ZEPOSIA is the First and Only S1P With No First-Dose Observation Required
NO First-Dose Observation Required
NO Genetic Testing Required
NO Ophthalmic Testing Required for Most Patients4a
Obtain a recent CBC (within 6 months or after discontinuation of prior MS therapy), including lymphocyte count
Obtain an ECG to determine whether preexisting conduction abnormalities are present
Obtain transaminase and bilirubin levels (within 6 months)
Evaluate current and prior medications
Patients without a confirmed history of VZV or without documented VZV vaccination should be tested for antibodies. If VZV or other live attenuated immunizations are required, administer at least 1 month prior to initiation
aDiabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation. A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA.1
CBC=complete blood count; ECG=electrocardiogram; MS=multiple sclerosis; S1P=sphingosine-1-phosphate; VZV=varicella-zoster virus.
An Up-Titration Schedule Should Be Used to Reach the Maintenance Dose, as a Transient Decrease in Heart Rate and AV Conduction Delays May Occur1
The Mean (CV%) Plasma Half-Life (t1/2) of ZEPOSIA Was Approximately 21 Hours (15%).1
The Mean (CV%) Effective Half-Life (t1/2) of the Active Metabolite CC112273 Was Approximately 11 Days.1
Note: The heart rate data shown here represent pooled data from both pivotal trials for ZEPOSIA (SUNBEAM and RADIANCE), which included a combined total of 882 patients who received the 0.92‑mg maintenance dose of ZEPOSIA and 885 patients who received Avonex 30 μg. All patients in the ZEPOSIA group received 0.23 mg on Day 1 and the dose was titrated upward over 8 days.
Heart rate data1,5
In data pooled from 2 trials, SUNBEAM (1 year) and RADIANCE (2 years), the following observations were made:
This information is intended for U.S. Healthcare Professionals.