ELREXFIO Highlights

(elranatamab-bcmm)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO.

ELREXFIOTM (elranatamab-bcmm) injection, for subcutaneous use
Initial U.S. Approval: 2023

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

See full prescribing information for complete boxed warning.

•
Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity. (2.2, 2.5, 5.1)
•
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. (2.5, 5.2)
•
ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS). (5.3)

INDICATIONS AND USAGE

ELREXFIO 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). (1)

DOSAGE AND ADMINISTRATION

ELREXFIO Dosing Schedule (2.2)
Dosing ScheduleDayELREXFIO Dose
*
Responders only week 25 onward.

Step-up Dosing Schedule

Day 1

Step-up dose 1

12 mg

Day 4

Step-up dose 2

32 mg

Day 8

First treatment dose

76 mg

Weekly Dosing Schedule

One week after first treatment dose and weekly thereafter through week 24

Subsequent treatment doses

76 mg

Biweekly (Every 2 Weeks) Dosing Schedule*

Week 25 and every 2 weeks thereafter

Subsequent treatment doses

76 mg

•
Patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose. (2.1)
•
For subcutaneous injection only. (2.2)
•
Administer pre-treatment medications as recommended. (2.3)
•
See Full Prescribing Information for instructions on preparation and administration. (2.6)

DOSAGE FORMS AND STRENGTHS

Injection:

•
76 mg/1.9 mL (40 mg/mL) in a single-dose vial. (3)
•
44 mg/1.1 mL (40 mg/mL) in a single-dose vial. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Infections: Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Do not initiate treatment in patients with active infections. (5.4)
•
Neutropenia: Monitor complete blood cell counts at baseline and periodically during treatment. (5.5)
•
Hepatotoxicity: Can cause elevated ALT, AST, and bilirubin. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. (5.6)
•
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.7, 8.1. 8.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) are 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 to 4 laboratory abnormalities (≥30%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO.

ELREXFIOTM (elranatamab-bcmm) injection, for subcutaneous use
Initial U.S. Approval: 2023

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

See full prescribing information for complete boxed warning.

•
Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing schedule to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity. (2.2, 2.5, 5.1)
•
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. (2.5, 5.2)
•
ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS). (5.3)

INDICATIONS AND USAGE

ELREXFIO 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). (1)

DOSAGE AND ADMINISTRATION

ELREXFIO Dosing Schedule (2.2)
Dosing ScheduleDayELREXFIO Dose
*
Responders only week 25 onward.

Step-up Dosing Schedule

Day 1

Step-up dose 1

12 mg

Day 4

Step-up dose 2

32 mg

Day 8

First treatment dose

76 mg

Weekly Dosing Schedule

One week after first treatment dose and weekly thereafter through week 24

Subsequent treatment doses

76 mg

Biweekly (Every 2 Weeks) Dosing Schedule*

Week 25 and every 2 weeks thereafter

Subsequent treatment doses

76 mg

•
Patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose. (2.1)
•
For subcutaneous injection only. (2.2)
•
Administer pre-treatment medications as recommended. (2.3)
•
See Full Prescribing Information for instructions on preparation and administration. (2.6)

DOSAGE FORMS AND STRENGTHS

Injection:

•
76 mg/1.9 mL (40 mg/mL) in a single-dose vial. (3)
•
44 mg/1.1 mL (40 mg/mL) in a single-dose vial. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Infections: Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately. Do not initiate treatment in patients with active infections. (5.4)
•
Neutropenia: Monitor complete blood cell counts at baseline and periodically during treatment. (5.5)
•
Hepatotoxicity: Can cause elevated ALT, AST, and bilirubin. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. (5.6)
•
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.7, 8.1. 8.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) are 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 to 4 laboratory abnormalities (≥30%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2023
Medication Guide

Health Professional Information

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