Zeposia Dosage

Generic name: OZANIMOD HYDROCHLORIDE 0.92mg
Dosage form: capsule
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on Aug 30, 2024.

Assessments Prior to First Dose of ZEPOSIA

Before initiation of treatment with ZEPOSIA, assess the following:

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.

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.

Liver Function Tests

Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels.

Ophthalmic Assessment

Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with ZEPOSIA.

Skin Examination

Obtain a baseline skin examination prior to or shortly after initiation of ZEPOSIA. If a suspicious skin lesion is observed, it should be promptly evaluated.

Current or Prior Medications

•: If patients are taking anti-neoplastic, non-corticosteroid 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.
•: Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction.

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.

If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA.

Recommended Dosage for Multiple Sclerosis and Ulcerative Colitis

Initiate ZEPOSIA with a 7-day titration, as shown in Table 1. 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.

Table 1: Dose Titration Regimen
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*

*Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should take 0.92 mg once every other day

Recommended Dosage in Patients with Hepatic Impairment

In patients with mild or moderate hepatic impairment (Child-Pugh class A or B), initiate ZEPOSIA with a 7-day titration, as shown in Table 1. After initial titration, the recommended dosage of ZEPOSIA in these patients is 0.92 mg taken orally once every other day, starting on Day 8.

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.

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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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill OZA 0.92 mg is Zeposia 0.92 mg — Zeposia 0.92 mg (OZA 0.92 mg)