AHFS Class:

• Antineoplastic Agents 10:00

Generic Name(s):

• Teclistamab-cqyv

Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is an antineoplastic agent.1

Multiple Myeloma

Teclistamab-cqyv is used for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1,  2,  3,  6 Teclistamab has been designated an orphan drug by the FDA for use in multiple myeloma.4 This indication is approved under accelerated approval based on response rate.1,  6 Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.1

Clinical Experience

The current indication for teclistamab-cqyv is based principally on the results of a single-arm, open-label, multicenter phase 1/2 study (MajesTEC-1) in 165 patients with relapsed or refractory multiple myeloma.1,  2,  3,  6 Enrolled patients received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1,  2,  3,  6 Patients with stroke, seizure, or allogeneic stem cell transplant within the past 6 months were excluded, as were patients with ECOG performance score of 2 or higher, known CNS or meningeal involvement, and most autoimmune diseases.1,  2,  3,  6 Patients received subcutaneous teclistamab step-up doses of 0.06 mg/kg and 0.3 mg/kg, followed by 1.5 mg/kg treatment doses once weekly until disease progression or unacceptable toxicity.1,  2,  3,  6 The median age in the efficacy population (N = 110) was 66 years; 56% of patients were male, 91% were White, 5% were Black or African American, and 3% were Asian.1,  2,  3,  6 The median number of prior lines of therapy for multiple myeloma was 5, and 78% of patients had received at least 4 prior lines of therapy; 81% had received stem cell transplant.1,  2,  3,  6 The primary efficacy endpoint of MajesTEC-1 was overall response, defined as a partial response or better.1,  2,  3,  6 The overall response rate was 61.8%, with 28.2% of patients experiencing a complete response or better.1,  2,  3,  6 The median time to first response was 1.2 months, and 66.5% of responders had continued response at 9 months.1,  2,  3,  6

Clinical Perspective

The National Comprehensive Cancer Network (NCCN) published a focused manuscript detailing the management of relapsed/refractory multiple myeloma.8 There are a variety of treatment options available for patients with relapsed/refractory disease and choice of therapy for an individual patient is dependent upon various factors including prior treatments and duration of response.8 In general, therapeutic options for previously treated multiple myeloma include systemic therapy, autologous hematopoietic cell transplantation (for eligible patients), or enrollment in a clinical trial.8 The NCCN recommends teclistamab-cqyv as one of several preferred options (e.g., elranatamab-bcmm, talquetamab-tgvs, idecabtagene vicleucel, ciltacabtagene autoleucel) for patients with relapsed/refractory multiple myeloma after at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory drug.8

General

Pretreatment Screening

• Assess liver enzyme and serum bilirubin concentrations prior to first dose.1
• Patients must enroll in REMS program and receive counseling on risks associated with cytokine release syndrome (CRS) and neurologic toxicity (including immune effector cell-associated neurotoxicity syndrome [ICANS]).1
• Assess for signs or symptoms of infection before initiating therapy; administer prophylactic antimicrobials according to guideline recommendations.1
• Assess complete blood cell (CBC) count at baseline.1
• Verify pregnancy status of females of reproductive potential.1

Patient Monitoring

• Patients should be hospitalized and monitored for CRS and neurotoxicity (including ICANS) for 48 hours after administration of each of the first 3 doses (i.e., step-up dosing schedule) of teclistamab.1 Hospitalization for 48 hours is also required for the next dose following some adverse reactions (e.g., CRS or ICANS Grade 2 or worse) and if doses within the step-up dosing schedule are repeated due to treatment delays.1
• Monitor for signs or symptoms of neurotoxicity, including ICANS, during treatment.1
• Monitor liver enzyme and serum bilirubin concentrations as clinically indicated during treatment.1
• Monitor for signs and symptoms of infection during treatment.1
• Monitor immunoglobulin concentrations during treatment and treat abnormalities according to guidelines.1
• Monitor CBC for neutropenia periodically during treatment and provide supportive care if neutropenia develops.1
• In patients with suspected CRS, consider laboratory monitoring for disseminated intravascular coagulation, hematology parameters, and pulmonary, cardiac, renal, and hepatic function.1

Premedication and Prophylaxis

• To reduce the risk of CRS and other adverse reactions, patients should be premedicated with dexamethasone 16 mg IV or oral (or an equivalent corticosteroid), diphenhydramine 50 mg IV or oral (or an equivalent histamine-1 receptor antagonist), and acetaminophen 650 mg to 1000 mg IV or oral (or an equivalent antipyretic) 1-3 hours prior to step-up dose 1, step-up dose 2, and the first treatment dose (i.e., doses within the step-up dosing schedule).1
• Premedication may need to be repeated for subsequent doses of teclistamab in patients who repeat doses within the step-up dosing schedule due to a treatment delay and for patients who developed CRS or ICANS after a prior dose, as described in Tables 5, 6, and 8.1
• Before initiating treatment with teclistamab, consider antiviral prophylaxis according to guideline recommendations to prevent herpes zoster reactivation.1

Dispensing and Administration Precautions

• Teclistamab is available as 10 mg/mL and 90 mg/mL concentrations; exercise caution to ensure the correct concentration is selected when calculating and preparing a dose.1

REMS

• Because of the risks of CRS and neurotoxicity, including ICANS, teclistamab is only available through a restricted distribution program called the Tecvayli and Talvey REMS program.1,  5 Information on the REMS program is available by calling 1-855-810-8064 or at [Web].1

Administration

Teclistamab is administered by subcutaneous injection only.1 Teclistamab is initially administered on a step-up dosing schedule (on days 1, 4, and 7 of the first week) followed by a once weekly treatment dosing schedule.1 For patients who achieve and maintain a complete response or better for at least 6 months, the dosing frequency may be reduced to every 2 weeks.1

Teclistamab should only be administered by a healthcare provider in a setting with adequate medical personnel and equipment to manage severe reactions, including CRS and ICANS.1 Due to the risk of CRS and neurotoxicity, patients should be hospitalized for 48 hours after administration of all doses within the step-up dosing schedule, including doses within the step-up dosing schedule that are repeated due to treatment delays, and for the next dose after some adverse reactions (e.g., CRS or ICANS Grade 2 or worse).1

The preferred site for subcutaneous injection of teclistamab is the abdomen; alternatively, the drug may be injected into other subcutaneous administration sites (e.g., thigh).1 Doses exceeding 2 mL should be divided equally into multiple syringes and injected into separate sites; injection sites should be spaced at least 2 cm apart.1 Do not inject into skin that is tattooed, scarred, red, bruised, tender, hard, or damaged.1

Teclistamab-cqyv is commercially available as ready-to-use 30 mg/3 mL (10 mg/mL) and 153 mg/1.7 mL (90 mg/mL) vials that require no further dilution prior to administration.1 The manufacturer recommends using the 10 mg/mL concentration for step-up doses 1 and 2, and the 90 mg/mL concentration for all other doses.1

The different concentrations should not be combined to create a dose.1 At the time of administration, draw the required injection volume into a syringe using a transfer needle; replace the transfer needle with an appropriate needle for injection prior to administration.1 Teclistamab is compatible with stainless steel injection needles and syringes made of polypropylene or polycarbonate.1 If the prepared dose is not immediately used, it can be stored in the syringe at 2-8°C or 15-30°C for up to 20 hours; discard syringe if not used within 20 hours.1 Any unused product should be discarded.1

Store unopened teclistamab vials in the refrigerator at 2-8°C in the original carton to protect it from light.1 Do not freeze or shake.1 Prior to administration, remove teclistamab from refrigeration and allow it to reach room temperature for at least 15 minutes; do not warm by any method other than exposure to ambient temperature.1 Upon reaching ambient temperature, gently swirl the vial for 10 seconds to mix.1

Inspect the solution for particulate matter or discoloration prior to administration.1 The solution should be clear to slightly opalescent and colorless to slightly yellow; discard the solution if it contains particles or is cloudy or discolored.1

Dosage

Multiple Myeloma

The recommended dosage of teclistamab-cqyv consists of step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by treatment doses of 1.5 mg/kg, based upon the patient's actual body weight, as described in Table 1.1 Once the treatment dosage is reached, teclistamab is administered once weekly until disease progression or unacceptable toxicity.1 For patients who achieve and maintain a complete response or better for at least 6 months, the dosing frequency may be reduced to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity.1

The manufacturer recommends using the 10 mg/mL concentration for step-up doses 1 and 2, and the 90 mg/mL concentration for all other doses.1 Tables 2, 3, and 4 display the manufacturer's recommended dosage rounding and volumes based on the dose being administered (e.g., step-up or treatment dose) and the drug concentration being used.1

Dosage Modification for Toxicity

Interruption of therapy may be necessary to manage toxicities related to teclistamab; reducing the dosage is not recommended.1 Part or all of the step-up dosing schedule may need to be repeated if therapy is delayed; recommendations for restarting therapy after a dose delay are described in Table 5.1

Cytokine Release Syndrome (CRS)

Identify CRS based on clinical presentation; evaluate and treat other causes of fever, hypoxia, and hypotension.1 Fever may not always be present concurrently with hypotension or hypoxia in patients with CRS due to interventions such as antipyretics or anticytokine therapy.1 If CRS is suspected, withhold therapy with teclistamab until CRS resolves.1 Table 6 describes the manufacturer's recommendations for managing CRS; management strategies described in current practice guidelines should also be considered.1 Supportive care for CRS may include intensive care for severe or life-threatening CRS.1 In patients with suspected CRS, consider laboratory monitoring for disseminated intravascular coagulation, hematology parameters, and pulmonary, cardiac, renal, and hepatic function.1

Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Withhold teclistamab therapy and consider neurologic evaluation at the first sign of neurotoxicity, including ICANS.1 Other causes of neurologic symptoms should be ruled out.1 Supportive care may include intensive care for severe or life-threatening neurotoxicity.1 Tables 7 and 8 describe the manufacturer's recommendations for managing non-ICANS neurotoxicity and ICANS neurotoxicity, respectively; management strategies described in current practice guidelines should also be considered.1 The Immune Effector Cell-Associated Encephalopathy (ICE) assessment can be used to assess the severity of ICANS and determine appropriate treatment.1

Infections

The manufacturer's recommendations for dosage modifications due to infection are described in Table 9.1

Hematologic Toxicity

The manufacturer's recommendations for dosage modifications due to hematologic toxicity are described in Table 10.1

Other Non-Hematologic Toxicity

The manufacturer's recommendations for dosage modifications due to other non-hematologic toxicity are described in Table 11.1

Special Populations

Hepatic Impairment

The manufacturer makes no specific dosage recommendations for patients with hepatic impairment.1 Patients who develop hepatotoxicity during treatment may require dose interruption or permanent discontinuation.1

Renal Impairment

The manufacturer makes no specific dosage recommendations for patients with renal impairment.1

Geriatric Use

The manufacturer makes no specific dosage recommendations for geriatric patients.1

Obesity

Volume of distribution and clearance increase for teclistamab with increasing body weight.1 The manufacturer makes no specific dosage recommendations for patients with actual body weight greater than 160 kg.1

Contraindications

• None.1

Warnings/Precautions

Warnings

Cytokine Release Syndrome (CRS)

The prescribing information for teclistamab includes a boxed warning stating that CRS, including life-threatening or fatal CRS, can occur in patients treated with the medication.1 Follow the step-up dosing schedule and administer premedications when initiating teclistamab to reduce the risk of CRS.1

In the MajesTEC-1 study, 72% of patients receiving teclistamab at the recommended dosage developed CRS.1,  2 Grade 1 CRS occurred in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%; 33% of patients developed recurrent CRS.1,  2 Most patients developed CRS after step-up dose 1 (42%), step-up dose 2 (35%), or the first treatment dose (24%).1,  2 Fewer than 3% of patients had a first occurrence of CRS following subsequent treatment doses of teclistamab.1,  2 Onset of CRS occurred a median of 2 days (range: 1-6 days) after the most recent dose and median CRS duration was 2 days (range: 1-9 days).1,  2

Monitor for CRS following administration of teclistamab.1 Signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes.1 At the first sign of CRS, immediately evaluate the patient for hospitalization and provide supportive care based on severity and current practice guidelines.1 Withhold teclistamab until CRS resolves; permanent discontinuation may be necessary based on severity.1

Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

The prescribing information for teclistamab includes a boxed warning stating that serious, life-threatening, or fatal neurotoxicity, including ICANS, can occur in patients treated with the medication.1

In the MajesTEC-1 study, 57% of patients receiving teclistamab at the recommended dosage developed neurotoxicity; Grade 3 or 4 neurotoxicity occurred in 2.4% of patients.1,  2 The most common neurotoxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%).1,  2 Grade 4 seizure and Guillain-Barré syndrome each occurred in one patient during long-term follow-up.1,  2

In the MajesTEC-1 study, 6% of patients receiving teclistamab at the recommended dosage developed ICANS; recurrent ICANS occurred in 1.8% of patients.1,  2 Most patients developed ICANS after step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%).1,  2 Fewer than 3% of patients had a first occurrence of CRS following subsequent treatment doses of teclistamab.1,  2 Onset of ICANS occurred a median of 4 days (range: 2-8 days) after the most recent dose and median ICANS duration was 3 days (range: 1-20 days).1,  2 Confusional state and dysgraphia were the most common clinical manifestations of ICANS.1,  2 Onset of ICANS can be concurrent with CRS, after CRS resolution, or in the absence of CRS.1

Monitor for signs or symptoms of neurotoxicity, including ICANS, during treatment.1 At the first sign of neurotoxicity (including ICANS), immediately evaluate the patient and provide supportive care based on severity and current practice guidelines.1 Withhold teclistamab until neurotoxicity resolves; permanent discontinuation may be necessary based on severity.1

Patients treated with teclistamab are at risk for CNS depression due to neurotoxicity.1 Patients should refrain from driving or operating heavy or dangerous machinery during and for 48 hours after completion of the step-up dosing schedule.1 Caution is also advised in the event of any new onset neurotoxicity until symptoms of neurotoxicity resolve.1

Other Warnings/Precautions

Hepatotoxicity

Hepatotoxicity, sometimes fatal, has been reported with teclistamab.1,  2 One patient receiving the recommended dosage of teclistamab in the MajesTEC-1 study died of hepatic failure.1,  2 Elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin concentrations occurred in 34%, 28%, and 6% of patients, respectively.1 Grade 3 or 4 elevations in AST, ALT, and total bilirubin occurred in 1.2%, 1.8%, and 0.6% of patients, respectively.1 Liver enzyme elevations can occur in the presence or absence of CRS.1

Monitor liver enzymes and bilirubin before initiating teclistamab and as clinically indicated during treatment.1 Based on the severity of liver enzyme or bilirubin elevations, teclistamab may need to be withheld or permanently discontinued.1

Infections

Severe, life-threatening, and fatal infections have been reported with teclistamab.1,  2 In the MajesTEC-1 study, serious infections (including opportunistic infections) occurred in 30% of patients receiving teclistamab at the recommended dosage.1,  2 Grade 3 or 4 infections occurred in 35% of patients and 4.2% of patients died from infections.1,  2

Monitor for signs and symptoms of infection prior to initiating teclistamab and during treatment.1 Administer prophylactic antimicrobials according to guideline recommendations.1 If infection occurs during treatment, treat according to standards of care.1 Based on the severity of infection, teclistamab may need to be withheld or permanently discontinued.1

Monitor immunoglobulin concentrations during treatment and treat abnormalities according to guidelines; infection precautions and antibiotic or antiviral prophylaxis may be needed.1

Neutropenia

Teclistamab can cause neutropenia and febrile neutropenia.1,  2 In the MajesTEC-1 study, decreased neutrophil count occurred in 84% of patients receiving teclistamab at the recommended dosage.1,  2 Grade 3 or 4 neutropenia occurred in 56% of patients, and 3% of patients developed febrile neutropenia.1,  2

Monitor CBC for neutropenia at baseline and periodically during treatment.1 If neutropenia develops, provide supportive care and monitor for signs of infection.1 Teclistamab may need to be withheld based on severity of neutropenia.1

Hypersensitivity and Administration Reactions

Systemic and localized administration reactions have been reported with teclistamab.1 Teclistamab may need to be withheld or permanently discontinued based on severity of reactions.1

In the MajesTEC-1 study, systemic reactions (including Grade 1 recurrent pyrexia and Grade 1 swollen tongue) occurred in 1.2% of patients receiving teclistamab at the recommended dosage.1

In the MajesTEC-1 study, local injection-site reactions occurred in 35% of patients receiving teclistamab at the recommended dosa 30% of reactions were Grade 1 reactions and 4.8% were Grade 2.1,  2

Immunogenicity

Patients in the MajesTEC-1 study received teclistamab at various dosages for up to 27 months by subcutaneous administration.1 One patient (0.5%) developed anti-teclistamab-cqyv antibodies during treatment.1 Due to the low occurrence of anti-teclistamab-cqyv antibodies, the effects of these antibodies on the pharmacokinetics, pharmacodynamics, effectiveness, and safety of the drug are unknown.1

Fetal/Neonatal Morbidity and Mortality

Teclistamab may cause fetal harm if administered to women during pregnancy based on its mechanism of action.1 Instruct women of reproductive potential to utilize effective contraception during treatment with teclistamab and for 5 months following the final dose.1 Advise women who become pregnant during treatment with teclistamab of the potential risk to the fetus.1

Specific Populations

Pregnancy

There are inadequate data on the developmental risks associated with the use of teclistamab in pregnant females.1 Reproductive and developmental studies have not been conducted with teclistamab in animals.1

Teclistamab may cause fetal harm if administered to women during pregnancy based on its mechanism of action.1 Teclistamab causes T-cell activation and cytokine release, and immune activation may interfere with maintenance of pregnancy.1 Human IgG is able to cross the placenta, thus teclistamab has the potential to be transmitted from the mother to the developing fetus.1 Teclistamab is associated with hypogammaglobulinemia; consider assessing immunoglobulin levels in newborns of mothers treated with the drug.1

Lactation

It is not known whether teclistamab is distributed into human milk.1 The effects of the drug on the breastfed infant or milk production also are not known.1 Human IgG is excreted in human milk, though the effects of local exposure and limited systemic exposure to teclistamab by the breastfed child are unknown.1 Because of the potential for serious adverse reactions to teclistamab in nursing infants, advise patients to discontinue nursing during therapy and for 5 months after the final dose.1

Females and Males of Reproductive Potential

Teclistamab may cause fetal harm when administered to women during pregnancy.1 Verify negative pregnancy status for females of reproductive potential before initiating therapy.1 Advise women of reproductive potential to utilize effective contraception during treatment with teclistamab and for 5 months following the final dose.1

The effects of teclistamab on female or male fertility have not been studied.1

Pediatric Use

Safety and efficacy of teclistamab have not been established in pediatric patients.1

Geriatric Use

In the MajesTEC-1 study, 48% of patients were 65 years of age or older, and 15% were 75 years of age or older.1 No overall differences in efficacy or safety were observed between patients 65 to 74 years of age and younger patients; the sample of patients 75 years of age or older was insufficient to assess whether there are differences in efficacy or safety compared to younger patients.1

Hepatic Impairment

No clinically meaningful differences in the pharmacokinetics of teclistamab were observed in patients with mild hepatic impairment (total bilirubin ≤ULN with AST >ULN or total bilirubin >1 to 1.5 times the ULN with any AST) and those with normal hepatic function.1 The pharmacokinetics of teclistamab in patients with moderate to severe hepatic impairment (total bilirubin >1.5 times the ULN with any AST) have not been studied.1

Renal Impairment

No clinically meaningful differences in the pharmacokinetics of teclistamab were observed in patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] of 30 to 89 mL/minute) and those with normal renal function.1 The pharmacokinetics of teclistamab in patients with severe renal impairment (eGFR <30 mL/minute) have not been studied.1

Common Adverse Effects

The most common adverse reactions (≥20%) are pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.1

The most common Grade 3 to 4 laboratory abnormalities (≥20%) are decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.1

Formal interaction studies have not been performed with teclistamab.1 Teclistamab may increase exposure to cytochrome P-450 (CYP) substrates.1

Drugs Affected by Hepatic Microsomal Enzyme

Teclistamab causes cytokine release, which may suppress cytochrome P-450 (CYP) enzyme activity, increasing exposure to CYP substrates.1 The highest risk of this interaction is expected to occur from initiation of the step-up dosing schedule until 7 days after the first treatment dose, and during or following CRS events.1 Monitor narrow therapeutic index drugs metabolized by CYP enzymes for increased serum concentrations or signs of toxicity.1 Dosage of CYP substrates may need to be adjusted during treatment with teclistamab.1

Description

Teclistamab-cqyv, a bispecific T-cell engaging antibody, binds to the CD3 receptor expressed on the surface of T-cells and to B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.1,  2 Teclistamab is a humanized, recombinant IgG4 derivative produced in Chinese hamster ovary cells.1 The drug consists of an anti-BCMA heavy and light chain and an anti-CD3 heavy and light chain.1

Multiple myeloma is characterized by the proliferation of cancerous plasma cell clones derived from B lymphocytes.6 Plasma cell clones grow in the bone marrow and can invade adjacent bone structures; effects include disruption of bone homeostasis and hematopoiesis, fracture, bone-related pain, renal impairment, and bacterial infections.6 In vitro, teclistamab activates T-cells, causes the release of proinflammatory cytokines, and results in the lysis of multiple myeloma cells.1 Increased serum concentrations of IL-6, IL-10, and IL-2R were measured during the teclistamab step-up dosing schedule.1

The mean bioavailability of teclistamab when administered subcutaneously is 72%, and the volume of distribution is 5.63 L.1 Maximum concentrations are reached at a median of 139 hours (range: 19-168 hours) after the first treatment dose and 72 hours (range: 24-168 hours) after the thirteenth treatment dose.1 Maximum concentration and total exposure (AUC) for teclistamab increase proportionally to dosage within the range of 0.08 mg/kg to 3 mg/kg.1 After 12 weekly treatment doses of teclistamab, 90% of steady state exposure is reached.1

Metabolic and elimination pathways were not specifically studied for teclistamab;1,  6 IgG monoclonal antibodies primarily undergo intracellular catabolism and lysosomal degradation to amino acids.7 Clearance of teclistamab decreases over time, with a mean maximal reduction of 40.8% from baseline to the thirteenth treatment dose; geometric mean clearance is 0.472 L/day at the thirteenth treatment dose.1 If discontinued after the thirteenth treatment dose, a 50% reduction from peak teclistamab concentrations is expected to occur after a median of 15 days, and a 97% reduction is expected at a median of 69 days.1 Volume of distribution and clearance increase for teclistamab with increasing body weight (41 to 139 kg).1

Advice to Patients

• Discuss the signs and symptoms associated with cytokine release syndrome (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 all doses within the teclistamab step-up dosing schedule.1
• Discuss the signs and symptoms associated with neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), such as headache, confusion, dysgraphia, motor dysfunction, neuropathy, or encephalopathy. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of teclistamab step-up dosing schedule and, in the event of new onset of any neurologic toxicity symptoms, until neurologic toxicity resolves.1
• Teclistamab is available only through a restricted program called Tecvayli and Talvey REMS. Inform patients that they will be given a patient wallet card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity which, if experienced, should prompt the patient to immediately seek medical attention.1
• Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.1
• Discuss the signs and symptoms of infection.1
• Discuss the signs and symptoms associated with neutropenia and febrile neutropenia.1
• Advise patients to immediately seek medical attention for any signs and symptoms of systemic administration-related reactions. Advise patients that local injection-site reactions may occur and to report any severe reactions.1
• Advise pregnant women to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with teclistamab and for 5 months after the last dose.1
• Advise women not to breastfeed during treatment with teclistamab and for 5 months after the last dose.1
• Stress importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
• Inform patients of other important precautionary information.1

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Only references cited for selected revisions after 1984 are available electronically.

1. Janssen Biotech, Inc. Tecvayli™ (teclistamab-cqyv) injection for subcutaneous use prescribing information. Horsham, PA; 2025 Aug.

2. Moreau P, Garfall AL, van de Donk NWCJ et al. Teclistamab in relapsed or refractory multiple myeloma. New Engl J Med . 2022;387:495-505.

3. Usmani SZ, Garfall AL, van de Donk NWCJ et al. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicenter, open-label, single-arm, phase 1 study. Lancet . 2021;398:665-74.

4. US Food and Drug Administration. Search orphan drug designations and approvals. From FDA website. Accessed 2025 Feb 18. [Web]

5. Tecvayli^® (teclistamab-cqyv) risk evaluation and mitigation strategy (REMS). Accessed 2025 Feb 18. [Web]

6. Center for Drug Evaluation and Research. Teclistamab-cqyv Multidiscipline Review 761291Orig1s000. Food and Drug Administration website. [Web]

7. Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017;6:576-88.

8. Kuma SK, Callander NS, Adekola K, et al. Multiple myeloma, version 2.2024. J Natl Compr Cancer Netw . 2023;21(12):1281-1301.