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%

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

46%

46% of patients (37/80) had at least 1 dose reduction of lenalidomide2*

78%

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

For information about premedications for MONJUVI, visit Recommended Premedications.

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 lenalidomide dosage modifications.