United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - teclistamab (unii: 54534mx6z9) (teclistamab - unii:54534mx6z9) - tecvayli is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on the mechanism of action, tecvayli may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tecvayli in pregnant women 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. 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. tecvayli may cause fetal harm when administered to a pregnant woman [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. the safety and efficacy of tecvayli have not been established in pediatric patients. 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. there is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - teclistamab, quantity: 153 mg - injection, solution - excipient ingredients: polysorbate 20; sodium acetate trihydrate; glacial acetic acid; sucrose; water for injections; disodium edetate - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Israel - English - Ministry of Health

j-c health care ltd - teclistamab - solution for injection - teclistamab 10 mg / 1 ml - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Israel - English - Ministry of Health

j-c health care ltd - teclistamab - solution for injection - teclistamab 90 mg / 1 ml - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multiple myeloma - antineoplastic agents - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Canada - English - Health Canada

janssen inc - teclistamab - solution - 30mg - teclistamab 30mg

Canada - English - Health Canada

janssen inc - teclistamab - solution - 153mg - teclistamab 153mg

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - teclistamab - injection, solution - teclistamab 10mg/ml

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - teclistamab - injection, solution - teclistamab 90mg/ml