Insulin human

HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.

Regulation of glucose metabolism is the primary activity of insulins, including HUMULIN R U-500. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

Adhere to administration instructions to reduce the risk of dosing errors. HUMULIN R U-500 is available as a single-patient-use KwikPen. Individualize dose of HUMULIN R U-500 based on metabolic needs, blood glucose monitoring results and glycemic control goal. Administer HUMULIN R U-500 subcutaneously two or three times daily 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Do NOT mix HUMULIN R U-500 with other insulins. Do NOT administer HUMULIN R U-500 intravenously. Do NOT perform dose conversion when using the HUMULIN R U-500 KwikPen. The dose window of the HUMULIN R U-500 KwikPen shows the number of units of HUMULIN R U-500 to be injected. Do NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe.

HUMULIN R U-500 is contraindicated: During episodes of hypoglycemia In patients who are hypersensitive to HUMULIN R U-500 or any of its excipients Do not use during episodes of hypoglycemia. Do not use in patients with hypersensitivity to HUMULIN R U-500 or any of its excipients.

Never share a HUMULIN R U-500 KwikPen between patients, even if the needle is changed. Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. Hypoglycemia: May be life-threatening. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue HUMULIN R U-500, monitor, and treat if indicated. Hypokalemia: May be life-threatening.

The following adverse reactions are discussed elsewhere: Hypoglycemia. Hypersensitivity Reactions. Hypokalemia. The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500. Because 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 HUMULIN R U-500 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500.

Table 1: Clinically Significant Drug Interactions with HUMULIN R U-500 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 HUMULIN R U-500 is co-administered with these drugs.

Storage Conditions for HUMULIN R U-500 Pens a When stored at room temperature, HUMULIN R U-500 KwikPen can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. Not In-use (Unopened) In-use (Opened) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36° to 46°F [2° to 8°C]) 3 mL single-patient-use HUMULIN R U-500 KwikPen a 28 days Until expiration date 28 days Do not refrigerate.