insulin lispro (Rx)

Brand and Other Names:Admelog, Humalog, more...Humalog Kwikpen, Humalog Junior KwikPen
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Dosing & Uses

AdultPediatric

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)
  • 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
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Type 1 or 2 Diabetes Mellitus

Rapid-acting human insulin analogue indicated to improve glycemic control in adults and children 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)
  • 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
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Type 1 Diabetes Mellitus

Rapid-acting human insulin analogue indicated to improve glycemic control in adults and children 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

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Interactions

Interaction Checker

and insulin lispro

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            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

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            Warnings

            Contraindications

            During episodes of hypoglycemia

            Systemic allergic reactions

            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

            Hypoglycemia

            • Hypoglycemia is the most common adverse reaction; severe hypoglycemia can cause seizures, may be life-threatening, or cause death
            • Decreased insulin requirements (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)
            • Increased insulin requirements (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
              • 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

            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
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            Pregnancy & Lactation

            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

            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

            Limited available data with Admelog in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

            Lactation

            Unknown whether insulin lispro is excreted in human milk

            Because many drugs are excreted in human milk, use insulin lispro with caution

            Compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses

            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.

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            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)

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            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 <q7days

            Change infusion sets and the infusion set insertion site <q3days

            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 Administration

            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

            Continuous subcutaneous infusion (insulin pump)

            • Administer by continuous subcutaneous infusion into SC tissue of the abdominal wall
            • Rotate infusion sites within the same region to reduce the risk of lipodystrophy

            IV Administration

            Administer insulin IV only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia

            Storage

            Admelog

            • Unopened 10 mL vials and 3 mL SoloStar pen
              • Refrigerate at 36-46°F [2-8°C] until expiration date OR Store at room temperature, <86°F [30°C] for up to 28 days
            • Opened 10 mL vials
              • Store at room temperature, <86°F [30°C] OR refrigerate at 36-46°F [2-8°C] for up to 28 days
            • Opened 3 mL SoloStar pen
              • Store at room temperature, <86°F [30°C] for up to 28 days
              • Do not refrigerate
            • Diluted Admelog for SC injection and infusion bags
              • Refrigerate at 36-46°F [2-8°C] for up to 24 hr OR
              • Store at room temperature, <86°F [30°C] for up to 4 hr

            Humalog

            • Unopened Humalog U-100 10 mL vials, 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
              • Refrigerate at 36-46°F [2-8°C] until expiration date OR
              • Store at room temperature, <86°F [30°C] for up to 28 days
            • Unopened 3 mL Humalog U-200 KwikPen (prefilled)
              • Refrigerate at 36-46°F [2-8°C] until expiration date OR
              • Store at room temperature, <86°F [30°C] for up to 28 days
            • Opened 10 mL Humalog U-100 vials
              • Store at room temperature, <86°F [30°C] OR refrigerate at 36-46°F [2-8°C] for up to 28 days
            • Opened Humalog U-100 3 mL cartridge, KwikPen (prefilled), Junior KwikPen (prefilled)
              • Store at room temperature, <86°F [30°C] for up to 28 days
              • Do not refrigerate
            • Opened 3 mL Humalog U-200 KwikPen (prefilled)
              • Store at room temperature, <86°F [30°C] for up to 28 days
              • Do not refrigerate
            • Diluted Humalog U-100 for SC Injection
              • Stored at 41°F (5°C) use for 28 days OR store at 86°F (30°C) for up to 14 days
              • Do not dilute Humalog contained in a cartridge or used in an external insulin pump
            • Diluted infusion bags
              • Refrigerate at 36-46°F (2-8°C) for 48 hr and then may be used at room temperature, <86°F [30°C] for up to an additional 48 hr
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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