Insulin aspart

Renal Impairment Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Garzulys dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions and Clinical Pharmacology].

Hepatic Impairment Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Garzulys dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions and Clinical Pharmacology].

Important Preparation and Administration Instructions Always check insulin labels before administration [see Warnings and Precautions] . Inspect Garzulys visually before use. It should appear clear and colorless. Do not use Garzulys if particulate matter or coloration is seen. Use Garzulys prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

Do not mix Garzulys with other insulins when administering using a continuous subcutaneous infusion pump.

Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Inject Garzulys subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. 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 [see Warnings and Precautions and Adverse Reactions ( 6.1 , 6.3 )]. Dial the Garzulys prefilled pen in 1-unit increments. Generally use Garzulys (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin. May dilute Garzulys with Insulin Diluting Medium for Garzulys for subcutaneous injection.

Diluting one part Garzulys to: Nine parts diluent will yield a concentration one-tenth that of Garzulys (equivalent to U-10). One part diluent will yield a concentration one-half that of Garzulys (equivalent to U-50). Continuous Subcutaneous Infusion (Insulin Pump) Can use this Garzulys product with the continuous subcutaneous insulin infusion pumps labeled for use with Garzulys or NOVOLOG.

Refer to the insulin pump user manual to see if Garzulys or NOVOLOG can be used with the insulin pump, in which case Garzulys can be used with the pump. Use Garzulys in accordance with the insulin pump system’s instructions for use. Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Administer Garzulys by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions and Adverse Reactions ( 6.1 , 6.3 )] . Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.

Change the Garzulys in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the Garzulys-specific information for in-use time because Garzulys-specific information may differ from general pump manual instructions. Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual.

Do not dilute or mix Garzulys when administering by continuous subcutaneous infusion. Do not expose Garzulys in the pump reservoir to temperatures greater than 98.6°F (37°C). Intravenous Administration Administer Garzulys intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 ) and How Supplied/Storage and Handling] .

Dilute Garzulys to concentrations from 0.05 unit per mL to 1 unit per mL insulin aspart-fsan in infusion systems using polypropylene infusion bags. Garzulys is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP.

Dosage Recommendations Individualize the dosage of Garzulys based on the route of administration, 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 or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )] .

When switching from another insulin to Garzulys, a different dosage of Garzulys may be needed [see Warnings and Precautions] . During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions] .