talquetamab (Rx)

Brand and Other Names:Talvey, talquetamab-tgvs

Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and talquetamab

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                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)

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                  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%)
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                  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
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                  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.

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                  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
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                  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
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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

                  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.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.