OCREVUS
OCRELIZUMAB · by ROCHE
Composition
Inj: Ocrelizumab 30 mg per 1 ml; 300mg/10ml concentrate for solution for infusion vials
Indications & Dosage
Primary progressive Multiple sclerosis, Relapsing forms of multiple sclerosis: BY IV INF: Adult: Initially 300 mg, then 300 mg after 2 weeks; maintenance 600 mg every 6 months; a minimum interval of 5 months should be maintained between each maintenance dose.
Administration
Administer only as an IV infusion through a dedicated line using an infusion set with a 0.2 or 0.22 micron in-line filter. Preparation of solution for infusion: Dilute into an infusion bag containing 0.9% sodium chloride injection, to a final drug concentration of approximately 1.2 mg/ml. Withdraw 10 ml (300 mg) of Ocrelizumab and inject into 250 ml, or withdraw 20 ml (600 mg) of Ocrelizumab and inject into 500 ml. Do not use other diluents to dilute Ocrelizumab since their use has not been tested. The product contains no preservative and is intended for single use only
Compatibility
Stable in NS
Stability
Store at 2C to 8C (36F to 46F) for up to 24 hours. After allowing the diluted bag to come to room temperature, use immediately.
Contraindications
Patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reaction to Ocrelizumab, active infection, active malignancies, severely immunocompromised patients
Precautions
Pre-medicate with recommended medication before each infusion. Patients should be screened for hepatitis B before treatment. Risk of hepatitis B infection and reactivation; patients with positive hepatitis B serology should be referred to a liver specialist. Patients should be closely monitored for signs of active hepatitis B infection during treatment and for up to a year following the last infusion risk of immunogenicity. Patients should also be monitored for cytopenias. Monitor for signs and symptoms of progressive multifocal leucoencephalopathy (PML) (including any new onset or worsening of neurological symptoms); if PML is suspected, interrupt treatment; discontinue if PML is confirmed. Monitor for infusion-related reactions during the infusion and observe patients for 1 hour after completion of the infusion; if severe pulmonary symptoms occur, permanently discontinue treatment.
Interactions
Live vaccines (avoid), BCG, belimumab, natalizumab, pimecrolimus, topical tacrolimus, fingolimod, leflunomide, tofacitinib, roflumilast, trastuzumab, nivolumab
Pregnancy
Contraindicated, use contraceptives during treatment and for 12 months after the last dose
Lactation
Contraindicated discontinue breast-feeding
Side Effects
Anaphylactic reaction, alopecia, anaemia, arthralgia, asthenia, constipation, diarrhea, cough, cytokine release syndrome, depression, dyspnea, fever, flushing, headache, hypertension, hypotension, infusion related reaction, leucopenia, nausea, neutropenia, pruritus, sweat changes, tachycardia, thrombocytopenia, tumour lysis syndrome, vomiting Rare: Progressive multifocal leukoencephalopathy, hepatitis B reactivation