Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/mL ([30mg/3mL]; 3-mL single-dose vials)
- 90mg/mL ([153mcg/1.7mL]; 1.7-mL single-dose vials)
Multiple Myeloma
Indicated for relapsed or refractory multiple myeloma in adults who have received >4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
Step up dosing schedule
- Administer pretreatment medications 1-3 hr before each step-up dose to reduce risk of cytokine release syndrome (CRS)
- Day 1 (step-up dose 1): 0.06 mg/kg SC x 1 dose
- Day 4 (step-up dose 2): 0.3 mg/kg SC x 1 dose; may give 2-4 days after step-up dose 1 or up to 7 days after step-up dose 1 to allow adverse reactions to resolve
- Day 7 (first treatment dose): 1.5 mg/kg SC x 1 dose; may give 2-4 days after step-up dose 2 or up to 7 days after step-up dose 2 to allow adverse reactions to resolve
Subsequent treatment doses
- Pretreatment medications may be required prior to administration of subsequent doses for patients who repeated doses within the step-up schedule following a dose delay or who experienced CRS following prior dose
- One week after first treatment dose and weekly thereafter: 1.5 mg/kg SC once weekly
Dosage Modifications
Restarting after delaying dose
- Owing to risk of CRS and neurologic toxicity, including ICANS, hospitalize patients for 48 hr after administering of all doses within step-up dosing schedule
- Premedicate before each step-up dose and monitor patients accordingly
- Step-up dose 1 delayed >7 days: Restart step-up dosing schedule at step-up dose 1 (0.06 mg/kg)
- Step-up dose 2 delayed 8-28 days: Repeat step-up dose 2 (0.3 mg/kg) and continue step-up dosing schedule
- Step-up dose 2 delayed >28 days: Restart step-up dosing schedule at step-up dose 1 (0.06 mg/kg)
- Any treatment dose delayed 8-28 days: Continue weekly dosing schedule at treatment dose (1.5 mg/kg)
- Any treatment dose delayed >28 days: Restart step-up dosing schedule at step-up dose 1 (0.06 mg/kg)
- If restarting, administer pretreatment medications before dose
- Consider benefit-risk of restarting therapy in patients who require a dose delay >28 days due to an adverse reaction
Cytokine release syndrome (CRS)
- Identify CRS based on clinical presentation
- Evaluate and treat other causes of fever, hypoxia, and hypotension
- If CRS is suspected, withhold until CRS resolves
- Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS
- Consider monitoring for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function
- Grade 1 temperature ≥100.4°F (38°C): Withhold until CRS resolves; premedicate before next dose
-
Grade 2 temperature ≥100.4°F (38°C) with:
- Hypotension responsive to fluids and not requiring vasopressors, and/or
- Oxygen requirement of low-flow nasal cannula (low-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min) or blow-by
- Withhold until CRS resolves; premedicate before next dose
- Hospitalize patients for 48 hr following next dose
-
Grade 3 temperature ≥100.4°F (38°C) with:
- Hypotension requiring 1 vasopressor with or without vasopressin, and/or
- Oxygen requirement of high-flow nasal cannula (low-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min) , face mask, nonrebreather mask, or Venturi mask
- First occurrence of Grade 3 CRS lasting <48 hr: Withhold until CRS resolves; provide supportive therapy, which may include intensive care; premedicate before next dose
- Hospitalize patients for 48 hr following next dose
- Recurrent Grade 3 CRS or Grade 3 CRS lasting ≥48 hr: Permanently discontinue; provide supportive therapy, which may include intensive care
-
Grade 4 temperature ≥100.4°F (38°C) with
- Hypotension requiring multiple vasopressors (excluding vasopressin), and/or
- Oxygen requirement of positive pressure (eg, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation)
- Permanently discontinue; provide supportive therapy, which may include intensive care
Neurologic toxicity
- First sign of neurologic toxicity: Withhold and consider neurology evaluation; rule out other causes of neurologic symptoms
- Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities
- Grade 1: Withhold until neurologic toxicity symptoms resolve or stabilize
- Grade 2 or Grade 3 (first occurrence): Withhold until neurologic toxicity symptoms improve to Grade ≤1; provide supportive therapy
- Grade 3 (recurrent) or Grade 4: Permanently discontinue; provide supportive therapy, which may include intensive care
Immune effector cell-associated neurotoxicity syndrome (ICANS)
- Refer to prescribing information for immune effector cell-associated encephalopathy (ICE) assessment
-
Grade 1
- ICE score 7-9, or
- Depressed level of consciousness and awakens spontaneously: Withhold until ICANS resolves
- Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting nonsedating, antiseizure medicines for seizure prophylaxis
-
Grade 2
- ICE score 3-6, or
- Depressed level of consciousness and awakens to voice: Withhold until ICANS resolves
- Administer dexamethasone 10 mg IV q6hr; continue until resolution to Grade ≤1 then taper
- Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting nonsedating, antiseizure medicines for seizure prophylaxis
-
Grade 3
- ICE score 0-2 (first occurrence), or
- Depressed level of consciousness and awakens only to tactile stimulus, or
- Seizures (eg, any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures), or
- Electroencephalogram (EEG) that resolve with intervention, or
- Raised intracranial pressure: focal/local edema on neuroimaging
- Withhold until ICANS resolves; administer dexamethasone 10 mg IV q6hr; continue use until resolution to Grade ≤1 then taper
- Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting nonsedating, antiseizure medicines for seizure prophylaxis; provide supportive therapy, which may include intensive care; hospitalize patients for 48 hr following next dose
- Recurrent Grade 3 ICANS: Permanently discontinue; administer dexamethasone 10 mg IV q6hr; continue use until resolution to Grade ≤1 then taper
- Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis
- Provide supportive therapy, which may include intensive care
-
Grade 4
- ICE score 0, or
- Depressed level of consciousness: Either patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or
- Seizures, either: Life-threatening prolonged seizure (>5 minutes), or repetitive clinical or electrical seizures without return to baseline in between, or
- Motor findings: Deep focal motor weakness such as hemiparesis or paraparesis, or
- Raised intracranial pressure/cerebral edema, with signs/symptoms such as: diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing triad
- Permanently discontinue and administer dexamethasone 10 mg IV q6hr; continue use until resolution to Grade ≤1 then taper; alternatively, consider administration of methylprednisolone 1,000 mg/day IV and continue methylprednisolone 1,000 mg/day IV ≥2 days
- Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting nonsedating, antiseizure medicines for seizure prophylaxis
Infections
- All grades: Withhold in patients with active infection during step-up dosing schedule
- Grade 3: Withhold subsequent treatment doses (ie, doses administered after step-up dosing schedule) until infection improves to Grade ≤1
- Grade 4: Consider permanent discontinue; if not permanently discontinued, withhold subsequent treatment doses (ie, doses administered after step-up dosing schedule) until infection improves to Grade ≤1
Hematologic toxicities
- ANC <0.5 x 109/L: Withhold until ANC ≥0.5 x 109/L
- Febrile neutropenia: Withhold until ANC ≥1 x 109/L and fever resolves
- Hemoglobin <8 g/dL: Withhold until hemoglobin ≥8 g/dL
- Platelet count <25,000/mcL or platelet count 25,000-50,000/mcL with bleeding: Withhold until platelet count ≥25,000/mcL and no evidence of bleeding
Other Nonhematologic adverse reactions
- Grade 3: Withhold until adverse reaction improves to Grade ≤1
- Grade 4: Consider permanent discontinue
- If not permanently discontinued, withhold subsequent treatment doses (ie, doses administered after step-up dosing schedule) until adverse reaction improves to Grade ≤1
Renal impairment
- Mild or moderate (eGFR 30-89 mL/min): No dosage adjustment necessary
- Severe (eGFR <30 mL/min): Pharmacokinetics unknown
Hepatic impairment
- Mild hepatic impairment (total bilirubin ≤1.5x ULN with any AST): No dosage adjustment necessary
- Moderate or severe (total bilirubin >1.5x ULN with any AST): Pharmacokinetics unknown
Dosing Considerations
Verify pregnancy status in females of reproductive potential
Monitoring parameters
- Due to risk of CRS and neurologic toxicity, including ICANS, hospitalize patients for 48 hours after administration of all doses within step-up dosing schedule
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (29)
- alfentanil
teclistamab will increase the level or effect of alfentanil by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- carbamazepine
teclistamab will increase the level or effect of carbamazepine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- clonidine
teclistamab will increase the level or effect of clonidine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- colchicine
teclistamab will increase the level or effect of colchicine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- cyclosporine
teclistamab will increase the level or effect of cyclosporine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- dihydroergotamine
teclistamab will increase the level or effect of dihydroergotamine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- disopyramide
teclistamab will increase the level or effect of disopyramide by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- divalproex sodium
teclistamab will increase the level or effect of divalproex sodium by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- ergotamine
teclistamab will increase the level or effect of ergotamine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- ethosuximide
teclistamab will increase the level or effect of ethosuximide by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- everolimus
teclistamab will increase the level or effect of everolimus by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- fentanyl
teclistamab will increase the level or effect of fentanyl by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- fosphenytoin
teclistamab will increase the level or effect of fosphenytoin by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- midazolam
teclistamab will increase the level or effect of midazolam by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- pacritinib
teclistamab will increase the level or effect of pacritinib by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- phenobarbital
teclistamab will increase the level or effect of phenobarbital by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- phenytoin
teclistamab will increase the level or effect of phenytoin by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- pimozide
teclistamab will increase the level or effect of pimozide by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- primidone
teclistamab will increase the level or effect of primidone by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- quinidine
teclistamab will increase the level or effect of quinidine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- quinine
teclistamab will increase the level or effect of quinine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- repaglinide
teclistamab will increase the level or effect of repaglinide by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- sirolimus
teclistamab will increase the level or effect of sirolimus by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- tacrolimus
teclistamab will increase the level or effect of tacrolimus by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- theophylline
teclistamab will increase the level or effect of theophylline by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- thioridazine
teclistamab will increase the level or effect of thioridazine by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- triazolam
teclistamab will increase the level or effect of triazolam by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- valproic acid
teclistamab will increase the level or effect of valproic acid by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
- warfarin
teclistamab will increase the level or effect of warfarin by altering metabolism. Use Caution/Monitor. Teclistamab causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP substrates. Monitor for increased concentrations or toxicities of sensitive CYP substrates. Adjust dose of CYP substrate drug as needed.
Minor (0)
Adverse Effects
>10%
All grades
- Lymphocyte count decreased (92%)
- White blood cell decreased (86%)
- Neutrophil count decreased (84%)
- Pyrexia (76%)
- Cytokine release syndrome (72%)
- Platelet count decreased (71%)
- Albumin decreased (68%)
- Hemoglobin decreased (67%)
- Musculoskeletal pain (44%)
- White blood cell decreased (41%)
- Alkaline phosphatase increased (42%)
- Phosphorus decreased (38%)
- Injection site reaction (37%)
- Gamma-glutamyl transferase increased (37%)
- Sodium decreased (35%)
- Fatigue (33%)
- Calcium (corrected) decreased (31%)
- Creatinine increased (30%)
- Upper respiratory tract infection (26%)
- Headache (25%)
- Nausea (25%)
- Pneumonia (24%)
- Diarrhea (21%)
- Constipation (18%)
- Hypoxia (18%)
- Hypotension (18%)
- Chills (16%)
- Bone pain (16%)
- Motor dysfunction (16%)
- Cardiac arrhythmia (16%)
- Sensory neuropathy (15%)
- Cough (15%)
- Pain (15%)
- Edema (13%)
- Encephalopathy (13%)
- Hemorrhage (12%)
- Hypertension (12%)
- Vomiting (12%)
- Hypogammaglobulinemia (11%)
- Urinary tract infection (11%)
- Decreased appetite (11%)
- Acute kidney injury (11%)
Grade 3 or 4
- Lymphocyte count decreased (84%)
- Neutrophil count decreased (56%)
- Hemoglobin decreased (33%)
- Platelet count decreased (22%)
- Pneumonia (15%)
1-10%
Grade 3 or 4
- Sodium decreased (10%)
- Gamma-glutamyl transferase increased (8%)
- Albumin decreased (6%)
- Urinary tract infection (5%)
- Hypertension (4.8%)
- Musculoskeletal pain (4.2%)
- Acute kidney injury (3.6%)
- Pyrexia (3%)
- Bone pain (3%)
- Creatinine increased (3%)
- Fatigue (2.4%)
- Upper respiratory tract infection (2.4%)
- Diarrhea (2.4%)
- Alkaline phosphatase increased (2.4%)
- Pain (1.8%)
- Hemorrhage (1.8%)
- Hypoxia (1.8%)
- Cardiac arrhythmia (1.8%)
- Hypogammaglobulinemia (1.2%)
- Sensory neuropathy (1.2%)
- Hypotension (1.2%)
- AST increased (1.2%)
- Calcium (corrected) decreased (1.2%)
<1%
Grade 3 or 4
- Injection site reaction (0.6%)
- Cytokine release syndrome (0.6%)
- Nausea (0.6%)
- Decreased appetite (0.6%)
- Vomiting (0.6%)
- Headache (0.6%)
Warnings
BLACK BOX WARNINGS
Cytokine release syndrome
- Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur
- Initiate treatment step-up dosing schedule to reduce risk of CRS
- Withhold until CRS resolves or permanently discontinue based on severity
Neurologic toxicity
- Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening reactions, can occur
- Monitor for signs or symptoms of neurologic toxicity, including ICANS, during treatment
- Withhold until neurologic toxicity resolves or permanently discontinue based on severity
- Owing to these risks, available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Tecvayli REMS
Contraindications
None
Cautions
Hepatotoxicity, including fatalities reported; monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated
Neutropenia and febrile neutropenia reported; monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines; monitor with neutropenia for signs of infection
Based on its mechanism of action, fetal harm may occur when administered to pregnant females
Hypersensitivity
- May cause both systemic administration-related reactions and local injection-site reactions; withhold or consider permanent discontinuation of therapy based on severity
- May cause systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue
- Injection-site reactions occurred reported
CRS
- May cause CRS, including life-threatening or fatal reactions
- Median time to onset of CRS was 2 days after most recent dose with a median duration of 2 days
- Clinical signs and symptoms of CRS included fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated AST/ALT
- Initiate therapy according to step-up dosing schedule to reduce risk of CRS
- Premedicate to reduce risk of CRS and monitor following administration
- At first sign of CRS, immediately evaluate for hospitalization
- Administer supportive care based on severity and consider further management per current practice guidelines
Neurologic toxicity
- Serious or life-threatening neurologic toxicity, including ICANS may occur
- Median time to onset of ICANS was 4 days after most recent dose with a median duration of 3 days
- Reported clinical manifestations were confusional state and dysgraphia
- Onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS
- Monitor for signs and symptoms of neurologic toxicity during treatment
- At first sign of neurologic toxicity, including ICANS, immediately evaluate and provide supportive therapy based on severity
- Due to potential for neurologic toxicity, treated patients are at risk of depressed level of consciousness
- Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hr after completion of step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves
Infections
- Severe, life-threatening, or fatal infections reported
- Monitor for signs and symptoms of infection before and during treatment and treat appropriately
- Administer prophylactic antimicrobials according to guidelines
- Monitor immunoglobulin levels during treatment and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis
REMS
- Available only through a restricted program under a REMS called Tecvayli REMS
-
Notable requirements of REMS include following:
- Prescribers must be certified with program by enrolling and completing training
- Prescribers must counsel treated patients about risk of CRS and neurologic toxicity, including ICANS, and provide patients with Patient Wallet Card
- Pharmacies and healthcare settings that dispense must be certified with REMS program and must verify prescribers are certified through REMS program
- Wholesalers and distributors must only distribute to certified pharmacies or healthcare settings
- Further information about Tecvayli REMS program is available at www.TECVAYLIREMS.com or by telephone at 1-855-810-8064
Drug interaction overview
- May cause release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates
- Highest risk of drug-drug interaction is expected to occur from initiating step-up dosing schedule up to 7 days after first treatment dose and during and after CRS
- Monitor for toxicity or concentrations of CYP substrates where minimal concentration changes may lead to serious adverse reactions
- Adjust dose of concomitant CYP substrate drug as needed
Pregnancy & Lactation
Pregnancy
Based on mechanism of action, fetal harm may occur when administered to pregnant females
There are no available data on use in pregnant females
No animal reproductive or developmental toxicity studies conducted
Teclistamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab may potentially transmit from mother to developing fetus
Advise females of potential risk to fetus
Verify pregnancy status of females of reproductive potential before initiating
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 5 months after final dose
Lactation
There are no data on the presence of teclistamab in human milk, effect on breastfed children, or effects on milk production
Maternal IgG is known to be present in human milk
Advise patients not to breastfeed during treatment and for 5 months after final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Bispecific T-cell engaging antibody binds to CD3 receptor on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells
Absorption
Peak plasma concentration: 23.8 mcg/mL
Peak plasma time: 139 hr (first treatment dose); 72 hr (13th treatment dose)
Trough plasma concentration: 21.1 mcg/mL
AUC: 3,838 mcg·hr/mL
Bioavailability: 72%
Distribution
Vd: 5.63 L
Elimination
Clearance: 0.472 L/day (13th treatment dose)
Administration
SC Preparation
Visually inspect vials for particulate matter and discoloration before administering, whenever solution and container permit
Solution appears clear to slightly opalescent, colorless to light yellow solution; discard if discolored, or cloudy, or foreign particles are present
Ready-to-use vials are supplied as 30 mg/3 mL (10 mg/mL) vial and 153 mg/1.7 mL (90 mg/mL) vials that do not need dilution before administering
Refer to prescribing information for appropriate drug volumes and vials in relation to patient’s weight
Do not combine vials of different concentrations to achieve treatment dose
Use aseptic technique to prepare and administer drug
Remove appropriate strength vial from refrigerator
Once removed, equilibrate vials to ambient temperature 15-30°C (59-86°F) for at least 15 minutes; do not warm in any other way
Once equilibrated, gently swirl vial for ~10 seconds to mix; do not shake
Withdraw required drug volume from vial(s) into an appropriately sized syringe using a transfer needle
Do not exceed 2 mL for each injection
Divide doses requiring >2 mL equally into multiple syringes
Compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material
Replace transfer needle with an appropriately sized needle for SC injection
Pretreatment Medications
Administer the following pretreatment medications 1-3 hr before each step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and first treatment dose, to reduce risk of CRS
Corticosteroid (dexamethasone 16 mg PO/IV)
Histamine-1 (H1) receptor antagonist (diphenhydramine 50 mg or equivalent PO/IV)
Antipyretics (acetaminophen 650 mg to 1,000 mg or equivalent PO/IV)
Patients requiring premedications before subsequent doses include those who: H4
Repeated doses within step-up schedule following a dose delay
Experienced CRS following previous dose
Prophylaxis for herpes zoster reactivation
- Before starting treatment, consider initiating antiviral prophylaxis to prevent herpes zoster reactivation per guidelines
SC Administration
Intended for SC administration by a healthcare provider
Adequate medical personnel and appropriate medical equipment required to manage severe reactions, including CRS and ICANS
Inject required volume into SC tissue of abdomen (preferred injection site)
Alternatively, may inject SC other sites (eg, thigh) If multiple injections required, injections should be at least 2 cm apart
Do not inject into tattoos or scars or areas where skin is red, bruised, tender, hard or not intact
Discard any unused product or waste material in accordance with local requirements
Monitoring
- Owing to risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hr after administration of all doses within the step-up dosing schedule
Storage
Unopened vials
- Refrigerate at 2-8°C (36-46°F) in original carton to protect from light
- Do not freeze
Prepared syringe
- If not used immediately, store at 2-8°C (36-46°F) or at ambient temperature 15-30°C (59-86°F) for up to 20 hr
- Discard syringe(s) after 20 hr, if not used
Images
Formulary
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- View the formulary and any restrictions for each plan.
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