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Prescribing InformationMedication GuideIndication ELREXFIO REMS Patient Site
Personalized support for your patients’ needs

Patients prescribed ELREXFIO are eligible to receive one-on-one support from a Pfizer Patient Access Navigator. This resource is available through Pfizer Oncology Together™, a support program that can help address individual patient needs.

Once ELREXFIO patients are enrolled, Patient Access Navigators can serve as a single point of contact to:

  • Support patients and their care teams with access and reimbursement assistance
  • Help with coordinating care between hospitals and outpatient sites
  • Answer insurance and logistical questions

How to enroll your patients

Help your ELREXFIO patients opt in to Patient Access Navigator support with the Pfizer Oncology Together Enrollment Form for Injectables. This form can also be used to enroll patients in other programs offered through Pfizer Oncology Together.

Step 1: Fill out the "Personalized Patient Support Programs" section for ELREXFIO on page 4 of the enrollment form and complete the required fields

Step 2: Work with your patients to fill out the information required to enroll in Patient Access Navigator support

Patients can also enroll online at PfizerOncologySignUp.com/injectable. To learn more, call 1-877-744-5671 (Monday–Friday 8 AM–8 PM ET).

 Visit Pfizer Oncology Together LoadingPatient Access Navigators can provide support for ELREXFIO patients during treatmentAccess assistanceAccess assistance

Patient Access Navigators can help facilitate the patient's access to ELREXFIO by:

  • Communicating insurance information to the patient and care team after Pfizer Oncology Together conducts a benefits verification
  • Discussing coverage options, reimbursement, and relevant medical policies to help with patient access
Patient financial assistance

Patient Access Navigators can connect patients to financial assistance resources, regardless of their insurance coverage.

  • If financial assistance is needed, Pfizer Oncology Together can also help identify resources for patients with Medicare, Medicaid, other government insurance, or those who don’t have health insurance
  • Co-pay assistance: Eligible,* commercially insured patients† may pay as little as $0 per ELREXFIO treatment‡ through the Pfizer Oncology Together Co-Pay Savings Program for Injectables
    • This program covers up to $25,000 per calendar year. There are no income requirements for patients to qualify. Limits, terms, and conditions apply
Visit PfizerCopay.com to enroll eligible, commercially insured patients in the Pfizer Co-Pay Savings Program for Injectables
LoadingTreatment coordination and support

During treatment initiation and follow-up appointments, Patient Access Navigators can provide support by:

  • Confirming the hospital discharge plans with the patient and their care team
  • Ensuring the patient is aware of the date, time, and location of their next treatment

Additionally, Patient Access Navigators can continue to support patients and caregivers during their initial months of treatment with ELREXFIO by§:

  • Providing appointment reminders for ongoing treatments
Terms and Conditions apply. Visit PfizerCopay.com/TC to learn more. No membership fees.For patients to be eligible for the lnjectables Co-Pay Program for ELREXFIO, they must have commercial insurance that covers ELREXFIO and they cannot be enrolled in a state or federally funded insurance program. Whether a co-pay expense is eligible for the lnjectables Co-Pay Program for ELREXFIO benefits will be determined at the time the benefit is paid. Co-pay expenses must be in connection with a separately paid claim for ELREXFIO administered in the outpatient setting.The lnjectables Co-Pay Program for ELREXFIO will pay the co-pay for ELREXFIO up to the annual assistance limit of $25,000 per calendar year per patient.Patient Access Navigators will provide support to patients through their first 6 months of ELREXFIO treatment.
Billing code: J1323 (Injection, elranatamab-bcmm, 1 mg)

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INDICATION AND USAGEELREXFIO™ (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
Important Safety InformationWARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity.

Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS.

Cytokine Release Syndrome (CRS): ELREXFIO can cause CRS, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 58% of patients who received ELREXFIO at the recommended dose, with Grade 1 CRS in 44% of patients, Grade 2 CRS in 14% of patients, and Grade 3 CRS in 0.5% of patients. Recurrent CRS occurred in 13% of patients. Most patients experienced CRS after the first step-up dose (43%) or the second step-up dose (19%), with 7% of patients having CRS after the first treatment dose and 1.6% of patients after a subsequent dose. The median time to onset of CRS was 2 (range: 1-9) days after the most recent dose, with a median duration of 2 (range: 1-19) days.

Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes.

Initiate therapy according to the ELREXFIO step-up dosing schedule to reduce risk of CRS and monitor patients following administration of ELREXFIO accordingly. Administer pretreatment medications prior to each dose in the step-up dosing schedule to reduce risk of CRS.

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, evaluate patients immediately for hospitalization. Manage CRS according to the recommendations and consider further management per current practice guidelines. Withhold or permanently discontinue ELREXFIO based on severity.

Neurologic Toxicity Including ICANS: ELREXFIO can cause serious or life-threatening neurologic toxicity, including ICANS.

In the clinical trial, neurologic toxicity occurred in 59% of patients who received ELREXFIO at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 7% of patients. Neurologic toxicities included headache (18%), encephalopathy (15%), motor dysfunction (13%), sensory neuropathy (13%), and Guillain-Barré Syndrome (0.5%).

In the clinical trial, ICANS occurred in 3.3% of patients who received ELREXFIO at the recommended dose. Most patients had ICANS after the first step-up dose (2.7%), 1 (0.5%) patient had ICANS after the second step-up dose, and 1 (0.5%) patient had ICANS after subsequent dose(s). Recurrent ICANS occurred in 1.1% of patients. The median time to onset was 3 (range: 1-4) days after the most recent dose, with a median duration of 2 (range: 1-18) days. The most frequent clinical manifestations of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 immune effector cell-associated encephalopathy (ICE) scores. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity occur. Monitor patients for signs and symptoms of neurologic toxicities during treatment with ELREXFIO. At the first sign of neurologic toxicity, including ICANS, evaluate and treat patients immediately based on severity. Withhold or permanently discontinue ELREXFIO based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, including ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness. Advise patients not to drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until symptoms resolve.

REMS: ELREXFIO is available only through a restricted program under a REMS called the ELREXFIO REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Hepatotoxicity: ELREXFIO can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 36% of patients, with Grade 3 or 4 ALT elevation occurring in 3.8%; elevated AST occurred in 40% of patients, with Grade 3 or 4 AST elevation occurring in 6%. Grade 3 or 4 total bilirubin elevations occurred in 0.5% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold ELREXFIO or consider permanent discontinuation of ELREXFIO based on severity.

Infections: ELREXFIO can cause severe, life-threatening, or fatal infections. In the clinical trial, in patients who received ELREXFIO at the recommended dose, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 31% and fatal infections in 7%. The most common serious infections reported (≥5%) were pneumonia and sepsis.

Do not initiate treatment with ELREXFIO in patients with active infections. Monitor patients for signs and symptoms of infection prior to and during treatment with ELREXFIO and treat appropriately. Withhold or permanently discontinue ELREXFIO based on severity. Administer prophylactic antimicrobial and antiviral medications according to current practice guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate.

Neutropenia: ELREXFIO can cause neutropenia and febrile neutropenia. In patients who received ELREXFIO at the recommended dose in the clinical trial, decreased neutrophils occurred in 62% of patients, with Grade 3 or 4 decreased neutrophils in 51%. Febrile neutropenia occurred in 2.2% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment. Provide supportive care according to current practice guidelines. Monitor patients with neutropenia for signs of infection. Withhold ELREXFIO based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, ELREXFIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose.

Adverse Reactions: In patients who received ELREXFIO, the most common adverse reactions (incidence ≥20%) were CRS, fatigue, injection-site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. The most common Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.ELREXFIO™ (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).Indication and Usage