Regeneron
Lynozyfic
page 1 of 6
4C
(near Multiple 
Myeleoma)
INDICATION AND USAGE
LYNOZYFIC 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 and description 
of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE 
EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
•  Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in 
patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce 
the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next 
dose or permanently discontinue based on severity.
•  Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome 
(ICANS), including serious or life-threatening reactions, can occur in patients receiving 
LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS 
during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until 
neurologic toxicity, including ICANS resolves, and modify the next dose or permanently 
discontinue based on severity.
•  Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available 
only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) 
called the LYNOZYFIC REMS.
The billing and coding information discussed in this guide is provided for informational purposes only, is subject to change, and should not be construed as 
legal advice. The codes listed herein may not apply to all patients or to all health plans. Conversely, additional codes not listed in this guide may apply to some 
patients. Providers should follow payer-specific coding requirements and exercise independent clinical judgment when selecting codes and submitting claims 
to accurately reflect the services and products furnished to a specific patient. Information provided in this guide is effective as of April 2026.
Effective April 1, 2026, the following J-code can be used for administrative 
and billing purposes specific to LYNOZYFIC:
Please ensure your systems are updated with this new information for the hospital outpatient setting.
LYNOZYFIC is billed in 1-mg units, per its HCPCS code.
Five units are billed for the 5-mg dose; 200 units are 
billed for the full 200-mg dose.
Injection, linvoseltamab-gcpt, 1 mg
J9601
HCPCS=Healthcare Common Procedure Coding System.

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