Drug Detail:Zeposia (Ozanimod [ oh-zan-i-mod ])
Generic Name: OZANIMOD HYDROCHLORIDE 0.92mg
Dosage Form: capsule
Drug Class: Selective immunosuppressants
Drug Detail:Zeposia (Ozanimod [ oh-zan-i-mod ])
Generic Name: OZANIMOD HYDROCHLORIDE 0.92mg
Dosage Form: capsule
Drug Class: Selective immunosuppressants
Before initiation of treatment with ZEPOSIA, assess the following:
Complete Blood Count
Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1)].
Cardiac Evaluation
Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.3)].
Liver Function Tests
Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.4)].
Ophthalmic Assessment
In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula [see Warnings and Precautions (5.8)].
Current or Prior Medications
Vaccinations
Patients without a healthcare professional-confirmed history of 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; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7)].
If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA.
Initiate ZEPOSIA with a 7-day titration, as shown in Table 1 [see Warnings and Precautions (5.3)]. After initial titration, the recommended dosage of ZEPOSIA is 0.92 mg taken orally once daily starting on Day 8.
Swallow ZEPOSIA capsules whole, with or without food [see Clinical Pharmacology (12.3)].
Days 1-4 |
0.23 mg once daily |
Days 5-7 |
0.46 mg once daily |
Day 8 and thereafter |
0.92 mg once daily |
If a dose of ZEPOSIA is missed during the first 2 weeks of treatment, reinitiate treatment using the titration regimen [see Dosage and Administration (2.2)].
If a dose of ZEPOSIA is missed after the first 2 weeks of treatment, continue with the treatment as planned.