MONJUVI

5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions : Monitor patients frequently during infusion. Interrupt or discontinue infusion based on severity. ( 2.5 , 5.1 ) Myelosuppression : Monitor complete blood counts. Manage using dose modifications and growth factor support. Interrupt or discontinue MONJUVI based on severity. ( 2.5 , 5.2 ) Infections : Bacterial, fungal and viral infections can occur during and following MONJUVI. Monitor patients for infections. ( 2.5 , 5.3 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 ) 5.1 Infusion-Related Reactions MONJUVI can cause infusion-related reactions [see Adverse Reactions ( 6.1 )] . In L-MIND, infusion-related reactions occurred in 6% of the 81 patients with DLBCL who received MONJUVI. Eighty percent of infusion-related reactions occurred during cycle 1 or 2. In inMIND, infusion-related reactions occurred in 16% of the 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab. Signs and symptoms included fever, chills, rash, flushing, dyspnea, and hypertension. These reactions were generally managed with temporary interruption of the infusion and/or with supportive medication. Premedicate patients prior to starting MONJUVI infusion [see Dosage and Administration ( 2.4 )] . Monitor patients frequently during infusion. Based on the severity of the infusion-related reaction, interrupt or discontinue MONJUVI [ see Dosage and Administration ( 2.5 )] . Institute appropriate medical management. 5.2 Myelosuppression MONJUVI can cause serious or severe myelosuppression, including neutropenia, lymphopenia, thrombocytopenia, and anemia [ see Adverse Reactions ( 6.1 ) ] . In L-MIND, among 81 patients with DLBCL who received MONJUVI, Grade 3 neutropenia was reported in 25%, Grade 3 thrombocytopenia in 12%, and Grade 3 anemia in 7%. Grade 4 neutropenia was reported in 25% and Grade 4 thrombocytopenia in 6%. Neutropenia led to treatment discontinuation in 3.7% of the patients with DLBCL. Febrile neutropenia occurred in 12%. In inMIND, among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab, new or worsening Grade 3 or 4 cytopenias included decreased neutrophils in 48% (Grade 4, 19%), decreased lymphocytes in 22% (Grade 4, 1.8%), decreased hemoglobin in 9%, and decreased platelets in 8% (Grade 4, 4%). Febrile neutropenia occurred in 4.4%. Monitor CBCs before each treatment cycle and throughout treatment. Monitor patients with neutropenia for signs of infection. Consider granulocyte colony-stimulating factor administration. Withhold MONJUVI based on the severity of the adverse reaction [see Dosage and Administration ( 2.5 )]. Refer to the lenalidomide prescribing information for dosage modifications. 5.3 Infections Fatal and serious infections, including opportunistic infections, occurred in patients during treatment with MONJUVI and following the last dose [ see Adverse Reactions ( 6.1 )]. In L-MIND, 73% of the 81 patients with DLBCL who received MONJUVI developed an infection. Grade 3 or higher infection occurred in 30%. Infection-related deaths occurred in 2.5% of patients, including a case of progressive multifocal leukoencephalophathy (PML). The most frequent Grade 3 or higher infection was pneumonia (7%). The most frequent infections of any grade were respiratory tract infections (51%, including pneumonias) and urinary tract infection (17%). Among 274 patients with FL who received MONJUVI in combination with lenalidomide and rituximab in inMIND, Grade 3 or higher infections occurred in 24%, including fatal infections in 1.1% of patients. The most frequent Grade ≥ 3 infections were respiratory tract infections (19%), including Grade 3 or higher pneumonia (14%) and COVID-19 infection (11%). Opportunistic infections of any grade occurred in 6% of patients, including herpes simplex or zoster infection (5%), fungal pneumonia (1.1%, including Pneumocytis jirovecii pneumonia in 0.4%), and cytomegalovirus (CMV) reactivation (0.4%). Monitor patients for signs and symptoms of infection and manage infections as appropriate. Consider infection prophylaxis per institutional guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MONJUVI and for 3 months after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . The combination of MONJUVI with lenalidomide and of MONJUVI with lenalidomide and rituximab is contraindicated in pregnant women because lenalidomide can cause birth defects and death of the unborn child. Refer to the lenalidomide prescribing information on use during pregnancy.

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%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite. ( 6.1 ) The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes. To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 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 in patients with relapsed or refractory DLBCL was evaluated in L-MIND [see Clinical Studies ( 14 .1 )]. 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%), 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. Table 4: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Adverse Reaction MONJUVI in Combination with Lenalidomide (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 Infections Respiratory tract infection Respiratory tract infection includes lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection, bronchitis, pneumonia, nasopharyngitis, and related terms. 51 12 Urinary tract infection Urinary tract infection includes urinary tract infection, urinary tract infection bacterial, and related terms. 17 4.9 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 Metabolism and nutrition disorders Decreased appetite 22 0 Hypokalemia 19 6 Musculoskeletal and connective tissue disorders Back pain 19 2.5 Muscle spasms 15 0 Skin and subcutaneous tissue disorders Rash Rash includes rash, rash maculopapular, rash pruritic, rash erythematous, and rash pustular. 15 2.5 Pruritus 10 1.2 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. Table 5: Select Laboratory Abnormalities (≥ 20%) Worsening from Baseline in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value. All Grades (%) Grade 3 or 4 (%) Chemistry Glucose increased 49 5 Calcium decreased 47 1.4 Gamma glutamyl transferase increased 34 5 Albumin decreased 26 0 Magnesium decreased 22 0 Urate increased 20 7 Phosphate decreased 20 5 Creatinine increased 20 1.4 Aspartate aminotransferase increased 20 0 Coagulation Activated partial thromboplastin time increased 46 4.1 Relapsed or Refractory Follicular Lymphoma The safety of MONJUVI in patients with relapsed or refractory FL was evaluated in the inMIND trial [see Clinical Studies (14.2)]. Patients received MONJUVI 12 mg/kg (N = 274) or placebo (N = 272) intravenously for a maximum of 12 cycles in combination with lenalidomide 20 mg (Days 1-21 of Cycles 1 to 12) and rituximab 375 mg/m 2 (Cycles 1 to 5). MONJUVI was administered as follows: 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. Table 6: Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Adverse Reaction MONJUVI in Combination with Lenalidomide and Rituximab (N = 274) Placebo in Combination with Lenalidomide and Rituximab (N = 272) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Infections Respiratory tract infection 56 18 56 9 COVID-19 infection Includes COVID-19, COVID-19 pneumonia, and coronavirus test positive. 34 Includes 2 cases in each arm with fatal outcome. 10 24 2.9 Pneumonia Includes pneumonia, COVID-19 pneumonia, pneumonia fungal, Pneumocystis jirovecii pneumonia, and other types of pneumonia. 18 14 11 Includes 3 cases with fatal outcome, including 2 reported under COVID-19 infection. 7 Upper respiratory tract infection Includes upper respiratory tract infection, nasopharyngitis, sinusitis, laryngitis, and related terms. 17 1.1 22 0.4 Gastrointestinal disorders Diarrhea 38 0.7 28 1.8 Constipation 29 0.7 25 0 Nausea 18 0.4 14 0.4 Abdominal pain 13 0 18 2.2 Skin and subcutaneous tissue disorders Rash Includes rash, urticaria, dermatitis, drug eruption, and related terms. 37 3.6 33 1.5 Pruritus 16 0.4 10 0 General disorders Fatigue Includes fatigue and asthenia. 34 2.9 25 0.7 Pyrexia 19 1.8 16 2.2 Mucositis Includes oropharyngeal pain, stomatitis, mucosal inflammation, mouth ulceration, odynophagia, aphthous ulcer, esophageal pain, and related terms. 17 0.4 11 0 Edema Includes edema, peripheral edema, pulmonary edema, generalized edema, and related terms. 11 0.7 17 1.1 Musculoskeletal and connective tissue disorders Musculoskeletal pain Includes back pain, pain in extremity, myalgia, bone pain, neck pain, spinal pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, and sacral pain. 24 0.4 16 0.4 Muscle contracture Includes muscle spasms and muscle contractions involuntary. 18 0 19 0 Respiratory, thoracic and mediastinal disorders Cough 21 0 19 0 Procedural complications Infusion-related reaction Includes infusion-related reaction and cytokine release syndrome. 16 0.7 16 0.4 Nervous system disorders Peripheral neuropathy Includes peripheral neuropathy, paresthesia, peripheral sensory neuropathy, neuralgia, dysesthesia, hyperesthesia, and peripheral motor neuropathy. 12 0 11 0.4 Headache 10 0.4 7 0 Metabolism and nutrition disorders Decreased appetite 10 0 9 0.7 The table includes a combination of grouped and ungrouped terms. Adverse reactions were graded using NCI CTCAE version 5.0 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%). Table 7: Select Laboratory Abnormalities (> 20%) Worsening from Baseline in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND Laboratory Abnormality MONJUVI in Combination with Lenalidomide and Rituximab The denominator used to calculate the rate varied from 268 - 274 based on the number of patients with a baseline value and at least 1 post-treatment value. Placebo in Combination with Lenalidomide and Rituximab All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematology Neutrophils decreased 75 48 71 44 Hemoglobin decreased 60 9 54 7 Lymphocytes decreased 57 22 51 19 Platelets decreased 40 8 43 9 Chemistry Alanine aminotransferase increased 47 1.5 42 1.5 Alkaline phosphatase increased 33 0 27 0 Creatinine increased 29 1.5 30 0.7 Aspartate aminotransferase increased 29 0 31 0.4 Glucose increased 28 0.4 28 1.1 Potassium decreased 24 3.3 24 3 Sodium decreased 24 1.5 22 0.4

<table><caption>Table 4: Adverse Reactions (&#x2265; 10%) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND</caption><col/><col/><col/><thead><tr><th styleCode=" Botrule Toprule Lrule Rrule" rowspan="2"><content styleCode="bold">Adverse Reaction</content></th><th align="center" styleCode=" Botrule Toprule Lrule Rrule" colspan="2"><content styleCode="bold">MONJUVI</content> <content styleCode="bold">in Combination with Lenalidomide</content> <content styleCode="bold">(N = 81)</content></th></tr><tr><th align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">All Grades (%)</content></th><th align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Grade 3 or 4 (%)</content></th></tr></thead><tbody><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Blood and lymphatic system disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Neutropenia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">51</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">49</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Anemia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">36</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Thrombocytopenia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">31</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Febrile neutropenia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">12</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">12</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Infections</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Respiratory tract infection<footnote ID="FOOT_24583">Respiratory tract infection includes lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection, bronchitis, pneumonia, nasopharyngitis, and related terms.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">51</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">12</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Urinary tract infection<footnote ID="FOOT_24584">Urinary tract infection includes urinary tract infection, urinary tract infection bacterial, and related terms.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4.9</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">General disorders and administration site conditions</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Fatigue<footnote ID="FOOT_24585">Fatigue includes asthenia and fatigue.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">38</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3.7</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Pyrexia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">24</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Peripheral edema</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">24</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Gastrointestinal disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Diarrhea</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">36</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Constipation</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Abdominal pain<footnote ID="FOOT_24586">Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">15</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Nausea</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">15</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Vomiting</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">15</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Cough</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">26</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Dyspnea</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">12</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Metabolism and nutrition disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Decreased appetite</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">22</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Hypokalemia</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">6</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Back pain</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.5</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Muscle spasms</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">15</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Skin and subcutaneous tissue disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Rash<footnote ID="FOOT_24587">Rash includes rash, rash maculopapular, rash pruritic, rash erythematous, and rash pustular.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">15</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.5</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Pruritus</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">10</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.2</td></tr></tbody></table>

<table><caption>Table 5: Select Laboratory Abnormalities (&#x2265; 20%) Worsening from Baseline in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma Who Received MONJUVI in L-MIND</caption><col/><col/><col/><thead><tr><th styleCode=" Botrule Toprule Lrule Rrule" rowspan="2"><content styleCode="bold">Laboratory Abnormality</content></th><th align="center" styleCode=" Botrule Toprule Lrule Rrule" colspan="2"><content styleCode="bold">MONJUVI in Combination with Lenalidomide<footnote ID="FOOT_24218">The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value.</footnote> </content></th></tr><tr><th align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">All Grades (%)</content></th><th align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Grade 3 or 4 (%)</content></th></tr></thead><tbody><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Chemistry</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Glucose increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">49</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">5</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Calcium decreased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">47</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.4</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Gamma glutamyl transferase increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">34</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">5</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Albumin decreased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">26</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Magnesium decreased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">22</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Urate increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">20</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Phosphate decreased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">20</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">5</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Creatinine increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">20</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.4</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Aspartate aminotransferase increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">20</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0</td></tr><tr><td colspan="3" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Coagulation</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Activated partial thromboplastin time increased</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">46</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">4.1</td></tr></tbody></table>

<table width="813px"><caption>Table 6: Adverse Reactions (&#x2265; 10%) in Patients with Relapsed or Refractory Follicular Lymphoma Who Received MONJUVI in inMIND</caption><col/><col/><col/><col/><col/><tbody><tr><td rowspan="2" styleCode=" Botrule Toprule Lrule Rrule"> <content styleCode="bold">Adverse Reaction</content></td><td align="center" colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>MONJUVI in Combination with Lenalidomide and Rituximab</paragraph><content styleCode="bold">(N = 274)</content> </td><td align="center" colspan="2" styleCode=" Botrule Toprule Lrule Rrule"> <paragraph>Placebo in Combination with Lenalidomide and Rituximab</paragraph><content styleCode="bold">(N = 272)</content></td></tr><tr><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Grade 3 or 4 (%)</content> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Grade 3 or 4 (%)</content></td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Infections</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Respiratory tract infection </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">56 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">18</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">56</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">9</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>COVID-19 infection<footnote ID="FOOT_25084"><paragraph>Includes COVID-19, COVID-19 pneumonia, and coronavirus test positive.</paragraph></footnote> </paragraph></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">34<footnote ID="FOOT_24219">Includes 2 cases in each arm with fatal outcome.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">10</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">24<footnoteRef IDREF="FOOT_24219"/> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.9</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Pneumonia<footnote ID="FOOT_25085">Includes pneumonia, COVID-19 pneumonia, pneumonia fungal, <content styleCode="italics">Pneumocystis jirovecii</content> pneumonia, and other types of pneumonia.</footnote> </paragraph></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">18</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">14</td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">11<footnote ID="FOOT_25083"><paragraph>Includes 3 cases with fatal outcome, including 2 reported under COVID-19 infection.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7</td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Upper respiratory tract infection<footnote ID="FOOT_25086"><paragraph>Includes upper respiratory tract infection, nasopharyngitis, sinusitis, laryngitis, and related terms.</paragraph></footnote> </paragraph></td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.1 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">22 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Gastrointestinal disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Diarrhea </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">38 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">28 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.8 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Constipation </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">29 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">25 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Nausea </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">18 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">14 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Abdominal pain </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">13 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">18 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.2 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Skin and subcutaneous tissue disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Rash<footnote ID="FOOT_25087"><paragraph>Includes rash, urticaria, dermatitis, drug eruption, and related terms.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">37 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">3.6 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">33 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.5 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Pruritus </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">16 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">10 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">General disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Fatigue<footnote ID="FOOT_25088">Includes fatigue and asthenia.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">34 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.9 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">25 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Pyrexia </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.8 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">16 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">2.2 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Mucositis<footnote ID="FOOT_25089">Includes oropharyngeal pain, stomatitis, mucosal inflammation, mouth ulceration, odynophagia, aphthous ulcer, esophageal pain, and related terms.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">11 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Edema<footnote ID="FOOT_25090"><paragraph>Includes edema, peripheral edema, pulmonary edema, generalized edema, and related terms.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">11 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">17 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">1.1 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Musculoskeletal pain<footnote ID="FOOT_25091"><paragraph>Includes back pain, pain in extremity, myalgia, bone pain, neck pain, spinal pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, and sacral pain.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">24 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">16 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Muscle contracture<footnote ID="FOOT_25092"><paragraph>Includes muscle spasms and muscle contractions involuntary.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">18 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Cough </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">21 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">19 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Procedural complications</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Infusion-related reaction<footnote ID="FOOT_25093"><paragraph>Includes infusion-related reaction and cytokine release syndrome.</paragraph></footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">16 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">16 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Nervous system disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Peripheral neuropathy<footnote ID="FOOT_25094">Includes peripheral neuropathy, paresthesia, peripheral sensory neuropathy, neuralgia, dysesthesia, hyperesthesia, and peripheral motor neuropathy.</footnote> </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">12 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">11 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Headache </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">10 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.4 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">7 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td></tr><tr><td colspan="5" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Metabolism and nutrition disorders</content> </td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule">Decreased appetite </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">10 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">9 </td><td align="center" styleCode=" Botrule Toprule Lrule Rrule">0.7 </td></tr><tr><td colspan="5">The table includes a combination of grouped and ungrouped terms. Adverse reactions were graded using NCI CTCAE version 5.0</td></tr></tbody></table>