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Adverse event reporting can be found at the bottom of the page
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The content of this website has been produced in line with the ELREXFIO®▼ (elranatamab) Summary of Product Characteristics for Great Britain and Northern Ireland. For ELREXFIO®▼ (elranatamab) Prescribing Information for Great Britain and Northern Ireland click here.
*ELREXFIO® is supplied as a ready-to-use solution that does not need dilution prior to administration. Aseptic technique should be used to prepare and administer ELREXFIO®.1
Pre-medication should be administered approximately 1 hour prior to the first three doses of ELREXFIO®, which includes step-up dose 1, step-up dose 2, and the first full treatment dose, to reduce the risk of CRS:1
Due to the risk of cytokine release syndrome (CRS) and ICANS, patients should be monitored for signs and symptoms for 48 hours after administration of each step-up dose and instructed to remain within proximity of a healthcare facility.1
Patients can continue treatment with ELREXFIO® until disease progression or unacceptable toxicity.1 In the phase 2 MagnetisMM-3 study, 48.0% of BCMA-directed therapy-naïve patients (n=123) received ELREXFIO® treatment for at least 6 months.2
Dose reductions of ELREXFIO® are not recommended. Dose delays may be required to manage toxicities related to ELREXFIO®. Please refer to the ELREXFIO® Summary of Product Characteristics for dose delay guidelines.1
Administration1
ELREXFIO® should be administered subcutaneously by a healthcare provider with adequately trained medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS.1
Step 1
Step 2
Step 3
ELREXFIO® is supplied as a ready-to-use solution that does not need dilution prior to administration. Aseptic technique should be used to prepare and administer ELREXFIO®. The required dose of ELREXFIO® should be administered into the subcutaneous tissue of the abdomen, the preferred injection site. Alternatively, ELREXFIO® can be injected into the subcutaneous tissue of the thigh. Do not inject into areas where the skin is red, bruised, tender, hard or areas where there are scars.
Inspect the product for discolouration or particulate matter. The solution will be clear to slightly opalescent and colourless to pale brown. Do not administer the solution if it is discoloured or contains particulate matter.
ELREXFIO® should be prepared according to the preparation instructions. For each dose, draw the specified dosage from the vial and then discard the vial, even if it contains remaining solution.
Preparation instructions for ELREXFIO®
| Dose | Dose Volume | Vial |
|---|---|---|
| 12 mg (Step-up dose 1) | 0.3 mL | 44 mg |
| 32 mg (Step-up dose 1) | 0.8 mL | 44 mg |
| 76 mg (Full treatment dose) | 1.9 mL | 76 mg |
Step 4
Step 5
Tab Number 3
Clean and prepare the injection site following proper aseptic technique before injecting all the liquid subcutaneously.
Dispose of the needle and needle cap appropriately into a sharps bin.
References:
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-UNP-GBR-7812. January 2024