Zeposia® (ozanimod; Bristol Myers Squibb) is now available 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.
The approval of Zeposia, a sphingosine 1-phosphate (S1P) receptor modulator, was based on data from 2 double-blind, parallel-group, active comparator-controlled clinical trials in patients with relapsing forms of MS. Results showed that in both trials, the annualized relapse rate was statistically significantly lower in patients treated with Zeposia than in patients who received interferon beta-1a. With regard to safety, the most common adverse reactions reported included upper respiratory tract infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
Before initiating therapy, a complete blood count (with lymphocyte count), an electrocardiogram, and liver function tests should be obtained; in patients with a history of uveitis or macular edema, an ophthalmic assessment is required. Patients should also be tested for antibodies to varicella zoster virus before starting therapy. Varicella zoster virus vaccination is recommended for antibody-negative patients prior to initiating Zeposia; live attenuated immunizations should be administered at least 1 month before starting treatment.
Zeposia is supplied in 0.23mg, 0.46mg, 0.92mg strength capsules. The 7-day Starter Pack includes four 0.23mg capsules and three 0.46mg capsules. The Starter Kit includes one 7-capsule Starter Pack and a bottle containing thirty 0.92mg capsules. Titration is required for treatment initiation. The 0.92mg capsules are used for maintenance dosing.
“Zeposia is the first and only S1P that requires no first dose observation,which may minimize the number of interactions RMS patients need to have with healthcare practitioners prior to initiating therapy during this unprecedented time of social distancing,” said Tina Deignan, vice president and US head of immunology, Bristol Myers Squibb.
For more information visit zeposia.com.