Rituximab INN
COMPOSITION: Each vial (50ml) contains Rituximab INN 500mg (10mg/ml) solution for IV infusion.
INDICATION:
• Non–Hodgkin’s Lymphoma (NHL): Rituximab is indicated
for the treatment of adult patients with: • Relapsed or refractory, low-grade
or follicular, CD20-positive, B-cell NHL as a single agent. • Previously
untreated follicular, CD20-positive, B-cell NHL in combination with first line
chemotherapy and, in patients achieving a complete or partial response to a
rituximab product in combination with chemotherapy, as single-agent maintenance
therapy. • Non-progressing (including stable disease), low-grade,
CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide,
vincristine, and prednisone (CVP) chemotherapy. • Previously untreated diffuse
large B-cell, CD20-positive NHL in combination with cyclophosphamide,
doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy
regimens. Rituximab is indicated for the treatment of pediatric patients aged 6
months and older with: • Previously untreated, advanced stage, CD20-positive
diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like
lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with
chemotherapy. • Chronic Lymphocytic
Leukemia (CLL): Rituximab, in combination with fludarabine and
cyclophosphamide (FC), is indicated for the treatment of adult patients with
previously untreated and previously treated CD20-positive CLL. • Rheumatoid Arthritis (RA): Rituximab,
in combination with methotrexate, is indicated for the treatment of adult
patients with moderately- to severely-active rheumatoid arthritis who have had
an inadequate response to one or more TNF antagonist therapies. • Granulomatosis with Polyangiitis (GPA)
(Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): Rituximab,
in combination with glucocorticoids, is indicated for the treatment of adult
and pediatric patients 2 years of age and older with Granulomatosis with
Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis
(MPA). • Pemphigus Vulgaris (PV):
Rituximab is indicated for the treatment of adult patients with moderate to
severe pemphigus vulgaris.
DOSAGE AND ADMINISTRATION: Administration only as an Intravenous Infusion: It should not be administered as an intravenous push or bolus. Rituximab should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. It should be premedicated before each infusion. Or, as directed by the registered physicians. Please see the full insert inside.
USE IN PREGNANCY: Rituximab can cause fetal harm when administered to a pregnant woman. Rituximab can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to Rituximab in-utero. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Lactation: There are limited data on the presence of Rituximab in human milk and the effect on the breastfed child, and there are no data on the effect on milk production. Rituximab has also been reported to be excreted at low concentrations in human breast milk. Given that the clinical significance of this finding for children is not known, Women should not be advised to breastfeed during treatment with Rituximab and for 6 months after the last dose due to the potential of serious adverse reactions in breastfed children.
PACKAGING: Each box contains one vial of 50ml sterile solution of Rituximab 500mg for IV infusion.
