MONJUVI

Indications and Usage, Relapsed or Refractory Follicular Lymphoma ( 1.2 ) 6/2025 Dosage and Administration, Recommended Dosage for Relapsed or Refractory Follicular Lymphoma ( 2.3 ) 6/2025 Dosage and Administration, Recommended Premedications and Prophylactic Medication ( 2.4 ) 6/2025 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 6/2025 Warnings and Precautions, Myelosuppression ( 5.2 ) 6/2025 Warnings and Precautions, Infections ( 5.3 ) 6/2025

1 INDICATIONS AND USAGE 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 (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). ( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). ( 1.2 ) Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. ( 1.2 , 14.3 ) 1.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma MONJUVI, 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 [ see Clinical Studies ( 14.1 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].

2 DOSAGE AND ADMINISTRATION Administer premedications prior to starting MONJUVI. ( 2.4 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) Diffuse Large B-cell Lymphoma The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.2 ) 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. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle. Administer MONJUVI in combination with lenalidomide for a maximum of 12 cycles and then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity. ( 2.2 ) Follicular Lymphoma The recommended dosage of MONJUVI is 12 mg/kg as an intravenous infusion according to the following dosing schedule: ( 2.3 ) Cycles 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. Administer MONJUVI in combination with lenalidomide (Cycles 1 to 12) and rituximab (Cycles 1 to 5). ( 2.3 ) 2.1 Important Dosing Information MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage for Relapsed or Refractory Diffuse Large B‐cell Lymphoma The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion in combination with lenalidomide, according to the dosing schedule in Table 1. Table 1: MONJUVI Dosing Schedule for Patients with Relapsed or Refractory DLBCL Cycle Each treatment cycle is 28 days. Dosing Schedule Cycle 1 Days 1, 4, 8, 15, and 22 Cycles 2 and 3 Days 1, 8, 15, and 22 Cycle 4 and beyond Days 1 and 15 Administer MONJUVI in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity [see Clinical Studies ( 14 .1 )] . Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations, including for patients with renal insufficiency. 2.3 Recommended Dosage for Relapsed or Refractory Follicular Lymphoma The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion in combination with lenalidomide and rituximab, according to the dosing schedule in Table 2. Table 2: MONJUVI Dosing Schedule for Patients with Relapsed or Refractory FL Cycle Each treatment cycle is 28 days. Dosing Schedule Cycles 1 to 3 Days 1, 8, 15, and 22 Cycles 4 to 12 Days 1 and 15 Administer MONJUVI in combination with lenalidomide 20 mg (Days 1-21 in Cycles 1 to 12) and rituximab 375 mg/m 2 (Cycles 1 to 5) [see Clinical Studies ( 14.2 )] . Refer to the rituximab prescribing information and the lenalidomide prescribing information for the respective dosage recommendations, including lenalidomide dosage recommendations for patients with renal insufficiency. 2.4 Recommended Premedications and Prophylactic Medication Premedication Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions [see Warnings and Precautions ( 5.1 )]. Premedications may include acetaminophen, histamine H 1 receptor antagonists, histamine H 2 receptor antagonists, and/or glucocorticosteroids. For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions. If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion. Thromboprophylaxis Refer to the lenalidomide prescribing information for recommendations on prophylaxis for venous and arterial thrombotic events. 2.5 Dosage Modifications for Adverse Reactions The recommended dosage modifications for adverse reactions are summarized in Table 3. Table 3: Dosage Modifications for Adverse Reactions Adverse Reaction Severity …

3 DOSAGE 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. For injection: 200 mg of tafasitamab-cxix as lyophilized powder in single-dose vial for reconstitution. ( 3 )

4 CONTRAINDICATIONS None. None.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions (5.1) ] Myelosuppression [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MORPHOSYS US INC. at 1-844-667-1992 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 was evaluated in L-MIND [see Clinical Studies (14) ]. Patients (n=81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: 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%), 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, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. Table 3 summarizes the adverse reactions in L-MIND. Table 3: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI in L-MIND Adverse Reaction MONJUVI (N=81) All Grades (%) Grade 3 or 4 (%) Blood and lymphatic system disorders Neutropenia 51 49 Anemia 36 7 Thrombocytopenia 31 17 Febrile neutropenia 12 12 General disorders and administration site conditions Fatigue Fatigue includes asthenia and fatigue 38 3.7 Pyrexia 24 1.2 Peripheral edema 24 0 Gastrointestinal disorders Diarrhea 36 1.2 Constipation 17 0 Abdominal pain Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper 15 1.2 Nausea 15 0 Vomiting 15 0 Respiratory, thoracic and mediastinal disorders Cough 26 1.2 Dyspnea 12 1.2 Infections Respiratory tract infection Respiratory tract infection includes: lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection 24 4.9 Urinary tract infection Urinary tract infection includes: urinary tract infection, Escherichia …

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. MONJUVI is administered in combination with lenalidomide, as well as in combination with lenalidomide and rituximab for up to 12 cycles. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS program. Clinical Considerations Fetal/Neonatal Adverse Reactions Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, MONJUVI may cause depletion of fetal CD19 positive immune cells. Defer administering live vaccines to neonates and infants exposed to tafasitamab-cxix in utero until a hematology evaluation is completed. Data Animal Data Animal reproductive studies have not been conducted with tafasitamab-cxix. Tafasitamab-cxix is an IgG antibody and thus has the potential to cross the placental barrier permitting direct fetal exposure and depleting fetal B lymphocytes. 8.2 Lactation Risk Summary There are no data on the presence of tafasitamab-cxix in human milk or the effects on the breastfed child or milk production. Maternal immunoglobulin G is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to MONJUVI are unknown. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with MONJUVI and for 3 months after the last dose. Refer to lenalidomide prescribing information for additional information. 8.3 Females and Males of Reproductive Potential MONJUVI can cause fetal B-cell depletion when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Refer to the prescribing information for lenalidomide for pregnancy testing requirements prior to initiating the combination of MONJUVI with lenalidomide or the combination of MONJUVI with lenalidomide and rituximab . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for 3 months after the last dose. Additionally, refer to the lenalidomide prescribing information for additional recommendations for contraception. Males Refer to the lenalidomide prescribing information for recommendations. 8.4 Pediatric Use The safety and effectiveness of MONJUVI in pediatric patients have not been established. 8.5 Geriatric Use Relapsed or Refractory Diffuse Large B-Cell Lymphoma Among the 81 patients who received MONJUVI and lenalidomide in L-MIND, 72% were 65 years and older, while 38% were 75 years and older. Clinical studies of MONJUVI did not include sufficient numbers of patients aged 65 and older to determine whether effectiveness differs compared to that of younger subjects. Patients 65 years and older had more serious adverse reactions (57%) than younger patients (39%). Relapsed or Refractory Follicular Lymphoma Among the 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab in inMIND, 137 (50%) were 65 years and older and 54 (20%) were 75 years and older. No clinically meaningful differences in safety or effectiveness were observed between these patients and younger patients.

12.1 Mechanism of Action Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.

11 DESCRIPTION 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).

16 HOW 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 73535–208–01). 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.