rocess that's currently irreversible.
RMS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function.14 These attacks—often called relapses, flare-ups or exacerbations—are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely with no apparent progression of disease.14 RMS is the most common disease course at the time of diagnosis.14 Approximately 85% of patients are initially diagnosed with RMS, compared with 10-15% with progressive forms of the disease.
About Zeposia (ozanimod)
Zeposia® is a sphingosine 1-phosphate(S1P)receptor modulator that binds with high affinity to S1P receptors 1and Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood1 The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown but may involve the reduction of lymphocyte migration into the central nervous system.
Zeposia is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn's disease.
Indication
Zeposia is indicated for the treatment of relapsing forms of multiple sclerosis(MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
Contraindications:
Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial, unless the patient has a functioning pacemaker
Patients with severe untreated sleep apnea
Patients taking a monoamine oxidase (MAO) inhibitor
Infections: Zeposia may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving Zeposia. Obtain a recent(i.e.,within 6 months or after discontinuation of prior MS therapy)complete blood count (CBC) including lymphocyte count before initiation of Zeposia. Delay initiation of Zeposia in patients with an active infection until the infection is resolved. Consider interruption of treatment with Zeposia if a patient develops a serious infection.Continue monitoring for infections up to 3 months after discontinuing Zeposia
Herpes zoster was reported as an adverse reaction in Zeposia-treated patients.Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate(S1P)receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus(VZV), should be tested for antibodies to VZV before initiating Zeposia. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with Zeposia
Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator.If CM is suspected, Zeposia should be suspended until cryptococcal infection has been excluded.If CM is d |
