about Vortuxi
Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes.
The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences.Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids.
Special Warnings and Precautions
Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function, Infections: Withhold Vortuxi and institute appropriate anti-infective therapy, Cardiac arrhythmias and angina: Discontinue infusions in case of serious or life-threatening events, Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms, Live virus vaccines: Do not administer live virus vaccines prior to or during Vortuxi, Cytope¬nias: Monitor blood counts at regular intervals
Rituximab Vortuxi
Composition
Rituximab (r-DNA Origin) 500 mg, Sodium chloride I.P. 450 mg, Tri sodium citrate dihydrate I.P. 367.5 mg, Polysorbate 80 I.P.35.0 mg, Water for Injections I.P. q.s. to 50ml.
Dosage Form
Injection: 500 mg/50 mL concentrate for solution for infusion in a single-use vial
Dosage and Administration
Administer only as an Intravenous Infusion. Do not administer as an intravenous push or bolus.Premedicate before each infusion with acetaminophen and an antihistamine.
Indications
Rituximab in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis.
Contraindications
Hypersensitivity to the active substance or to murine proteins, or to any of the excipients.
Warnings and Precautions
Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function.