MYXREDLIN

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 stoppin...

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 reaction...

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 )

• 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...

7 DRUG INTERACTIONS

Table 1Clinically 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. Inte...