Table 10: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received TECVAYLI in MajesTEC-1
Adverse Reactions	TECVAYLI (N=165)
Adverse Reactions	Any Grade (%)	Grade 3 or 4 (%)
Adverse reactions were graded based on CTCAE Version 4.03, with the exception of CRS, which was graded per ASTCT 2019 criteria.
* Only grade 3 adverse reactions occurred. † Injection site reaction includes application site erythema, injection site bruising, injection site cellulitis, injection site discomfort, injection site erythema, injection site hematoma, injection site induration, injection site inflammation, injection site edema, injection site pruritus, injection site rash, injection site reaction and injection site swelling. ‡ Fatigue includes asthenia and fatigue. § Pain includes ear pain, flank pain, groin pain, oropharyngeal pain, pain, pain in jaw, toothache and tumor pain. ¶ Edema includes face edema, fluid overload, fluid retention, edema peripheral and peripheral swelling. # Hypogammaglobulinemia includes hypogammaglobulinemia and hypoglobulinemia. Þ Musculoskeletal pain includes arthralgia, back pain, muscle discomfort, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain and pain in extremity. ß Upper respiratory tract infection includes bronchitis, influenza like illness, nasopharyngitis, pharyngitis, respiratory tract infection, respiratory tract infection bacterial, rhinitis, rhinovirus infection, sinusitis, tracheitis, upper respiratory tract infection and viral upper respiratory tract infection. à Pneumonia includes COVID-19 pneumonia, enterobacter pneumonia, lower respiratory tract infection, metapneumovirus pneumonia, pneumocystis jirovecii pneumonia, pneumonia, pneumonia adenoviral, pneumonia klebsiella, pneumonia moraxella, pneumonia pneumococcal, pneumonia pseudomonal, pneumonia respiratory syncytial viral, pneumonia staphylococcal and pneumonia viral. è Includes the following fatal adverse reactions: hemorrhage (n=1), pneumonia (n=3). ð Urinary tract infection includes cystitis, cystitis escherichia, cystitis klebsiella, escherichia urinary tract infection, urinary tract infection and urinary tract infection bacterial. ø 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. ý Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis. £ Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence. ¥ Hemorrhage includes conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemoperitoneum, hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, melena, mouth hemorrhage and subdural hematoma. Œ Hypertension includes essential hypertension and hypertension. œ Cough includes allergic cough, cough, productive cough and upper-airway cough syndrome. Ɖ Cardiac arrhythmia includes atrial flutter, cardiac arrest, sinus bradycardia, sinus tachycardia, supraventricular tachycardia, tachycardia and ventricular tachycardia. A Acute kidney injury includes acute kidney injury and renal impairment.
General disorders and administration site conditions
Pyrexia	76	3 *
Injection site reaction †	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 #	11	1.2 *
Musculoskeletal and connective tissue disorders
Musculoskeletal pain Þ	44	4.2 *
Bone pain	16	3 *
Infections
Upper respiratory tract infection ß	26	2.4 *
Pneumonia à è	24	15
Urinary tract infection ð	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 ø	16	0
Sensory neuropathy ý	15	1.2 *
Encephalopathy £	13	0
Vascular disorders
Hypotension	18	1.2 *
Hemorrhage ¥è	12	1.8
Hypertension Œ	12	4.8 *
Respiratory, thoracic, and mediastinal disorders
Hypoxia	18	1.8
Cough œ	15	0
Cardiac disorders
Cardiac arrhythmia Ɖ	16	1.8
Metabolism and nutrition disorders
Decreased appetite	11	0.6 *
Renal and urinary disorders
Acute kidney injury A	11	3.6

teclistamab

Product monograph

Family members