Elranatamab

Elranatamab is a prescription medication indicated for relapsed or refractory multiple myeloma in adults who have received at least four and more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.   

• Elranatamab is available under the following different brand names: Elrexfio, elranatamab-bcmm

Common side effects of Elranatamab include:

• tiredness 
• decreased appetite
• injection site reaction, such as redness, itching, pain, rash bruising, rash, swelling, tenderness 
• cough
• diarrhea
• nausea
• rash
• muscle and bone pain
• fever

Serious side effects of Elranatamab include:

• cytokine release syndrome (CRS)
• neurologic problems
• decreased white blood cell counts
• liver problems

Rare side effects of Elranatamab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for SC

• 40 mg/mL (1.1-mL or 1.9-mL single-dose vial)

Ready-to-use SC solution

Multiple myeloma

Adult dosage

• Weekly dosing schedule
• Step-up dosing schedule
  • Hospitalize for 48 hours after administering the first step-up dose and for 24 hours after the second step-up dose
  • Premedicate before each dose in a 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 × 1 dose
  • Day 4 (step-up dose 2)
  • 32 mg SC × 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 × 1 dose
  • Maintain at least 3 days between step-up dose 2 and the first treatment dose
  • Second treatment dose through week 24
  • 1 week after the first treatment dose and weekly thereafter (subsequent treatment doses) through week 24: 76 mg SC every week
  • Maintain at least 6 days between treatment doses
  • Week 25 and thereafter (responders ONLY)
  • One week after week-24 dose and then every 2 weeks thereafter: 76 mg SC every 2 weeks
  • Maintain at least 6 days between treatment doses
  • Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Elranatamab has severe interactions with no other drugs
• Elranatamab has serious interactions with no other drugs
• Elranatamab has moderate interactions with at least 47 other drugs
• Elranatamab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Elranatamab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Elranatamab?"

Cautions

• Drug available only through restricted Risk Evaluation and Mitigation Strategy (REMS) program
• Based on its mechanism of action, a drug may cause fetal harm when administered to pregnant women
• CRS
  • Can cause CRS, including life-threatening or fatal reactions
  • 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
  • Counsel patients to seek medical attention if signs or symptoms of CRS occur
  • At the first sign of CRS, immediately evaluate the 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 the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity, withhold or permanently discontinue the 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 for a 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 hours 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 the 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 the severity
• Drug interaction overview
  • CYP enzyme suppression
    • Monitor sensitive CYP substrates for toxicity or drug concentrations
    • Elranatamab causes the release of cytokines that may suppress the 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 and Lactation

• Because of its mechanism of action, the drug may cause fetal harm when administered to pregnant women
• 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 a finding of B-cell depletion in nonpregnant animals, elranatamab can cause B-cell lymphocytopenia in infants exposed in utero
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 4 months after the last dose
• Lactation
  • Data are not available regarding the presence of elranatamab in human milk, its effects on breastfed children, or 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 the last dose