Dosage and Administration

DOSAGE AND ADMINISTRATION
OF MONJUVI + LENALIDOMIDE

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

L-MIND: HEMATOLOGIC TOXICITIES MANAGEMENT AND DOSING MODIFICATIONS^1-3

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

RECOMMENDED PREMEDICATIONS¹

Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize IRRs. Premedications may include acetaminophen, histamine H₁ receptor antagonists, histamine H₂ receptor antagonists, and/or glucocorticosteroids.

For patients not experiencing IRRs during the first 3 infusions, premedication is optional for subsequent infusions.

If a patient experiences an IRR, administer premedications before each subsequent infusion.

For details on dosage modifications and management of adverse reactions for IRRs and myelosuppression, please refer to the full Prescribing Information.

For more information about preparation and administration, storage and handling, and how MONJUVI is supplied, please refer to the full Prescribing Information.

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

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: