EBANGA Solution for injection Ref.[50362] Active ingredients: Ansuvimab

2.1 Recommended Dosage for Adult and Pediatric Patients

The recommended dosage of EBANGA is 50 mg/kg administered as a single intravenous (IV) infusion over 60 minutes. EBANGA must be reconstituted with Sterile Water for Injection, USP then further diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to IV infusion [see Dosage and Administration (2.2)].

2.2. Preparation, Administration, and Storage Instructions

EBANGA must be prepared and administered under the supervision of a health care professional.

Reconstitution Instructions:

• Aseptically reconstitute and further dilute EBANGA prior to IV infusion. Do not administer as an IV push or bolus.
• More than one vial may be needed for a full dose. Calculate the dose (mg) based on the patient’s actual weight in kg and the number of EBANGA vials required [see Dosage and Administration (2.1)].
• Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes. If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours.
• Immediately upon reaching ambient temperature, use a sterile 10 mL syringe and an 18-gauge needle to withdraw 7.7 mL of Sterile Water for Injection, USP. Insert the needle tip into the EBANGA vial. Holding horizontally, angle the needle down at an approximate 45° angle, above the lyophilized powder, which has a cake-like appearance. Slowly inject the diluent along the wall of the vial and without any air to avoid foaming and bubbles.
• Gently swirl (do NOT shake) for approximately 10 seconds; then set the vial down to rest for at least 10 seconds. Repeat until the cake is dissolved. This may take up to 20 minutes.
• Upon reconstitution, one vial delivers 8 mL of solution that is clear to slightly opalescent and colorless to slightly yellow containing 50 mg/mL of ansuvimab-zykl. Do NOT administer and discard the vial if the reconstituted solution is discolored or contains visible particles.
• Dilute the EBANGA solution immediately upon reconstitution. If needed, the reconstituted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F), protected from light, for up to 4 hours. This 4-hour window includes time required for further dilution and EBANGA solution should be infused immediately upon further dilution.

Dilution Instructions:

• Following reconstitution, EBANGA must be further diluted prior to IV infusion.
  • Use an 18-20 gauge, 1-1.5" needle with an appropriately sized syringe up to 60 mL to perform the dilution steps.
  • Prepare the EBANGA IV dosing solution using an appropriately sized syringe up to 60 mL.
• For patients weighing ≥2 kg, prepare the diluent using either a latex-free, di-ethylhexylphthalate (DEHP)-free 0.9% Sodium Chloride Injection USP infusion bag, or latex-free, DEHP-free 5% Dextrose Injection USP infusion bag. For patients weighing 0.5 to <2 kg use a pump-compatible syringe (Table 1).
  • For adult and pediatric patients, either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP can be used as the diluent.
  • The total volume of the infusion solution to be administered is based on the patient’s body weight and is specified in Table 1.For patients weighing 0.5 to <2 kg:
  • Use a 10 mL syringe compatible with the IV infusion pump.
  • Fill the 10 mL syringe with the appropriate amount of diluent (Table 1).
  • Add the calculated volume of EBANGA to the 10 mL syringe (Table 1).
  • Mix the diluted solution by gentle inversion (3 to 5 times) until admixed. Do not shake. For patients weighing ≥2 kg:
  • Select a diluent solution infusion bag size of appropriate fill volume based on the patient’s body weight (see Table 1).
  • Withdraw and discard from the bag a volume of diluent solution that will leave remaining in the bag the appropriate volume based on the patient’s weight (see Table 1). Then add the calculated volume of EBANGA to the bag based on the patient’s weight (see Table 1).

For example, for a 55 kg patient, withdraw and discard 150 mL of diluent from a 250 mL infusion bag. Then add 55 mL of EBANGA to obtain a total infusion volume of 155 mL.

• • Gently invert the IV bag 5 to 10 times until the diluted solution is admixed. Do NOT shake.
• Infuse the EBANGA solution immediately upon dilution. If needed, the diluted infusion solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F), for up to 4 hours. Do not freeze the diluted solution. If refrigerated, allow approximately 20 minutes for the diluted solution to come to ambient temperature prior to use. These time limits include reconstitution time.

Prepare a medical label including patient weight in kg, date, and time of reconstitution.

• Discard vial(s) and all unused contents.

Table 1. EBANGA Volume, Diluent Volume and Total Infusion Volume by Body Weight:

^* The recommended diluent volume ensures the final concentration of the diluted solution is approximately 8-30 mg/mL.
^† For IV bag administration, the diluent volume column includes the volume of diluent needed to remain in the infusion bag.

Administration:

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not administer if discolored or if the vial contains visible particles.
• Do not mix with or administer as an infusion with other medicinal products.
• Prepare the IV infusion line with 1.2 micron in-line filter extension set.
• Administer the IV infusion solution over 60 minutes.
  • The diluted EBANGA IV solution can be infused via a central line or peripheral catheter. Do not administer EBANGA as an IV push or bolus.
  • Do not co-administer other drugs simultaneously through the same infusion line.
  • Infusions may be slowed or stopped if necessary, to alleviate any side effects.
• At the end of the infusion, if a syringe pump was used, then remove the syringe and flush the line with 2 to 5 ml of diluent, but not to exceed the total infusion volume. If an infusion bag was used, replace the empty bag and flush the line by infusing at least 25 mL of the diluent, to ensure complete product administration.

Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake.

Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes. If for any reason reconstitution cannot proceed immediately upon reaching ambient temperature, vials that have NOT been reconstituted may be kept at ambient temperature, protected from light, for no more than 24 hours.

After reconstitution, if storage is needed, the entire storage time for the reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours refrigerated at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2)].

The expiration date for the product is available via a product-specific website with frequent update. The Quick Response (QR) Code at the end of this leaflet is scannable via mobile phone and will direct the user to the EBANGA website. Users will be asked to register for authorized access to lot- specific information via the Lot No. printed on the box containing one, four, or eight 36-vial carton(s). Please access the website using the QR code provided. Alternatively, please go to: www.EBANGA.com. Do not use EBANGA beyond the expiration date available via this website.