Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.
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 or UC 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 (5.3)].
Liver Function Tests
Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.4)].
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
- 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 [see Warnings and Precautions (5.1) and Drug Interactions (7)].
- Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction [see Warnings and Precautions (5.3) and Drug Interactions (7)].
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.
Recommended Dosage for Multiple Sclerosis and Ulcerative Colitis
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)].
0.23 mg once daily
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 [see Recommended Dosage in Patients with Hepatic Impairment (2.3).]
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 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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.
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