Kirsty Dosage

Important Preparation and Administration Instructions

• Always check insulin labels before administration.

• Inspect KIRSTY visually before use. It should appear clear and colorless. Do not use KIRSTY if particulate matter or coloration is seen.

• In patients with visual impairment who rely on audible clicks to dial their dose, use KIRSTY prefilled pen with caution.

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

Preparation and Administration Instructions for the Approved Routes of Administration

Subcutaneous Injection

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Inject KIRSTY subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.

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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.

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Dial the KIRSTY prefilled pen in 1-unit increments.

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Generally use KIRSTY (administered by subcutaneous injection) in regimens with an intermediate-or long-acting insulin.

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May dilute KIRSTY with Insulin Diluting Medium for KIRSTY for subcutaneous injection. Diluting one part KIRSTY to:
• Nine parts diluent will yield a concentration one-tenth that of KIRSTY (equivalent to U-10).
• One part diluent will yield a concentration one-half that of KIRSTY (equivalent to U-50). Discard any unused diluent after opening the vial of Insulin Diluting Medium for KIRSTY.

Continuous Subcutaneous Infusion (Insulin Pump)

• Can use this KIRSTY product with the continuous subcutaneous insulin infusion pumps labeled for use with KIRSTY or NOVOLOG. Refer to the insulin pump user manual to see if KIRSTY or NOVOLOG can be used with the insulin pump, in which case KIRSTY can be used with the pump. Use KIRSTY in accordance with the insulin pump system’s instructions for use.

• Train patients using continuous subcutaneous insulin fusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
• Administer KIRSTY 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.

• Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.

• Change the KIRSTY in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the KIRSTY-specific information for in-use time because KIRSTY-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 KIRSTY when administering by continuous subcutaneous infusion.

• Do not expose KIRSTY in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

• Administer KIRSTY intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

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

Dosage Recommendations

• Individualize the dosage of KIRSTY 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.

• When switching from another insulin to KIRSTY, a different dosage of KIRSTY may be needed.

• During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring.

Dosage Modifications for Drug Interactions

Dosage modification may be needed when KIRSTY is used concomitantly with certain drugs.

Instructions for Mixing KIRSTY with Other Insulins