Brand Name
Monjuvi
Generic Name
Tafasitamab-cxix
View Brand Information FDA approval date: August 05, 2020
Form: Injection
What is Monjuvi (Tafasitamab-cxix)?
MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant . 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.
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Brand Information
MONJUVI (Tafasitamab-cxix)
1DOSAGE FORMS AND STRENGTHS
For injection: 200 mg of tafasitamab-cxix as white to slightly yellowish lyophilized powder in single-dose vial for reconstitution and further dilution.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infusion-related reactions
- Myelosuppression
- Infections
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Diffuse Large B-cell Lymphoma
The safety of MONJUVI in patients with relapsed or refractory DLBCL was evaluated in L-MIND
- Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle;
- Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle;
- Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.
Among patients who received MONJUVI, 57% were exposed for 6 months or longer, 42% were exposed for greater than one year, and 24% were exposed for greater than two years.
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%), and 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 interruptions 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, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
Table 4 summarizes the adverse reactions in L-MIND.
Clinically relevant adverse reactions in < 10% of patients with relapsed or refractory DLBCL who received MONJUVI in L-MIND were:
- Blood and lymphatic system disorders: lymphopenia (6%)
- General disorders and administration site conditions: infusion-related reaction (6%)
- Infections: sepsis (4.9%)
- Investigations: weight decreased (4.9%)
- Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%)
- Neoplasms: basal cell carcinoma (1.2%)
- Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%)
- Respiratory, thoracic and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%)
- Skin and subcutaneous tissue disorders: erythema (4.9%), alopecia (2.5%), hyperhidrosis (2.5%)
Table 5 summarizes the laboratory abnormalities in L-MIND.
Relapsed or Refractory Follicular Lymphoma
The safety of MONJUVI in patients with relapsed or refractory FL was evaluated in the inMIND trial
- Cycle 1 to 3: Days 1, 8, 15, and 22 of each 28-day cycle;
- Cycles 4 to 12: Days 1 and 15 of each 28-day cycle.
In the MONJUVI arm, 54% of patients completed all 12 cycles. The median age in that arm was 64 years (range: 36-88 years); 20% were age 75 years or older; 55% were male; 80% were White, 15% Asian, and 0.4% Black.
In the MONJUVI arm, serious adverse reactions occurred in 33% of patients, including serious infections in 24% of patients (including pneumonia and COVID-19 infection). Other serious adverse reactions in ≥ 2% of patients included renal insufficiency (3.3%), second primary malignancies (2.9%), and febrile neutropenia (2.6%). Fatal adverse reactions occurred in 1.5% of patients, including from COVID‑19, sepsis, and adenocarcinoma.
Adverse reactions led to permanent discontinuation of MONJUVI in 11% of patients and dosage interruptions in 74%. The most frequent adverse reactions leading to dosage interruptions of MONJUVI were neutropenia (37% of all patients), COVID-19 (22%), pneumonia (11%), and infusion-related reaction (8%).
The most common adverse reactions (≥ 20%) in recipients of MONJUVI, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.
Table 6 summarizes the adverse reactions in inMIND. Adverse reactions occurring at least 5% more frequently in the MONJUVI arm included COVID-19 infection, pneumonia, diarrhea, pruritus, fatigue, musculoskeletal pain, and mucositis.
In the MONJUVI arm, clinically relevant adverse reactions in < 10% of patients with relapsed or refractory FL included thrombosis, febrile neutropenia, second primary malignancy, sepsis, interstitial lung disease, and tumor lysis syndrome.
Table 7 summarizes the laboratory abnormalities in inMIND. Grade 4 laboratory abnormalities in > 1% of patients included neutrophils decreased (19%), platelets decreased (4%) and lymphocytes decreased (1.8%).
4DESCRIPTION
Tafasitamab-cxix is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. It is produced by recombinant DNA technology in mammalian cells (Chinese hamster ovary). Tafasitamab-cxix has a molecular weight of approximately 150 kDa.
MONJUVI (tafasitamab-cxix) for injection is supplied as a sterile, preservative-free, white to slightly yellowish lyophilized powder in a single-dose vial for intravenous use after reconstitution and further dilution. After reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration is 40 mg/mL with a pH of 6.0. Each single-dose vial contains 200 mg tafasitamab-cxix, citric acid monohydrate (3.7 mg), polysorbate 20 (1 mg), sodium citrate dihydrate (31.6 mg) and trehalose dihydrate (378.3 mg).
5HOW SUPPLIED/STORAGE AND HANDLING
MONJUVI (tafasitamab-cxix) for injection is a sterile, preservative-free, white to slightly yellowish lyophilized powder for reconstitution supplied as a 200 mg single-dose vial.
Each 200 mg vial is individually packaged in a carton (NDC 50881–013–03).
Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not shake. Do not freeze.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Infusion-Related Reactions
Advise patients to contact their healthcare provider if they experience signs and symptoms of infusion‑related reactions
Myelosuppression
Inform patients about the risk of myelosuppression. Advise patients to immediately contact their healthcare provider for a fever of 100.4°F (38°C) or greater or signs or symptoms of bruising or bleeding. Advise patients of the need for periodic monitoring of blood counts
Infections
Inform patients about the risk of infections. Advise patients to immediately contact their healthcare provider for a fever of 100.4°F (38°C) or greater or signs or symptoms of infection
Embryo-Fetal Toxicity
- Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for 3 months after the last dose
- 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
Advise women not to breastfeed during treatment with MONJUVI and for 3 months after the last dose
Manufactured by:
Incyte Corporation
Wilmington, DE 19803
U.S. License No. 2228
MONJUVI and the MONJUVI logo are registered trademarks of Incyte.
Patent Information: www.incyte.com/patents
© 2025 Incyte Corporation. All rights reserved.
7PRINCIPAL DISPLAY PANEL - 200 mg Vial Carton
NDC 50881–013–03
MONJUVI
For Injection
200 mg/vial
For Intravenous
Single-dose vial
1 Vial
Incyte