YARTEMLEA Solution for injection Ref.[116145] Active ingredients: Narsoplimab

2.1 Recommended Dosage

The recommended dosage of YARTEMLEA is provided in Table 1.

Table 1. Recommended Dosage of YARTEMLEA in Adult and Pediatric Patients Two Years of Age and Older with TA-TMA:

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

2.2 Important Preparation and Administration Instructions

• Administer diluted YARTEMLEA as an intravenous infusion through a polyvinyl chloride (PVC) or PVC-lined infusion line with a 0.2-micron polyethersulfone (PES) inline filter and a polyurethane catheter.
• For adults and pediatric patients weighing 10 kg or more, prepare YARTEMLEA in an intravenous bag, diluted to final concentration of 0.8 mg/mL to 8 mg/mL and administer by gravity infusion or via an infusion pump [see Dosage and Administration (2.3 and 2.5)].
• For pediatric patients weighing less than 10 kg, prepare YARTEMLEA in a polypropylene syringe, diluted to final concentration of 0.8 mg/mL and administer via a syringe pump [see Dosage and Administration (2.4 and 2.5)].

2.3 Preparation Instructions into an Intravenous Bag

This section describes preparation of YARTEMLEA for adults and pediatric patients weighing 10 kg or more in an intravenous bag.

1. Preparation

a. Use aseptic technique to prepare YARTEMLEA.

b. Parenteral drug-product vial should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. YARTEMLEA is a clear to slightly opalescent, slightly yellow to yellow-brown solution. If discoloration or particles are observed in the vial, discard it.

c. Calculate the dose (mg) based on the patient's body weight and the total volume (mL) of YARTEMLEA solution required.

d. Remove the YARTEMLEA vial from the refrigerator and allow the vial to come to room temperature (18°C to 25°C [64°F to 77°F]) for 30 minutes. Vial must be used to prepare the appropriate dosing solution within 4 hours following removal from refrigerated storage.

2. Dilution for Intravenous Bag Infusion

a. Withdraw the required volume of YARTEMLEA solution from the vial using a polypropylene syringe and dilute in a polyvinyl chloride (PVC) infusion bag of 5% Dextrose Injection, USP to make a final concentration of 0.8 mg/mL to 8 mg/mL with a total volume not to exceed 50 mL.

b. Discard any unused portion left in the vial.

c. Gently invert infusion bag 10 times to mix the diluted solution. Do not shake.

d. Following dilution of YARTEMLEA in the infusion bag, the solution may become opalescent, and small translucent-to-white particles may appear. Discard prepared solution if particulate matter, other than translucent-towhite particles, is observed.

2.4 Preparation Instructions into an Intravenous Syringe

This section describes preparation of YARTEMLEA for pediatric patients weighing less than 10 kg in a syringe.

1. Preparation:

a. Use aseptic technique to prepare YARTEMLEA.

b. Parenteral drug-product vial should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. YARTEMLEA is a clear to slightly opalescent, slightly yellow to yellow-brown solution. If discoloration or particles are observed in the vial, discard it.

c. Calculate the dose (mg) based on the patient's body weight and the total volume (mL) of YARTEMLEA solution required.

d. Remove the YARTEMLEA vial from the refrigerator and allow the vial to come to room temperature (18°C to 25°C [64°F to 77°F]) for 30 minutes. Vial must be used to prepare the appropriate dosing solution within 4 hours following removal from refrigerated storage.

2. Dilution for Intravenous Syringe Infusion:

a. Withdraw the required volume of YARTEMLEA solution from the vial using a polypropylene syringe. Discard any unused portion left in the vial.

b. Dilute in 5% Dextrose Injection, USP to make a final concentration of 0.8 mg/mL with a total volume not to exceed 50 mL.

c. Gently invert syringe 10 times to mix the diluted solution. Do not shake.

d. Following dilution of YARTEMLEA in the syringe, the solution may become opalescent, and small translucent-to-white particles may appear. Discard prepared solution if particulate matter, other than translucent-towhite particles, is observed.

e. Remove air bubbles from the syringe before administration.

2.5 Storage and Administration

Storage of Diluted Product:

• If the prepared diluted solution is not used immediately, store the diluted YARTEMLEA solution at room temperature at 18°C to 25°C (64°F to 77°F) for up to 4 additional hours.
• Discard unused YARTEMLEA solution if not used within 4 hours from the time of dilution to the end of the infusion. Administration
• Administer YARTEMLEA diluted solution intravenously by gravity infusion or via infusion pump (for solution prepared in an intravenous bag) or via syringe pump (for solution prepared in a syringe) over 30 minutes through a PVC or PVC-lined infusion line with a 0.2-micron polyethersulfone (PES) in-line filter and a polyurethane catheter.
• Flush the intravenous line at the end of the infusion with sufficient volume of 5% Dextrose Injection, USP to clear the line of YARTEMLEA infusion solution.
• Do not co-administer other drugs through the same intravenous line.

There is no known antidote for YARTEMLEA and YARTEMLEA is not dialyzable. If an overdose occurs, institute general supportive measures. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Store YARTEMLEA vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. Do not shake. Do not use beyond the expiration date stamped on the carton.