Dosing & Uses
Dosage Forms & Strengths
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; 3 mL)
- 100 units/mL (Lyumjev KwikPen; Lyumjev Junior KwikPen; Lyumjev Tempo Pen; 3 mL)
- 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 KwikPen dose increment: 0.5 unit; maximum dose/injection is 30 units
Type 1 or 2 Diabetes Mellitus
Rapid-acting human insulin analogue indicated to improve glycemic control in patients with type 1 or 2 diabetes mellitus
Type 1 diabetes mellitus
- 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
Type 2 diabetes mellitus
- 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% qWeek or q2Weeks once self-monitoring of blood glucose (SMBG) is achieved (ADA guidelines 2018)
Dosage Modifications
Dose adjustment and increased frequency of glucose monitoring
- See Warnings
- Coadministration of drugs that increase the risk of hypoglycemia, and drugs that may increase or decrease blood glucose lowering effects
- Renal and hepatic impairment: May increase risk for hypoglycemia
Dosing Considerations
Do not mix SC injection with insulin preparations other than NPH insulin
Do not mix IV or continuous SC infusions with any other insulins
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
Do NOT perform dose conversion when using either the Humalog U-100 or U-200 KwikPens; the dose window shows number of insulin units to be delivered and no conversion is needed
Do NOT mix Humalog U-200 with any other insulins
Do NOT administer Humalog U-200 using a continuous subcutaneous infusion pump (i.e., insulin pump); insulin pump is to be used only for Humalog U-100
Do NOT administer Humalog U-200 intravenously
Dosage Forms & Strengths
injectable solution
- 100 units/mL (Humalog; 10mL vial)
- 100 units/mL (Admelog; 10mL vial)
injectable pen
- 100 units/mL (Humalog KwikPen; Humalog Junior KwikPen 3mL pen or cartridge)
- 100 units/mL (Admelog SoloStar; 3 mL)
- 100 units/mL (Lyumjev KwikPen; Lyumjev Junior KwikPen; Lyumjev Tempo Pen; 3 mL)
- 200 units/mL (Humalog KwikPen; 3mL pen)
- KwikPen dose increment: 1 unit; maximum dose/injection is 60 units
- Junior KwikPen dose increment: 0.5 unit; maximum dose/injection is 30 units
Type 1 Diabetes Mellitus
Admelog, Humalog only
Rapid-acting human insulin analogue indicated to improve glycemic control in patients with diabetes mellitus
<3 years: Safety and efficacy not established
≥3 years: 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)
See also Administration
Type 2 Diabetes Mellitus
Safety and efficacy not established
Dosing Considerations
Approved for use in children aged ≥3 yr for SC daily injections and for SC continuous infusion by external insulin pump
Do NOT perform dose conversion when using either the Humalog U-100 or U-200 KwikPens; the dose window shows number of insulin units to be delivered and no conversion is needed
Humalog U-200 with not for mixing with any other insulins
Dosage of human insulin, which is always expressed in USP units, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Admelog
- Severe hypoglycemia, after 52 weeks (13.5%)
- Nasopharyngitis, in combination with insulin glargine (13.1%)
Humalog (Type 1 Diabetes)
- Flu syndrome (34.6%)
- Pharyngitis (33.3%)
- Rhinitis (29.6%)
- Headache (24.7%)
- Pain (19.8%)
- Increased cough (17.3%)
- Infection (13.6%)
Humalog (Type 2 Diabetes)
- Headache (11.6%)
- Pain (10.8%)
- Infection (10.1%)
Admelog
- Upper respiratory tract infection, in combination with insulin glargine (6%)
- Severe hypoglycemia, after 26 weeks (2.4%)
Humalog, continuous SC insulin infusion
- Infusion site reactions (2.6%)
Humalog (Type 1 Diabetes)
- Accidental injury (8.6%)
- Diarrhea (8.6%)
- Myalgia (7.4%)
- Abdominal pain (7.4%)
- Asthenia (7.4%)
- Bronchitis (7.4%)
- Urinary tract infection (6.2%)
- Dysmenorrhea (6.2%)
- Surgical procedure (6.2%)
- Fever (6.2%)
- Nausea (6.2%)
Humalog (Type 2 Diabetes)
- Rhinitis (8.1%)
- Surgical procedure (7.4%)
- Pharyngitis (6.6%)
Frequency Not Defined
Hypoglycemia
Pallor
Palpitation
Redness
Hunger
Nausea
Tachycardia
Lipodystrophy
Lipohypertrophy
Local allergic reaction
Hypokalemia
Postmarketing Reports
Medication errors
Localized cutaneous amyloidosis
Warnings
Contraindications
During episodes of hypoglycemia
Hypersensitivity to drug or excipients
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 correlates 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 & Lactation
Pregnancy
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
Animal data
- In a combined fertility and embryo-fetal development study, female rats were given SC insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human SC dose of 1 unit/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19; fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter
Lactation
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Protein hormone; stimulates glucose uptake by peripheral cells
Regulates glucose metabolism; insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis; targets include skeletal muscle, liver, and adipose tissue
Absorption
Humalog
- Average time required to attain near normoglycemia for IV administration was 129 minutes
- Mean area under the glucose infusion rate curves: 125 g (Humalog U-200) and 126 g (Humalog U-100)
- Bioavailability: 55-77% following SC; well absorbed
- Onset: 0.5-5 hr (initial); 0.5-2.5 hr Duration of action: ≤5 hr
- Peak plasma time, 0.1 to 0.4 unit/kg dose: 0.5-1.5 hr
- Mean observed area under the serum insulin concentration-time curve from time zero to infinity was 2360 pmol·hr/L (Humalog U-200) and 2390 pmol·hr/L (Humalog U-200)
Admelog
- Mean area under the glucose infusion rate curves, SC use: 1953.5 mg/kg
- Mean maximum glucose infusion rate, SC use: 9.97 mg/min/kg
- Mean observed area under the serum insulin concentration-time curve from time zero to infinity was 12800 pg⋅hr/mL
- Peak insulin lispro concentration: 5070 pg/mL
- Median peak plasma time: 0.83 hr
Distribution
Vd: 1.55 L/kg (0.1 unit/kg-dose); 0.72 L/kg (0.2 unit/kg-dose)
Metabolism
Human metabolism studies have not been conducted Animal studies indicate that the metabolism of insulin lispro is identical to regular human insulin
Elimination
Half-life, SC use: 1 hr
Mean clearance, IV use: 21.0 mL/min/kg (0.1 unit/kg dose); 9.6 mL/min/kg (0.2 unit/kg dose)
Mean half-life: 0.85 hr (0.1 unit/kg); 0.92 hr (0.2 unit/kg)
Administration
IV Preparation
Dilute insulin lispro to concentrations from 0.1 unit/mL to 1 unit/mL using 0.9% NaCl
SC Preparation
Admelog
- Dilute with sterile 0.9% NaCl
- Diluting 1 part Admelog to 1 part 0.9% NaCl will yield a concentration one-half of Admelog (equivalent to U-50)
Humalog U-100
- Dilute with sterile diluent for Humalog
- Diluting 1 part Humalog to 9 parts diluent will yield a concentration one-tenth of Humalog (equivalent to U-10)
- Diluting 1 part Humalog to 1 part diluent will yield a concentration one-half of Humalog (equivalent to U-50)
Continuous SC Infusion (Insulin Pump) Preparation
Do not dilute or mix insulin lispro when administering by continuous subcutaneous infusion
Change insulin lispro in the pump reservoir Change infusion sets and the infusion set insertion site Do not expose insulin lispro in pump reservoir to temperatures >98.6°F (37°C) Use insulin lispro in accordance with the insulin infusion pump systems instructions for use See insulin infusion pump system labeling to determine if insulin lispro can be used with the pump system SC use only Administer dose within 15 minutes before a meal or immediately after a meal Should generally be used in regimens with intermediate or long-acting insulin Administer by SC injection in the abdominal wall, thigh, upper arm, or buttocks Rotate injection site within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy Administer insulin IV only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemiaSC Administration
Continuous subcutaneous infusion (insulin pump)
IV Administration
Storage
Admelog
Unopened 10 mL vials and 3 mL SoloStar pen
Opened 10 mL vials
Opened 3 mL SoloStar pen
Diluted Admelog for SC injection and infusion bags
Humalog
Unopened Humalog U-100 10 mL vials, 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
Unopened 3 mL Humalog U-200 KwikPen (prefilled)
Opened 10 mL Humalog U-100 vials
Opened Humalog U-100 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
Opened 3 mL Humalog U-200 KwikPen (prefilled)
Diluted Humalog U-100 for SC Injection
Diluted infusion bags
Lyumjev
Unopened Lyumjev U-100 or 10 mL vials, 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
Unopened 3 mL Lyumjev U-200 KwikPen (prefilled)
Opened 10 mL Lyumjev U-100 vials
Opened Lyumjev U-100 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
Opened 3 mL Lyumjev U-200 KwikPen (prefilled)
Diluted Lyumjev
Images
Patient Handout
Formulary
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