Dosing & Uses
Dosage Forms & Strengths
injectable solution for SC
- 2mg/mL (1.5-mL single-dose vial)
- 40mg/mL (single-dose vial)
- Ready-to-use SC solution
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
Hospitalize for 48 hr after all doses within step-up dosing schedule
All doses based on actual body weight (ABW)
Weekly dosing schedule
-
Step-up dosing schedule
- Day 1 (step-up dose #1): 0.01 mg/kg SC x 1 dose
- Day 4 (step-up dose #2): 0.06 mg/kg SC x 1 dose
- Day 7 (first treatment dose): 0.4 mg/kg SC x 1 dose
- Step-up dose #2 and first treatment dose: May be administered between 2 and 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions
-
Second treatment dose and thereafter
- 1 week after first treatment dose and weekly thereafter (subsequent treatment doses): 0.4 mg/kg SC qWeek
- May maintain minimum of 6 days between weekly doses
- Continue until disease progression or unacceptable toxicity
Biweekly dosing schedule
-
Step-up dosing schedule
- Day 1 (step-up dose #1): 0.01 mg/kg SC x 1 dose
- Day 4 (step-up dose #2): 0.06 mg/kg SC x 1 dose
- Day 7 (step-up dose #3): 0.4 mg/kg SC x 1 dose
- Day 10 (first treatment dose): 0.8 mg/kg SC x 1 dose
- Step-up doses #2 and #3: May be administered between 2 and 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions
- Step-up dose #3: May be administered between 2-7 days
-
Second treatment dose and thereafter
- 2 weeks after first treatment dose and q2Weeks thereafter (subsequent treatment doses): 0.8 mg/kg SC q2Weeks
- May maintain minimum of 12 days between biweekly doses
- Continue until disease progression or unacceptable toxicity
Dosage Modifications
Restarting after dose delay (weekly dosing schedule)
- Premedicate before restarting therapy
- After resumption, resume weekly dosing schedule accordingly
-
0.01 mg/kg (last dose administered)
- >7 days elapsed from last dose: Restart step-up dosing schedule at 0.01 mg/kg (step-up dose #1)
0.06 mg/kg (last dose administered)
- 8-28 days elapsed from last dose: Repeat 0.06 mg/kg (step-up dose #2), and continue step-dosing schedule
- >28 days: Restart step-up dosing schedule at 0.01 mg/kg (step-up dose #1)
-
0.4 mg/kg (last dose administered)
- 8-28 days elapsed from last dose: Continue dosing schedule with 0.4 mg/kg weekly (treatment dose)
- 29-56 days: Repeat 0.06 mg/kg (step-up dose #2) and continue step-dosing schedule
- >56 days: Consider permanent discontinuation; if restarting, begin with step-up dosing schedule at 0.01 mg/kg (step-up #1 dose)
Restarting after dose delay (biweekly-dosing schedule)
- Premedicate before restarting therapy
- After resumption, resume biweekly dosing schedule accordingly
-
0.01 mg/kg (last dose administered)
- >7 days elapsed from last dose: Restart step-up dosing schedule at 0.01 mg/kg (step-up dose #1)
-
0.06 mg/kg (last dose administered)
- 8-28 days elapsed from last dose: Repeat 0.06 mg/kg (step-up dose #2), and continue step-dosing schedule
- >28 days: Restart step-up dosing schedule at 0.01 mg/kg (step-up dose #1)
-
0.4 mg/kg (last dose administered)
- 8-28 days elapsed from last dose: Repeat 0.4 mg/kg (step-up dose #3), and continue step-dosing schedule
- 29-56 days: Repeat 0.06 mg/kg (step-up dose #2), and continue step-dosing schedule
- >56 days: Consider permanent discontinuation; if restarting, begin with step-up dosing schedule at 0.01 mg/kg (step-up dose #1)
-
0.8 mg/kg (last dose administered)
- 15-28 days elapsed from last dose: Continue dosing schedule with 0.8 mg/kg q2Weeks (treatment dose)
- 29-56 days: Restart step-up dosing schedule at 0.4 mg/kg (step-up dose #3)
- >56 days: Consider permanent discontinuation; if restarting, begin with step-up dosing schedule at 0.01 mg/kg (step-up #1 dose)
Cytokine release syndrome (CRS)
- 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, and pulmonary, cardiac, renal, and hepatic function
- Following the above recommendations for restarting therapy after dose delays
-
Grade 1
- Defined as temperature ≥100.4ºF (38ºC)
- Withhold until CRS resolves
- Premedicate before next dose
-
Grade 2
- Defined as temperature ≥100.4ºF (38ºC) with hypotension responsive to fluids and not requiring vasopressors OR requiring oxygen via low-flow nasal cannula or blow-by
- Withhold until CRS resolves
- Premedicate before next dose
- Hospitalize patient for 48 hr following next dose
-
Grade 3 (duration <48 hr)
- Defined as temperature ≥100.4ºF (38ºC) with hypotension requiring one vasopressor with or without vasopressin OR requiring oxygen via low-flow nasal cannula, non-rebreather mask, or Venturi mask
- Withhold until CRS resolves
- Provide supportive therapy, which may include intensive care
- Premedicate before next dose
- Hospitalize patient for 48 hr following next dose
-
Recurrent grade 3 or duration ≥48 hr
- Defined as temperature ≥100.4ºF (38ºC) with hypotension requiring one vasopressor with or without vasopressin OR requiring oxygen via low-flow nasal cannula, non-rebreather mask, or Venturi mask
- Permanently discontinue
- Provide supportive therapy, which may include intensive care
-
Grade 4
- Defined as temperature ≥100.4ºF (38ºC) with hypotension requiring one vasopressor with or without vasopressin OR requiring oxygen via 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 (including ICANS)
- Rule out other causes of neurologic symptoms
- Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities, including immune effector cell–associated neurotoxicity syndrome (ICANS)
- Following the above recommendations for restarting therapy after dose delays
-
Grade 1
- ICE score 7-9 OR depressed level of consciousness (awakens spontaneously and not attributable to other causes)
- Withhold until ICANS resolves
- Monitor neurologic symptoms, and consider further evaluation and management from specialists (eg, neurologist)
- Consider nonsedating antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
-
Grade 2
- ICE score 3-6 OR depressed level of consciousness (awakens to voice and not attributable to other causes)
- Withhold until ICANS resolves
- Administer dexamethasone 10 mg IV q6hr; continue until resolution to Grade ≤1, then taper
- Monitor neurologic symptoms, and consider further evaluation and management from specialists (eg, neurologist)
- Consider nonsedating antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- Hospitalize patient for 48 hr following next dose
-
Grade 3 (first occurrence)
- ICE score 1-2, OR
- Depressed level of consciousness (awakens to voice and not attributable to other causes), OR
- Seizures (any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures on electroencephalogram [EEG] that resolve with intervention), OR
- Raised intracranial pressure: focal/local edema on neuroimaging
- If ICE score is 0, but patient is arousable (eg, awake with global aphasia) and able to perform assessment
- Withhold until ICANS resolves
- Administer dexamethasone 10 mg IV q6hr; continue until resolution to Grade ≤1, then taper
- Monitor neurologic symptoms, and consider further evaluation and management from specialists (eg, neurologist)
- Consider nonsedating antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- Provide supportive therapy, which may include intensive care
- Hospitalize patient for 48 hr following next dose
-
Recurrent Grade 3
- Permanently discontinue
- Administer dexamethasone 10 mg IV q6hr; continue until resolution to Grade ≤1, then taper
- Monitor neurologic symptoms, and consider further evaluation and management from specialists (eg, neurologist)
- Consider nonsedating antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- Provide supportive therapy, which may include intensive care
-
Grade 4
- ICE score 0 (patient is unarousable and unable to perform ICE assessment), OR
- Depressed level of consciousness (patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse; stupor or coma), OR
- Seizures (life-threatening prolonged seizure (>5 min); 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, decerebrate or decorticate posturing, cranial nerve VI palsy, papilledema, or Cushing’s triad
- Permanently discontinue
- Administer dexamethasone 10 mg IV q6hr; continue until resolution to Grade ≤1, then taper
- Alternatively, consider methylprednisolone 1000 mg/day IV and continue for ≥2 days
- Monitor neurologic symptoms, and consider further evaluation and management from specialists (eg, neurologist)
- Consider nonsedating antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
- Provide supportive therapy, which may include intensive care
Neurologic toxicity (excluding ICANS)
- Following the above recommendations for restarting therapy after dose delays
- Grade 1: Withhold until resolves or stabilizes
- Grade 2 OR first occurrence of Grade 3: Withhold until symptoms improve to Grade ≤1; provide supportive therapy
- Grade 4 or recurrent Grade 3: Permanently discontinue; provide supportive therapy
Oral toxicity and weight loss
- Grade 1-2: Provide supportive care; consider withholding if unresponsive to supportive care
- Grade 3: Withhold until resolution to Grade ≤1, and provide supportive care
- Grade 4: Permanently discontinue
Infections
- All grades: Withhold in step-up phase until infection resolves
- Grade 3: Withhold during treatment phase until infection resolves to Grade ≤1 within 28 days
- Grade 4: Consider permanent discontinuation; if drug is not permanently discontinued, withhold subsequent treatment doses (ie, doses administered after step-up dosing schedule) until adverse reaction improves to Grade ≤1
- For Grade 3 or 4, if drug is withheld for >28 days, restart step-up dosing when infection improves to Grade ≤1
Hematologic toxicities
- Absolute neutrophil count (ANC) <0.5 × 109/L: Withhold until ANC ≥0.5 × 109/L
- Febrile neutropenia: Withhold until ANC ≥1 × 109/L and fever resolves
- Hemoglobin <8 g/dL: Withhold until hemoglobin ≥8 g/dL
- Platelet count <25,000/mcL or 25,000-50,000/mcL with bleeding: Withhold until platelet count ≥25,000/mcL and no evidence of bleeding
Skin reactions
- Grade 3-4: Withhold until adverse reaction improves to Grade 1 or baseline
Other nonhematologic adverse reactions
- Grade 3: Withhold until adverse reaction improves to Grade 1 or baseline
- Grade 4: Consider permanent discontinuation; 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 (CrCl 30-89 mL/min): No dosage adjustment necessary
- Severe (CrCl <30 mL/min): Pharmacokinetics are unknown
Hepatic impairment
- Mild or moderate (total bilirubin ≤3x ULN and any AST): No dosage adjustment necessary
- Severe (total bilirubin >3x and any AST): Pharmacokinetics are unknown
Dosing Considerations
Verify pregnancy status of females of reproductive potential before initiating
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- etrasimod
etrasimod, talquetamab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod. .
Monitor Closely (47)
- alfentanil
talquetamab will increase the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- alosetron
talquetamab will increase the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- bendamustine
talquetamab will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- carbamazepine
talquetamab will increase the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clomipramine
talquetamab will increase the level or effect of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clonidine
talquetamab will increase the level or effect of clonidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clozapine
talquetamab will increase the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- colchicine
talquetamab will increase the level or effect of colchicine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- cyclosporine
talquetamab will increase the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- dihydroergotamine
talquetamab will increase the level or effect of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- disopyramide
talquetamab will increase the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- divalproex sodium
talquetamab will increase the level or effect of divalproex sodium by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- duloxetine
talquetamab will increase the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ergotamine
talquetamab will increase the level or effect of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ethosuximide
talquetamab will increase the level or effect of ethosuximide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- everolimus
talquetamab will increase the level or effect of everolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl
talquetamab will increase the level or effect of fentanyl by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl iontophoretic transdermal system
talquetamab will increase the level or effect of fentanyl iontophoretic transdermal system by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl transdermal
talquetamab will increase the level or effect of fentanyl transdermal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fluvoxamine
talquetamab will increase the level or effect of fluvoxamine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fosphenytoin
talquetamab will increase the level or effect of fosphenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- mexiletine
talquetamab will increase the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- midazolam
talquetamab will increase the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- olanzapine
talquetamab will increase the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pacritinib
talquetamab will increase the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- phenobarbital
talquetamab will increase the level or effect of phenobarbital by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- phenytoin
talquetamab will increase the level or effect of phenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pimozide
talquetamab will increase the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pirfenidone
talquetamab will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pomalidomide
talquetamab will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- primidone
talquetamab will increase the level or effect of primidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- quinidine
talquetamab will increase the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- quinine
talquetamab will increase the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ramelteon
talquetamab will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- rasagiline
talquetamab will increase the level or effect of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- repaglinide
talquetamab will increase the level or effect of repaglinide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- riluzole
talquetamab will increase the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ropinirole
talquetamab will increase the level or effect of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- sirolimus
talquetamab will increase the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tacrolimus
talquetamab will increase the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tasimelteon
talquetamab will increase the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- theophylline
talquetamab will increase the level or effect of theophylline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
talquetamab will increase the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS. - thioridazine
talquetamab will increase the level or effect of thioridazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tizanidine
talquetamab will increase the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- triazolam
talquetamab will increase the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- valproic acid
talquetamab will increase the level or effect of valproic acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- warfarin
talquetamab will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Talquetamab causes cytokine release syndrome (CRS) that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates. This is more likely to occur from initiation of talquetamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
Minor (0)
Adverse Effects
>10%
Any grade
- Lymphocyte count decreased (90%)
- Pyrexia (83%)
- Cytokine release syndrome (CRS) (76%)
- White blood cell (WBC) count decreased (73%)
- Dysgeusia (70%)
- Hemoglobin decreased (67%)
- Albumin decreased (66%)
- Neutrophil count decreased (64%)
- Platelet count decreased (62%)
- Nail disorder (50%)
- Alkaline phosphatase (ALP) increased (49%)
- Phosphate decreased (44%)
- Musculoskeletal pain (43%)
- Skin disorder (41%)
- Rash (38%)
- Gamma-glutamyl transferase (GGT) increased (38%)
- Fatigue (37%)
- Weight decreased (35%)
- Dry mouth (34%)
- ALT increased (33%)
- AST increased (31%)
- Potassium decreased (31%)
- Sodium decreased (31%)
- Xerosis (30%)
- Dysphagia (23%)
- Upper respiratory tract infection (22%)
- Diarrhea (21%)
- Hypotension (21%)
- Headache (21%)
- Chills (19%)
- Pruritus (19%)
- Bacterial infection including sepsis (19%)
- Decreased appetite (19%)
- Pain (18%)
- Stomatitis (18%)
- Nausea (18%)
- Cough (17%)
- Constipation (16%)
- Encephalopathy (15%)
- Edema (14%)
- Sensory neuropathy (14%)
- Injection site reaction (13%)
- Oral disorder (12%)
- COVID-19 (11%)
- Dyspnea (11%)
- Tachycardia (11%)
Grade 3 or 4
- Lymphocyte count decreased (80%)
- WBC count decreased (35%)
- Neutrophil count decreased (35%)
- Hemoglobin decreased (30%)
- Platelet count decreased (22%)
- Phosphate decreased (13%)
1-10%
Immune effector cell-associated neurotoxicity syndrome (ICANS) (<10%)
Viral infection (<10%)
All grades
- Fungal infection (10%)
- Motor dysfunction (10%)
- Hypoxia (10%)
Grade 3 or 4
- Bacterial infection including sepsis (9%)
- GGT increased (7%)
- Sodium decreased (6%)
- Pyrexia (4.7%)
- Potassium decreased (4.4%)
- Fatigue (3.5%)
- Rash (3.5%)
- AST increased (3.3%)
- Musculoskeletal pain (3.2%)
- Hypotension (2.9%)
- Upper respiratory tract infection (2.7%)
- COVID-19 (2.7%)
- ALT increased (2.7%)
- Albumin decreased (2.1%)
- Pain (1.8%)
- Encephalopathy (1.8%)
- Dyspnea (1.8%)
- CRS (1.5%)
- Weight decreased (1.5%)
- ALP increased (1.5%)
- Hypoxia (1.5%)
- Stomatitis (1.2%)
- Decreased appetite (1.2%)
<1%
Grade 3 or 4
- Dysphagia (0.9%)
- Diarrhea (0.9%)
- Fungal infection (0.6%)
- Headache (0.6%)
- Motor dysfunction (0.6%)
- Tachycardia (0.6%)
- Skin disorder (0.3%)
- Pruritus (0.3%)
Warnings
Black Box Warnings
Cytokine release syndrome (CRS)
- CRS reported, including life-threatening or fatal reactions
- Initiate with step-up dosing to reduce risk of CRS
- If CRS occurs, withhold talquetamab until resolved or permanently discontinue based on severity
Neurologic toxicity
- Neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur
- Monitor for signs and symptoms of neurologic toxicity including ICANS during treatment, and treat promptly
- Withhold or permanently discontinue talquetamab on the basis of severity
REMS
- Owing to risk of CRS and neurologic toxicity, drug is available only through a restricted program called the TALVEY Risk Evaluation and Mitigation Strategy (REMS) or by telephone at 1-855-810-8064
-
REMS requirements
- Prescribers must be certified with the program by enrolling and completing training
- Prescribers must counsel patients receiving talquetamab about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with patient wallet card
- Pharmacies and healthcare settings that dispense talquetamab must be certified with the TALVEY REMS program and must verify that prescribers are certified through the TALVEY REMS program
- Wholesalers and distributers must distribute drug only to certified pharmacies
Contraindication
None
Cautions
Drug available only through restricted REMS program
On the basis of its mechanism of action, drug may cause fetal harm when administered to pregnant females
Cytokine release syndrome (CRS)
- Can cause CRS, including life-threatening or fatal reactions (see Dosing and Black Box Warnings for step-wise dosing and premedication)
- Clinical signs and symptoms include, but are not limited to, pyrexia, hypotension, chills, hypoxia, headache, and tachycardia
- Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC)
- Counsel patients to seek medical attention should signs or symptoms of CRS occur
- At the first sign of CRS, immediately evaluate patient for hospitalization; institute treatment with supportive care based on severity, and consider further management per current practice guidelines
Neurologic toxicity
- Can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS)
- The most frequent neurologic toxicities were headache, encephalopathy, sensory neuropathy, and motor dysfunction
- ICANS onset can be concurrent with CRS, following resolution of CRS, or in the absence of CRS
- Clinical signs and symptoms of ICANS may include, but are not limited to, confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia
- Monitor for signs and symptoms of neurologic toxicity during treatment
- At first sign, including ICANS, immediately evaluate patient and provide supportive care based on severity; withhold or permanently discontinue drug on the basis of severity, and consider further management per current practice guidelines
-
Driving or operating machinery
- Owing to potential neurologic toxicity, patients are at risk of depressed level of consciousness
- Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hr after completion, or in the event of new onset of any neurological symptoms, until symptoms resolve
Oral toxicity and weight loss
- Oral toxicities reported, including dysgeusia, dry mouths, dysphagia, and stomatitis
- Can cause weight loss, regardless of having an oral toxicity
- Monitor for signs and symptoms of oral toxicity
- Counsel patients to seek medical attention if signs or symptoms of oral toxicity occur. and provide supportive care as per current clinical practice. including consultation with a nutritionist
- Monitor weight regularly during therapy; evaluate clinically significant weight loss further; withhold or permanently discontinue on the basis of severity
Infections
- Can cause serious infections, including life-threatening or fatal infections
- Monitor for signs and symptoms of infection before and during treatment, and treat appropriately
- Administer prophylactic antimicrobials according to local guidelines
- Withhold or consider permanent discontinuation as recommended on the basis of severity
Cytopenias
- Cytopenias reported, including neutropenia and thrombocytopenia
- Monitor complete blood cell counts during treatment, and withhold as recommended on the basis of severity
Skin toxicity
- Serious skin reactions reported, including rash, maculopapular rash, erythema, and erythematous rash
- Monitor for skin toxicity, including rash progression
- Consider early intervention and treatment to manage skin toxicity
- Withhold as recommended on the basis on severity
Hepatotoxicity
- Hepatotoxicity reported
- Liver enzyme elevation may occur with or without CRS
- Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated
- Withhold or consider permanent discontinuation on the basis of severity
Drug interaction overview
-
CYP enzyme suppression
- Monitor sensitive CYP substrates for toxicity or drug concentrations
- Talquetamab causes release of cytokines that may suppress activity of CYP enzymes, resulting in increased exposure of CYP substrates
- Increased exposure of CYP substrates is more likely to occur from initiation of step-up dosing up to 14 days after the first treatment dose and during and after CRS
Pregnancy & Lactation
Pregnancy
On the basis of its mechanism of action, drug may cause fetal harm when administered to pregnant females; verify pregnancy status of females of reproductive potential before initiating
Talquetamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
Human immunoglobulin G (IgG) is known to cross the placenta; therefore, talquetamab may potentially be transmitted from the mother to the developing fetus
There are no available data on use in pregnant females to evaluate for drug-associated risks
No animal reproductive or developmental toxicity studies have been conducted
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 3 months after last dose
Lactation
Data are not available regarding presence of talquetamab in human milk, effects on breastfed children, or effect on milk production
Maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure in breastfed children are unknown
Owing to potential for serious adverse reactions in breastfed children, do not breastfeed during treatment and for 3 months after last 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 humanized monoclonal antibody against CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen, with potential antineoplastic activity
Upon administration, talquetamab binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells, which results in cross-linking of T-cells and tumor cells, and induces a potent cytotoxic T-lymphocyte response against GPRC5D-expressing tumor cells
GPRC5D is overexpressed on certain tumors (eg, multiple myeloma), while minimally expressed on normal, healthy cells, and plays a key role in tumor cell proliferation
Absorption
Bioavailability: 59%
Trough plasma concentration
- 0.4 mg qWeek dose (at Week 16): 2,410 ng/mL
- 0.8 mg q2Weeks dose (at Week 16): 1,930 ng/mL
Peak plasma concentration
- 0.4 mg qWeek dose (at Week 16): 2,940 ng/mL
- 0.8 mg q2Weeks dose(at Week 16): 3,410 ng/mL
Average plasma concentration
- 0.4 mg qWeek dose (at Week 16): 2,730 ng/mL
- 0.8 mg q2Weeks dose (at Week 16): 2,770 ng/mL
Peak plasma time
- 0.4 mg/kg qWeek: 3.7 days (first dose); 2.5 days (17th day treatment dose)
- 0.8 mg/kg q2Weeks: 3.4 days (first dose); 3.6 days (9th treatment dose)
Distribution
Vd: 10.1 L
Metabolism
Metabolized into small peptides by catabolic pathways
Elimination
Clearance: 0.9 L/day (16 weeks after first treatment dose)
Half-life
- First treatment dose: 8.4 days
- 16 weeks after first treatment: 12.2 days
Administration
SC Compatibility
Drug is compatible with stainless-steel injection needles and polypropylene or polycarbonate syringe material
Premedication
Administer 1-3 hr before each dose in step-up dosing schedule to reduce risk of CRS
Corticosteroid (PO/IV dexamethasone, 16 mg or equivalent)
Antihistamines (PO/IV diphenhydramine, 50 mg or equivalent)
Antipyretics (PO/IV acetaminophen, 650-1,000 or equivalent)
Subsequent doses: May require premedications for patients repeating doses within the step-up dosing schedule due to dose delays OR for patients who experienced CRS
SC Preparation
Visually inspect drug products for particulate matter and discoloration before administering; solution is colorless to light yellow; discard if solution is discolored or cloudy or if foreign particles are present
Remove appropriate-strength vial(s) from refrigerator, and equilibrate 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 the vial for ~10 seconds to mix; do not shake
2 mg/mL vial and 40 mg/mL vial are supplied as ready-to-use solutions for injection; no dilution needed before administration
Do not combine vials of different concentrations to achieve treatment dose
Use aseptic technique to prepare and administer
Refer to prescribing information to determine total dose, injection volume, and number of vials required on the basis of the patient’s actual body weight
Withdraw required injection 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
Drug is compatible with stainless-steel injection needles and polypropylene or polycarbonate syringe material
Replace transfer needle with an appropriately sized needle for injection
SC Administration
SC administration only
Administer by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions (eg, CRS, ICANS)
Inject into SC tissue of abdomen (preferred injection site)
Alternative sites: SC tissue at other sites (eg, thigh)
If multiple injections are required, injections should be ≥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 medicinal product or waste material in accordance with local requirements
Storage
Unopened vial
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
- Do NOT freeze
Prepared syringe
- If not used immediately, refrigerate at 2-8ºC (36-46ºF) for up to 24 hr, then at room temperature of 15-30ºC (59-86ºF) for up to 24 hr
- Discard if stored for >24 hr refrigerated or >24 hr at room temperature
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
