myxredlin

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…

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…

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 )

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) ]

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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 )