Myxredlin Drug Information

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

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. • Do not add supplementary medication or additives. • Do not use in series connections. • Do not shake.

Do not freeze. Discard any unused portion.

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.

Dosage

Adjustment due to Drug Interactions • Dosage adjustment may be needed when MYXREDLIN is used concomitantly with certain drugs.

• The following adverse reactions are also discussed elsewhere in the labeling:
• Hypoglycemia
• Hypersensitivity Reactions
• Hypokalemia 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. 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.

• Table 1: Clinically Significant Drug Interactions with MYXREDLIN
• 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.
• 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.
• Drugs that may increase or decrease the blood glucose lowering effect: Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
• Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

Pregnancy Risk Summary Available 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 Considerations Disease-associated maternal and/or embryo/fetal risk Poorly 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. Data Human Data While 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.

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.

• 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

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.