1. MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage IRRs1
  2. The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in the table below1
  3. Administer MONJUVI in combination with lenalidomide 25 mg orally on days 1 to 21 of each 28-day cycle for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity1
  4. Refer to the lenalidomide prescribing information for lenalidomide dosage and recommendations1
  5. Administer MONJUVI as an intravenous infusion1
    1. 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 hours1
      1. In the L-MIND study, after the first 30 minutes, the rate of infusion was increased to 125 mL/h over a 2-hour period2
    2. Administer all subsequent infusions within 1.5 to 2 hours1
    3. In the L-MIND study, vital signs were measured immediately prior to infusion, at 15 minutes (+/- 5 minutes), 30 minutes (+/- 10 minutes), every 60 minutes (+/- 15 minutes), and at the end of the infusion (+/- 20 minutes)2
The cycle length for MONJUVI is 28 days1
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Cycle 1                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
Cycles 2 and 3                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
Cycles 4 to 12                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
Lenalidomide 25 mg daily
                                                         
After 12 cycles, continue MONJUVI                                                        
monotherapy until disease progression                                                        
or unacceptable toxicity                                                        
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
                                                         
After 12 cycles, continue MONJUVI monotherapy until disease progression or unacceptable toxicity
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
MONJUVI 12 mg/kg
                                                         
Cycle 1
MONJUVI 12 mg/kg on days 1, 4*, 8, 15, 22
Lenalidomide 25 mg daily by mouth on days 1 to 21
*Loading dose on day 4 is given in cycle 1 only.
Cycle 2 and 3
MONJUVI 12 mg/kg on days 1, 8, 15, 22
Lenalidomide 25 mg daily by mouth on days 1 to 21
Cycle 4 to 12
MONJUVI 12 mg/kg on days 1, 15
Lenalidomide 25 mg daily by mouth on days 1 to 21
After 12 cycles, continue MONJUVI monotherapy until disease progression or unacceptable toxicity
MONJUVI 12 mg/kg on days 1, 15

L-MIND: HEMATOLOGIC TOXICITIES MANAGEMENT AND DOSING MODIFICATIONS1-3

Administer MONJUVI in combination with lenalidomide 25 mg orally for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity1

Refer to the lenalidomide prescribing information for lenalidomide dosing recommendations.1

44% of patients in L-MIND received concomitant granulocyte-colony stimulating factor2

46% of patients (37/80) had at least one dose reduction of lenalidomide2*

78% of patients (62/80) were able to receive a lenalidomide dose of ≥20 mg/day over the duration of their treatment3*

  1. Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%1
  2. Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%1

*81 patients were enrolled; 80 patients received MONJUVI plus lenalidomide and 1 received MONJUVI alone.2

DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS1

  1. In the L-MIND study, IRRs occurred in 6% of the 81 patients. 80% of the IRRs occurred during cycle 1 or 2

Management guidelines for IRRs and myelosuppression

Dosage modifications for infusion-related reactions (IRRs)
GRADE 2 (moderate)
  1. Interrupt infusion immediately and manage signs and symptoms
  2. Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred
GRADE 3 (severe)
  1. Interrupt infusion immediately and manage signs and symptoms
  2. Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred
  3. If after rechallenge the reaction returns, stop the infusion immediately
GRADE 4 (life-threatening)
  1. Stop the infusion immediately and permanently discontinue MONJUVI
Dosage modifications for myelosuppression
Platelet count of 50,000/mcL or less
  1. Withhold MONJUVI and lenalidomide and monitor CBC weekly until platelet count is 50,000/mcL or higher
  2. Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications
Neutrophil count of 1,000/mcL or less for at least 7 days
OR
Neutrophil count of 1,000/mcL or less with an increase of body temperature to 100.4 °F (38 °C) or higher
OR
Neutrophil count less than 500/mcL
  1. Withhold MONJUVI and lenalidomide and monitor CBC weekly until neutrophil count is 1,000/mcL or higher
  2. Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications

CBC=complete blood count.

Refer to the lenalidomide prescribing information for dosage modifications.

PREPARATION AND ADMINISTRATION OF MONJUVI

  • 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.

Administration

  1. Administer MONJUVI as an intravenous infusion.1
    1. 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 hours1
      1. In the L-MIND study, after the first 30 minutes, the rate of infusion was increased to 125 mL/h over a 2-hour period2
    2. Administer all subsequent infusions within 1.5 to 2 hours1
    3. In the L-MIND study, vital signs were measured immediately prior to infusion, at 15 minutes (+/- 5 minutes), 30 minutes (+/- 10 minutes), every 60 minutes (+/- 15 minutes), and at the end of the infusion (+/- 20 minutes)2
  2. Infuse the entire contents of the bag containing MONJUVI.1
  3. Do not co-administer other drugs through the same infusion line.1
  4. No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylenterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.1

COUNSELING YOUR PATIENTS1

Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise your patients to contact their provider if they experience signs and symptoms of:

Infusion-related reactions

  1. Advise patients to contact their healthcare provider if they experience signs and symptoms of infusion-related reactions

Myelosuppression

  1. Advise patients of the need for periodic monitoring of blood counts

Infections

  1. Fever of 100.4 °F (38 °C) or greater or signs or symptoms of infection should be reported immediately

Embryo-fetal toxicity

  1. Advise pregnant women of the potential risk to a fetus. Women of reproductive potential should inform their healthcare provider of a known or suspected pregnancy
  2. Advise women of reproductive potential to use effective contraception during treatment with MONJUVI and for at least 3 months after the last dose
  3. Advise patients that lenalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide is only available through a REMS program

Lactation

  1. Advise women not to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose