on of treatment with MAYZENT should be considered if a patient develops a serious infection.
Cryptococcal Infections
Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with anothersphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have also occurred with MAYZENT. Physiciansshould be vigilant for clinical symptoms or signs of CM. Patients with symptoms or signs consistent with a cryptococcalinfection should undergo prompt diagnostic eva luation and treatment. MAYZENT treatment should be suspended until acryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
Herpes Viral Infections
Cases of herpes viral infection, including one case of reactivation of VZV infection leading to varicella zoster meningitis,have been reported in the development program of MAYZENT. In Study 1, the rate of herpetic infections was 4.6% inMAYZENT-treated patients compared to 3.0% of patients receiving placebo. In Study 1, an increase in the rate of herpeszoster infections was reported in 2.5% of MAYZENT-treated patients compared to 0.7% of patients receiving placebo.
Patients without a healthcare professional confirmed history of varicella (chickenpox) or without documentation of a fullcourse of vaccination against VZV should be tested for antibodies to VZV before initiating MAYZENT (see Vaccinationsbelow).
Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain caused by the JC virus(JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severedisability. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressiveweakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, andorientation leading to confusion and personality changes.
No cases of PML have been reported in MAYZENT-treated patients in the development program; however, PML hasbeen reported in patients treated with a S1P receptor modulator and other multiple sclerosis (MS) therapies and has beenassociated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physiciansshould be vigilant for clinical symptoms or MRI findings that may be suggestive of PML. MRI findings may be apparentbefore clinical signs or symptoms. If PML is suspected, treatment with MAYZENT should be suspended until PML hasbeen excluded.
Prior and Concomitant Treatment with Anti-neoplastic, Immune-Modulating, or Immunosuppressive TherapiesAnti-neoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should becoadministered with caution because of the risk of additive immune system effects during such therapy [see DrugInteractions (7.1)].
Vaccinations
Patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course ofvaccination against VZV should be tested for antibodies to VZV before initiating MAYZENT treatment. A full course ofvaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment withMAYZENT, following which initiation of treatment with MAYZENT should be postponed for 4 weeks to allow the fulleffect of vaccination to occur.
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