Lymphir Dosage

2.1 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 .

2.2 Recommended Dosage

The recommended dosage of LYMPHIR is 9 mcg/kg/day actual body weight administered as an intravenous infusion over 60 minutes on Days 1 through 5 of a 21-day treatment cycle. Administer LYMPHIR until disease progression or unacceptable toxicity.

2.3 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 .

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.

2.4 Dosage Modifications for Adverse Reactions

Dosage modifications for adverse reactions with LYMPHIR are shown in Table 2 below.

* Based on NCI CTCAE version 5.0

Restarting after Dosage Delay Due to Toxicity

2.5 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 notuse 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.