HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
ELREXFIO (elranatamab-bcmm)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
ELREXFIO Quick Finder
Highlights
Boxed Warning
WARNING: 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...
Did you find an answer to your question?
Yes
No
Indications and Usage
1 INDICATIONS AND USAGE
ELREXFIO is 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...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Information
Administer ELREXFIO subcutaneously according to the step-up dosing schedule to reduce the incidence and...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
ELREXFIO injection is a clear to slightly opalescent, and colorless to pale brown liquid solution available as:
- •
- 76 mg/1.9 mL (40 mg/mL) in a single-dose vial
- • ...
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Cytokine Release Syndrome (CRS)
ELREXFIO can cause CRS, including life-threatening or fatal reactions [see...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in labeling:
- •
- Cytokine Release Syndrome [see Warnings...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
For certain CYP substrates, minimal changes in the concentration may lead to serious adverse reactions. Monitor for toxicity or drug concentrations of such CYP substrates when co-administered with...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on the mechanism of action, ELREXFIO may cause fetal harm when...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a bispecific, humanized immunoglobulin 2-alanine (IgG2Δa) kappa antibody derived from two monoclonal...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody that binds...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity or genotoxicity studies have been conducted with elranatamab-...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 Relapsed or Refractory Multiple Myeloma
The efficacy of ELREXFIO monotherapy was evaluated in patients with relapsed or refractory multiple...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ELREXFIOTM (elranatamab-bcmm) injection is a sterile, preservative-free, clear to slightly opalescent, and...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Didn’t find what you were looking for? Contact us.
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.