TECVAYLI

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Can cause hepatotoxicity, including fatalities. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity ( 2.5 , 5.4 ) Infections : Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. ( 2.5 , 5.5 ) Neutropenia : Monitor complete blood cell counts at baseline and periodically during treatment. Withhold TECVAYLI based on severity. ( 2.5 , 5.6 ) Hypersensitivity and Other Administration Reactions : Can cause systemic administration-related reactions and local injection site reactions. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity. ( 2.5 , 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions [see Adverse Reactions (6.1) ] . In the clinical trials (monotherapy and combination therapy trials; N=448), CRS occurred in 64% of patients who received TECVAYLI at the recommended dosage, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 (37%), step-up dose 2 (32%), or the initial treatment dose (20%)). CRS first occurred following subsequent doses of TECVAYLI in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS [see Dosage and Administration (2.1 , 2.5) ] . Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly [see Dosage and Administration (2.3 , 2.5) ] . At the first sign of CRS, immediately evaluate the patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity [see Dosage and Administration (2.5) ] . TECVAYLI is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ]. 5.2 Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome TECVAYLI can cause serious, life-threatening or fatal neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1) ] . In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each). In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI as monotherapy at the recommended dosage [see Adverse Reactions (6.1) ] . Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI doses. The median time to onset of ICANS was 4 days (range: 2 to 8 days) after the most recent TECVAYLI dose with a median duration of 3 days (range: 1 to 20 days). The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule [see Adverse Reactions (6.1) ] . The median time to onset of ICANS was 2 days (range: 1 to 3 days) after the most recent dose and the median duration of ICANS was 2 days (range: 1 to 2 days). The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines [see Dosage and Administration (2.5) ] . Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness [see Adverse Reactions (6.1) ] . Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves [see Dosage and Administration (2.1) ] . TECVAYLI is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ]. 5.3 TECVAYLI and TALVEY REMS TECVAYLI is available only through a restricted program under a REMS called the "TECVAYLI and TALVEY REMS" because of the risks of CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1 , 5.2) ]. Notable requirements of the TECVAYLI and TALVEY REMS include the following: Prescribers must be certified with the REMS by enrolling and completing training. Prescribers must counsel patients receiving TECVAYLI about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with Patient Wallet Card. Pharmacies and healthcare settings that dispense TECVAYLI must be certified with this REMS and must verify prescribers are certified through this REMS. Wholesalers and distributers must only distribute TECVAYLI to certified pharmacies or healthcare settings. Further information about the "TECVAYLI and TALVEY REMS" is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064. 5.4 Hepatotoxicity TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin at baseline and during TECVAYLI treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ]. 5.5 Infections TECVAYLI can cause severe, life-threatening, or fatal infections. In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections occurred in 35% of patients, and fatal infections occurred in 4.2% of patients [see Adverse Reactions (6.1) ] . In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections occurred in 54% of patients and fatal infections occurred in 4.6% of patients [see Adverse Reactions (6.1) ] . Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines [see Dosage and Administration (2.3) ] . Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ] . Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL. 5.6 Neutropenia TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients [see Adverse Reactions (6.1) ]. Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI based on severity [see Dosage and Administration (2.5) ] . 5.7 Hypersensitivity and Other Administration Reactions TECVAYLI can cause both systemic administration-related reactions and local injection-site reactions. Systemic Reactions In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic-administration reactions, which included recurrent pyrexia and rash. Local Reactions In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients with Grade 1 injection-site reactions in 29% and Grade 2 in 9%. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity [see Dosage and Administration (2.5) ] . 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .

6 ADVERSE REACTIONS The following adverse reactions are also described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity including ICANS [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Infections [see Warnings and Precautions (5.5) ] Neutropenia [see Warnings and Precautions (5.6) ] Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy are pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. ( 6.1 ) The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj are hypogammaglobulinemia, upper respiratory tract infection, cytokine release syndrome, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis and weight decreased. ( 6.1 ) The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) are decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed/Refractory Multiple Myeloma In Combination with Daratumumab and Hyaluronidase-fihj The safety of TECVAYLI in combination with daratumumab and hyaluronidase-fihj (N=283) compared with either daratumumab and hyaluronidase-fihj, pomalidomide and dexamethasone (DPd) or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) (N=290) was evaluated in patients with relapsed or refractory multiple myeloma in MajesTEC-3 [see Clinical Studies (14.1) ] . Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg once weekly, followed by TECVAYLI 3 mg/kg every two weeks, followed by TECVAYLI 3 mg/kg every four weeks, subcutaneously. Among patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj the median exposure was 32 (range 0.03 to 43) months. Among patients who received DPd or DVd the median exposure was 16 (range 0.03 to 45) months. Serious adverse reactions occurred in 71% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj. Serious adverse reactions reported in ≥3% of patients included pneumonia (33%), upper respiratory tract infection (15%), cytokine release syndrome (10%), COVID-19 (7%), sepsis (6%), second primary malignancy (5%), pyrexia (4.9%), febrile neutropenia (4.6%), and gastroenteritis (4.2%). Fatal adverse reactions occurred in 2.5% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj, and included sepsis (0.7%), pneumonia (0.4%), sudden death (0.4%), myocardial infarction (0.4%), enterovirus myocarditis (0.4%) and hemophagocytic lymphohistiocytosis (0.4%). Permanent discontinuation of TECVAYLI due to adverse reactions occurred in 6% of patients. Adverse reactions leading to discontinuation of TECVAYLI in more than one patient were pneumonia (1.1%), diarrhea (0.7%), fatigue (0.7%), second primary malignancy (0.7%), upper respiratory tract infection (0.7%) and cough (0.7%). Dosage interruptions of TECVAYLI due to an adverse reaction occurred in 94% of patients. Adverse reactions which required dosage interruption of TECVAYLI in ≥5% of patients included neutropenia (53%), upper respiratory tract infection (48%), COVID-19 (34%), pneumonia (34%), thrombocytopenia (14%), cytokine release syndrome (13%), gastroenteritis (10%), cough (10%), pyrexia (8%), diarrhea (7%), sepsis (6%) and fatigue (5%). The most common adverse reactions (≥20%) were hypogammaglobulinemia, upper respiratory tract infection, cytokine release syndrome, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells and decreased platelets. Table 12 summarizes the adverse reactions in MajesTEC-3. Table 12: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3 Adverse Reaction TECVAYLI with daratumumab and hyaluronidase-fihj (N=283) DPd or DVd (N=290) Any Grade (%) Grade 3 or 4 (%) Any Grade (%) Grade 3 or 4 (%) DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Adverse reactions were graded according to NCI-CTCAE Version 5.0, with the exception of ICANS and CRS, which were graded by ASTCT 2019 consensus grading system; adverse reactions that were considered symptoms of CRS or ICANS were not included. Immune system disorders Hypogammaglobulinemia Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 400 mg/dL following treatment with TECVAYLI. 84 6 60 1.4 Cytokine release syndrome 60 0 0 0 Infections Upper respiratory tract infection Upper respiratory tract infection includes bronchitis, bronchiolitis, pharyngitis, rhinitis, sinusitis, sinobronchitis, tracheitis, and tracheobronchitis and other related terms. 79 17 62 13 COVID-19 Includes other related terms. 45 6 33 2.1 Pneumonia Pneumonia includes atypical pneumonia, bacterial pneumonia, fungal pneumonia, viral pneumonia, and other related terms. Includes the following fatal adverse reactions: Tec-Dara: Pneumonia (n=1); DPd/DVd: Pneumonia (n=2). 42 33 35 28 Gastroenteritis 20 4.9 8 0.7 Urinary tract infection 17 2.8 13 1 Herpes virus infection 11 2.1 6 0.3 Respiratory, thoracic and mediastinal disorders Cough 53 0.7 24 0 Dyspnea 13 1.8 20 2.1 Gastrointestinal disorders Diarrhea 52 3.9 31 2.4 Nausea 23 0 12 0.3 Vomiting 17 0 7 0 Abdominal pain 16 0.7 13 0 Constipation 14 0 20 0.3 Musculoskeletal and connective tissue disorders Musculoskeletal pain 50 1.4 47 4.5 General disorders and administration site conditions Injection site reaction Includes injection site reactions related to teclistamab, daratumumab and hyaluronidase-fihj, or bortezomib. 41 0 4.5 0 Fatigue 39 3.9 40 4.1 Pyrexia 37 1.4 19 0.3 Edema 13 0.4 22 0.3 Nervous system disorders Headache 26 1.4 12 0.3 Sensory neuropathy Sensory neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, paraesthesia, neuralgia, peripheral neuropathy, polyneuropathy, sciatica and other related terms. 17 0.7 25 0.3 Motor dysfunction Motor dysfunction includes balance disorder, dysarthria, dysphonia, gait disturbance, muscle contracture, muscle spasms, muscle spasticity, muscle twitching, muscular weakness, myopathy, peripheral motor neuropathy, tremor and other related terms. 14 0 30 1 Investigations Weight decreased 20 2.8 7 1.4 Metabolism and nutrition disorders Decreased appetite 19 1.1 7 0 Cardiac disorders Cardiac arrhythmia 11 1.1 8 2.1 Neoplasms Second primary malignancy 11 4.6 9 4.8 Vascular disorders Hypertension 11 4.6 6 2.4 Clinically relevant adverse reactions in <10% of patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj included sepsis, encephalopathy, CMV infection, febrile neutropenia and ICANS. Table 13 summarizes laboratory abnormalities in MajesTEC-3. Table 13: Select Laboratory Abnormalities (≥30%) that Worsened from Baseline in Patients with Multiple Myeloma who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3 Laboratory Abnormality TECVAYLI with daratumumab and hyaluronidase-fihj (N=283) DPd or DVd (N=290) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Percentages calculated with the number of subjects with a baseline and at least one post-treatment value for each lab test as denominator. Laboratory toxicity grades are derived based on NCI CTCAE Version 5.0. The denominator used to calculate the incidence varied from 137 to 282 in Tec-Dara and 135 to 289 in DPd/DVd based on the number of patients with a baseline value and at least one post-treatment value. Hematology Lymphocyte Count Decreased 99 95 93 64 White Blood Cell Decreased 94 60 96 74 Neutrophil Count Decreased 91 78 94 84 Platelet Count Decreased 73 21 72 25 Hemoglobin Decreased 64 17 61 19 Chemistry Alanine Aminotransferase Increased 60 5 33 2.4 Aspartate Aminotransferase Increased 55 3.9 22 1.7 Potassium Decreased 52 15 35 8 GGT Increased 51 5 24 0 Sodium Decreased 46 10 37 6 Lipase Increased 49 18 21 4.7 Serum Amylase Increased 31 7 13 0 Monotherapy The safety of TECVAYLI monotherapy (N=165) in patients with relapsed or refractory multiple myeloma was evaluated in MajesTEC-1 [see Clinical Studies (14.1) ] . Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg, subcutaneously once weekly. Among patients who received TECVAYLI, 47% were exposed for 6 months or longer and 7% were exposed for one year or longer. The median age of patients who received TECVAYLI was 64 years (range: 33 to 84 years); 58% were male; 81% were White, 13% were Black or African American, and 2% were Asian. Serious adverse reactions occurred in 54% of patients who received TECVAYLI. Serious adverse reactions in >2% of patients included pneumonia (15%), cytokine release syndrome (8%), sepsis (6%), general physical health deterioration (6%), COVID-19 (6%), acute kidney injury (4.8%), pyrexia (4.8%), musculoskeletal pain (2.4%), and encephalopathy (2.4%). Fatal adverse reactions occurred in 5% of patients who received TECVAYLI, including COVID-19 (1.8%), pneumonia (1.8%), septic shock (0.6%), acute renal failure (0.6%), and hemoperitoneum (0.6%). Permanent discontinuation of TECVAYLI due to adverse reactions occurred in 1.2% of patients. Adverse reactions resulting in permanent discontinuation of TECVAYLI included pneumonia (adenoviral and pneumocystis jirovecii pneumonia in the same patient) and hypercalcemia. Dosage interruptions of TECVAYLI due to an adverse reaction occurred in 73% of patients. Adverse reactions which required dosage interruption in >5% of patients included neutropenia, pneumonia, pyrexia, cytokine release syndrome, upper respiratory tract infection, and COVID-19. The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. Table 14 summarizes the adverse reactions in MajesTEC-1. Table 14: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received TECVAYLI in MajesTEC-1 Adverse Reactions TECVAYLI (N=165) Any Grade (%) Grade 3 or 4 (%) Adverse reactions were graded based on NCI-CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria. General disorders and administration site conditions Pyrexia 76 3 Only grade 3 adverse reactions occurred. Injection site reaction Includes other related terms. 37 0.6 Fatigue 33 2.4 Chills 16 0 Pain 15 1.8 Edema 13 0 Immune system disorders Cytokine release syndrome 72 0.6 Hypogammaglobulinemia Hypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia. 11 1.2 Musculoskeletal and connective tissue disorders Musculoskeletal pain 44 4.2 Bone pain 16 3 Infections Upper respiratory tract infection Upper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tracheitis and other related terms. 26 2.4 Pneumonia Pneumonia includes bacterial pneumonia, viral pneumonia, and other related terms. Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3). 24 15 Urinary tract infection 11 5 Gastrointestinal disorders Nausea 25 0.6 Diarrhea 21 2.4 Constipation 18 0 Vomiting 12 0.6 Nervous system disorders Headache 25 0.6 Motor dysfunction Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and VI th nerve paralysis. 16 0 Sensory neuropathy Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis. 15 1.2 Encephalopathy Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence. 13 0 Vascular disorders Hypotension 18 1.2 Hemorrhage 12 1.8 Hypertension 12 4.8 Respiratory, thoracic, and mediastinal disorders Hypoxia 18 1.8 Cough 15 0 Cardiac disorders Cardiac arrhythmia 16 1.8 Metabolism and nutrition disorders Decreased appetite 11 0.6 Renal and urinary disorders Acute kidney injury 11 3.6 Clinically relevant adverse reactions in <10% of patients who received TECVAYLI included febrile neutropenia, sepsis, ICANS, seizure, Guillain-Barré syndrome, hepatic failure, and new onset or reactivated viral infections (including adenovirus, hepatitis B virus (HBV), cytomegalovirus (CMV), varicella zoster virus (VZV), herpes simplex virus (HSV), and progressive multifocal leukoencephalopathy (PML). Table 15 summarizes laboratory abnormalities in MajesTEC-1. Table 15: Select Laboratory Abnormalities (≥30%) That Worsened from Baseline in TECVAYLI Treated Patients with Multiple Myeloma in MajesTEC-1 Laboratory Abnormality TECVAYLI (N=165 The denominator used to calculate the rate varied from 164 to 165 based on the number of patients with a baseline value and at least one post-treatment value. ) All Grades (%) Grade 3 or 4 (%) Laboratory toxicity grades are derived based on NCI CTCAE Version 4.03. Hematology Lymphocyte count decreased 92 84 White blood cell decreased 86 41 Neutrophil count decreased 84 56 Platelet count decreased 71 22 Hemoglobin decreased 67 33 Chemistry Albumin decreased 68 6 Alkaline phosphatase increased 42 2.4 Phosphorus decreased 38 13 Gamma-glutamyl transferase increased 37 8 Sodium decreased 35 10 Aspartate aminotransferase increased 34 1.2 Calcium (corrected) decreased 31 1.2 Creatinine increased 30 3

<table width="95%"><caption>Table 12: Adverse Reactions (&#x2265;10%) in Patients with Multiple Myeloma Who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3</caption><col width="40%" align="left" valign="middle"/><col width="15%" align="center" valign="middle"/><col width="15%" align="center" valign="middle"/><col width="15%" align="center" valign="middle"/><col width="15%" align="center" valign="middle"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2">Adverse Reaction</th><th styleCode="Rrule" valign="top" colspan="2">TECVAYLI with daratumumab and hyaluronidase-fihj (N=283)</th><th styleCode="Rrule" valign="top" colspan="2">DPd or DVd (N=290)</th></tr><tr><th styleCode="Rrule" align="center">Any Grade (%)</th><th styleCode="Rrule" align="center">Grade 3 or 4 (%)</th><th styleCode="Rrule" align="center">Any Grade (%)</th><th styleCode="Rrule" align="center">Grade 3 or 4 (%)</th></tr></thead><tfoot><tr><td colspan="5" align="left">DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone.</td></tr><tr><td colspan="5" align="left">Adverse reactions were graded according to NCI-CTCAE Version 5.0, with the exception of ICANS and CRS, which were graded by ASTCT 2019 consensus grading system; adverse reactions that were considered symptoms of CRS or ICANS were not included.</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Immune system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypogammaglobulinemia<footnote>Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 400 mg/dL following treatment with TECVAYLI.</footnote></td><td styleCode="Rrule">84</td><td styleCode="Rrule">6 </td><td styleCode="Rrule">60</td><td styleCode="Rrule">1.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cytokine release syndrome</td><td styleCode="Rrule">60</td><td styleCode="Rrule">0</td><td styleCode="Rrule">0</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Infections</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Upper respiratory tract infection<footnote>Upper respiratory tract infection includes bronchitis, bronchiolitis, pharyngitis, rhinitis, sinusitis, sinobronchitis, tracheitis, and tracheobronchitis and other related terms.</footnote></td><td styleCode="Rrule">79</td><td styleCode="Rrule">17</td><td styleCode="Rrule">62</td><td styleCode="Rrule">13</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> COVID-19<footnote ID="t12f1">Includes other related terms.</footnote></td><td styleCode="Rrule">45</td><td styleCode="Rrule">6</td><td styleCode="Rrule">33</td><td styleCode="Rrule">2.1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pneumonia<footnote>Pneumonia includes atypical pneumonia, bacterial pneumonia, fungal pneumonia, viral pneumonia, and other related terms.</footnote><footnote>Includes the following fatal adverse reactions: Tec-Dara: Pneumonia (n=1); DPd/DVd: Pneumonia (n=2).</footnote></td><td styleCode="Rrule">42</td><td styleCode="Rrule">33</td><td styleCode="Rrule">35</td><td styleCode="Rrule">28</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Gastroenteritis<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">20</td><td styleCode="Rrule">4.9</td><td styleCode="Rrule">8</td><td styleCode="Rrule">0.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Urinary tract infection<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">17</td><td styleCode="Rrule">2.8</td><td styleCode="Rrule">13</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Herpes virus infection<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">2.1</td><td styleCode="Rrule">6</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cough<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">53</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">24</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Dyspnea<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">13</td><td styleCode="Rrule">1.8</td><td styleCode="Rrule">20</td><td styleCode="Rrule">2.1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Gastrointestinal disorders </content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Diarrhea<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">52</td><td styleCode="Rrule">3.9</td><td styleCode="Rrule">31</td><td styleCode="Rrule">2.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">23</td><td styleCode="Rrule">0</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">17</td><td styleCode="Rrule">0</td><td styleCode="Rrule">7</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Abdominal pain<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">16</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Constipation</td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td><td styleCode="Rrule">20</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Musculoskeletal pain<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">50</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">47</td><td styleCode="Rrule">4.5</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">General disorders and administration site conditions</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Injection site reaction<footnoteRef IDREF="t12f1"/><footnote>Includes injection site reactions related to teclistamab, daratumumab and hyaluronidase-fihj, or bortezomib.</footnote></td><td styleCode="Rrule">41</td><td styleCode="Rrule">0</td><td styleCode="Rrule">4.5</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">39</td><td styleCode="Rrule">3.9</td><td styleCode="Rrule">40</td><td styleCode="Rrule">4.1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pyrexia</td><td styleCode="Rrule">37</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">19</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Edema<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">13</td><td styleCode="Rrule">0.4</td><td styleCode="Rrule">22</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Nervous system disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">26</td><td styleCode="Rrule">1.4</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Sensory neuropathy<footnote>Sensory neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, paraesthesia, neuralgia, peripheral neuropathy, polyneuropathy, sciatica and other related terms.</footnote></td><td styleCode="Rrule">17</td><td styleCode="Rrule">0.7</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0.3</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Motor dysfunction<footnote>Motor dysfunction includes balance disorder, dysarthria, dysphonia, gait disturbance, muscle contracture, muscle spasms, muscle spasticity, muscle twitching, muscular weakness, myopathy, peripheral motor neuropathy, tremor and other related terms.</footnote></td><td styleCode="Rrule">14</td><td styleCode="Rrule">0</td><td styleCode="Rrule">30</td><td styleCode="Rrule">1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Investigations</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Weight decreased</td><td styleCode="Rrule">20</td><td styleCode="Rrule">2.8</td><td styleCode="Rrule">7</td><td styleCode="Rrule">1.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Metabolism and nutrition disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">19</td><td styleCode="Rrule">1.1</td><td styleCode="Rrule">7</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Cardiac disorders</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cardiac arrhythmia<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">1.1</td><td styleCode="Rrule">8</td><td styleCode="Rrule">2.1</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Neoplasms</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Second primary malignancy<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">4.6</td><td styleCode="Rrule">9</td><td styleCode="Rrule">4.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Vascular disorders</content></td></tr><tr><td styleCode="Lrule Rrule"> Hypertension<footnoteRef IDREF="t12f1"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">4.6</td><td styleCode="Rrule">6</td><td styleCode="Rrule">2.4</td></tr></tbody></table>

<table width="95%"><caption>Table 13: Select Laboratory Abnormalities (&#x2265;30%) that Worsened from Baseline in Patients with Multiple Myeloma who Received TECVAYLI in Combination with Daratumumab and Hyaluronidase-fihj in MajesTEC-3</caption><col width="40%" align="left" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><col width="15%" align="center" valign="bottom"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2">Laboratory Abnormality</th><th styleCode="Rrule" colspan="2">TECVAYLI with daratumumab and hyaluronidase-fihj (N=283)</th><th styleCode="Rrule" colspan="2">DPd or DVd (N=290)</th></tr><tr><th styleCode="Rrule" align="center">All Grades (%)</th><th styleCode="Rrule" align="center">Grade 3 or 4 (%)</th><th styleCode="Rrule" align="center">All Grades (%)</th><th styleCode="Rrule" align="center">Grade 3 or 4 (%)</th></tr></thead><tfoot><tr><td colspan="5" align="left">DPd = daratumumab and hyaluronidase-fihj, pomalidomide, dexamethasone; DVd = daratumumab and hyaluronidase-fihj, bortezomib, dexamethasone. Percentages calculated with the number of subjects with a baseline and at least one post-treatment value for each lab test as denominator. Laboratory toxicity grades are derived based on NCI CTCAE Version 5.0.</td></tr><tr><td colspan="5" align="left">The denominator used to calculate the incidence varied from 137 to 282 in Tec-Dara and 135 to 289 in DPd/DVd based on the number of patients with a baseline value and at least one post-treatment value.</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Hematology</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Lymphocyte Count Decreased</td><td styleCode="Rrule">99</td><td styleCode="Rrule">95</td><td styleCode="Rrule">93</td><td styleCode="Rrule">64</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> White Blood Cell Decreased</td><td styleCode="Rrule">94</td><td styleCode="Rrule">60</td><td styleCode="Rrule">96</td><td styleCode="Rrule">74</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Neutrophil Count Decreased</td><td styleCode="Rrule">91</td><td styleCode="Rrule">78</td><td styleCode="Rrule">94</td><td styleCode="Rrule">84</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Platelet Count Decreased</td><td styleCode="Rrule">73</td><td styleCode="Rrule">21</td><td styleCode="Rrule">72</td><td styleCode="Rrule">25</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hemoglobin Decreased</td><td styleCode="Rrule">64</td><td styleCode="Rrule">17</td><td styleCode="Rrule">61</td><td styleCode="Rrule">19</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5"><content styleCode="bold">Chemistry</content></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Alanine Aminotransferase Increased</td><td styleCode="Rrule">60</td><td styleCode="Rrule">5</td><td styleCode="Rrule">33</td><td styleCode="Rrule">2.4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Aspartate Aminotransferase Increased</td><td styleCode="Rrule">55</td><td styleCode="Rrule">3.9</td><td styleCode="Rrule">22</td><td styleCode="Rrule">1.7</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Potassium Decreased</td><td styleCode="Rrule">52</td><td styleCode="Rrule">15</td><td styleCode="Rrule">35</td><td styleCode="Rrule">8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> GGT Increased</td><td styleCode="Rrule">51</td><td styleCode="Rrule">5</td><td styleCode="Rrule">24</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Sodium Decreased</td><td styleCode="Rrule">46</td><td styleCode="Rrule">10</td><td styleCode="Rrule">37</td><td styleCode="Rrule">6</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Lipase Increased</td><td styleCode="Rrule">49</td><td styleCode="Rrule">18</td><td styleCode="Rrule">21</td><td styleCode="Rrule">4.7</td></tr><tr><td styleCode="Lrule Rrule"> Serum Amylase Increased</td><td styleCode="Rrule">31</td><td styleCode="Rrule">7</td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr></tbody></table>

<table width="95%"><caption>Table 14: Adverse Reactions (&#x2265;10%) in Patients with Multiple Myeloma Who Received TECVAYLI in MajesTEC-1</caption><col width="50%" align="left" valign="bottom"/><col width="25%" align="center" valign="bottom"/><col width="25%" align="center" valign="bottom"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" rowspan="2">Adverse Reactions</th><th styleCode="Rrule" colspan="2">TECVAYLI (N=165)</th></tr><tr><th styleCode="Rrule" align="center">Any Grade (%)</th><th styleCode="Rrule" align="center">Grade 3 or 4 (%)</th></tr></thead><tfoot><tr><td colspan="3" align="left">Adverse reactions were graded based on NCI-CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">General disorders and administration site conditions</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pyrexia</td><td styleCode="Rrule">76</td><td styleCode="Rrule">3<footnote ID="t14f1">Only grade 3 adverse reactions occurred.</footnote></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Injection site reaction<footnote ID="t14f2">Includes other related terms.</footnote></td><td styleCode="Rrule">37</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Fatigue<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">33</td><td styleCode="Rrule">2.4<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Chills</td><td styleCode="Rrule">16</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pain<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">15</td><td styleCode="Rrule">1.8<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Edema<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Immune system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cytokine release syndrome</td><td styleCode="Rrule">72</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypogammaglobulinemia<footnote>Hypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia.</footnote></td><td styleCode="Rrule">11</td><td styleCode="Rrule">1.2<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Musculoskeletal pain<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">44</td><td styleCode="Rrule">4.2<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Bone pain</td><td styleCode="Rrule">16</td><td styleCode="Rrule">3<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Infections</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Upper respiratory tract infection<footnote>Upper respiratory tract infection includes bronchitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, tracheitis and other related terms.</footnote></td><td styleCode="Rrule">26</td><td styleCode="Rrule">2.4<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Pneumonia<footnote>Pneumonia includes bacterial pneumonia, viral pneumonia, and other related terms.</footnote><footnote ID="t14f3">Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3).</footnote></td><td styleCode="Rrule">24</td><td styleCode="Rrule">15</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Urinary tract infection<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">5<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Nausea</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Diarrhea</td><td styleCode="Rrule">21</td><td styleCode="Rrule">2.4<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Constipation</td><td styleCode="Rrule">18</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Vomiting</td><td styleCode="Rrule">12</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Nervous system disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Headache</td><td styleCode="Rrule">25</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Motor dysfunction<footnote>Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and VI^th nerve paralysis.</footnote></td><td styleCode="Rrule">16</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Sensory neuropathy<footnote>Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis.</footnote></td><td styleCode="Rrule">15</td><td styleCode="Rrule">1.2<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Encephalopathy<footnote>Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence.</footnote></td><td styleCode="Rrule">13</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Vascular disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypotension</td><td styleCode="Rrule">18</td><td styleCode="Rrule">1.2<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hemorrhage<footnoteRef IDREF="t14f2"/><footnoteRef IDREF="t14f3"/></td><td styleCode="Rrule">12</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypertension<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">12</td><td styleCode="Rrule">4.8<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Respiratory, thoracic, and mediastinal disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Hypoxia</td><td styleCode="Rrule">18</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cough<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">15</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Cardiac disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Cardiac arrhythmia<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">16</td><td styleCode="Rrule">1.8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Metabolism and nutrition disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"> Decreased appetite</td><td styleCode="Rrule">11</td><td styleCode="Rrule">0.6<footnoteRef IDREF="t14f1"/></td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule"><content styleCode="bold">Renal and urinary disorders</content></td><td styleCode="Rrule"/><td styleCode="Rrule"/></tr><tr><td styleCode="Lrule Rrule"> Acute kidney injury<footnoteRef IDREF="t14f2"/></td><td styleCode="Rrule">11</td><td styleCode="Rrule">3.6</td></tr></tbody></table>