Regeneron
Lynozyfic
page 2 of 6
4C
(near Multiple 
Myeleoma)
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IMPORTANT SAFETY INFORMATION (cont’d)
Warnings and Precautions
Cytokine Release Syndrome (CRS): LYNOZYFIC can cause CRS, which can be serious or 
life-threatening. In LINKER-MM1, CRS occurred in 46% (54/117) of patients who received LYNOZYFIC 
at the recommended dose, with Grade 1 CRS occurring in 35% (41/117) of patients, Grade 2 in 10% 
(12/117), and Grade 3 in 0.9% (1/117). Thirty-eight percent (45/117) of patients had CRS following 
step-up dose 1, including 1 patient who experienced Grade 3 CRS; 8% (9/117) had an initial CRS event 
following a subsequent dose. Seventeen percent (19/113) of patients developed CRS after step-up 
dose 2, 10% (11/111) developed CRS after the first full 200-mg dose of LYNOZYFIC, and 3.6% (4/110) 
developed CRS after the second full dose. Recurrent CRS occurred in 20% (23/117) of patients. The 
median time to onset of CRS from the end of infusion was 11 (range: -1 to 184) hours after the most 
recent dose, with a median duration of 15 (range: 1 to 76) hours.  
Clinical signs and symptoms of CRS included, but were not limited to pyrexia, chills, hypoxia, 
tachycardia, and hypotension. Administer pretreatment medications and initiate therapy according 
to LYNOZYFIC step-up dosing to reduce the incidence and severity of CRS. Monitor patients for signs 
and symptoms of CRS after infusion. Counsel patients to seek immediate medical attention should 
signs or symptoms of CRS occur.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice 
guidelines, and administer supportive care; withhold LYNOZYFIC until CRS resolves and modify the 
next dose or permanently discontinue LYNOZYFIC based on severity.  
Please see additional Important Safety Information and Brief Summary of Prescribing Information, 
including Boxed WARNING, for LYNOZYFIC on the following pages.
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