Teclistamab: Drug information

For additional information see "Teclistamab: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Cytokine release syndrome:

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving teclistamab. Initiate treatment with teclistamab step-up dosing schedule to reduce risk of CRS. Withhold teclistamab until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity including immune effector cell-associated neurotoxicity syndrome:

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious and life-threatening reactions, can occur with teclistamab. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold teclistamab until neurologic toxicity resolves or permanently discontinue based on severity.

Risk Evaluation and Mitigation Strategy Program:

Because of the risk of CRS and neurologic toxicity, including ICANS, teclistamab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS.

Brand Names: US

Tecvayli

Brand Names: Canada

Tecvayli

Pharmacologic Category

Antineoplastic Agent, Anti-BCMA;
Antineoplastic Agent, Anti-CD3;
Antineoplastic Agent, Bispecific T Cell Engager;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Dosage guidance:

Safety: Due to the risk of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), patients should be hospitalized for 48 hours after all doses within the teclistamab step-up dosing schedule (step-up doses 1 and 2, as well as the first treatment dose). Premedicate with a corticosteroid (IV or oral dexamethasone 16 mg), a histamine H₁ antagonist (IV or oral diphenhydramine 50 mg or equivalent), and antipyretics (oral or IV acetaminophen 650 to 1,000 mg or equivalent) 1 to 3 hours prior to teclistamab step-up dose 1, step-up dose 2, and the first treatment dose to reduce the risk and severity of CRS. Premedication may be necessary prior to subsequent doses in patients who repeat doses within the teclistamab step-up dosing schedule (following a dose delay), or who experienced CRS following the prior teclistamab dose.

Clinical considerations: Administer prophylactic antimicrobials according to clinical practice guidelines. Consider antiviral prophylaxis prior to teclistamab initiation to prevent herpes zoster reaction, per clinical guidelines.

Multiple myeloma, relapsed or refractory

Multiple myeloma, relapsed or refractory:

Note: Dose is based on actual body weight.

Day 1 (step-up dose 1): SUBQ: 0.06 mg/kg once.

Day 4 (step-up dose 2): SUBQ: 0.3 mg/kg once. Note: Step-up dose 2 may be administered 2 to 4 days after step-up dose 1 and, if necessary, up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.

Day 7 (first treatment dose): SUBQ: 1.5 mg/kg once. Note: The first treatment dose may be administered 2 to 4 days after step-up dose 2 and, if necessary, up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.

Weekly dosing schedule: SUBQ: 1.5 mg/kg once weekly, starting 1 week after the first treatment dose and weekly thereafter; continue until disease progression or unacceptable toxicity (Ref).

Biweekly (every 2 weeks) dosing schedule (only in patients who have achieved and maintained a complete response or better for ≥6 months): SUBQ: 1.5 mg/kg once every 2 weeks; continue until disease progression or unacceptable toxicity.

**Recommendations for Restarting Teclistamab^a After Dose Delay**
Last teclistamab dose administered	Duration of delay from the last teclistamab dose administered	Action
^aPatients should be hospitalized for 48 hours after all doses within the teclistamab step-up dosing schedule.
^bAdminister premedication prior to teclistamab administration and monitor accordingly.
^cConsider risk/benefit of restarting teclistamab if a dose delay of >28 days occurs due to an adverse reaction.
Step-up dose 1	>7 days	Restart teclistamab^b step-up dosing schedule at 0.06 mg/kg (step-up dose 1).
Step-up dose 2	8 to 28 days	Repeat teclistamab^b at 0.3 mg/kg (step-up dose 2) and resume the step-up dosing schedule.
Step-up dose 2	>28 days^c	Restart teclistamab^b step-up dosing schedule at 0.06 mg/kg (step-up dose 1).
Any weekly treatment dose	≤28 days	Continue teclistamab at last treatment dose in weekly schedule (1.5 mg/kg once weekly).
	29 to 56 days^c	Restart teclistamab^b step-up dosing schedule at 0.3 mg/kg (step-up dose 2).
	>56 days^c	Restart teclistamab^b step-up dosing schedule at 0.06 mg/kg (step-up dose 1).
Any biweekly (every 2 weeks) treatment dose	≤63 days^c	Continue teclistamab at last treatment dose in biweekly schedule (1.5 mg/kg once every 2 weeks).
	64 to 112 days^c	Restart teclistamab^b step-up dosing schedule at 0.3 mg/kg (step-up dose 2).
	>112 days^c	Restart teclistamab^b step-up dosing schedule at 0.06 mg/kg (step-up dose 1).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function estimated using the modification of diet in renal disease (MDRD) equation.

eGFR 30 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in teclistamab pharmacokinetics were observed based on eGFR 30 to 89 mL/minute.

eGFR <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (effects on teclistamab pharmacokinetics are unknown).

Dosing: Liver Impairment: Adult

Liver function impairment prior to treatment initiation:

Mild impairment (total bilirubin ≤ ULN with AST > ULN or total bilirubin >1 to 1.5 times ULN with any AST): There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in teclistamab pharmacokinetics was observed based on mild hepatic impairment.

Moderate or severe impairment (total bilirubin >1.5 times ULN with any AST): There are no dosage adjustments provided in the manufacturer's labeling (effects on teclistamab pharmacokinetics are unknown).

Acute hepatotoxicity during treatment: Withhold or consider permanent teclistamab discontinuation depending on the severity.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m²experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).

Dosing: Adjustment for Toxicity: Adult

Teclistamab dose reductions are not recommended for adverse reactions; however, dose delays may be necessary to manage toxicities. May require repeat step-up dosing depending on the duration of delay.

Cytokine release syndrome: If cytokine release syndrome (CRS) is suspected, interrupt teclistamab until resolved; manage according to the table below and per clinical practice guidelines. Supportive therapy for CRS may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation, hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function. Evaluate and treat other causes of fever, hypoxia, and hypotension.

**Teclistamab-Related CRS Management**
CRS grade	Symptoms	Actions
^aFever may be masked by antipyretics or anticytokine therapy.
^b Tocilizumab may be considered in the management of persistent grade 2, severe (grade 3), or life-threatening (grade 4) CRS associated with bi-specific T-cell engager (BiTE) therapy (EMN [Ludwig 2023]; Lee 2014; Maude 2014); tocilizumab or corticosteroids were used (in the teclistamab clinical trial) to manage CRS in some patients (Martin 2023; Moreau 2022).
^c CPAP = continuous positive airway pressure; BiPAP = bilevel positive airway pressure.
Grade 1	Temperature ≥38°C (100.4°F)^aattributed to CRS.	Withhold teclistamab until CRS resolves. Administer premedication prior to the next teclistamab dose.
Grade 2	Temperature ≥38°C (100.4°F)^a attributed to CRS, with hypotension responsive to fluids and not requiring vasopressors and/or oxygen requirement of low-flow nasal cannula (≤6 L/minute) or blow-by.	Withhold teclistamab until CRS resolves. Administer premedication prior to the next teclistamab dose. Patients should be hospitalized for 48 hours following the next teclistamab dose.
Grade 3	Temperature ≥38°C (100.4°F)^a attributed to CRS, with hypotension requiring one vasopressor with or without vasopressin and/or oxygen requirement of high-flow nasal cannula (>6 L/minute), face mask, nonrebreather mask, or Venturi mask.	First occurrence of grade 3 CRS with duration <48 hours: Withhold teclistamab until CRS resolves. Provide supportive therapy^b as clinically necessary (may include intensive care). Administer premedication prior to the next teclistamab dose. Patients should be hospitalized for 48 hours following the next teclistamab dose.
Grade 3		Recurrent grade 3 CRS or grade 3 CRS with duration ≥48 hours: Permanently discontinue teclistamab and provide supportive therapy^b as clinically necessary (may include intensive care).
Grade 4	Temperature ≥38°C (100.4°F)^a attributed to CRS, with hypotension requiring multiple vasopressors (excluding vasopressin) and/or oxygen requirement of positive pressure (eg, CPAP, BiPAP, intubation, and mechanical ventilation).^c	Permanently discontinue teclistamab and provide supportive therapy^b as clinically necessary (may include intensive care).

Neurologic toxicity: Monitor for signs/symptoms of neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) and other neurotoxicities. Rule out other causes of neurologic signs/symptoms. Interrupt teclistamab at the first sign of neurologic toxicity, including ICANS, and consider neurology evaluation. Supportive therapy may include intensive care for severe or life-threatening neurologic toxicities. Manage according to the table below and per clinical practice guidelines.

**Teclistamab-Related Neurologic Toxicity Management**
Adverse reaction	Severity	Actions
^aBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.
^bManagement is determined by the most severe event (not attributable to any other cause).
^cIf patient is arousable and able to perform immune effector cell-associated encephalopathy (ICE) assessment: Orientation (oriented to year, month, city, hospital = 4 points) Naming (name 3 objects, eg, point to clock, pen, button = 3 points) Following commands (eg, “show me 2 fingers” or “close your eyes and stick out your tongue” = 1 point) Writing (ability to write a standard sentence = 1 point) Attention (count backwards from 100 by 10 = 1 point) If unarousable and unable to perform ICE assessment (grade 4 ICANS = 0 points).
^dNot attributable to any other cause.
Neurologic toxicity (excluding ICANS)	Grade 1	Withhold teclistamab until neurologic toxicities/symptoms resolve or stabilize.
	Grade 2 or grade 3 (first occurrence)	Withhold teclistamab until neurologic toxicities/symptoms improve to ≤ grade 1. Provide supportive therapy as clinically appropriate.
	Recurrent grade 3 or grade 4	Permanently discontinue teclistamab. Provide supportive therapy as clinically appropriate (may include intensive care).
Recommendations for management of teclistamab-related ICANS
ICANS grade^a	Presenting symptoms^b	Actions
Grade 1	ICE score 7 to 9^c, or depressed level of consciousness^d(awakens spontaneously)	Withhold teclistamab until ICANS resolves. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (eg, consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication).
Grade 2	ICE score 3 to 6^c, or depressed level of consciousness^d (awakens to voice)	Withhold teclistamab until ICANS resolves. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue until resolution to ≤ grade 1, then taper. Monitor neurologic symptoms and consider consultation with neurologist/other specialists for further evaluation and management (eg, consideration for initiating seizure prophylaxis with nonsedating, antiseizure medication). Patients should be hospitalized for 48 hours following the next teclistamab dose.
Grade 3	ICE score 0 to 2^c, or depressed level of consciousness^d (awakens only to tactile stimulus), or seizures^d (either any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures on EEG that resolve with intervention), or raised intracranial pressure (focal/local edema on neuroimaging^d)	First occurrence of grade 3 ICANS: Manage as per grade 2 ICANS. Provide supportive therapy as clinically appropriate (may include intensive care).
Grade 3		Recurrent grade 3 ICANS: Permanently discontinue teclistamab. Manage as per grade 2 ICANS. Provide supportive therapy as clinically appropriate (may include intensive care).
Grade 4	ICE score 0^c, or depressed level of consciousness^d (either unarousable or requires vigorous/repetitive tactile stimuli to arouse, or stupor or coma), or seizures^d (either life-threatening prolonged seizure >5 minutes, or repetitive clinical or electrical seizures without return to baseline in between), or motor findings^d (deep focal motor weakness such as hemiparesis or paraparesis), or raised intracranial pressure/cerebral edema^d, with signs/symptoms including diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing triad	Permanently discontinue teclistamab. Manage as per grade 2 ICANS. Alternatively, instead of dexamethasone, consider methylprednisolone 1,000 mg IV daily and continue methylprednisolone 1,000 mg IV daily for ≥2 days. Provide supportive therapy as clinically appropriate (may include intensive care).

**Recommended Teclistamab Dosage Modifications for Other Adverse Reactions**
Adverse reaction	Severity	Actions
Hematologic toxicity	ANC <500/mm³	Withhold teclistamab until ANC is ≥500/mm³.
	Febrile neutropenia	Withhold teclistamab until ANC is ≥1,000/mm³ and fever resolves.
	Hemoglobin <8 g/dL	Withhold teclistamab until hemoglobin is ≥8 g/dL.
	Platelets <25,000/mm³ or platelets 25,000 to 50,000/mm³ with bleeding	Withhold teclistamab until platelets are ≥25,000/mm³ and no evidence of bleeding.
Hypersensitivity reactions (systemic or local)	Withhold or consider permanently discontinuing teclistamab based on reaction severity.
Infections	Monitor immunoglobulin levels during treatment; manage according to guidelines, including infection precautions and antibiotic/antiviral prophylaxis.
	All grades	Withhold teclistamab for active infection during the step-up dosing schedule.
	Grade 3	Withhold subsequent teclistamab treatment doses (doses administered after step-up dosing schedule) until infection improves to ≤ grade 1.
	Grade 4	Consider permanent discontinuation of teclistamab. If not permanently discontinued, withhold subsequent treatment doses (doses administered after step-up dosing schedule) until infection improves to ≤ grade 1.
Other nonhematologic adverse reactions	Grade 3	Withhold teclistamab until adverse reaction improves to ≤ grade 1.
Other nonhematologic adverse reactions	Grade 4	Consider permanent discontinuation of teclistamab. If not permanently discontinued, withhold subsequent treatment doses (doses administered after step-up dosing schedule) until adverse reaction improves to ≤ grade 1.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Cardiac arrhythmia (16%), edema (13%), hypertension (12%), hypotension (18%)

Endocrine & metabolic: Decreased serum albumin (68%), decreased serum calcium (corrected: 31%), decreased serum phosphate (38%), decreased serum sodium (35%)

Gastrointestinal: Constipation (18%), decreased appetite (11%), diarrhea (21%; grade 3: 2%), nausea (25%; grade 3: <1%), vomiting (12%; grade 3: <1%)

Genitourinary: Urinary tract infection (11%)

Hematologic & oncologic: Decreased hemoglobin (67%; grades 3/4: 33%), decreased neutrophils (84%; grades 3/4: 56%), decreased platelet count (71%; grades 3/4: 22%), decreased white blood cell count (86%; grades 3/4: 41%), hemorrhage (12%; grades 3/4: 2%), hypogammaglobulinemia (11%; grade 3: 1%), lymphocytopenia (92%; grades 3/4: 84%)

Hepatic: Increased gamma-glutamyl transferase (37%), increased serum alanine aminotransferase (28%), increased serum alkaline phosphatase (42%), increased serum aspartate aminotransferase (34%)

Hypersensitivity: Cytokine release syndrome (72%)

Infection: Infection (30%; including opportunistic infection, serious infection, sepsis [6%], viral infection [<10%; including cytomegalovirus disease, herpes simplex infection, progressive multifocal leukoencephalopathy, reactivation of HBV, varicella zoster infection])

Local: Injection-site reaction (37%; including bruising at injection site, cellulitis at injection site, erythema at injection site, hematoma at injection site, induration at injection site, inflammation at injection site, injection-site pruritus, rash at injection site, swelling at injection site)

Nervous system: Chills (16%), encephalopathy (13%), fatigue (33%; including asthenia), headache (25%), motor dysfunction (16%; including abnormal gait, cogwheel rigidity, hypokinesia, muscle rigidity, muscle spasm, myasthenia, nerve palsy [sixth nerve palsy], psychomotor agitation, tremor, voice disorder), neurotoxicity (57%; including immune effector cell-associated neurotoxicity syndrome [ICANS]: 6%), pain (15%), peripheral sensory neuropathy (15%; including dysesthesia, hypoesthesia, neuralgia, oral hypoesthesia, oral paresthesia, paresthesia, sciatica)

Neuromuscular & skeletal: Musculoskeletal pain (44%), ostealgia (16%)

Renal: Acute kidney injury (11%), increased serum creatinine (30%)

Respiratory: Cough (15%), hypoxia (18%), pneumonia (24%), upper respiratory tract infection (26%)

Miscellaneous: Fever (76%)

1% to 10%:

Hematologic & oncologic: Febrile neutropenia (3%)

Hepatic: Increased serum bilirubin (6%)

<1%:

Hepatic: Hepatic failure

Nervous system: Guillain-Barré syndrome, seizure

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to teclistamab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cytokine release syndrome: Cytokine release syndrome (CRS), including fatal or life-threatening reactions, may occur with teclistamab. In the clinical trial, CRS occurred in approximately three-fourths of patients, with one-half of events being grade 1 (grade 2 and 3 events also occurred); recurrent CRS has been reported in approximately one-third of patients. Most patients experienced CRS following step-up dose 1, step-up dose 2, or the initial treatment dose. Only a small percentage of patients experienced first occurrence of CRS with subsequent teclistamab doses. The median time to onset of CRS was 2 days (range: 1 to 6 days) after the most recent dose and the median duration was 2 days (range: 1 to 9 days). Common manifestations of CRS included (but were not limited to) fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes. Patients should seek immediate medical attention if signs/symptoms of CRS occur at any time.

• Cytopenias: Teclistamab may cause neutropenia and febrile neutropenia. Neutropenia was reported in the majority of patients, with grade 3 or 4 neutropenia in over 50% of patients; febrile neutropenia occurred in some patients.

• Hepatotoxicity: Hepatotoxicity may occur with teclistamab, including fatalities. Elevated AST and ALT occurred in over one-third and one-quarter of patients, respectively, with a small percentage of grade 3 or 4 elevations; total bilirubin elevations (including grade 3 or 4 events) were also reported. Liver enzyme elevation may occur with or without concurrent CRS.

• Hypersensitivity reactions: Teclistamab may cause both systemic and local injection site–related reactions. A small number of patients experienced systemic administration reactions, which consisted of grade 1 recurrent pyrexia and grade 1 swollen tongue. Over one-third of patients developed injection-site reactions; most reactions were grade 1, with some grade 2 events.

• Infection: Teclistamab may cause severe, life-threatening, or fatal infections. Serious infections (including opportunistic infections) occurred in almost one-third of patients, with a similar percentage of grade 3 or 4 infections; fatal infection was reported in some patients.

• Neurologic toxicity: Teclistamab may cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). In a clinical trial, over 50% of patients experienced neurologic toxicity, with grade 3 or 4 events occurring in some. Headache, motor dysfunction, sensory neuropathy, and encephalopathy were the most frequently reported neurologic toxicities. Grade 4 seizure and fatal Guillain-Barre syndrome were reported with longer follow-up. ICANS was observed in some patients; most patients experienced ICANS following step-up dose 1, step-up dose 2, or the initial treatment dose. A small number of patients developed ICANS following subsequent doses. The median time to ICANS onset was 4 days (range: 2 to 8 days) with a median duration of 3 days (range: 1 to 20 days). Confusional state and dysgraphia were the most common ICANS clinical manifestations. The onset of ICANS may be concurrent with, following resolution of, or in the absence of CRS. Patients are at risk of depressed level of consciousness; advise patients to not drive or operate heavy or potentially dangerous machinery during and for 48 hours after completion of the step-up dosing schedule and with new onset of any neurologic toxicity symptoms until resolution.

Other warnings/precautions:

• REMS program: Due to the risks of CRS and neurologic toxicity, teclistamab is available only through a restricted program under the Tecvayli and Talvey REMS program. Further information about the TECVAYLI and TALVEY REMS program is available at https://www.TEC-TALREMS.com or at 1-855-810-8064.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Tecvayli: Teclistamab-cqyv 30 mg/3 mL (10 mg/mL) (3 mL); Teclistamab-cqyv 153 mg/1.7 mL (90 mg/mL) (1.7 mL) [contains edetate (edta) disodium]

Generic Equivalent Available: US

Pricing: US

Solution (Tecvayli Subcutaneous)

30 mg/3 mL (per mL): $790.18

153 mg/1.7 mL (per mL): $7,111.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Tecvayli: Teclistamab-cqyv 30 mg/3 mL (10 mg/mL) (3 mL); Teclistamab-cqyv 153 mg/1.7 mL (90 mg/mL) (1.7 mL) [contains edetate (edta) disodium]

Prescribing and Access Restrictions

Tecvayli is available through specialty distributors. Information is available at https://janssenlabels.com/package-insert/product-patient-information/TECVAYLI-specialty-flashcard.pdf.

Administration: Adult

SUBQ: Administer SUBQ into the abdomen (preferred injection site); may be administered at other sites (eg, thigh). Doses requiring >2 mL total volume should be equally divided into multiple syringes. If multiple injection sites are required, they should be at least 2 cm apart. Do not inject into tattoos, scars, or areas where the skin is red, bruised, tender, hard, or not intact. For SUBQ administration only.

Administer in a facility with adequate personnel and appropriate equipment to manage severe adverse reactions.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Tecvayli: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s003lbl.pdf#page=28

Use: Labeled Indications

Multiple myeloma, relapsed or refractory: Treatment of relapsed or refractory multiple myeloma in adults who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Medication Safety Issues

Sound-alike/look-alike issues:

Teclistamab may be confused with belantamab vedotin, epcoritamab, tafasitamab, talquetamab, tarlatamab, Tecentriq, tislelizumab, tisotumab vedotin, toripalimab, trastuzumab, tremelimumab.

Tecvayli may be confused with Talvey.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Teclistamab may increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 5 months after the last teclistamab dose.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Teclistamab is a humanized monoclonal antibody (IgG₄). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Based on the mechanism of action, in utero exposure to teclistamab may cause fetal harm. Due to risk of hypogammaglobulinemia, consider assessing immunoglobulin levels of newborns exposed to teclistamab in utero.

Breastfeeding Considerations

It is not known if teclistamab is present in breast milk.

Teclistamab is a humanized monoclonal antibody (IgG₄). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 5 months after the last dose of teclistamab.

Monitoring Parameters

Monitor blood counts, liver enzymes, and bilirubin at baseline and periodically during therapy. Monitor immunoglobulin levels during treatment. Consider laboratory testing to monitor for disseminated intravascular coagulation, as well as pulmonary, cardiac, and renal function. Verify pregnancy status prior to treatment initiation (in patients who could become pregnant).

Due to the risk for cytokine release syndrome (CRS) and neurologic toxicity, patients should be hospitalized for 48 hours after administration of teclistamab step-up doses including the first treatment dose. Monitor for CRS (signs/symptoms may include fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes) and signs/symptoms of neurologic toxicity. Monitor for signs/symptoms of infection (before and after treatment), monitor for signs of systemic or local hypersensitivity reactions.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Teclistamab is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody, and bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Teclistamab binds to the CD3 receptor on the surface of T-cells, and BCMA expressed on the surface of multiple myeloma cells, which results in T-cell activation, the release of various proinflammatory cytokines, and the lysis of BCMA-expressing multiple myeloma cells (Moreau 2022).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: 5.63 L.

Bioavailability: SUBQ: 72%.

Time to peak: 139 hours (range: 19 to 168 hours) after the first treatment dose; 72 hours (range: 24 to 168 hours) after the 13th weekly treatment dose.

Excretion: Clearance: Decreases over time; mean clearance is 0.472 L/day at the 13th weekly treatment dose.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(QA) Qatar: Tecvayli

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048 doi:10.1200/JCO.21.00471 [PubMed 33939491]
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014;124(2):188-195. doi:10.1182/blood-2014-05-552729 [PubMed 24876563]
Ludwig H, Terpos E, van de Donk N, et al. Prevention and management of adverse events during treatment with bispecific antibodies and CAR T cells in multiple myeloma: a consensus report of the European Myeloma Network. Lancet Oncol. 2023;24(6):e255-e269. doi:10.1016/S1470-2045(23)00159-6 [PubMed 37269857]
Martin TG, Mateos MV, Nooka A, et al. Detailed overview of incidence and management of cytokine release syndrome observed with teclistamab in the MajesTEC-1 study of patients with relapsed/refractory multiple myeloma. Cancer. 2023;129(13):2035-2046. doi:10.1002/cncr.34756 [PubMed 36991547]
Maude SL, Barrett D, Teachey DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014;20(2):119-122. doi:10.1097/PPO.0000000000000035 [PubMed 24667956]
Moreau P, Garfall AL, van de Donk NW, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478 [PubMed 35661166]
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]
Tecvayli (teclistamab) [prescribing information]. Horsham, PA: Janssen Biotech Inc; November 2024.
Tecvayli (teclistamab) [product monograph]. Toronto, Ontario, Canada: Janssen Inc; July 2024.

Topic 139997 Version 67.0

خرید پکیج

Teclistamab: Drug information