ZEPOSIA Capsule (2020)
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Celgene Corporation
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1. Indications and Usage
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in ...
2. Dosage and Administration
2.1 Assessments Prior to First Dose of ZEPOSIA Before initiation of treatment with ZEPOSIA, assess the following: <u>Complete Blood Count:</u> Obtain a recent (i.e., within the last 6 months or after discontinuation ...
3. Dosage Forms and Strengths
ZEPOSIA is available as capsules in the following dosage strengths: Ozanimod 0.23 mg: light grey opaque body/light grey opaque cap imprinted with black ink OZA on the cap and 0.23 mg on the body Ozanimod ...
4. Contraindications
ZEPOSIA is contraindicated in patients who: In the last 6 months, have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring ...
5. Warnings and Precautions
5.1 Infections Risk of Infections ZEPOSIA causes a mean reduction in peripheral blood lymphocyte count to 45% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues ...
6. Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Infections <em>[see Warnings and Precautions (5.1)]</em> Bradyarrhythmia and Atrioventricular Conduction Delays <em>[see ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
7. Drug Interactions
7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies ZEPOSIA has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women. In animal studies, administration of ozanimod during pregnancy produced adverse effects ...
8.2. Lactation
Risk Summary There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Following oral administration of ozanimod, ...
8.3. Females and Males of Reproductive Potential
Contraception Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Clinical studies of ZEPOSIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly ...
8.6. Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of the ozanimod major active metabolites is unknown <em>[see Clinical Pharmacology (12.3)]</em>. Use of ZEPOSIA in patients with hepatic impairment ...
11. Description
ZEPOSIA contains ozanimod, a S1P receptor modulator and is supplied as ozanimod hydrochloride (HCl). The chemical name of ozanimod HCl is 5-(3-{(1S)1[(2-hydroxyethyl)amino]-2,3-dihydro-1<em>H</em>-inden-4-yl}-1,2,4-oxadiazol-5-yl) ...
12.1. Mechanism of Action
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Ozanimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the ...
12.2. Pharmacodynamics
Reduction in Blood Lymphocyte Counts In active-controlled MS clinical trials, mean lymphocyte counts decreased to approximately 45% of baseline at 3 months (approximate mean blood lymphocyte counts 0.8 ...
12.3. Pharmacokinetics
The steady state exposure parameters of ozanimod and its major active metabolite, CC112273 are summarized in Table 3. <b>Table 3. Exposure Parameters of Ozanimod and its Major Metabolite*:</b> Parameters ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Oral administration of ozanimod (0, 8, 25, or 80 mg/kg/day) to Tg.rasH2 mice for 26-weeks resulted in an increase in hemangioma and hemangiosarcoma (combined) in males and females at the ...
14. Clinical Studies
The efficacy of ZEPOSIA was demonstrated in 2 randomized, double-blind, double-dummy, parallel-group, active comparator-controlled clinical trials of similar design, in patients with relapsing forms of ...
16.1. How Supplied
ZEPOSIA is available as capsules in the following dosage strengths: Ozanimod 0.23 mg: light grey opaque body/light grey opaque cap imprinted with black ink OZA on the cap and 0.23 mg on the body Ozanimod ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Infections Inform patients that they may be more likely to get infections, some of which could be life-threatening, ...