{
 "query": "teclistamab",
 "ingredient": "teclistamab",
 "slug": "teclistamab",
 "rxcui": "2619426",
 "brands": [],
 "names": [
  "teclistamab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "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...",
  "indications_and_usage": "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 ).",
  "contraindications": "None. None. ( 4 )",
  "warnings_and_cautions": "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 reacti...",
  "warnings": "",
  "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 (\u226520%) 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 (\u226520%) 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 (\u226520%) with TECVAYLI (as monother...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Boxed Warnings 8/2025 Indications and Usage ( 1 ) 3/2026 Dosage and Administration ( 2.1 , 2.2 , 2.4 , 2.5 , 2.6 ) 3/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 3/2026",
  "information_for_patients": "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, ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: Mar 2026 MEDICATION GUIDE TECVAYLI \u00ae [tek vay lee] (teclistamab-cqyv) injection, for subcutaneous use What is the most important information I should know about TECVAYLI? TECVAYLI can cause side effects that are serious, life-threatening or cause death, including cytokine release syndrome (CRS) and neurologic problems. Cytokine Release Syndrome (CRS). Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever (100.4 \u00b0F or higher) difficulty breathing chills dizziness or lightheadedness fast heartbeat feeling anxious confusion or restlessness headache increased liver enzymes in your blood. See \" What are the possible side effects of TECVAYLI? \" for information about the signs and symptoms of liver problems. Due to the risk of CRS, you will receive TECVAYLI on a \"step-up dosing\" schedule. You should be hospitalized for 48 hours after the first and second step-up doses and should stay close to a healthcare facility and be monitored by a healthcare provider for 48 hours after you receive your first treatment dose. During the step-up ...",
  "clinical_studies": "14.1 Relapsed or Refractory Multiple Myeloma In Combination with Daratumumab and Hyaluronidase - fihj The efficacy of TECVAYLI in combination with subcutaneous daratumumab and hyaluronidase-fihj compared with investigator's choice of either daratumumab and hyaluronidase-fihj, pomalidomide and dexamethasone (DPd) or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) was evaluated in adult patients with relapsed or refractory multiple myeloma in a randomized, open-label, multi-center study (MajesTEC-3) (NCT05083169). The study included patients who had previously received one to three prior lines of therapy including a proteasome inhibitor and lenalidomide. Patients who had received only one prior line of therapy must have been refractory to lenalidomide. Patients who had disease refractory to a prior anti-CD38 monoclonal antibody therapy, or who had received any prior BCMA-directed therapy were excluded. Patients received TECVAYLI in combination with daratumumab and hyaluronidase-fihj as follows: Subcutaneous TECVAYLI step-up doses of 0.06 mg/kg and 0.3 mg/kg, followed by TECVAYLI 1.5 mg/kg once weekly from Weeks 2 to 8, then 3 mg/kg every two weeks from Weeks 9 ...",
  "brand_name": "TECVAYLI",
  "manufacturer": "Janssen Biotech, Inc.",
  "application_number": "BLA761291",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260310",
  "set_id": "54e0f974-ccee-44ea-9254-40e9883cee1e",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": true
 },
 "faers": {
  "total": 1511,
  "serious": 1375,
  "death": 332,
  "hospitalization": 638,
  "primary_suspect": 1510,
  "top_reactions": [
   [
    "Cytokine Release Syndrome",
    328
   ],
   [
    "Immune Effector Cell-Associated Neurotoxicity Syndrome",
    130
   ],
   [
    "Plasma Cell Myeloma",
    122
   ],
   [
    "Pneumonia",
    115
   ],
   [
    "Covid-19",
    104
   ],
   [
    "Pyrexia",
    103
   ],
   [
    "Drug Ineffective",
    97
   ],
   [
    "Infection",
    74
   ],
   [
    "Neutropenia",
    67
   ],
   [
    "Off Label Use",
    61
   ],
   [
    "Sepsis",
    55
   ],
   [
    "Death",
    53
   ],
   [
    "Febrile Neutropenia",
    51
   ],
   [
    "Hypogammaglobulinaemia",
    46
   ],
   [
    "Anaemia",
    42
   ]
  ],
  "by_year": {
   "2020": 1,
   "2021": 5,
   "2022": 173,
   "2023": 636,
   "2024": 254,
   "2025": 316,
   "2026": 126
  },
  "by_year_primary": {
   "2020": 1,
   "2021": 5,
   "2022": 173,
   "2023": 636,
   "2024": 254,
   "2025": 315,
   "2026": 126
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 72,
  "completed": 2,
  "terminated": 2,
  "with_results": 0,
  "industry": 46,
  "phase3": 13,
  "results_share": 0.0,
  "terminated_share": 0.027777777777777776
 },
 "pubmed": {
  "rct": 4,
  "meta": 4,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "teclistamab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 59,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death appears in 2.4x the share of reports seen across all of FAERS (-11)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 27,
   "letter": "F",
   "why": [
    "4 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 61,
 "grade": "D",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, plasma cell myeloma, pneumonia. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}