Denileukin diftitox

Important Dosing Instructions Prior to starting each treatment cycle, assess hepatic and renal function. If serum albumin is less than 3 g/dL, delay administration of LYMPHIR until serum albumin is greater than or equal to 3 g/dL [see Warnings and Precautions] .

Recommended Premedications Administer premedications prior to starting a LYMPHIR infusion in Cycles 1 through 3, as outlined in Table 1, to reduce the risk of infusion-related reactions [see Warnings and Precautions] . [See table below.] Antihistamine Diphenhydramine 25 mg intravenously or other antihistamine per local institutional guidelines At least 30 minutes prior to infusion Antiemetic Per institutional guidelines At least 30 minutes prior to infusion Hydration 250 to 500 mL 0.9% Sodium Chloride Injection intravenously (or other amount of fluid considered to be most appropriate for the subject’s condition) At least 30 minutes prior to infusion If patients experience a Grade 2 or higher infusion reaction, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid such as dexamethasone 4 mg (or equivalent) via slow intravenous push, for at least 3 cycles.

Preparation and Administration Reconstitute and further dilute LYMPHIR prior to administration. Administer as an intravenous infusion over 60 minutes. Use aseptic technique to prepare LYMPHIR. LYMPHIR does not contain a preservative or anti-microbial agent. Care should be taken during preparation and administration of LYMPHIR to prevent inadvertent microbial contamination.

Reconstitution Calculate the dose (mcg), total volume (mL) of solution required, and number of vials of LYMPHIR needed based on the patient’s actual body weight (kg). More than one vial may be needed for a full dose. Remove the vial(s) of LYMPHIR from the refrigerator and allow to stand for approximately 30 minutes to reach to room temperature [20°C to 25°C (68°F to 77°F)].

Reconstitute each LYMPHIR vial with 2.1 mL of Sterile Water for Injection to obtain a final concentration of 150 mcg/mL. If more than one vial is needed to make a complete dose, use a separate syringe and needle for each vial. Gently swirl the vial. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The reconstituted solution should be clear and colorless. Discard if the solution is not clear, colorless, and contains particulate matter. Use the reconstituted LYMPHIR solution immediately to prepare the drug product. Dilution Use only plastic syringes or soft plastic intravenous bags. Do not use glass containers. Maintain concentration of LYMPHIR at 15 mcg/mL or higher during all steps in the preparation of the solution for intravenous infusion.

Withdraw the calculated dose from the vial(s) with a sterile syringe and inject it into an empty intravenous bag. Dilute with 0.9% Sodium Chloride Injection to final concentration of 15 mcg/mL or higher. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if the prepared solution is cloudy or particulates are present. If not used immediately, store the diluted LYMPHIR solution at room temperature [20°C to 25°C (68°F to 77°F)] for up to 4 hours. Protect diluted solution from light. Administration Administer infusion solution intravenously over 60 minutes through an intravenous line using a syringe pump or intravenous infusion bag.

Do not administer through in-line filter. Do not mix LYMPHIR with other drugs or administer other drugs through the same infusion line. At the end of the infusion, discard any empty or unused portions of LYMPHIR immediately.