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Osiren MS

Prospect

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Formula

OSIREN MSN 0.23 mg: Each hard capsule of OSIREN MS 0.23 mg contains: Active ingredient: Ozanimod 0.23 mg (Equivalent to 0.25 mg of Ozanimod Hydrochloride). OSIREN MS 0.46 mg: Each hard capsule of OSIREN MS 0.46 mg contains: Active ingredient: Ozanimod 0.46 mg (Equivalent to 0.50 mg of Ozanimod Hydrochloride). OSIREN MS 0.92 mg Each hard capsule of OSIREN MS 0.92 mg contains: Active ingredient: Ozanimod 0.92 mg (Equivalent to 1.00 mg of Ozanimod Hydrochloride). Each capsule contains: Fingolimod (as Fingolimod Hydrochloride) 0.5 mg.

Mechanism of Action

Selective immunosuppressant.

Indications

OSIREN MS (Ozanimod 0.23 mg, 0.46 mg and 0.92 mg) is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

Dosage and Administration

The recommended dose is 0.92 mg of Ozanimod once daily. An initial dosing schedule of escalating doses of Ozanimod from day 1 through day 7 is required: Days 1-4: 0.23 mg once daily, Days 5-7: 0.46 mg once a day Days 8 and thereafter: 0.92 mg once daily

Package Size

Starter pack: OSIREN MS 0.23 mg/OSIREN MS 0.46 mg Each pack contains: 1 blister with 4 hard capsules of OSIREN MS 0.23 mg and 1 blister with 4 hard capsules of OSIREN MS 0.23 mg and 1 blister with 4 hard capsules of OSIREN MS 0.23 mg and 1 blister with 4 hard capsules of OSIREN MS 0.46 mg.

Maintenance treatment package: OSIREN MS 0.92 mg Each package contains 28 hard capsules.