Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied MYXREDLIN (insulin human) in 0.9% 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. Do not use after the expiration date printed on the carton and container label. If needed, MYXREDLIN may be removed from the original carton and stored at room temperature up to 77°F (25°C) for up to 30 days. 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.; 16.1 How Supplied MYXREDLIN (insulin human) in 0.9% 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; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-0126-12 Rx only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit / mL) 100 mL Single-Dose Galaxy container (REGULAR) Insulin Human Discard unused portion Sterile Nonpyrogenic For Intravenous Infusion Only Cautions: Do not add supplemental medication or additives. Must not be used in series connections. Check for minute leaks and solution clarity. Each mL 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. Dosage: See prescribing information. Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do Not Shake. Do Not Freeze. If needed, may store at room temperature up to 77°F (25°C) up to 30 days. Discard after 30 days if stored at room temperature. Baxter logo Code 2G3322 Baxter, Galaxy and Myxredlin are trademarks of Baxter International Inc. or its subsidiaries Baxter Healthcare Corporation Deerfield, IL 60015 USA U.S. License no. 0140 Product of USA 07-34-00-2341 CONTAINS INSULIN 303380126125 Carton Label MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only NDC 0338-0126-12 MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit / mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT AND EXP 303380126125 Sterile, Nonpyrogenic Each mL 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. No preservative. Dosage: For Intravenous Infusion Only. See prescribing information. Caution: Do not add supplemental medication or additives. Rx only Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do Not Shake. Do Not Freeze. If needed, may store MYXREDLIN at room temperature up to 77°F (25°C) up to 30 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 30 days if stored at room temperature. Discard 30 days after storing at room temperature. Discard After: (Month) (Day) (Year) (to be completed by dispensing pharmacist) Baxter, Galaxy and Myxredlin are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation Deerfield, IL 60015 USA U.S. License no. 0140 Product of USA 07-01-00-1676 MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only NDC 0338-0126-12 Rx Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only (REGULAR) Insulin Human USE CARTON TO PROTECT CONTENTS FROM LIGHT WHILE REFRIGERATED Code 2G3322 1 Single-Dose GALAXY container Discard unused portion Baxter Logo G Representative Container Label 0338-0126-12 panel 1 of 3 Representative Container Label 0338-0126-12 panel 2 of 3 Representative Container Label 0338-0126-12 panel 3 of 3 Representative Carton Label 0338-0126-12 1 of 2 Representative Carton Label 0338-0126-12 2 of 2
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied MYXREDLIN (insulin human) in 0.9% 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. Do not use after the expiration date printed on the carton and container label. If needed, MYXREDLIN may be removed from the original carton and stored at room temperature up to 77°F (25°C) for up to 30 days. 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.
- 16.1 How Supplied MYXREDLIN (insulin human) in 0.9% 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
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-0126-12 Rx only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit / mL) 100 mL Single-Dose Galaxy container (REGULAR) Insulin Human Discard unused portion Sterile Nonpyrogenic For Intravenous Infusion Only Cautions: Do not add supplemental medication or additives. Must not be used in series connections. Check for minute leaks and solution clarity. Each mL 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. Dosage: See prescribing information. Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do Not Shake. Do Not Freeze. If needed, may store at room temperature up to 77°F (25°C) up to 30 days. Discard after 30 days if stored at room temperature. Baxter logo Code 2G3322 Baxter, Galaxy and Myxredlin are trademarks of Baxter International Inc. or its subsidiaries Baxter Healthcare Corporation Deerfield, IL 60015 USA U.S. License no. 0140 Product of USA 07-34-00-2341 CONTAINS INSULIN 303380126125 Carton Label MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only NDC 0338-0126-12 MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit / mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT AND EXP 303380126125 Sterile, Nonpyrogenic Each mL 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. No preservative. Dosage: For Intravenous Infusion Only. See prescribing information. Caution: Do not add supplemental medication or additives. Rx only Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do Not Shake. Do Not Freeze. If needed, may store MYXREDLIN at room temperature up to 77°F (25°C) up to 30 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 30 days if stored at room temperature. Discard 30 days after storing at room temperature. Discard After: (Month) (Day) (Year) (to be completed by dispensing pharmacist) Baxter, Galaxy and Myxredlin are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation Deerfield, IL 60015 USA U.S. License no. 0140 Product of USA 07-01-00-1676 MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection CONTAINS INSULIN HUMAN 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only NDC 0338-0126-12 Rx Only MYXREDLIN Insulin Human in 0.9% Sodium Chloride Injection 100 units per 100 mL (1 unit/mL) For Intravenous Infusion Only (REGULAR) Insulin Human USE CARTON TO PROTECT CONTENTS FROM LIGHT WHILE REFRIGERATED Code 2G3322 1 Single-Dose GALAXY container Discard unused portion Baxter Logo G Representative Container Label 0338-0126-12 panel 1 of 3 Representative Container Label 0338-0126-12 panel 2 of 3 Representative Container Label 0338-0126-12 panel 3 of 3 Representative Carton Label 0338-0126-12 1 of 2 Representative Carton Label 0338-0126-12 2 of 2
Overview
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 C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5808. Figure 1: Structural formula of Insulin Human MYXREDLIN (insulin human) in 0.9% 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. Structural Formula Insulin Human
Indications & Usage
MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. MYXREDLIN is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
Dosage & Administration
• Inspect MYXREDLIN visually before use. It should appear clear and colorless. Do not use MYXREDLIN if particulate matter or coloration is seen. ( 2.1 ) • Administer MYXREDLIN intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels. ( 2.1 ) • Do not add supplementary medication or additives. ( 2.1 ) • Do not use in series connections. ( 2.1 ) • Do not shake or freeze. Discard unused portion. ( 2.1 ) • Individualize dose based on metabolic needs, blood glucose monitoring results, and glycemic control goal. ( 2.2 ) • Dosage adjustments may be needed with changes in nutrition, renal, or hepatic function or during acute illness. ( 2.2 ) 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) ].
Warnings & Precautions
• Hyper- or Hypoglycemia with Changes in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring. ( 5.1 ) • Hypoglycemia: May be life-threatening. Factors which may increase the risk include changes in nutrition and co-administered medication and patients with renal or hepatic impairment. Increased frequency of blood glucose monitoring is recommended in patients at increased risk. ( 5.2 ) • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue MYXREDLIN, monitor, and treat if indicated. ( 5.3 ) • Hypokalemia: May be life-threatening. Monitor potassium levels and treat if indicated. ( 5.4 ) • 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. ( 5.5 ) 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 Hypoglycemia Factors 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 Hypoglycemia Patients 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.
Contraindications
MYXREDLIN is contraindicated: • During episodes of hypoglycemia • In patients with hypersensitivity to insulin human or any of the excipients in MYXREDLIN • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to insulin human or any of the excipients in MYXREDLIN ( 4 )
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 Reports The 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 intensification Intensification 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 reactions Severe, life-threatening, generalized allergy, including anaphylaxis. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction with MYXREDLIN. Hypokalemia MYXREDLIN can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Peripheral edema Insulins, including MYXREDLIN, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Weight gain Weight gain can occur with insulin therapies, including MYXREDLIN, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Immunogenicity As 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. Adverse reactions observed with insulin human injection include hypoglycemia, allergic reactions, weight gain and edema ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Table 1: Clinically Significant Drug Interactions with MYXREDLIN Drugs that May Increase the Risk of Hypoglycemia Drugs: 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 MYXREDLIN Drugs: 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 MYXREDLIN Drugs: 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 Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine. Intervention: Increased frequency of glucose monitoring may be required when MYXREDLIN is co-administered with these drugs. • Drugs that may increase the risk of hypoglycemia: 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. ( 7 ) • Drugs that may decrease the blood glucose lowering effect: 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. ( 7 ) • Drugs that may increase or decrease the blood glucose lowering effect: Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine. ( 7 ) • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine. ( 7 )
Storage & Handling
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. Do not use after the expiration date printed on the carton and container label. If needed, MYXREDLIN may be removed from the original carton and stored at room temperature up to 77°F (25°C) for up to 30 days. 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.
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