monitoring of blood glucose and serum potassium; appropriate medical supervision is required. Do not administer insulin mixtures intravenously.

To minimize adsorption to IV solution bag: Note: Refer to institution-specific protocols where appropriate.

If new tubing is not needed: Wait a minimum of 30 minutes between the preparation of the solution and the initiation of the infusion.

If new tubing is needed: After receiving the insulin drip solution, the administration set should be attached to the IV container and the entire line should be flushed with a priming infusion of 20 to 50 mL of the insulin solution (Goldberg 2006; Hirsch 2006). Wait 30 minutes, and then flush the line again with the insulin solution prior to initiating the infusion.

Because of adsorption, the actual amount of insulin being administered via IV infusion could be substantially less than the apparent amount. Therefore, adjustment of the IV infusion rate should be based on effect and not solely on the apparent insulin dose. The apparent dose may be used as a starting point for determining the subsequent SubQ dosing regimen (Moghissi 2009); however, the transition to SubQ administration requires continuous medical supervision, frequent monitoring of blood glucose, and careful adjustment of therapy. In addition, SubQ insulin should be given 1 to 4 hours prior to the discontinuation of IV insulin to prevent hyperglycemia (Moghissi 2009).

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage/Stability

Unopened vials, cartridges, and prefilled pens may be stored under refrigeration between 2°C and 8°C (36°F to 46°F) until the expiration date or at room temperature <30°C (<86°F) for 28 days; do not freeze; keep away from heat and light. Once punctured (in use), vials may be stored under refrigeration or at room temperature <30°C (<86°F); use within 28 days. Cartridges and prefilled pens that have been punctured (in use) should be stored at room temperatures <30°C (<86°F) and used within 28 days; do not freeze or refrigerate. When used for CSII, insulin lispro contained within an external insulin pump reservoir should be changed every 7 days and insulin lispro contained within a 3 mL cartridge should be discarded after 7 days; discard if exposed to temperatures >37°C (>98.6°F).

Diluted solution for SubQ administration:

Humalog: After dilution may store at 30°C (86°F) for 14 days or at 5°C (41°F) for 28 days.

Admelog: After dilution may store at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at 30°C (86°F) for up to 4 hours.

Diluted solution for IV infusion:

Humalog: Stable in NS for 48 hours when stored under refrigeration between 2°C and 8°C (36°F to 46°F); may then be used at room temperature for an additional 48 hours.

Admelog: Stable in NS for 24 hours when stored at 2°C to 8°C (36°F to 46°F) or for up to 4 hours room temperature.

Preparation for Administration: Adult

For SubQ administration: Do not dilute insulin contained in a cartridge, prefilled pen, or external insulin pump.

Humalog vials: May be diluted with Sterile Diluent for Humalog to a concentration of 10 units/mL (U-10) or 50 units/mL (U-50).

Admelog vials: May be diluted with sterile normal saline in equal parts to yield a concentration of 50 units/mL (U-50).

For IV infusion: Insulin lispro U 100 may be diluted in NS to concentrations of 0.1 to 1 units/mL. Humalog U 200 may not be administered intravenously.

Preparation for Administration: Pediatric

Parenteral:

SubQ: Humalog vials: May be diluted with the universal diluent, Sterile Diluent for Humalog, Humulin N, Humulin R, Humulin 70/30, and Humulin R U-500, to a concentration of 10 units/mL (U-10) or 50 units/mL (U-50). Do not dilute insulin contained in a cartridge, prefilled pen, or external insulin pump. May be mixed in the same syringe with NPH insulin. When mixing insulin lispro with NPH insulin, lispro should be drawn into the syringe first; administer immediately after mixing.

IV: May be diluted in NS to concentrations of 0.1 to 1 units/mL.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), severe injection site irritation, vision changes, chills, severe dizziness, passing out, mood changes, seizures, slurred speech, difficulty breathing, shortness of breath, excessive weight gain, swelling of arms or legs, or injection site change in skin to thick or thin (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  High alert medication:
  Geriatric Patients: High-Risk Medication:
  Other safety concerns:
Contraindications

Hypersensitivity to insulin lispro or any component of the formulation; during episodes of hypoglycemia

Warnings/Precautions

Concerns related to adverse effects:

• Glycemic control: The most common adverse effect of insulin is hypoglycemia. The timing of hypoglycemia differs among various insulin formulations. Hypoglycemia may result from changes in meal pattern (eg, macronutrient content or timing of meals), changes in the level of physical activity, increased work or exercise without eating or changes to coadministered medications. Hyperglycemia is also a concern; may occur with CSII pump or infusion set malfunctions or insulin degradation; hyper- or hypoglycemia may result from changes in insulin strength, manufacturer, type or administration method. Use of long-acting insulin preparations (eg, insulin detemir, insulin glargine) may delay recovery from hypoglycemia. Patients with renal or hepatic impairment may be at a higher risk. Symptoms differ in patients and may change over time in the same patient; awareness may be less pronounced in those with long standing diabetes, diabetic nerve disease, patients taking beta-blockers or in those who experience recurrent hypoglycemia. Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage, or even death. Insulin requirements may be altered during illness, emotional disturbances, or other stressors. Instruct patients to use caution with ethanol; may increase risk of hypoglycemia.

• Hypersensitivity: Hypersensitivity reactions (serious, life-threatening and anaphylaxis) have occurred. If hypersensitivity reactions occur, discontinue administration and initiate supportive care measures.

• Hypokalemia: Insulin (especially IV insulin) causes a shift of potassium from the extracellular space to the intracellular space, possibly producing hypokalemia. If left untreated, hypokalemia may result in respiratory paralysis, ventricular arrhythmia and even death. Use with caution in patients at risk for hypokalemia (eg, loop diuretic use). Monitor serum potassium frequently with IV insulin use and supplement potassium when necessary.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment. Dosage requirements may be reduced and patients may require more frequent dose adjustment and glucose monitoring.

• Renal impairment: Use with caution in patients with renal impairment. Dosage requirements may be reduced and patients may require more frequent dose adjustment and glucose monitoring.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Hospitalized patients with diabetes: Exclusive use of a sliding scale insulin regimen (insulin regular) in the inpatient hospital setting is strongly discouraged. In the critical care setting, continuous IV insulin infusion (insulin regular) has been shown to best achieve glycemic targets. In noncritically ill patients with either poor oral intake or taking nothing by mouth, basal insulin or basal plus bolus is preferred. In noncritically ill patients with adequate nutritional intake, a combination of basal insulin, nutritional, and correction components is preferred. An effective insulin regimen will achieve the goal glucose range without the risk of severe hypoglycemia. A blood glucose value <70 mg/dL should prompt a treatment regimen review and change, if necessary, to prevent further hypoglycemia (ADA 2018).

Dosage form specific issues:

• Humalog KwikPen devices: Do not perform dose conversion when using KwikPen; the dose window shows the number of units to be delivered and no conversion is needed.

• Humalog U 200 (200 units/mL) KwikPen: Do not transfer product from the KwikPen to a syringe for administration. Do not mix with other insulins, administer in a CSII pump, or administer IV.

• Multiple-dose injection pens: According to the CDC, pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).

Other warnings/precautions:

• CSII administration: Insulin lispro U-100 (eg, 100 units/mL) may be administered via CSII; do not dilute or mix with other insulins. Rule out external pump failure if unexplained hyperglycemia or ketosis occurs; temporary SubQ insulin administration may be required until the problem is identified and corrected.

• IV administration: Insulin lispro U 100 (eg, 100 units/mL) may be administered IV in selected clinical situations to control hyperglycemia; close monitoring of blood glucose and serum potassium as well as medical supervision is required.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Geriatric Considerations

Intensive glucose control (HbA1c <6.5%) has been linked to increased all-cause and cardiovascular mortality, hypoglycemia requiring assistance, and weight gain in adult type 2 diabetes. How “tightly” to control a geriatric patient’s blood glucose needs to be individualized. Such a decision should be based on several factors, including the patient’s functional and cognitive status, how well he/she recognizes hypoglycemic or hyperglycemic symptoms, and how to respond to them and other disease states. An HbA1c <7.5% is an acceptable endpoint for a healthy older adult, while <8% to 8.5% is acceptable for elderly patients, depending on the level of comorbidities, functional and cognitive status, and living situation (eg, caregiver present to assist, long-term care facility) (ADA 2018b). Depending on the living situation and who is giving the injection, assessment of the correct use of prefilled pen devices should be performed. The strength, dexterity, and multistep nature of the use of this type of device can make it difficult for some older adult patients. Initial doses may require considerations for renal function in the elderly with dosing adjusted subsequently based on blood glucose monitoring. For elderly patients with diabetes who are relatively healthy, attaining target goals for aspirin use, blood pressure, lipids, smoking cessation, and diet and exercise may be more important than normalized glycemic control.

Insulin has been implicated as a major cause of adverse effects requiring hospitalization, especially in those ≥80 years of age (Budnitz 2011). Care should be taken to ensure appropriate monitoring is undertaken when initiating or titrating insulin in an older adult. Other rapid-acting insulins, such as insulin lispro, have been associated with more hypoglycemia than other insulin regimens in older adults, and a monitoring plan should take this into account.

Pregnancy Risk Factor

B

Pregnancy Considerations

Insulin lispro has not been shown to cross the placenta at standard clinical doses (Boskovic 2003; Holcberg 2004; Jovanovic 1999).

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2018; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2018; Blumer 2013; Lambert 2013).

Insulin requirements tend to fall during the first trimester of pregnancy and increase in the later trimesters, peaking at 28 to 32 weeks’ gestation. Following delivery, insulin requirements decrease rapidly (ACOG 2005).

Insulin therapy is the preferred treatment of type 1 and type 2 diabetes in pregnant women, as well as GDM when pharmacologic therapy is needed (ACOG 190 2018; ADA 2018). Insulin lispro may be used to treat diabetes in pregnant women (ACOG 190 2018; Blumer 2013; Lambert 2013).

Breast-Feeding Considerations

Both exogenous and endogenous insulin are present in breast milk (study not conducted with this preparation) (Whitmore 2012). Breastfeeding is encouraged for all women, including those with type 1, type 2, or GDM (ACOG 2005; ADA 2018; Blumer 2013; Metzger 2007). A small snack (such as milk) before breastfeeding may help decrease the risk of hypoglycemia in women with pregestational diabetes (ACOG 2005; Reader 2004). All types of insulin may be used while breastfeeding (Metzger 2007). The manufacturer considers the use of insulin lispro to be compatible with breastfeeding, although adjustments of the mothers insulin dose may be needed.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Endocrine & metabolic: Severe hypoglycemia (2% to 14%)

Immunologic: Antibody development (type 2 diabetics; 19%; type 1 diabetics: 23%)

Local: Infusion site reaction (type 1 diabetes: 21% to 24%; includes erythema and occlusion)

1% to 10%: Neuromuscular & skeletal: Myalgia (7%; most likely secondary to excipient metacresol)

Frequency not defined:

Cardiovascular: Peripheral edema

Endocrine & metabolic: Hypoglycemia, hypokalemia, weight gain

Hypersensitivity: Hypersensitivity reaction

Local: Hypertrophy at injection site, injection site reaction (including local reactions secondary to excipient metacresol), lipoatrophy at injection site

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

None known.

Drug Interactions 

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Beta-Blockers: May enhance the hypoglycemic effect of Insulins. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Edetate CALCIUM Disodium: May enhance the hypoglycemic effect of Insulins. Risk C: Monitor therapy

Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Insulins. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Exceptions: Liraglutide. Risk D: Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Liraglutide: May enhance the hypoglycemic effect of Insulins. Management: If liraglutide is used for the treatment of diabetes (Victoza), consider insulin dose reductions. The combination of liraglutide and insulin should be avoided if liraglutide is used exclusively for weight loss (Saxenda). Risk D: Consider therapy modification

Macimorelin: Insulins may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Maitake: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Metreleptin: May enhance the hypoglycemic effect of Insulins. Management: Insulin dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Pioglitazone: May enhance the adverse/toxic effect of Insulins. Specifically, the risk for hypoglycemia, fluid retention, and heart failure may be increased with this combination. Management: If insulin is combined with pioglitazone, dose reductions should be considered to reduce the risk of hypoglycemia. Monitor patients for fluid retention and signs/symptoms of heart failure. Risk D: Consider therapy modification

Pramlintide: May enhance the hypoglycemic effect of Insulins. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Risk D: Consider therapy modification

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Rosiglitazone: Insulins may enhance the adverse/toxic effect of Rosiglitazone. Specifically, the risk of fluid retention, heart failure, and hypoglycemia may be increased with this combination. Risk X: Avoid combination

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy

Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors: May enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Monitoring Parameters

Diabetes mellitus: Plasma glucose, electrolytes, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2018]); renal function, hepatic function, weight

IV administration: Close monitoring of blood glucose and serum potassium

Reference Range

Recommendations for glycemic control in nonpregnant adults with diabetes (ADA 2018):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics)

Preprandial capillary blood glucose: 80 to 130 mg/dL

Peak postprandial capillary blood glucose: <180 mg/dL

Recommendations for glycemic control in older adults (≥65 years) with diabetes (ADA 2018):

HbA1c: <7.5% (healthy); <8% (complex/intermediate health); <8.5% (very complex/poor health) (individualization may be appropriate based on patient and caregiver preferences)

Preprandial capillary blood glucose: 90 to 130 mg/dL (healthy); 90 to 150 mg/dL (complex/intermediate health); 100 to 180 mg/dL (very complex/poor health)

Bedtime capillary blood glucose: 90 to 150 mg/dL (healthy); 100 to 180 mg/dL (complex/intermediate health); 110 to 200 mg/dL (very complex/poor health)

Recommendations for glycemic control in pediatric (all age groups) patients with type 1 diabetes (ADA 2018):

HbA1c: <7.5% (individualization may be appropriate based on patient-specific characteristics; <7% is reasonable if it can be achieved without excessive hypoglycemia)

Preprandial capillary blood glucose: 90 to 130 mg/dL

Bedtime and overnight capillary blood glucose: 90 to 150 mg/dL

Recommendations for hospitalized adult patients with diabetes (ADA 2018): Target glucose range: 140 to 180 mg/dL (majority of critically ill and noncritically ill patients; <140 mg/dL may be appropriate for selected patients, if it can be achieved without excessive hypoglycemia). Initiate insulin therapy for persistent hyperglycemia at ≥180 mg/dL

Recommendations for perioperative care in adult patients with diabetes (ADA 2018): Target glucose range during perioperative period: Consider targeting 80 to 180 mg/dL

Advanced Practitioners Physical Assessment/Monitoring

Obtain HbA1c (at least twice annually if meeting goals and quarterly for patients not meeting treatment goals or with therapy change), serum glucose, electrolytes, renal function tests, and liver function tests. Monitor closely blood glucose and serum potassium in patients receiving IV administration. Monitor weight. Monitor for hypoglycemia at regular intervals during therapy. Teach patient proper use, including appropriate injection technique and syringe/needle disposal, and monitoring requirements. Refer to dietician and/or diabetes self-management education.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor for hypoglycemia at regular intervals during therapy. Teach patient proper use, including appropriate injection technique and syringe/needle disposal, and monitoring requirements. Educate and instruct patient to report signs of hypoglycemia (dizziness, headache, fatigue, weakness, shaking, fast heartbeat, confusion, hunger, or sweating) or hypokalemia (muscle pain or weakness, muscle cramps, or an abnormal heartbeat). May need referral to dietician and/or diabetes self-management education.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Admelog: 100 units/mL (3 mL, 10 mL) [contains metacresol]

HumaLOG: 100 units/mL (3 mL, 10 mL) [contains metacresol, phenol]

Generic: 100 units/mL (10 mL)

Solution Pen-injector, Subcutaneous:

Admelog SoloStar: 100 units/mL (3 mL) [contains metacresol]

HumaLOG Junior KwikPen: 100 units/mL (3 mL) [contains metacresol, phenol]

HumaLOG KwikPen: 100 units/mL (3 mL); 200 units/mL (3 mL) [contains metacresol, phenol]

Generic: 100 units/mL (3 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

HumaLOG: 100 units/mL (3ml) [contains METACRESOL]

Solution Pen-injector, Subcutaneous:

HumaLOG KwikPen: 200 units/mL (3ml) [contains METACRESOL]

Anatomic Therapeutic Chemical (ATC) Classification
  • A10AB04
  • A10AC04
  • A10AD04
Generic Available (US)

Yes

Pricing: US

Solution (Admelog Subcutaneous)

100 units/mL (per mL): $28.02

Solution (HumaLOG Subcutaneous)

100 units/mL (per mL): $32.96

Solution Cartridge (HumaLOG Subcutaneous)

100 units/mL (per mL): $40.84

Solution Pen-injector (Admelog SoloStar Subcutaneous)

100 units/mL (per mL): $36.07

Solution Pen-injector (HumaLOG Junior KwikPen Subcutaneous)

100 units/mL (per mL): $42.43

Solution Pen-injector (HumaLOG KwikPen Subcutaneous)

100 units/mL (per mL): $42.43

200 units/mL (per mL): $84.86

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Insulin acts via specific membrane-bound receptors on target tissues to regulate metabolism of carbohydrate, protein, and fats. Target organs for insulin include the liver, skeletal muscle, and adipose tissue.

Within the liver, insulin stimulates hepatic glycogen synthesis. Insulin promotes hepatic synthesis of fatty acids, which are released into the circulation as lipoproteins. Skeletal muscle effects of insulin include increased protein synthesis and increased glycogen synthesis. Within adipose tissue, insulin stimulates the processing of circulating lipoproteins to provide free fatty acids, facilitating triglyceride synthesis and storage by adipocytes; also directly inhibits the hydrolysis of triglycerides. In addition, insulin stimulates the cellular uptake of amino acids and increases cellular permeability to several ions, including potassium, magnesium, and phosphate. By activating sodium-potassium ATPases, insulin promotes the intracellular movement of potassium.

Normally secreted by the pancreas, insulin products are manufactured for pharmacologic use through recombinant DNA technology using either E. coli or Saccharomyces cerevisiae. Insulin lispro differs from human insulin by containing a lysine and proline at positions B28 and B29, respectively, in comparison to the proline and lysine found at B28 and B29 in human insulin. Insulins are categorized based on the onset, peak, and duration of effect (eg, rapid-, short-, intermediate-, and long-acting insulin). Insulin lispro is a rapid-acting insulin analog.

Pharmacodynamics/Kinetics

Note: Onset and duration of hypoglycemic effects depend upon the route of administration (absorption and onset of action are more rapid after deeper IM injections than after SubQ), site of injection (onset and duration are progressively slower with SubQ injection into the abdomen, arm, buttock, or thigh respectively), volume and concentration of injection, and the preparation administered. Rate of absorption, onset, and duration of activity may be affected by exercise, presence of lipodystrophy, local blood supply, and/or temperature.

Onset of action: SubQ: 0.25-0.5 hours

Peak effect: SubQ: 0.5-2.5 hours

Duration: SubQ: ≤5 hours

Distribution: Vd: IV: 0.72-1.55 L/kg (inversely related to dose)

Bioavailability: 55% to 77%

Half-life elimination: ~1 hour

Time to peak, plasma: SubQ: 0.5-1.5 hours

Excretion: Urine

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Insulin clearance may be reduced in patients with impaired renal function.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: In general, morning appointments are advisable in patients with diabetes since endogenous cortisol levels are typically higher at this time; because cortisol increases blood sugar levels, the risk of hypoglycemia is less. It is important to confirm that the patient has eaten normally prior to the appointment and has taken all scheduled medications. If a procedure is planned with the expectation that the patient will alter normal eating habits ahead of time (eg, conscious sedation), diabetes medication dose may need to be modified in consultation with the patient’s physician. Patients with well-controlled diabetes can usually be managed conventionally for most surgical procedures. Although patients with diabetes usually recognize signs and symptoms of hypoglycemia and self-intervene before changes in or loss of consciousness occurs, they may not. Staff should be trained to recognize the signs (eg, unusual behavior or profuse sweating in patients who have diabetes) and treat patients who have hypoglycemia; a glucometer should be used to test patient blood glucose levels. Every dental office should have a protocol for managing hypoglycemia in conscious and unconscious patients. Having snack foods or oral glucose tablets or gels available, especially in practices where a large number of surgical procedures are performed, is also prudent (American Diabetes Association 2017).

Effects on Bleeding

No information available to require special precautions

Index Terms

Humalog Junior KwikPen; Lispro Insulin

FDA Approval Date
June 14, 1996
References

Admelog (insulin lispro) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis US; October 2018.

Admelog (insulin lispro) [product monograph]. Laval, Quebec, Canada: Sanofi-aventis Canada Inc; October 2017.

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Clinical Management Guidelines for Obstetrician-Gynecologists. Number 60, March 2005. Pregestational Diabetes Mellitus. Obstet Gynecol. 2005; 105(3):675-685.[PubMed 15738045]

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018;131(2):e49-e64.[PubMed 29370047]

American Diabetes Association (ADA). Diabetes Care. 2018;41(suppl 1):S1-S159. Available at: http://care.diabetesjournals.org/content/41/Supplement_1. Accessed October 9, 2018.[PubMed 29222382]

Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249.[PubMed 24194617 ]

Boskovic R, Feig DS, Derewlany L, et al. Transfer of insulin lispro across the human placenta: In vitro perfusion studies. Diabetes Care. 2003; 26(5):1390-1394.[PubMed 12716794]

Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-2012.[PubMed 22111719]

Centers for Disease Control and Prevention (CDC). CDC clinical reminder: insulin pens must never be used for more than one person. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed January 9, 2012.

Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015. Endocr Pract. 2015;21(suppl 1):1-87. doi: 10.4158/EP15672.GL.[PubMed 25869408]

Holcberg G, Tsadkin-Tamir M, Sapir O, et al. Transfer of insulin lispro across the human placenta. Eur J Obstet Gynecol Reprod Biol. 2004; 115(1):117-118.[PubMed 15223182]

Humalog (insulin lispro injection [rDNA origin] solution) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; October 2018.

International Diabetes Federation, International Society for Pediatric and Adolescent Diabetes. Global IDF/ISPAD Guideline for Diabetes in Childhood and Adolescence. 2011. Available at http://www.idf.org/e-library/guidelines/80-the-global-idf-ispad-guidelines-for-diabetes-in-childhood-and-adolescence.html. Last accessed: April 27 2017.

Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38(1):140-149.[PubMed 25538310]

Jacobi J, Bircher N, Krinsley J, et al. Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients. Crit Care Med. 2012;40(12):3251-3276.[PubMed 23164767]

Jovanovic L, Ilic S, Pettitt DJ, et al. Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care. 1999;22(9):1422-1427.[PubMed 10480503]

Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults: A consensus report. J Am Geriatr Soc. 2012; doi: 10.1111/jgs.12035.[PubMed 23106132]

Kitabchi AE, Umpierrez GE, Miles JM, et al. Hyperglycemic crises in adult patients with diabetes. Diabetes Care. 2009; 32(7):1335-1343.[PubMed 19564476]

Lambert K, Holt RI. The use of insulin analogues in pregnancy. Diabetes Obes Metab. 2013;15(10):888-900.[PubMed 23489521 ]

Ling J, Hu M, Hagerup T, et al. Lispro insulin: adsorption and stability in selected intravenous devices. Diabetes Educ. 1999;25(2):237-245.[PubMed 10531849]

Metzger BE, Buchanan TA, Coustan DR, et al. Summary and recommendations of the fifth International workshop-conference on gestational diabetes mellitus,” Diabetes Care. 2007, 30(Suppl 2):251-260.[PubMed 17596481]

Moghissi ES, Korytkowski MT, DiNardo M, et al. American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement on Inpatient Glycemic Control. Endocr Pract. 2009;15(4):353-369.[PubMed 19454396]

Reader D, Franz MJ. Lactation, diabetes, and nutrition recommendations. Curr Diab Rep. 2004;4(5):370-376.[PubMed 15461903]

Thompson CD, Vital-Carona J, Faustino EV. The effect of tubing dwell time on insulin adsorption during intravenous insulin infusions. Diabetes Technol Ther. 2012;14(10):912-916.[PubMed 22746979]

Umpierrez GE, Cuervo R, Karabell A, et al. Treatment of diabetic ketoacidosis with subcutaneous insulin aspart. Diabetes Care. 2004; 27(8):1873-1878.[PubMed 15277410]

Umpierrez GE, Latif K, Stoever J, et al. Efficacy of subcutaneous insulin lispro versus continuous intravenous regular insulin for the treatment of patients with diabetic ketoacidosis. Am J Med. 2004;117(5):291-296.[PubMed 15336577]

Whitmore TJ, Trengove NJ, Graham DF, Hartmann PE. Analysis of insulin in human breast milk in mothers with type 1 and type 2 diabetes mellitus. Int J Endocrinol. 2012;2012:296368.[PubMed 22500167]

Brand Names: International

Humalog (AE, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CN, CO, CY, CZ, DE, DK, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HN, HR, HU, ID, IE, IN, IS, IT, JM, JP, KE, KW, LB, LK, LR, LT, LU, LV, MA, ML, MR, MT, MU, MW, MX, NE, NG, NL, NO, PK, PT, PY, QA, RO, RU, SA, SC, SD, SE, SI, SK, SL, SN, SR, TH, TN, TR, TT, TW, TZ, UG, UY, VE, VN, ZA, ZM, ZW); Humalog Lispro (CR, GT, HN, IL, KR, NI, PA, PE, SV); Humalog Miriopen (JP); Humalog Mix NPL (AT, BE, BG, CH, CZ, DE, DK, FI, FR, GB, GR, HN, IE, IT, NO, PT, RU, SE, TR); Humaloh (UA); Insul Lispro (BD); Insulin Humalog (PL); Insuline Lispro Humalog (FR); Liprolog (AT, BE, BG, CH, CZ, DE, DK, FI, FR, GB, GR, HN, IE, IT, NO, PT, RU, SE, TR)

Insulin Lispro (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(IN soo lin LYE sproe)

Brand Names: US

Admelog; Admelog SoloStar; HumaLOG; HumaLOG Junior KwikPen; HumaLOG KwikPen

Brand Names: Canada

Humalog; HumaLOG KwikPen

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to insulin or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have low blood sugar.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this drug. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Wear disease medical alert ID (identification).
  • Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid drinking alcohol or taking products that have alcohol in them while taking this drug.
  • Do not share your insulin product with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know you have.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • U-200 shot product:
  • This brand of insulin is 2 times stronger than other brands. Use extra care when you measure a dose. Accidental overdose may lead to very bad side effects or life-threatening low blood sugar. Talk with the doctor.
  • This drug must not be used in an insulin pump. If you have questions, talk with the doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Very bad irritation where the shot was given.
  • Change in eyesight.
  • Chills.
  • Very bad dizziness or passing out.
  • Mood changes.
  • Seizures.
  • Slurred speech.
  • Trouble breathing.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in skin to thick or thin where the shot was given.
  • Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Weight gain.
  • Flu-like signs.
  • Nose or throat irritation.
  • Headache.
  • Cough.
  • Upset stomach.
  • Stomach pain.
  • Diarrhea.
  • Feeling tired or weak.
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • It is given as a shot into the fatty part of the skin.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take within 15 minutes before or right after a meal.
  • Move site where you give the shot each time.
  • Do not give into red or irritated skin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Follow the diet and workout plan that your doctor told you about.
  • Be sure you know what to do if you do not eat as much as normal or if you skip a meal.
  • Do not use outdated insulin.
  • Vials:
  • Do not draw into a syringe and store for future use.
  • Some brands must not be mixed with other types of insulin. Be sure you know whether your brand can be mixed with another type of insulin.
  • If you are using this drug in a pump, be sure you know how to use it. Follow what your doctor has told you or read the package insert. Change the drug and parts of the pump when you have been told.
  • If this drug is used in an insulin pump, be sure you have another way of using insulin if the pump does not work. Talk with the doctor.
  • Cartridges and prefilled pens:
  • Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
  • This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.
  • Do not move this drug from the pen to a syringe or mix with other types of insulin.
What do I do if I miss a dose?
  • Be sure you know what to do if you forget to take a dose.
  • If you are not sure what to do if you miss a dose, call your doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store unopened containers in a refrigerator. Do not freeze.
  • Do not use if it has been frozen.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • Protect from heat and light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Vials:
  • After opening, store in the refrigerator or at room temperature. Throw away any part not used after 28 days.
  • Cartridges and prefilled pens:
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 28 days.
  • Take off the needle after each shot. Do not store this device with the needle on it.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Insulin Lispro (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(IN soo lin LYE sproe)

Brand Names: US

Admelog; Admelog SoloStar; HumaLOG; HumaLOG Junior KwikPen; HumaLOG KwikPen

Brand Names: Canada

Humalog; HumaLOG KwikPen

What is this drug used for?
  • It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has low blood sugar.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Low blood sugar may happen with this drug. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
  • Low blood potassium may happen with this drug. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
  • Be sure your child has the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your child’s dose ready. If you have any questions, call the doctor or pharmacist.
  • It may be harder to control your child’s blood sugar during times of stress like when your child has a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your child’s blood sugar. Talk with the doctor.
  • Have your child wear disease medical alert ID (identification).
  • If your child can drive, do not let your child drive if his/her blood sugar has been low. There is a greater chance of a crash.
  • Have your child’s blood sugar checked as you have been told by your child’s doctor.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Alcohol interacts with this drug. Be sure your child does not drink alcohol or take products that have alcohol in them.
  • Do not share your child’s insulin product with another person. This includes any pens, cartridge devices, needles, or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know your child has.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • U-200 shot product:
  • This brand of insulin is 2 times stronger than other brands. Use extra care when you measure a dose. Accidental overdose may lead to very bad side effects or life-threatening low blood sugar. Talk with the doctor.
  • This drug must not be used in an insulin pump. If you have questions, talk with the doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Very bad irritation where the shot was given.
  • Change in eyesight.
  • Chills.
  • Very bad dizziness or passing out.
  • Mood changes.
  • Seizures.
  • Slurred speech.
  • Trouble breathing.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Change in skin to thick or thin where the shot was given.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when this drug is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if your child has any of these signs. Follow what you have been told to do if your child gets low blood sugar. This may include giving your child glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Weight gain.
  • Flu-like signs.
  • Nose or throat irritation.
  • Headache.
  • Cough.
  • Upset stomach.
  • Stomach pain.
  • Diarrhea.
  • Feeling tired or weak.
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • It is given as a shot into the fatty part of the skin.
  • If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • Give within 15 minutes before or right after a meal.
  • Move site where you give the shot each time.
  • Do not give into red or irritated skin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • Be sure you know what to do if your child does not eat as much as normal or if your child skips a meal.
  • Do not give outdated insulin.
  • Vials:
  • Do not draw into a syringe and store for future use.
  • Some brands must not be mixed with other types of insulin. Be sure you know whether your brand can be mixed with another type of insulin.
  • If you are using this drug in a pump, be sure you know how to use it. Follow what your doctor has told you or read the package insert. Change the drug and parts of the pump when you have been told.
  • If this drug is used in an insulin pump, be sure you have another way of using insulin if the pump does not work. Talk with the doctor.
  • Cartridges and prefilled pens:
  • Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
  • This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.
  • Do not move this drug from the pen to a syringe or mix with other types of insulin.
What do I do if my child misses a dose?
  • Be sure you know what to do if you forget to give your child a dose.
  • If you are not sure what to do if you miss giving your child a dose, call the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store unopened containers in a refrigerator. Do not freeze.
  • Do not use if it has been frozen.
  • If an unopened container has been stored at room temperature, be sure you know how long you can leave this drug at room temperature before you need to throw it away. If you are not sure, talk with the doctor or pharmacist.
  • Protect from heat and light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Vials:
  • After opening, store in the refrigerator or at room temperature. Throw away any part not used after 28 days.
  • Cartridges and prefilled pens:
  • Store opened cartridges and pens at room temperature. Throw away any part not used after 28 days.
  • Take off the needle after each shot. Do not store this device with the needle on it.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.