Identical amino acid sequence to Lantus® (insulin glargine injection)1,2

BASAGLAR amino acid identical to Lantus

BASAGLAR was approved based, in part, on results of an extensive clinical development program.1

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CONTRAINDICATIONS
BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or one of its excipients.
WARNINGS AND PRECAUTIONS
BASAGLAR KwikPen® must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.

See what a diabetes expert says about BASAGLAR®

(insulin glargine injection) 100 units/mL

BASAGLAR® (insulin glargine injection) 100 units/mL
Clinical reprints

Read published ELEMENT 1 (type 1 diabetes) and ELEMENT 2 (type 2 diabetes) clinical studies comparing BASAGLAR with Lantus products (approved in the US or outside the US).

Access ELEMENT 1 Study

Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab. 2015;17:726-733.

Access ELEMENT 2 Study

Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17:734-741.

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WARNINGS AND PRECAUTIONS
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.

BASAGLAR® (insulin glargine injection) 100 units/mL
Pharmacokinetic (PK) profile

BASAGLAR and Lantus (US-approved) PD properties over a 24-hour period3

BASAGLAR and Lantus (US-approved) PK properties over a 24-hour period

A phase 1 randomized, double-blind, single-dose, 2-treatment, 4-period, crossover, replicate treatment, euglycemic clamp study with 91 healthy subjects evaluated the PK and pharmacodynamic (PD) profiles for BASAGLAR and Lantus (US-approved) given subcutaneously as single, 0.5 unit/kg doses.3

PK results: Based on statistical comparisons of area under the plasma concentration–time curve from 0 to 24 hours (AUC0-24) and maximum plasma concentration (Cmax) of BASAGLAR and Lantus (US-approved), the ratios of least squares (LS) geometric means were 0.90 and 0.92 for AUC0-24 and Cmax, respectively, with 90% confidence intervals (CIs) for the ratios contained within the prespecified interval of 0.80 to 1.25.3

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WARNINGS AND PRECAUTIONS
Accidental mix-ups between another insulin glargine product (100 units/mL) and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.

BASAGLAR® (insulin glargine injection) 100 units/mL
Pharmacodynamic (PD) profile

BASAGLAR and Lantus (US-approved) PD properties over a 24-hour period3

BASAGLAR and Lantus (US-approved) PD properties over a 24-hour period

*Glucose infusion rate.

Approved in the US.

A phase 1 randomized, double-blind, single-dose, 2-treatment, 4-period, crossover, replicate treatment, euglycemic clamp study with 91 healthy subjects evaluated the PK and PD profiles for BASAGLAR and Lantus (US-approved) given subcutaneously as single, 0.5 unit/kg doses.3

PD results: Based on statistical comparisons of total glucose infusion over the clamp duration (Gtot) and maximum glucose infusion rate (Rmax) of BASAGLAR and Lantus (US-approved), the ratios of LS geometric means were 0.91 and 0.93, respectively, for Gtot and Rmax, with 90% CIs for the ratios contained within the prespecified interval of 0.80 to 1.25.3

The pharmacodynamic profile of BASAGLAR demonstrated sustained glucose-lowering activity over 24 hours with no pronounced peak1,3

SELECT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.

24-hour PD profile

BASAGLAR® (insulin glargine injection) 100 units/mL
A follow-on biologic to Lantus

How a follow-on biologic gets approved in the US4

Approval process for a follow-on biologic in the US

BASAGLAR is not considered a biosimilar in the US. It is considered a biosimilar in the European Union (EU) because it was approved under their biosimilar regulatory pathway.

SELECT SAFETY INFORMATION
ADVERSE REACTIONS
All insulin products, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.

Indications and Important Safety Information
Indication

BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

LIMITATION OF USE

BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or one of its excipients.

WARNINGS AND PRECAUTIONS

BASAGLAR KwikPen® must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.

Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.

Accidental mix-ups between another insulin glargine product (100 units/mL) and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between BASAGLAR 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 BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.

All insulin products, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

ADVERSE REACTIONS

Adverse reactions commonly associated with insulin glargine products (5% or greater incidence) are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.

DRUG INTERACTIONS

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.

BV HCP ISI 24JUN2016

For more information, please see Full Prescribing Information, including Patient Information and Instructions for Use.

BASAGLAR and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates and are available by prescription only.

References
1. BASAGLAR [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 2. Lantus [Prescribing Information]. Bridgewater, NJ: sanofi-aventis U.S. LLC; 2015. 3. Linnebjerg H, Lam EC, Seger ME, et al. Diabetes Care. 2015;38:2226-2233. 4. Rosenstock J, Hollander P, Bhargava A, et al. Diabetes Obes Metab. 2015;17:734-741. 5. Data on file, Lilly USA, LLC. BAS20160408A. 6. Data on file, Lilly USA, LLC. BAS20160811B. 7. Blevins TC, Dahl D, Rosenstock J, et al. Diabetes Obes Metab. 2015;17:726-733. 8. Data on file, Lilly USA, LLC. BAS20151103E. 9. Data on file, Lilly USA, LLC. BAS20160811A. 10. Gerstein HC, Yale JF, Harris SB, et al. Diabet Med. 2006;23:736-742. 11. BASAGLAR KwikPen [Instructions for Use]. Indianapolis, IN: Eli Lilly and Company.