Insulin Lispro

Insulin Lispro is a prescription medication used to treat Type 1 or 2 Diabetes Mellitus. 

• Insulin Lispro is available under the following different brand names: Admelog, Humalog, Humalog Kwikpen, Humalog Junior KwikPen, Admelog Solostar, Insulin Lispro-aabc, Lyumjev.

Adult and pediatric dosage

Injectable solution

• 100 units/mL (Humalog; 10mL vial)
• 100 units/mL (Admelog; 10mL vial)
• 100 units/mL (Lyumjev; 10mL vial)

Injectable pen

• 100 units/mL (Humalog KwikPen; Humalog Junior KwikPen 3mL pen or cartridge)
• 100 units/mL (Admelog SoloStar; 3mL)
• 100 units/mL (Lyumjev KwikPen; Lyumjev Junior KwikPen; Lyumjev Tempo Pen; 3mL)
• 200 units/mL (Humalog KwikPen; 3mL pen)
• 200 units/mL (Lyumjev KwikPen; 3mL pen)
• KwikPen dose increment: 1 unit; maximum dose/injection is 60 units
• Junior KwickPen dose increment; 0.5 unit; maximum dose/injection is 30 units

Type 1 or 2 Diabetes Mellitus

Type 1 diabetes mellitus

Adult dosage

• Usual daily maintenance range is 0.5-1 unit/kg/day in divided doses; nonobese may require 0.4-0.6 unit/kg/day; obese may require 0.8-1.2 units/kg/day
• Intermediate- or long-acting insulin: Approximately one-third of the total daily insulin requirements SC
• Rapid-acting or short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements

Pediatric dosage

Admelog, Humalog only

• Children younger than 3 years of age: Safety and efficacy not established
• Children 3 years of age or older: 0.4-1 units/kg/day SC of total insulin with higher amounts required during puberty; otherwise, use adult dosing (0.5-1 unit/kg/day) (ADA guidelines 2018)

Type 2 diabetes mellitus

Adult dosage

• Intermediate- or long-acting insulin: 10 units/day SC (or 0.1-0.2 unit/kg/day) at bedtime generally recommended
• Short-acting insulin: If necessary, start up to 4 units, 0.1 unit/kg SC within 15 min before each meal, or 10% basal dose; if A1C <8%, consider decreasing basal insulin dose by same amount
• Increase by 1-2 units or 10-15% once per week or every two weeks once self-monitoring of blood glucose (SMBG) is achieved (ADA guidelines 2018)

Pediatric dosage

• Safety and efficacy not established

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Insulin Lispro include:

• low blood sugar, 
• itching, 
• mild skin rash, and
• thickening or hollowing of the skin at the injection site

Serious side effects of Insulin Lispro include:

• redness or swelling at the injection site, 
• itching, 
• skin rash over the entire body, 
• trouble breathing, 
• fast heartbeats, 
• lightheadedness, 
• swelling in the tongue or throat, 
• weight gain, 
• swelling in the hands or feet, 
• shortness of breath, 
• leg cramps, 
• constipation, 
• irregular heartbeats, 
• fluttering in the chest, 
• increased thirst or urination, 
• numbness or tingling, 
• muscle weakness, and
• limp feeling

Rare side effects of Insulin Lispro include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Insulin Lispro has severe interactions with the following drug:
  • pramlintide
• Insulin Lispro has serious interactions with the following drugs:
  • ethanol
  • macimorelin
• Insulin Lispro has moderate interactions with at least 127 other drugs.
• Insulin Lispro has minor interactions with at least 80 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• During episodes of hypoglycemia.
• Hypersensitivity to drugs or excipients.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Insulin Lispro?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Insulin Lispro?”

Cautions

• Never share a pen between patients even if the needle is changed
• Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia; adjust dosage cautiously and closely monitor blood glucose
• May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium
• Do not transfer Humalog U-200 from the KwikPen to a syringe for administration; the markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia
• Insulin pump or insulin infusion set malfunction or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis; promptly identify and correct the cause of hyperglycemia or ketosis is necessary; interim insulin lispro injections may be required; patients using continuous SC insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure
• Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones
• Severe, life-threatening, generalized allergy including anaphylaxis may occur; if hypersensitivity reactions occur, discontinue treatment; treat accordingly and monitor until resolution of signs and symptoms
• Hyperglycemia or hypoglycemia with changes in insulin regimen
  • Hypoglycemia is the most common adverse reaction; severe hypoglycemia can cause seizures, may be life-threatening, or cause death
  • Decreased insulin requirements may require dose adjustment (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)
  • Increased insulin requirements may require dose adjustment (eg, fever, hyperthyroidism, trauma, infection, surgery)
  • Self-monitoring of blood glucose is essential in preventing and managing of hypoglycemia; closely monitor high-risk patients and patients who have reduced symptomatic awareness of hypoglycemia
  • Risk of hypoglycemia after an injection correlate to the insulin’s duration of action and highest when the glucose lowering effect of the insulin is maximal; glucose lowering effect time course of insulin lispro may vary in different individuals or at different times in the same individual and depends on many conditions, (eg, area of injection, injection site blood supply, temperature
  • Other factors which may increase the risk of hypoglycemia include changes in meal pattern (eg, macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitant medications
  • Patients with renal or hepatic impairment may be at higher risk of hypoglycemia
  • Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
  • Changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased
  • Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia
  • 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 injection site to unaffected areas and closely monitor for hypoglycemia
  • For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
• Drug interactions overview
  • Coadministration with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (eg, octreotide) may increase the risk of hypoglycemia (see Dosage Modifications)
  • Coadministered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (eg, epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones may decrease glucose lowering effects of insulin lispro (see Dosage Modifications)
  • Glucose lowering effect of insulin lispro may be increased or decreased with coadministered with beta blockers, clonidine, lithium salts, and alcohol; pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia
  • Signs and symptoms of hypoglycemia may be blunted when beta blockers, clonidine, guanethidine, and reserpine are coadministered with insulin lispro

Pregnancy and Lactation

• Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
• Diabetes or gestational diabetes patients’ insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery
• Female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking insulin lispro
• Published studies with human insulins suggest optimizing overall glycemic control (eg, postprandial control, before conception, during pregnancy) improves fetal outcome
• Limited available data with Admelog in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
• Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
• There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; one small published study reported that exogenous insulin was present in human milk; however, there is insufficient information to determine effects of drug on breastfed infant and no available information on effects on milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for insulin, any potential adverse effects on breastfed child from drug or from underlying maternal condition.