Preparation and Administration for MONJUVI

  1. Reconstitute and dilute MONJUVI prior to infusion1

Reconstitution1

  1. Calculate the dose (mg) and determine the number of vials needed.
  2. Reconstitute each 200 mg MONJUVI vial with 5 mL Sterile Water for Injection, USP with the stream directed toward the wall of each vial to obtain a final concentration of 40 mg/mL tafasitamab-cxix.
  3. Gently swirl the vial(s) until completely dissolved. Do not shake or swirl vigorously. Complete dissolution may take up to 5 minutes.
  4. Visually inspect the reconstituted solution for particulate matter or discoloration. The reconstituted solution should appear as a colorless to slightly yellow solution. Discard the vial(s) if the solution is cloudy, discolored, or contains visible particles.
  5. Use the reconstituted MONJUVI solution immediately. If needed, store the reconstituted solution in the vial for a maximum of 12 hours either refrigerated at 36 °F to 46 °F (2 °C to 8 °C) or room temperature at 68 °F to 77 °F (20 °C to 25 °C) before dilution. Protect from light during storage.

Dilution1

  1. Determine the volume (mL) of the 40 mg/mL reconstituted MONJUVI solution needed based on the required dose.
  2. Remove a volume equal to the required MONJUVI solution from a 250 mL 0.9% Sodium Chloride Injection, USP infusion bag and discard it.
  3. Withdraw the necessary amount of MONJUVI and slowly dilute in the infusion bag that contains the 0.9% Sodium Chloride Injection, USP to a final concentration of 2 mg/mL to 8 mg/mL. Discard any unused portion of MONJUVI remaining in the vial.
  4. Gently mix the intravenous bag by slowly inverting the bag. Do not shake. Visually inspect the infusion bag with the diluted MONJUVI infusion solution for particulate matter and discoloration prior to administration.
  5. If not used immediately, store the diluted MONJUVI infusion solution refrigerated for up to 18 hours at 36 °F to 46 °F (2 °C to 8 °C) and/or at room temperature for up to 12 hours at 68 °F to 77 °F (20 °C to 25 °C). The room temperature storage includes time for infusion. Protect from light during storage.

Do not shake or freeze the reconstituted or diluted infusion solutions.

Administration1

  1. Administer MONJUVI as an intravenous infusion
    • For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then, increase the rate so that the infusion is administered within 1.5 to 2.5 hours
    • Administer all subsequent infusions within 1.5 to 2 hours
  2. Infuse the entire contents of the bag containing MONJUVI.
  3. Do not co-administer other drugs through the same infusion line.
  4. No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylene terephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.

How MONJUVI is supplied, stored, and handled1

  1. MONJUVI for injection is a sterile, preservative-free,  white to slightly yellowish lyophilized powder for  reconstitution supplied as a 200-mg, single-dose vial
  2. Each 200-mg vial is individually packaged in a carton (NDC 50881-013-03)
Thermometer
  1. Store refrigerated at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light
  2. Do not shake
  3. Do not freeze