IMAAVY Concentrate for solution for injection Ref.[115559] Active ingredients: Nipocalimab

2.1 Recommended Vaccination

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Because IMAAVY causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage

Dilute IMAAVY prior to administration. Administer via intravenous infusion only [see Dosage and Administration (2.3)].

The recommended initial dosage of IMAAVY is 30 mg/kg administered once via intravenous infusion over at least 30 minutes. Two weeks after the initial dosage administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dosage every two weeks thereafter.

If a scheduled infusion appointment is missed, the maintenance dosage of IMAAVY should be administered as soon as possible. Resume dosing every two weeks thereafter.

2.3 Preparation and Administration Instructions

Prior to administration, dilute IMAAVY single-dose vials with only 0.9% sodium chloride injection using the instructions below. For patients who weigh 40 kg or more, the total volume to be administered is 250 mL; for patients who are 12 years or older and weigh less than 40 kg, the total volume to be administered is 100 mL (see Preparation).

Preparation:

Prepare the solution for infusion using aseptic technique as follows:

• Calculate the dosage (mg), total drug volume (mL) of IMAAVY solution required, and the number of IMAAVY vials needed, based on the patient's current weight [see Dosage and Administration (2.2)]. Each single-dose vial of IMAAVY is at a concentration of 185 mg/mL.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the solution in each vial is colorless to slightly brownish, clear to slightly opalescent, and free of visible particles. Do not use if visible particles are present or if the solution is discolored (other than colorless to slightly brownish).
• Gently withdraw the calculated volume of IMAAVY from the vial(s). Discard any unused portion of the vials.
• Dilute total volume withdrawn of IMAAVY by adding to an infusion container containing 0.9% sodium chloride injection to a final volume of:
  • 250 mL for patients who weigh 40 kg or more, or
  • 100 mL for patients who weigh less than 40 kg.Only use infusion containers made of polyolefin, polypropylene, or polyvinylchloride.
• Gently invert the infusion container at least 10 times to mix the solution. Do not shake.
• Verify that a uniform solution has been achieved by visual inspection. Do not use if particulate matter or discoloration is present.

Storage Conditions of the Diluted Solution

• Administer the diluted IMAAVY solution immediately after preparation.
• If the diluted IMAAVY solution is not used immediately:
  • Protect from light.
  • Store refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours.
  • Do not freeze.
  • After preparation or removal from the refrigerator, use or discard the IMAAVY diluted solution within 12 hours, including infusion time. During these 12 hours, store under ambient light at 15°C to 30°C (59°F to 86°F).

Administration:

• If the diluted solution is refrigerated prior to administration, allow to warm to room temperature. Do not use external heat sources to warm IMAAVY.
• Administer the diluted solution by intravenous infusion only using an infusion set with an in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometer or less). Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride.
• Do not infuse IMAAVY concomitantly in the same intravenous line with other agents.
• Administer IMAAVY infusion intravenously over at least 30 minutes for the initial dose (30 mg/kg) and at least 15 minutes for subsequent doses (15 mg/kg).
• If an adverse reaction occurs during administration of IMAAVY, the infusion may be slowed or stopped at the discretion of the healthcare professional.
• Monitor the patient for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction [see Warnings and Precautions (5.2, 5.3)].

Unopened Vials

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

Diluted Solution

For storage of the diluted IMAAVY solution, see Dosage and Administration (2.3).