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 (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.
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 REMS.
Note: 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).
Premedication: Premedicate 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.
Premedication should include 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).
Prophylaxis: 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:
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 until disease progression or unacceptable toxicity (Ref).
|
Last teclistamab dose administered |
Duration of delay from the last teclistamab dose administered |
Action |
|---|---|---|
|
a Patients should be hospitalized for 48 hours after all doses within the teclistamab step-up dosing schedule. | ||
|
b Administer premedication prior to teclistamab administration and monitor accordingly. | ||
|
c Consider 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 teclistamabb step-up dosing schedule at 0.06 mg/kg (step-up dose 1). |
|
Step-up dose 2 |
8 to 28 days |
Repeat teclistamabb step-up dose 2 (0.3 mg/kg) and resume the step-up dosing schedule. |
|
>28 daysc |
Restart teclistamabb step-up dosing schedule at 0.06 mg/kg (step-up dose 1). | |
|
Any treatment dose |
8 to 28 days |
Continue teclistamab weekly dosing schedule at 1.5 mg/kg once weekly. |
|
>28 daysc |
Restart teclistamabb 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.
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).
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).
Refer to adult dosing.
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/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).
Teclistamab dose reductions are not recommended for adverse reactions; however, dose delays may be necessary to manage toxicities. Refer to "Dosing: Adult" for recommendations on restarting teclistamab (step-up doses) after dose delays.
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.
|
CRS grade |
Symptoms |
Actions |
|---|---|---|
|
a Fever may be masked by antipyretics or anticytokine therapy. | ||
|
b CPAP = continuous positive airway pressure; BiPAP = bilevel positive airway pressure. | ||
|
Grade 1 |
Temperature ≥38°C (100.4°F)a attributed 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 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. |
|
Recurrent grade 3 CRS or grade 3 CRS with duration ≥48 hours: Permanently discontinue teclistamab and provide supportive care 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).b |
Permanently discontinue teclistamab and provide supportive care 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.
|
Adverse reaction |
Severity |
Actions |
|---|---|---|
|
a Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. | ||
|
b Management is determined by the most severe event (not attributable to any other cause). | ||
|
c If patient is arousable and able to perform immune effector cell-associated encephalopathy (ICE) assessment:
If unarousable and unable to perform ICE assessment (grade 4 ICANS = 0 points). | ||
|
d Not 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 care as clinically appropriate (may include intensive care). | |
|
Recommendations for management of teclistamab-related ICANS | ||
|
ICANS gradea |
Presenting symptomsb |
Actions |
|
Grade 1 |
ICE score 7 to 9c, or depressed level of consciousnessd (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 6c, or depressed level of consciousnessd (awakens to voice) |
Withhold teclistamab until ICANS resolves. Administer dexamethasone 10 mg IV every 6 hours (or equivalent); continue dexamethasone 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 2c, or depressed level of consciousnessd (awakens only to tactile stimulus), or seizuresd (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 neuroimagingd) |
First occurrence of grade 3 ICANS: Manage as per grade 2 ICANS. Provide supportive therapy as clinically appropriate (may include intensive care). |
|
Recurrent grade 3 ICANS: Permanently discontinue teclistamab. Manage as per grade 2 ICANS. Provide supportive therapy as clinically appropriate. | ||
|
Grade 4 |
ICE score 0c, or depressed level of consciousnessd (either unarousable or requires vigorous/repetitive tactile stimuli to arouse, or stupor or coma), or seizuresd (either life-threatening prolonged seizure >5 minutes, or repetitive clinical or electrical seizures without return to baseline in between), or motor findingsd (deep focal motor weakness such as hemiparesis or paraparesis), or raised intracranial pressure/cerebral edemad, 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 with dexamethasone as per grade 2 ICANS. Alternatively, consider methylprednisolone 1,000 mg IV daily for ≥2 days. 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). Provide supportive therapy as clinically appropriate (may include intensive care). |
|
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 until infection improves to ≤ grade 1. | |
|
Grade 4 |
Consider permanent discontinuation of teclistamab. If not permanently discontinued, withhold subsequent treatment doses until infection improves to ≤ grade 1. | |
|
Other nonhematologic adverse reactions |
Grade 3 |
Withhold teclistamab until adverse reaction improves to ≤ grade 1. |
|
Grade 4 |
Consider permanent discontinuation of teclistamab. If not permanently discontinued, withhold subsequent treatment doses until adverse reaction improves to ≤ grade 1. | |
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]
No
Tecvayli is available through specialty distributors. Information is available at https://janssenlabels.com/package-insert/product-patient-information/TECVAYLI-specialty-flashcard.pdf.
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.
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.
Teclistamab may be confused with belantamab vedotin, tafasitamab, Tecentriq, tremelimumab.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
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%)
Immunologic: Cytokine release syndrome (72%)
Infection: Infection (30%, including opportunistic infection and serious infection; sepsis [6%]; viral infection [<10%; including reactivation of HBV, cytomegalovirus, varicella zoster virus, and herpes simplex virus])
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 [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-Barre syndrome, seizure
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Cytokine release syndrome: Cytokine release syndrome (CRS), including fatal or life-threatening reactions, may occur; recurrent CRS has also 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 a case of 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: Teclistamab is available only through a restricted program under a REMS called the Tecvayli REMS Program. Further information is available at www.tecvaylirems.com or 1-855-810-8064.
None known.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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
Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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.
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.
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.
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.
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).
Distribution: Vd: 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 treatment dose.
Excretion: Clearance: Decreases over time; mean clearance is 0.472 L/day at the 13th treatment dose.
Solution (Tecvayli Subcutaneous)
30 mg/3 mL (per mL): $708.00
153 mg/1.7 mL (per mL): $6,372.00
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