Basic Information
ZEPOSIA CAPSULES 0.92 MG
CAPSULE
Regulatory Information
SIN16786P
May 17, 2023
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
Company Information
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Active Ingredients
Strength: 0.92 mg
Detailed Information
Contraindications
**4.3 Contraindications** - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Immunodeficient state (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients who in the last 6 months experienced myocardial infarction (MI), unstable angina, stroke, transient ischaemic attack (TIA), decompensated heart failure requiring hospitalisation or New York Heart Association (NYHA) Class III/IV heart failure. - Patients with history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block or sick sinus syndrome unless the patient has a functioning pacemaker. - Severe active infections, active chronic infections such as hepatitis and tuberculosis (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Active malignancies. - Severe hepatic impairment (Child-Pugh class C). - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients who are taking a monoamine oxidase (MAO) inhibitor.
Indication Information
**4.1 Therapeutic indications** Multiple sclerosis Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features, to decrease the frequency of clinical exacerbations. (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).