Generic name: OZANIMOD HYDROCHLORIDE 0.92mg
Dosage form: capsule
Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.
Assessments Prior to First Dose of ZEPOSIA
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 therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1)].
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 (5.2)].
Liver Function Tests
Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.3)].
In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula [see Warnings and Precautions (5.7)].
Current or Prior Medications
- If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with ZEPOSIA [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].
- Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].
Test patients for antibodies to varicella zoster virus (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 (7.3)]. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA.
After initial titration (see Treatment Initiation), the recommended maintenance dosage of ZEPOSIA is 0.92 mg taken orally once daily starting on Day 8.
ZEPOSIA capsules should be swallowed whole and can be administered with or without food.
Initiate ZEPOSIA with a 7-day titration, as shown in Table 1 [see Warnings and Precautions (5.2)].
|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|
Reinitiation of ZEPOSIA After Treatment Interruption
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.
Frequently asked questions
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More about Zeposia (ozanimod)
- Side Effects
- During Pregnancy
- Imprints, Shape & Color Data
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: selective immunosuppressants
- FDA Approval History