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See related MabThera infusion information |
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Manufacturer |
Roche |
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Distributor |
DKSH |
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Contents |
Rituximab |
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Indications |
Treatment of relapsed or chemoresistant indolent B-cell non-Hodgkin's lymphomas. Treatment of previously untreated CD20 positive indolent B-cell non-Hodgkin's stage III-IV follicular lymphoma (FL) in combination w/ chemotherapy. Maintenance treatment of follicular lymphoma after response to induction therapy. Combination w/ CHOP chemotherapy in treatment of CD20 positive diffused large B-cell non-Hodgkin's lymphoma (DLCL). Treatment of previously untreated & relapsed/refractory of patients w/ chronic lymphocytic leukaemia (CLL). Combination w/ methotrexate in the treatment of moderate to severe, active RA in adults who have had inadequate response or intolerance to DMARDs &/or tumour necrosis factor (TNF) inhibitor therapies. Reduce progression rate of joint damage.
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Dosage |
Relapsed low-grade non-Hodgkin's lymphoma 375 mg/m2 BSA via IV infusion once wkly for 4 wk or 375 mg/m2 BSA in combination w/ any chemotherapy. Maintenance treatment for patients who responded to induction 375 mg/m2 once every 2 mth until disease progression or max 2 yr for previously untreated FL patients & every 3 mth until disease progression or max 2 yr for relapsed/refractory patients. DLCL 375 mg/m2 BSA, administered on day 1 of each chemotherapy cycle for 8 cycles after IV administration of the glucocorticoid component of CHOP. Other components of CHOP (cyclophosphamide, doxorubicin & vincristine) should be given after MabThera administration. Maintenance treatment for patients who responded to induction 375 mg/m2 once every 3 mth until disease progression or max 2 yr. CLL 375 mg/m2 on day 1 of the 1st treatment cycle followed by 500 mg/m2 on day 1 of cycle 2-6 combine w/ any chemotherapy after MabThera infusion. Premed: Methylprednisolone 100 mg IV 30 min prior to MabThera to decrease the rate & severity of acute infusion reactions. 1st infusion: 50 mg/hr IV infusion through a dedicated line; can be escalated in 50-mg/hr increments every 30 min to a max of 400 mg/hr. Subsequent infusions: 100 mg/hr & increased by 100-mg/hr increments every 30 min to a max of 400 mg/hr. RA 1,000 mg IV infusion followed 2 wk later by the 2nd 1,000 mg IV infusion. Further courses should be given no sooner than 16 wk following the previous course. Premed: Methylprednisolone 100 mg IV 30 min prior to MabThera to decrease the rate & severity of acute infusion reactions. 1st infusion: Initially 50 mg/hr IV infusion through a dedicated line; can be escalated in 50-mg/hr increments every 30 min to a max of 400 mg/hr. Subsequent infusions: 100 mg/hr; increased by 100-mg/hr increments every 30 min to a max of 400 mg/hr.
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Overdosage |
View MabThera overdosage for action to be taken in the event of an overdose. |
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Contraindications |
Hypersensitivity to rituximab or to murine proteins. Lactation.
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Special Precautions |
Patients w/ a high number (>25,000 mm3) of circulating malignant cells or high tumour burden eg CLL & Mantle cell lymphoma; history of pulmonary insufficiency, pulmonary tumor infiltration. Withhold antihypertensive medications 12 hr prior to & throughout MabThera infusion. History of cardiac disease. Neutrophil count <1.5 x 109/L &/or platelet count <75 x 109/L. Infusion reaction, infection. Immunization. Progressive multifocal leukoencephalopathy. Pregnancy. Women of childbearing age should employ effective contraceptive methods during & for up to 12 mth after treatment w/ MabThera. Childn.
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Adverse Drug Reactions |
Cytokine release syndrome, mainly comprised of fever, chills & rigors. Bronchoconstriction, mild & transient increases in liver function parameters, diarrhea, dyspepsia, anorexia, arthralgia, myalgia, pain, hypertonia, dizziness, anxiety, paresthesia, hypoesthesia, agitation, insomnia, nervousness, cough, sinusitis, bronchitis, resp disease, night sweats, sweating, herpes simplex, herpes zoster, lacrimation disorder, conjunctivitis, dysgeusia, dysuria, hematuria, severe vision loss, hearing loss, loss of other senses, facial nerve palsy, HTN, hypotension, rash, pruritus, rhinitis, throat irritation, urticaria, hot flush, hypercholesterolemia, UTI, OA, migraine, infection, upper resp tract infection.
View ADR Monitoring Form |
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Drug Interactions |
[Click for MabThera detailed prescribing infomation]
View more drug interactions with MabThera |
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Pregnancy Category (US FDA) |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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Caution For Usage |
For caution against possible variation of physical aspect of medicine... click to view MabThera detailed prescribing infomation |
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Storage |
View MabThera storage conditions for details to ensure optimal shelf-life. |
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Description |
View MabThera description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View MabThera mechanism of action for pharmacodynamics and pharmacokinetics details. |
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