Dosing & Uses
Dosage Forms & Strengths
injectable solution for SC
- 40mg/mL (1.1-mL or 1.9-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
Weekly dosing schedule
-
Step-up dosing schedule
- Hospitalize for 48 hr after administering first step-up dose and for 24 hr after second step-up dose
- Premedicate before each dose in step-up dosing schedule (ie, step-up dose 1, step-up dose 2, first treatment dose) as recommended
- Day 1 (step-up dose 1): 12 mg SC x 1 dose
-
Day 4 (step-up dose 2)
- 32 mg SC x 1 dose
- Maintain at least 2 days between step-up dose 1 and step-up dose 2
-
Day 8 (first treatment dose)
- 76 mg SC x 1 dose
- Maintain at least 3 days between step-up dose 2 and first treatment dose
-
Second treatment dose through Week 24
- 1 week after first treatment dose and weekly thereafter (subsequent treatment doses) through Week 24: 76 mg SC qWeek
- Maintain at least 6 days between treatment doses
-
Week 25 and thereafter (responders ONLY)
- 1 week after Week-24 dose and then q2Weeks thereafter: 76 mg SC q2Weeks
- Maintain at least 6 days between treatment doses
- Continue until disease progression or unacceptable toxicity
Dosage Modifications
Dosage reductions are not recommended
Restarting after dose delay
- Premedicate before restarting any dose
-
12 mg (last dose administered)
- ≤14 days elapsed from last dose: Restart at step-up dose 2 (32 mg); if tolerated, may increase to 76 mg 4 days later
- >14 days: Restart step-up dosing schedule at step-up dose 1 (12 mg)
-
32 mg (last dose administered)
- ≤14 days elapsed from last dose: Restart at 76 mg
- 15-28 days: Restart at step-up dose 2 (32 mg); if tolerated, may increase to 76 mg 1 week later
- >28 days: Restart step-up dosing schedule at step-up dose 1 (12 mg)
- Note: Consider benefit-risk ratio of restarting therapy in patients who require dose delay >42 days because of an adverse reaction
-
76 mg (last dose administered)
- ≤42 days elapsed from last dose: Restart at 76 mg
- 43-84 days: Restart at step-up dose 2 (32 mg); if tolerated, may increase to 76 mg 1 week later
- >84 days: Restart step-up dosing schedule at step-up dose 1 (12 mg)
Cytokine release syndrome (CRS)
- Identify CRS on the basis of clinical presentation
- Evaluate and treat other causes of fever, hypoxia, and hypotension
- Manage CRS accordingly, and consider further management per current practice guidelines
- 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
- Fever may not always be present concurrently with hypotension or hypoxia; it may be masked by antipyretics or anticytokine therapy
- Follow the above recommendations for restarting therapy after dose delays
-
Grade 1
- Defined as temperature ≥100.4°F (38°C)
- Withhold until CRS resolves
- Premedicate before next dose
-
Grade 2
- Defined as temperature ≥100.4°F (38°C) 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
- Monitor daily for 48 hr following next dose
- Instruct patient to remain within proximity of a healthcare facility, and consider hospitalization
-
Grade 3 (first occurrence)
- Defined as temperature ≥100.4°F (38°C) with hypotension requiring one vasopressor with or without vasopressin OR requiring oxygen via high-flow nasal cannula, nonrebreather mask, or Venturi mask
- Withhold until CRS resolves
- Provide supportive therapy, which may include intensive care
- Monitor daily for 48 hr following next dose
- Instruct patient to remain within proximity of a healthcare facility, and consider hospitalization
- Premedicate before next dose
-
Recurrent grade 3
- Defined as temperature ≥100.4°F (38°C) with hypotension requiring one vasopressor with or without vasopressin OR requiring oxygen via high-flow nasal cannula, nonrebreather mask, or Venturi mask
- Permanently discontinue
- Provide supportive therapy, which may include intensive care
-
Grade 4
- Defined as temperature ≥100.4°F (38°C) 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, or 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
- If patient is arousable and able to perform Immune Effector Cell–Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, eg, point to clock, pen, button = 3 points); Following Commands (eg, “show me 2 fingers” or “close your eyes and stick out your tongue” = 1 point); Writing (ability to write a standard sentence = 1 point); and Attention (count backwards from 100 by ten = 1 point)
- If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points
-
Grade 1
- ICE score 7-9 OR depressed level of consciousness (patient awakens spontaneously; 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 (patient awakens to voice; 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
- Monitor daily for 48 hr following next dose
- Instruct patient to remain within proximity of a healthcare facility, and consider hospitalization
-
Grade 3 (first occurrence)
- ICE score 1-2, OR
- Depressed level of consciousness (patient awakens to voice; not attributable to other causes), OR
- Seizures (any clinical seizure, focal or generalized, that resolves rapidly, or nonconvulsive seizures on electroencephalography [EEG] that resolve with intervention), OR
- Raised intracranial pressure: focal/local edema on neuroimaging, OR
- 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 for 3 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)
- Follow 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, which may include intensive care
Hematologic toxicities
- Follow the above recommendations for restarting therapy after dose delays
- 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 bleeding is evident
Infections and other nonhematologic adverse reactions
- Follow the above recommendations for restarting therapy after dose delays
- Grade 3: Withhold until adverse reaction improves to Grade 1 or baseline
- 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
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 (0)
Monitor Closely (47)
- alfentanil
elranatamab will increase the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- alosetron
elranatamab will increase the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- bendamustine
elranatamab will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- carbamazepine
elranatamab will increase the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clomipramine
elranatamab will increase the level or effect of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clonidine
elranatamab will increase the level or effect of clonidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- clozapine
elranatamab will increase the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- colchicine
elranatamab will increase the level or effect of colchicine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- cyclosporine
elranatamab will increase the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- dihydroergotamine
elranatamab will increase the level or effect of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- disopyramide
elranatamab will increase the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- divalproex sodium
elranatamab will increase the level or effect of divalproex sodium by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- duloxetine
elranatamab will increase the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ergotamine
elranatamab will increase the level or effect of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ethosuximide
elranatamab will increase the level or effect of ethosuximide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- everolimus
elranatamab will increase the level or effect of everolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl
elranatamab will increase the level or effect of fentanyl by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl iontophoretic transdermal system
elranatamab will increase the level or effect of fentanyl iontophoretic transdermal system by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fentanyl transdermal
elranatamab will increase the level or effect of fentanyl transdermal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fluvoxamine
elranatamab will increase the level or effect of fluvoxamine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- fosphenytoin
elranatamab will increase the level or effect of fosphenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- mexiletine
elranatamab will increase the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- midazolam
elranatamab will increase the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- olanzapine
elranatamab will increase the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pacritinib
elranatamab will increase the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- phenobarbital
elranatamab will increase the level or effect of phenobarbital by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- phenytoin
elranatamab will increase the level or effect of phenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pimozide
elranatamab will increase the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pirfenidone
elranatamab will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- pomalidomide
elranatamab will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- primidone
elranatamab will increase the level or effect of primidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- quinidine
elranatamab will increase the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- quinine
elranatamab will increase the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ramelteon
elranatamab will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- rasagiline
elranatamab will increase the level or effect of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- repaglinide
elranatamab will increase the level or effect of repaglinide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- riluzole
elranatamab will increase the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- ropinirole
elranatamab will increase the level or effect of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- sirolimus
elranatamab will increase the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tacrolimus
elranatamab will increase the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tasimelteon
elranatamab will increase the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- theophylline
elranatamab will increase the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
elranatamab will increase the level or effect of theophylline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS. - thioridazine
elranatamab will increase the level or effect of thioridazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- tizanidine
elranatamab will increase the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- triazolam
elranatamab will increase the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- valproic acid
elranatamab will increase the level or effect of valproic acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
- warfarin
elranatamab will increase the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Elranatamab 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 elranatamab step-up dosing up to 14 days after the first treatment dose and during and after CRS.
Minor (0)
Adverse Effects
>10%
All grades
- Lymphocyte count decreased (91%)
- White blood cell decreased (69%)
- Hemoglobin decreased (68%)
- Neutrophil count decreased (62%)
- Platelet count decreased (61%)
- CRS (58%)
- Albumin decreased (55%)
- Fatigue (43%)
- AST increased (40%)
- Creatinine increased (38%)
- Injection site reaction (37%)
- Diarrhea (36%)
- Potassium decreased (36%)
- ALT increased (36%)
- Upper respiratory tract infection (34%)
- Alkaline phosphatase increased (34%)
- Musculoskeletal pain (34%)
- Pneumonia (32%)
- Creatinine clearance (32%)
- Decreased appetite (26%)
- Rash (25%)
- Cough (24%)
- Nausea (22%)
- Pyrexia (21%)
- Headache (19%)
- Edema (18%)
- Cardiac arrhythmia (16%)
- Constipation (15%)
- Dyspnea (15%)
- Sepsis (15%)
- Encephalopathy (15%)
- Vomiting (14%)
- Hypogammaglobulinemia (13%)
- Dry skin (13%)
- Sensory neuropathy (13%)
- Motor dysfunction (13%)
- Hemorrhage (13%)
- Insomnia (13%)
- Urinary tract infection (12%)
Grade 3 or 4
- Lymphocyte count decreased (84%)
- Neutrophil count decreased (51%)
- Hemoglobin decreased (43%)
- White blood cell decreased (40%)
- Platelet count decreased (32%)
- Pneumonia (19%)
- Sepsis (11%)
1-10%
All grades
- Skin exfoliation (10%)
- Fall (10%)
Grade 3 or 4
- Creatinine clearance (10%)
- Potassium decreased (8%)
- Fatigue, Grade 3 only (6%)
- Albumin decreased (6%)
- AST increased (6%)
- Upper respiratory tract infection (4.9%)
- Urinary tract infection, Grade 3 only (4.4%)
- Dyspnea, Grade 3 only (3.3%)
- ALT increased (3.8%)
- Creatinine increased (3.3%)
- Pyrexia, Grade 3 only (2.7%)
- Musculoskeletal pain, Grade 3 only (2.7%)
- Encephalopathy, Grade 3 only (2.7%)
- Hypogammaglobulinemia (2.2%)
- Motor dysfunction, Grade 3 only (2.2%)
- Cardiac arrhythmia (2.2%)
- Hemorrhage (1.6%)
- Edema, Grade 3 only (1.1%)
- Diarrhea, Grade 3 only (1.1%)
- Decreased appetite, Grade 3 only (1.1%)
- Alkaline phosphatase increased (1.1%)
<1%
Grade 3 or 4
- CRS, Grade 3 only (0.5%)
- Headache (0.5%)
- Sensory neuropathy, Grade 3 only (0.5%)
- Fall, Grade 3 only (0.5%)
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 elranatamab 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 elranatamab based on severity
REMS
- Owing to risk of CRS and neurologic toxicity, drug is available only through a restricted program called the Elrexfio Risk Evaluation and Mitigation Strategy (REMS) or by telephone at 1-844-923-7845
-
REMS requirements
- Prescribers must be certified with the program by enrolling and completing training
- Prescribers must counsel patients receiving elranatamab about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with patient wallet card
- Pharmacies and healthcare settings that dispense elranatamab must be certified with the ELREXFIO REMS program and must verify that prescribers are certified through the ELREXFIO REMS program
- Wholesalers and distributors must distribute drug only to certified pharmacies
Contraindications
None
Cautions
Drug available only through restricted Risk Evaluation and Mitigation Strategy (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 stepwise 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 according to 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, motor dysfunction, sensory neuropathy, and Guillain-Barré syndrome
- ICANS onset can be concurrent with CRS, after the resolution of CRS, or in the absence of CRS
- Monitor for signs and symptoms of neurologic toxicity during treatment
- At first sign of neurologic toxicity, including ICANS, immediately evaluate patient, and provide supportive care based on severity; withhold or permanently discontinue drug according to 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 neurologic symptoms, until symptoms resolve
Infections
- Can cause serious infections, including life-threatening or fatal infections
- Do not initiate therapy in patients with active 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 according to severity
Neutropenia
- Can cause neutropenia and febrile neutropenia
- Monitor CBC counts at baseline and periodically during treatment
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 according to severity
Drug interaction overview
-
CYP enzyme suppression
- Monitor sensitive CYP substrates for toxicity or drug concentrations
- Elranatamab 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
Advise women of the potential risk to the fetus
Elranatamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
Additionally, based on finding of B-cell depletion in nonpregnant animals, elranatamab can cause B-cell lymphocytopenia in infants exposed in utero
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 4 months after last dose
Lactation
Data are not available regarding presence of elranatamab 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
Do not breastfeed during treatment and for 4 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
Antibody that binds to both CD3 on T-cell and B-cell maturation antigen (BCMA), which is expressed on the surface of multiple myeloma cells
This results in cross-linking of T-cells and myeloma cells, and induces a potent cytotoxic T-lymphocyte response against BCMA-expressing cells
Absorption
Bioavailability: 56.2%
Peak plasma time: 7 days
Average plasma concentration
- First full 76-mg dose: 3.1 mcg/mL
- End of weekly dose (week 24): 32.7 mcg/mL
- Steady-state (biweekly dosing): 18.4 mcg/mL
Maximum plasma concentration
- First full 76-mg dose: 3.8 mcg/mL
- End of weekly dose (week 24): 33.6 mcg/mL
- Steady-state (biweekly dosing): 20.1 mcg/mL
Trough plasma concentration
- First full 76-mg dose: 3.3 mcg/mL
- End of weekly dose (week 24): 31.2 mcg/mL
- Steady-state (biweekly dosing): 15.9 mcg/mL
Distribution
Vd: 7.76 L
Metabolism
Metabolized into small peptides by catabolic pathways
Elimination
Half-life: 22 days (76-mg dose)
Clearance 0.324 L/day (after 24 weeks)
Administration
SC Compatibility
Drug is compatible with stainless-steel injection needles and polypropylene or polycarbonate syringe material
Premedication
Administer ~1 hr before first three doses in the step-up dosing schedule (ie, step-up dose 1, step-up dose 2, first treatment dose)
Acetaminophen (or equivalent) 650 mg PO
Dexamethasone (or equivalent) 20 mg PO/IV
Diphenhydramine (or equivalent) 25 mg PO
SC Preparation
Visually inspect drug products for particulate matter and discoloration before administering; solution is opalescent, and colorless to pale brown; discard if solution is discolored or cloudy or if foreign particles are present
Vials are for single use in a single patient and do not contain any preservatives
Use aseptic technique to prepare and administer
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
Withdraw required injection volume from vial into an appropriately sized syringe with stainless steel injection needles (30 gauge or wider) and polypropylene or polycarbonate syringe material; discard unused portion
Required injection volumes for total dose
- 12-mg dose: 0.3 mL (use 44 mg/1.1 mL single-dose vial)
- 32-mg dose: 0.8 mL (use 44 mg/1.1 mL single-dose vial)
- 76-mg dose: 1.9 mL
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)
Do not inject into tattoos or scars or areas where skin is red, bruised, tender, hard, or not intact
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 2-30ºC (36-86ºF) for up to 4 hr
Images
Formulary
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- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
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