NDC 0338-0126 Myxredlin

Insulin Human

NDC Product Code 0338-0126

NDC Code: 0338-0126

Proprietary Name: Myxredlin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Insulin Human What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0338 - Baxter Healthcare Corporation
    • 0338-0126 - Myxredlin

NDC 0338-0126-12

Package Description: 12 CONTAINER in 1 CARTON > 100 mL in 1 CONTAINER

NDC Product Information

Myxredlin with NDC 0338-0126 is a a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Myxredlin is insulin human. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Baxter Healthcare Corporation

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Myxredlin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • INSULIN HUMAN 1 [iU]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Insulin - [EPC] (Established Pharmacologic Class)
  • Insulin - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Baxter Healthcare Corporation
Labeler Code: 0338
FDA Application Number: NDA208157 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-12-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Myxredlin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

2.1 Important Administration Instructions

  • •Inspect MYXREDLIN visually before use. It should appear clear and colorless. Do not use MYXREDLIN if particulate matter or coloration is seen. •Administer MYXREDLIN intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels [see Warnings and Precautions (5.2, 5.4)]. •Do not add supplementary medication or additives. •Do not use in series connections. •Do not shake. Do not freeze. Discard any unused portion.

2.2 Dosage Information

  • •Individualize and adjust the dosage of MYXREDLIN based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal. •Dosage adjustments may be needed with changes in nutrition, changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.1, 5.2) and Use in Specific Populations (8.6, 8.7)].

2.3 Dosage Adjustment Due To Drug Interactions

  • •Dosage adjustment may be needed when MYXREDLIN is used concomitantly with certain drugs [see Drug Interactions (7)].

3 Dosage Forms And Strengths

Injection: 100 units insulin human in 100 mL of 0.9% sodium chloride (1 unit per mL) as a clear, colorless solution in a single-dose container.

4 Contraindications

  • MYXREDLIN is contraindicated: •During episodes of hypoglycemia •In patients with hypersensitivity to insulin human or any of the excipients in MYXREDLIN

5.1 Hyperglycemia Or Hypoglycemia With Changes In Insulin Regimen

Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.2)] or hyperglycemia. These changes should be made cautiously and under close medical supervision and the frequency of blood glucose monitoring should be increased.

5.2 Hypoglycemia

Hypoglycemia is the most common adverse reaction of all insulins, including MYXREDLIN. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time.Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or in patients who experience recurrent hypoglycemia.Risk Factors for HypoglycemiaFactors which may increase the risk of hypoglycemia include changes in nutrition and co-administered medication [see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

5.3 Hypersensitivity And Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with MYXREDLIN. Generalized allergy to insulin may manifest as a whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. If hypersensitivity reactions occur, discontinue MYXREDLIN; treat per standard of care and monitor until symptoms and signs resolve. MYXREDLIN is contraindicated in patients who have had hypersensitivity reactions to insulin human or any of the excipients in MYXREDLIN [see Contraindications (4)].

5.4 Hypokalemia

All insulins, including MYXREDLIN, 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 and treat if indicated.

5.5 Fluid Retention And Heart Failure With Concomitant Use Of Ppar-Gamma Agonists

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. Patients treated with insulin, including MYXREDLIN, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

6 Adverse Reactions

  • The following adverse reactions are also discussed elsewhere in the labeling: •Hypoglycemia [see Warnings and Precautions (5.2)] •Hypersensitivity Reactions [see Warnings and Precautions (5.3)] •Hypokalemia [see Warnings and Precautions (5.4)]Adverse Reactions from Clinical Studies or Postmarketing ReportsThe following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of insulin human injection. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.Adverse reactions associated with insulin initiation and glucose control intensificationIntensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.Hypersensitivity reactionsSevere, life-threatening, generalized allergy, including anaphylaxis.HypoglycemiaHypoglycemia is the most commonly observed adverse reaction with MYXREDLIN.HypokalemiaMYXREDLIN can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.Peripheral edemaInsulins, including MYXREDLIN, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.Weight gainWeight gain can occur with insulin therapies, including MYXREDLIN, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.ImmunogenicityAs with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. Increases in titers of anti-insulin antibodies that react with human insulin have been observed in patients treated with subcutaneous insulin human injection.

7 Drug Interactions

Table 1: Clinically Significant Drug Interactions with MYXREDLINDrugs that May Increase the Risk of HypoglycemiaDrugs: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.Intervention:Dose adjustment and increased frequency of glucose monitoring may be required when MYXREDLIN is co-administered with these drugs.Drugs that May Decrease the Blood Glucose Lowering Effect of MYXREDLINDrugs:Atypical antipsychotics (e.g., olanzapine and clozapine), 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.Intervention:Dose adjustment and increased frequency of glucose monitoring may be required when MYXREDLIN is co-administered with these drugs.Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of MYXREDLINDrugs:Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.Intervention:Dose adjustment and increased frequency of glucose monitoring may be required when MYXREDLIN is co-administered with these drugs.Drugs that May Blunt Signs and Symptoms of HypoglycemiaDrugs:Beta-blockers, clonidine, guanethidine, and reserpine.Intervention:Increased frequency of glucose monitoring may be required when MYXREDLIN is co-administered with these drugs.

8.1 Pregnancy

Risk SummaryAvailable data from published studies over decades have not established an association with human insulin use during pregnancy and 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). Animal reproduction studies were not performed.The estimated background risk of major birth defects is 6-10% in women with pre-gestational 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.Clinical ConsiderationsDisease-associated maternal and/or embryo/fetal riskPoorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.DataHuman DataWhile available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. All available studies have methodological limitations including lack of blinding, unclear methods of randomization, and small sample size.

8.2 Lactation

Risk SummaryAvailable data from published literature suggest that exogenous human insulin products, including insulin human injection, are transferred into human milk. There are no adverse reactions reported in the breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including MYXREDLIN, on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MYXREDLIN and any potential adverse effects on the breastfed infant from MYXREDLIN or from the underlying maternal condition.

8.4 Pediatric Use

MYXREDLIN is indicated to improve glycemic control in pediatric patients with diabetes mellitus.The dosage of MYXREDLIN must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose to reduce the risk of hypoglycemia [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)].

8.5 Geriatric Use

The effect of age on the pharmacokinetics and pharmacodynamics of insulin human injection has not been studied.Elderly patients using MYXREDLIN, may be at increased risk of hypoglycemia due to co-morbid disease [see Warnings and Precautions (5.2)].

8.6 Renal Impairment

The effect of renal impairment on the pharmacokinetics and pharmacodynamics of MYXREDLIN has not been studied. Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent MYXREDLIN dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.2)].

8.7 Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of MYXREDLIN has not been studied. Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent MYXREDLIN dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.2)].

10 Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia. More severe episodes with coma, seizure, or neurologic impairment can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained monitoring may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately. [see Warnings and Precautions (5.2, 5.4)]

11 Description

Insulin human is a short-acting human insulin. It is a polypeptide hormone and is produced by recombinant DNA technology, utilizing Pichia pastoris (a yeast) as the production organism. Insulin human is regular human insulin and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808.Figure 1: Structural formula of Insulin HumanMYXREDLIN (insulin human in sodium chloride injection) for intravenous use is a sterile, preservative-free, nonpyrogenic, clear, aqueous, and colorless solution supplied in a 100 mL GALAXY single-dose container. MYXREDLIN contains 100 units of insulin human in 100 milliliters of 0.9% sodium chloride injection. Each milliliter of solution contains 1 unit Insulin Human, USP; 0.412 mg Dibasic Sodium Phosphate Anhydrous, USP; 0.29 mg Monobasic Sodium Phosphate Monohydrate, USP; 9 mg Sodium Chloride, USP; and Water for Injection, USP. The pH range is 6.5-7.2.

12.1 Mechanism Of Action

The primary activity of insulin, including MYXREDLIN is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

12.2 Pharmacodynamics

MYXREDLIN is a short-acting insulin. The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals, within the same individual, and different doses. In a double-blind, randomized, crossover, euglycemic glucose clamp study described below, the average onset of action, defined as start of intravenous glucose infusion during the clamp, was approximately 21 minutes after starting of the intravenous infusion administration. The glucose infusion rate gradually increased to a maximum response of 13.7 mg/kg/min after 5 hours of human insulin infusion.

12.3 Pharmacokinetics

In a double-blind, randomized, crossover, euglycemic glucose clamp study, fifty eight healthy male subjects between 19 and 50 years of age received an intravenous infusion of either MYXREDLIN or another human insulin at 1 milliUnit/kg/min for 6 hours (0.36 units/kg total dose). On average, insulin concentrations of about 300 pM were attained approximately from 1.5 hours to 6 hours after starting intravenous infusion of MYXREDLIN, followed by a return to the baseline level 1.5 hours after stopping intravenous infusion.Metabolism and EliminationThe mean terminal half-life from concentration data after stopping the intravenous infusion was estimated to be 23.4 minutes in healthy volunteers.Specific PopulationThe effects of gender, age, obesity, renal and hepatic impairment on the pharmacodynamics and pharmacokinetics of insulin human injection have not been studied.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin human injection.Human insulin is not mutagenic in the following in vitro tests: The chromosomal aberration assay in human lymphocytes, the micronucleus assay in mouse polychromatic erythrocytes, and the mutation frequency assay in Chinese hamster cells.Standard reproduction and teratology studies in animals, including fertility assessments have not been conducted with insulin human injection.

16.1 How Supplied

  • MYXREDLIN (insulin human in sodium chloride injection) contains 100 units/100 mL (1 unit/mL) of insulin human in 0.9% sodium chloride and is a clear, colorless solution available as: 100 mL single-dose GALAXY container, package of 12, NDC 0338-0126-12

16.2 Storage And Handling

Store MYXREDLIN in the refrigerator (36°F to 46°F [2°C to 8°C]) in the original carton to protect from light until administration. Do not use after the expiration date printed on the carton and container label.If needed, MYXREDLIN may be stored at room temperature up to 77°F (25°C) for up to 30 days in the original carton. Once stored at room temperature, do not place back in the refrigerator. Discard MYXREDLIN after 30 days if stored at room temperature.Do not freeze and do not use MYXREDLIN if it has been frozen. Do not shake.

17 Patient Counseling Information

HypoglycemiaInform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia.Hypersensitivity ReactionsAdvise patients that hypersensitivity reactions have occurred with insulin human injection [see Warnings and Precautions (5.3)].

Other

Manufactured by:Baxter Healthcare CorporationDeerfield, IL 60015 USABaxter, Galaxy and Myxredlin are trademarks of Baxter International Inc.07-19-01-067

* Please review the disclaimer below.

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