Identical amino acid sequence to Humalog1,2
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Similar pharmacokinetic (PK) profile to Humalog: fast absorption and rapid onset of action1,3
MEAN PLASMA INSULIN CONCENTRATION VS TIME |
PK RESULTS:
The median time to maximum plasma insulin concentration was ~50 minutes (0.83 hours) after injection. The mean observed area under the plasma insulin concentration time curve from time zero to infinity and peak plasma insulin concentration were 12,800 pg/hr/mL and 5070 pg/mL, respectively.1
STUDY DESIGN
This study was a single-center, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycemic clamp study. Adult patients (N=30) with type 1 diabetes were randomized to receive 0.3 U/kg dose of either ADMELOG or Comparator (Humalog, or a non-US-approved insulin lispro, 100 Units/mL) under fasted conditions. The pharmacokinetic and pharmacodynamic profiles were evaluated over 12 hours.1,3
The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables.
Similar pharmacodynamic (PD) profile to Humalog: short duration of action1,3
GLUCOSE INFUSION RATE VS TIME |
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PD RESULTS:
The mean (SD) time to maximum effect of ADMELOG was approximately 2.07 (0.78) hours. The mean (SD) area under the glucose infusion rate curves and mean (SD) maximum glucose infusion rate were 1953.5 (547.3) mg/kg and 9.97 (2.37) mg/min/kg, respectively.1
STUDY DESIGN:
This study was a single-center, randomized, double-blind, 3-treatment, 3-period, 6-sequence, crossover, euglycemic clamp study. Adult patients (N=30) with type 1 diabetes were randomized to receive 0.3 U/kg dose of either ADMELOG or Comparator (Humalog, or a non–US-approved insulin lispro, 100 Units/mL) under fasted conditions. The PK and PD profiles were evaluated over 12 hours.1,3
The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables.
GIR=glucose infusion rate; SD=standard deviation.
Coverage & Savings
Local coverage details and savings offer for eligible patients
Indication for ADMELOG® (insulin lispro injection) 100 Units/mL
ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adults with type 2 diabetes and adults and children (3 years and older) with type 1 diabetes.
Important Safety Information
Important Safety Information
CONTRAINDICATIONS
ADMELOG is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin lispro or to any of its excipients.
WARNINGS AND PRECAUTIONS
Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
Hypoglycemia is the most common adverse reaction associated with insulins, including ADMELOG, and may be life-threatening.
Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between ADMELOG and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including ADMELOG. If hypersensitivity reactions occur, discontinue ADMELOG, treat per standard of care and monitor until symptoms and signs resolve.
All insulin products, including ADMELOG, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia.
Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.
ADVERSE REACTIONS
Adverse reactions associated with ADMELOG include hypoglycemia, hypokalemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (eg, beta-blockers, clonidine, guanethidine, and reserpine).
IMPORTANT SAFETY INFORMATION FOR ADMELOG® (INSULIN LISPRO INJECTION) SOLOSTAR®
ADMELOG SoloStar is a disposable single-patient-use prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels.
IMPORTANT SAFETY INFORMATION FOR ADMELOG® (INSULIN LISPRO INJECTION) USE IN PUMP
Pump failure or insulin infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause is necessary. Interim subcutaneous injections with ADMELOG may be required. Patients using a pump must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
Click here for Full Prescribing Information.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
*Eligibility Restrictions & Offer Terms:
Insulins Valyou Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying patients will pay $35 per 30 Day Supply. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190(833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).
Sanofi Insulins Co-pay Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661(866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).
References:
1. ADMELOG Prescribing Information.
2. Humalog Prescribing Information.
3. Kapitza C, Nowotny I, Lehmann A, et al. Diabetes Obes Metab. 2017;19(5):622-627.
All registered trademarks cited are property of their respective owners.
Important Safety Information
CONTRAINDICATIONS
ADMELOG is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin lispro or to any of its excipients.
WARNINGS AND PRECAUTIONS
Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen including, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
Hypoglycemia is the most common adverse reaction associated with insulins, including ADMELOG, and may be life-threatening.
Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between ADMELOG and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including ADMELOG. If hypersensitivity reactions occur, discontinue ADMELOG, treat per standard of care and monitor until symptoms and signs resolve.
All insulin products, including ADMELOG, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia.
Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.
ADVERSE REACTIONS
Adverse reactions associated with ADMELOG include hypoglycemia, hypokalemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (eg, beta-blockers, clonidine, guanethidine, and reserpine).
IMPORTANT SAFETY INFORMATION FOR ADMELOG® (INSULIN LISPRO INJECTION) SOLOSTAR®
ADMELOG SoloStar is a disposable single-patient-use prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels.
IMPORTANT SAFETY INFORMATION FOR ADMELOG® (INSULIN LISPRO INJECTION) USE IN PUMP
Pump failure or insulin infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause is necessary. Interim subcutaneous injections with ADMELOG may be required. Patients using a pump must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
Click here for Full Prescribing Information.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
*Eligibility Restrictions & Offer Terms:
Insulins Valyou Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying patients will pay $35 per 30 Day Supply. To pay $35 per 30 Day Supply, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190(833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).
Sanofi Insulins Co-pay Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment. Sanofi reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661(866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).