MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage IRRs¹
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
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
Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations¹
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

See Recommended Premedications for more information about MONJUVI premedications.

The cycle length for MONJUVI is 28 days

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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	■														■

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

Download the Management Guide

Provides a comprehensive overview of MONJUVI to help healthcare professionals manage treatment.

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*It is unclear if tafasitamab or loncastuximab tesirine or if any other CD-19 directed therapy would have a negative impact on the efficacy of subsequent anti-CD19 CAR T⁠-⁠cell therapy.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Adverse Reactions

Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%).

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%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

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%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%).

The most common adverse reactions (≥20%) were neutropenia (51%), fatigue (38%), anemia (36%), diarrhea (36%), thrombocytopenia (31%), cough (26%), pyrexia (24%), peripheral edema (24%), respiratory tract infection (24%), and decreased appetite (22%).

Indication & Usage

MONJUVI (tafasitamab-cxix), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see the full Prescribing Information for additional Important Safety Information.

Adverse Reactions

Indication & Usage

Please see the full Prescribing Information for additional Important Safety Information.

Dosing & Administration

Dosing and administration of MONJUVI + lenalidomide

Download the Management Guide

Indication & Usage

Important Safety Informationand Indication

Warnings and Precautions

Adverse Reactions

Indication & Usage

Indication & Usage

Important Safety Informationand Indication

Warnings and Precautions

Adverse Reactions

Indication & Usage