pharmacopeia
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/api/v1/drug/insulin-lispro

Mechanism of action

Sourced from openFDA

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production.

Insulin Receptor

Indications

Sourced from openFDA
  • ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Contraindications

Sourced from openFDA
  • ADMELOG is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions (5.3) ] . in patients who are hypersensitive to insulin lispro or to any of the excipients in ADMELOG [see Warnings and Precautions (5.5) ].contraindicated

Dosage & administration

Sourced from openFDA

See Full Prescribing Information for important preparation and administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) Subcutaneous injection ( 2.2 ): Administer ADMELOG by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if ADMELOG can be used. Use in accordance with the insulin pump instructions for use. Administer ADMELOG by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Do not mix with other insulins or diluents in the pump. Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY after dilution and under medical supervision. ( 2.2 ) The dosage of ADMELOG must be individualized based on the route of administration and the patient's metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) 2.1 Important Preparation and Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4) ] . Inspect ADMELOG visually before use. It should appear clear and colorless. Do not use ADMELOG if particulate matter or coloration is seen.

Warnings & precautions

Sourced from openFDA

Never share an ADMELOG SoloStar disposable prefilled pen or syringe between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. ( 5.3 , 6 , 7 , 8.6 , 8.7 ) Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. ( 5.4 ) Hypersensitivity Reactions: May be life-threatening. Discontinue ADMELOG, monitor and treat if indicated. ( 5.5 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.6 ) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.7 ) Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer ADMELOG by subcutaneous injection if pump malfunction occurs.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions with Subcutaneous Injections of ADMELOG Two clinical trials with ADMELOG were conducted: one in patients with type 1 diabetes and one in patients with type 2 diabetes [see Clinical Studies (14) ] . The data in Table 1 reflect the exposure of 252 patients with type 1 diabetes to ADMELOG with mean exposure duration of 49 weeks. The type 1 diabetes population had the following characteristics: Mean age was 43 years and mean duration of diabetes was 20 years. Fifty-nine percent were male, 80% were White, 6% were Black or African American and 7% were Hispanic. At baseline, the mean eGFR was 90 mL/min/1.73 m 2 and 49% of patients had eGFR ≥90 mL/min/1.73 m 2 . The mean BMI was 26 kg/m 2 .

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . Pregnant rats and rabbits were exposed to another insulin lispro product in animal reproduction studies during organogenesis. Fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. No adverse effects on embryo-fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.24 times the human subcutaneous dose of 1.0 unit/kg/day [see Data ] . The estimated background risk of major birth defects is 6%–10% in women with pregestational diabetes with a HbA1c >7% and has been reported to be as high as 20%–25% in women with a HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The pharmacokinetic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a study enrolling 30 patients with type 1 diabetes. In this study, the mean observed area under the plasma insulin lispro concentration-time curve from time zero to infinity and peak plasma insulin lispro concentration were 12800 pg∙hr/mL and 5070 pg/mL, respectively.

Overdosage

Sourced from openFDA

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Approval history

Sourced from openFDA
  • Jun 14, 1996BLABLA020563Lilly
  • Dec 22, 1999BLABLA021018Lilly
  • Dec 22, 1999BLABLA021017Lilly
  • May 26, 2015BLABLA205747Eli Lilly And Co
  • Dec 11, 2017BLABLA209196Sanofi-aventis Us
  • Jun 15, 2020BLABLA761109Eli Lilly And Co

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Humalog, Injection, U-100 Tempo Pen (NDC 0002-8213-05)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Lyumjev, Injection, U-100 Tempo Pen (NDC 0002-8235-05)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Lyumjev, Injection, U-100 Tempo Pen Sample (NDC 0002-8235-99)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
137,510 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Blood Glucose Increased38,97128%
  2. 2Incorrect Dose Administered9,3466.8%
  3. 3Blood Glucose Decreased8,9026.5%
  4. 4Drug Ineffective8,3116.0%
  5. 5Visual Impairment5,5394.0%
  6. 6Nausea4,9333.6%
  7. 7Malaise4,0132.9%
  8. 8Hypoglycaemia3,8582.8%
  9. 9Fatigue3,8552.8%
  10. 10Drug Dose Omission3,7512.7%
  11. 11Fall3,5002.5%
  12. 12Underdose3,3802.5%
  13. 13Diarrhoea3,2632.4%
  14. 14Vomiting3,2372.4%
  15. 15Glycosylated Haemoglobin Increased3,2012.3%

Literature

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Recent PubMed references pinned to Insulin Lispro as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 364 ClinicalTrials.gov registrations naming Insulin Lispro as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Insulin Lispro work?
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production.
What is Insulin Lispro used for?
According to FDA labeling, Insulin Lispro carries indications including: ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Insulin Lispro?
Insulin Lispro is classified as Insulins and analogues for injection, fast-acting, Insulins and analogues for injection, intermediate-acting, Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting, Insulin Analog, Insulin Receptor Agonists, Decreased Glycogenolysis, Decreased Lipolysis, Increased Glucose Transport into Cells, Increased Glycogenesis, Increased Lipogenesis, Increased Protein Synthesis.
What are the brand names for Insulin Lispro?
Insulin Lispro is marketed under brand names including Admelog, Humalog, Humalog Mix, Lyumjev.
What are the contraindications for Insulin Lispro?
Insulin Lispro labeling lists contraindications including: ADMELOG is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions (5.3) ] . in patients who are hypersensitive to insulin lispro or to any of the excipients in ADMELOG [see Warnings and Precautions (5.5) ].. Always consult the full prescribing information and a clinician.
Note. Data for insulin-lispro is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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