Rituxsanbe

Rituximab

Relapsed or chemoresistant low-grade or follicular, CD20 +ve, B-cell non-Hodgkin's lymphoma (NHL). Treatment of patients w/ stage III-IV follicular lymphoma in combination w/ CVP chemotherapy. Maintenance treatment for patients w/ follicular lymphoma after response to induction therapy. Treatment of CD20 +ve diffuse large B-cell NHL in combination w/ CHOP chemotherapy.

Low-grade or follicular NHL 375 mg/m² as IV infusion once wkly for 4 wk. In combination w/ any chemotherapy, 375 mg/m² for 8 cycles w/ R-CVP (21 days/cycle), R-MCP (28 days/cycle), R-CHOP (21 days/cycle); 6 cycle if a complete remission is achieved after 4 cycles, 6 cycles w/ R-CHVP-interferon (21 days/cycle), administered on day 1 of each chemotherapy cycle. Retreatment following relapse in NHL 375 mg/m² as IV infusion once wkly for 4 wk. Maintenance treatment 375 mg/m² once every 2 mth until disease progression or for a max period of 2 yr (12 infusions). Maintenance therapy for relapsed/refractory patients 375 mg/m² once every 3 mth until disease progression or for a max period of 2 yr. Diffuse large B cell NHL 375 mg/m², administered on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP.

Hypersensitivity to rituximab or to murine proteins. Active, severe infections. Patients in a severely immunocompromised state. Patients who have or had progressive multifocal leukoence-phalopathy (PML). Severe heart failure (NYHA class IV) or severe uncontrolled cardiac disease.

Hypersensitivity reactions. Not to be initiated in patients w/ severe active infections; active hepatitis B disease. Discontinue in case of TEN & SJS. Interrupt treatment immediately if patient develops severe cytokine release syndrome. Resolve or rule out tumour lysis syndrome & pulmonary infiltration in patients w/ initial improvement of clinical symptoms followed by deterioration. High risk of developing infusion-related reactions in patients w/ CLL & mantle cell lymphoma; closely monitor patients experiencing pulmonary events or other severe infusion-related symptoms. History of pulmonary insufficiency or w/ pulmonary tumour infiltration. Consider prophylaxis for tumour lysis syndrome in patients at risk of developing rapid tumour lysis; perform appropriate lab monitoring & closely followed; w/holding antihypertensive medications 12 hr prior to & throughout therapy. Closely monitor patients w/ history of cardiac disease. Patients w/ neutrophil count <1.5 x 10⁹/L &/or platelet count <75 x 10⁹/L. Regular full blood counts including platelet counts. History of hepatitis B infection when used in association w/ cytotoxic chemotherapy. Perform HBV screening in all patients before initiation of treatment. Consider PML in patients w/ NHL or CLL. Vaccination w/ live virus vaccines following rituximab IV/SC therapy. Women of child-bearing potential should use effective contraception while receiving & for 12 mth following treatment. Pregnancy. Nursing mothers. Not recommended in childn.

Neuropenia, thrombocytopenia; alopecia. Monotherapy/Maintenance Therapy: Bacterial, viral infections; leucopenia; angioedema; nausea; pruritus, rash; fever, chills, asthenia, headache; decreased IgG levels. Sepsis, pneumonia, febrile infection, herpes zoster, resp tract infection, fungal infections, infections of unknown aetiology; anemia; hypersensitivity; hyperglycaemia, decreased wt, peripheral edema, face edema, increased LDH, hypocalcemia; paresthesia, hypoesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety; lacrimation disorder, conjunctivitis; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder; HTN, orthostatic hypotension, hypotension; bronchospasm, resp disease, chest pain, dyspnea, cough, rhinitis; vomiting, diarrhea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation; urticaria, sweating, night sweats; hypertonia, myalgia, arthralgia, back pain, neck pain, pain; tumour pain, flushing, malaise, cold syndrome. In Combination with Chemotherapy in NHL & CLL: Bronchitis; febrile neutropenia. Sinusitis, hepatitis B; pancytopenia, granulocytopenia; skin disorder; fatigue, shivering.

Patients w/ human anti-mouse Ab or anti-chimeric Ab titres may develop allergic or hypersensitivity reactions when treated w/ other diagnostic or therapeutic monoclonal Ab.

Targeted Cancer Therapy

L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.

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