BASAGLAR® (insulin glargine) injection 100 units/mL is a follow-on biologic with an identical amino acid sequence to Lantus® (insulin glargine injection)1,2

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

The submission included results from pharmacokinetic (PK) and pharmacodynamic (PD) studies, as well as phase 3 studies in people with type 1 and type 2 diabetes.

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

BASAGLAR pharmacokinetic (PK) profile

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

BASAGLAR PK profile vs Lantus*†

*Serum insulin concentration.

Approved in the US.

Study design

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

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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 pharmacodynamic (PD) profile

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

BASAGLAR PD profile vs Lantus*†

*Mean glucose infusion rate.

Approved in the US.

Study design

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

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Accidental mix-ups between insulin products have been reported. To avoid hypoglycemia due to medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.

References:

  1. BASAGLAR [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
  2. Lantus [Prescribing Information]. Bridgewater, NJ: sanofi-aventis U.S. LLC; 2018.
  3. Linnebjerg H, Lam EC, Seger ME, et al. Diabetes Care. 2015;38:2226-2233.

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 any of the excipients in BASAGLAR.

WARNINGS AND PRECAUTIONS

BASAGLAR prefilled pens 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, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. 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 insulin products have been reported. To avoid hypoglycemia due to 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 insulins, 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 insulins, 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 (>5%) associated with insulin glargine products 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 risk of hypoglycemia may increase when antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics are co-administered with BASAGLAR.

The blood glucose lowering effect of BASAGLAR may decrease when co-administered with atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. The blood glucose lowering effect of BASAGLAR may increase or decrease when co-administered with alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.

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

BV HCP ISI 27JUL2021