Insulin,dosage

Adhere to administration instructions to reduce the risk of dosing errors. HUMULIN R U-500 is available as a single-patient-use KwikPen or multiple-dose vial. Patients using the vial must be prescribed the U-500 insulin syringe to avoid medication errors. 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. Do NOT perform dose conversion when using a U-500 insulin syringe. Use only a U-500 insulin syringe with the HUMULIN R U-500 vial.

2.1 Important

Administration Instructions Prescribe HUMULIN R U-500 ONLY to patients who require more than 200 units of insulin per day. HUMULIN R U-500 is available as a single-patient-use KwikPen or multiple-dose vial. Patients using the vial must be prescribed the U-500 insulin syringe to avoid medication errors. Instruct patients using the vial presentation to use only a U-500 insulin syringe and on how to correctly draw the prescribed dose of HUMULIN R U-500 into the U-500 insulin syringe. Confirm that the patient has understood these instructions and can correctly draw the prescribed dose of HUMULIN R U-500 with their syringe. Instruct patients to always check the insulin label before administration to confirm the correct insulin product is being used. Inspect HUMULIN R U-500 visually for particulate matter and discoloration. Only use HUMULIN R U-500 if the solution appears clear and colorless. Instruct patients to inject HUMULIN R U-500 subcutaneously into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring. Use HUMULIN R U-500 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose. DO NOT administer HUMULIN R U-500 intravenously. DO NOT dilute or mix HUMULIN R U-500 with any other insulin products or solutions.

2.2 Dosing Instructions

Instruct patients to inject HUMULIN R U-500 subcutaneously usually two or three times daily approximately 30 minutes before meals. Individualize and titrate the dosage of HUMULIN R U-500 based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function, changes in medications or during acute illness to minimize the risk of hypoglycemia or hyperglycemia.

2.3 Delivery of HUMULIN R U-500

Using the HUMULIN R U-500 Disposable Prefilled KwikPen Device The HUMULIN R U-500 KwikPen dials in 5 unit increments and delivers a maximum dose of 300 units per injection. 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 and NO dose conversion is required. DO NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe for administration as overdose and severe hypoglycemia can occur.

2.4 Delivery of HUMULIN R U-500

Using the Vial Presentation and the U-500 Insulin Syringe DO NOT perform dose conversion when using a U-500 insulin syringe. The markings on the U-500 insulin syringe show the number of units of HUMULIN R U-500 to be injected. Each marking on the syringe represents 5 units of insulin. Prescribe patients a U-500 insulin syringe to administer HUMULIN R U-500 from the vial to avoid administration errors. DO NOT use any other type of syringe.