Tecvayli
Teclistamab-cqyv · Injection · Subcutaneous
Uses
1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 ).
Dosage and administration
For subcutaneous injection only. ( 2.1 ) Patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitored daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule. ( 2.1 ) See Full Prescribing Information for the recommended dosage for TECVAYLI monotherapy and combination therapy. ( 2.2 , 2.3 ) Administer pretreatment medications as recommended. ( 2.3 ) Refer to Tables 8, 9, 10, and 11 to determine the total dose, injection volume, and number of vials based on the patient's body weight. ( 2.6 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.6 ) 2.1 Important Dosage and Administration Information TECVAYLI is for subcutaneous injection only. Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Tables 1 and 2 [see Dosage and Administration (2.3) ] . Administer TECVAYLI subcutaneously according to the step-up dosing schedule in Tables 1 and 2 to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Instruct patients to remain within proximity of a healthcare facility and monitor them daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1 , 5.2) ] . Refer to Tables 8, 9, 10, and 11 to determine the dosage based on predetermined weight ranges [see Dosage and Administration (2.6) ] . 2.2 Recommended TECVAYLI Dosage In Combination with Daratumumab and Hyaluronidase-fihj The recommended dosing schedule for TECVAYLI in combination with subcutaneous daratumumab and hyaluronidase-fihj is provided in Table 1. TECVAYLI should be administered until disease progression or unacceptable toxicity. Table 1: TECVAYLI Dosage Schedule in Combination with Daratumumab and Hyaluronidase-fihj Dosing schedule Week/Day TECVAYLI Dosage See Table 3 for recommendations on restarting TECVAYLI after dose delays. Concomitant Therapy Day 0 N/A Daratumumab and hyaluronidase-fihj Step-up dosing schedule The Step-up dosing schedule is a component of the recommended TECVAYLI dosage but is not applicable for the daratumumab and hyaluronidase-fihj dosing. Day 1 Step-up dose 1 (0.06 mg/kg) Step-up dose 1 must be administered 20 hours or more after the daratumumab and hyaluronidase-fihj dose. N/A Day 3 Step-up dose 2 (0.3 mg/kg) Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and if adverse reactions occur, step-up dose 2 may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. N/A Day 7 First treatment dose (1.5 mg/kg) First treatment dose (1.5 mg/kg) may be given between 2 to 4 days after step-up dose 2 and if adverse reactions occur, first full treatment dose may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions. , Administer TECVAYLI at least 3 hours after the daratumumab and hyaluronidase-fihj dose for the first treatment dose. For subsequent doses, administer TECVAYLI at least 15 minutes after the daratumumab and hyaluronidase-fihj dose. Daratumumab and hyaluronidase-fihj Weekly dosing schedule Weeks 2 to 8 1.5 mg/kg once weekly , Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses. Daratumumab and hyaluronidase-fihj once weekly Biweekly (every two weeks) dosing schedule Weeks 9 to 24 3 mg/kg every two weeks , Maintain a minimum of 12 days between 3 mg/kg every two weeks doses. Daratumumab and hyaluronidase-fihj every two weeks Every four weeks dosing schedule Week 25 onwards 3 mg/kg every four weeks , Maintain a minimum of 25 days between 3 mg/kg every four weeks doses. Daratumumab and hyaluronidase-fihj every four weeks For dosage and administration instructions for daratumumab and hyaluronidase-fihj, see Clinical Studies (14.1) and refer to daratumumab and hyaluronidase-fihj monotherapy Prescribing Information. Monotherapy The recommended dosing schedule for TECVAYLI monotherapy is provided in Table 2. TECVAYLI should be administered until disease progression or unacceptable toxicity. Table 2: TECVAYLI Dosage Schedule for Monotherapy Dosing schedule Day Dosage All Patients Step-up dosing schedule See Table 3 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.4) ] . Day 1 Step-up dose 1 0.06 mg/kg Day 4 Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. Step-up dose 2 0.3 mg/kg Day 7 First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions. First treatment dose 1.5 mg/kg Weekly dosing schedule One week after first treatment dose and once weekly thereafter Maintain a minimum of 5 days between 1.5 mg/kg once weekly doses Subsequent treatment doses 1.5 mg/kg once weekly Patients who have achieved and maintained a complete response or better for a minimum of 6 months Biweekly (every two weeks) dosing schedule The dosing frequency may be decreased to 1.5 mg/kg every two weeks. Maintain a minimum of 12 days between 1.5 mg/kg every two week doses 2.3 Recommended Pretreatment Medications Administer the following pretreatment medications 1 to 3 hours before each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose (see Tables 1 and 2 ), to reduce the risk of CRS [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .
Dosage forms and strengths
Injection 30 mg/3 mL (10 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial. 153 mg/1.7 mL (90 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial. Injection 30 mg/3 mL (10 mg/mL) in a single-dose vial ( 3 ) 153 mg/1.7 mL (90 mg/mL) in a single-dose vial ( 3 )
Contraindications
None. None. ( 4 )
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) ] .
Side effects
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.
Drug interactions
7 DRUG INTERACTIONS TECVAYLI causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of certain cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates, which may increase the risk of adverse reactions of the CYP substrates. The highest risk of drug-drug interaction is expected to occur after initiation of TECVAYLI step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS [see Warnings and Precautions (5.1) ] . Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate as needed. Certain CYP Substrates : Monitor for toxicity and/or concentrations of CYP substrates where minimal increases in concentration may lead to serious adverse reactions. Consider decreasing the dosage of the concomitant CYP substrate, as needed ( 7 ).
Use in specific populations
Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TECVAYLI in pregnant patients to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to TECVAYLI are unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with TECVAYLI and for 5 months after the last dose. 8.3 Females and Males of Reproductive Potential TECVAYLI may cause fetal harm when administered to a pregnant patient [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating TECVAYLI. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of TECVAYLI. 8.4 Pediatric Use The safety and efficacy of TECVAYLI have not been established in pediatric patients. 8.5 Geriatric Use Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness. Of the 291 patients with relapsed or refractory multiple myeloma treated with TECVAYLI at the recommended dosage in combination with daratumumab and hyaluronidase-fihj in MajesTEC-3, 51% were younger than 65 years of age, 39% were 65 to 74 years of age, and 11% were 75 years of age or older. No overall differences in effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in effectiveness compared to younger patients. There was a higher incidence of serious adverse reactions in patients 75 years of age or older (83%) and in patients 65 to 74 years of age (77%) as compared to patients younger than 65 years of age (63%).
Pregnancy
8.1 Pregnancy Risk Summary Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient [see Clinical Pharmacology (12.1) ] . There are no available data on the use of TECVAYLI in pregnant patients to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Pediatric use
8.4 Pediatric Use The safety and efficacy of TECVAYLI have not been established in pediatric patients.
Geriatric use
8.5 Geriatric Use Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness. Of the 291 patients with relapsed or refractory multiple myeloma treated with TECVAYLI at the recommended dosage in combination with daratumumab and hyaluronidase-fihj in MajesTEC-3, 51% were younger than 65 years of age, 39% were 65 to 74 years of age, and 11% were 75 years of age or older. No overall differences in effectiveness were observed between patients 65 to 74 years of age compared to younger patients. The study did not include a sufficient number of patients 75 years of age or older to assess whether there are differences in effectiveness compared to younger patients. There was a higher incidence of serious adverse reactions in patients 75 years of age or older (83%) and in patients 65 to 74 years of age (77%) as compared to patients younger than 65 years of age (63%).
Description
Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody. Teclistamab-cqyv is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. Teclistamab-cqyv consists of an anti-BCMA heavy chain and light chain and an anti-CD3 heavy chain and light chain with two interchain disulfide bonds connecting the two arms. The molecular weight of teclistamab-cqyv is approximately 146 kDa. TECVAYLI ® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied in a single-dose vial for subcutaneous administration. Each TECVAYLI 3 mL single-dose vial contains 30 mg of teclistamab-cqyv, edetate disodium (0.054 mg), glacial acetic acid (0.72 mg), polysorbate 20 (1.2 mg), sodium acetate (2.7 mg), sucrose (240 mg), and Water for Injection, USP. Each TECVAYLI 1.7 mL single-dose vial contains 153 mg of teclistamab-cqyv, edetate disodium (0.031 mg), glacial acetic acid (0.41 mg), polysorbate 20 (0.68 mg), sodium acetate (1.5 mg), sucrose (140 mg), and Water for Injection, USP.
Mechanism of action
12.1 Mechanism of Action Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro , teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING TECVAYLI ® (teclistamab-cqyv) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied as follows: One 30 mg/3 mL (10 mg/mL) single-dose vial in a carton: NDC: 57894-449-01 One 153 mg/1.7 mL (90 mg/mL) single-dose vial in a carton: NDC: 57894-450-01 Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze.
Storage
Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze.
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of both step-up dose 1 and step-up dose 2. Advise patients to remain within proximity of a healthcare facility and that they will be monitored daily for 48 hours after the first treatment dose within the TECVAYLI step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ]. Neurologic Toxicity including ICANS Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, confusion, dysgraphia, decreased level of consciousness, aphasia, apraxia, somnolence, disorientation, motor dysfunction, neuropathy, or encephalopathy. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity, including ICANS. 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, including ICANS symptoms until neurologic toxicity resolves [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ]. TECVAYLI and TALVEY REMS TECVAYLI is available only through a restricted program called TECVAYLI and TALVEY REMS. Inform patients that they will be given a Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3) ]. Hepatotoxicity Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.4) ]. Infections Discuss the signs and symptoms of infection [see Dosage and Administration (2.5) and Warnings and Precautions (5.5) ] . Neutropenia Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5) and Warnings and Precautions (5.6) ] . Hypersensitivity and Other Administration Reactions Advise patients to immediately seek medical attention for any signs and symptoms of systemic administration-related reactions. Advise patients that local injection-site reactions may occur and to report any severe reactions [see Warnings and Precautions (5.7) ]. Embryo-Fetal Toxicity Advise pregnant patients and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise women not to breastfeed during treatment with TECVAYLI and for 5 months after the last dose [see Use in Specific Populations (8.2) ] .
Label text from the FDA structured product label by Janssen Biotech, Inc. (revised Mar 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Teclistamab in 2 products
Tecvayli NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 57894-449 | Teclistamab 10 mg/mL Injection | Janssen Biotech, Inc. | BLA |
| 57894-450 | Teclistamab 90 mg/mL Injection | Janssen Biotech, Inc. | BLA |
Frequently asked questions
What is Tecvayli used for?
1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy,…
What are the side effects of Tecvayli?
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… See the full label for the complete list.
Who makes Tecvayli?
Tecvayli is listed by 1 labeler in the FDA NDC directory, including Janssen Biotech, Inc..