Rixathon

Non-Hodgkin's lymphoma (NHL): Previously untreated adults w/ stage III-IV follicular lymphoma in combination w/ chemotherapy; maintenance therapy for treatment of follicular lymphoma patients responding to induction therapy; monotherapy for treatment of adults w/ stage III-IV follicular lymphoma who are chemoresistant or are in their 2nd or subsequent relapse after chemotherapy; treatment of adults w/ CD20 +ve diffuse large B cell non-Hodgkin's lymphoma in combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy; combination w/ chemotherapy for treatment of paed patients (aged ≥6 mth to <18 yr) w/ previously untreated advanced stage CD20 +ve diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL): Combination w/ chemotherapy for treatment of patients w/ previously untreated & relapsed/refractory CLL. RA: Combination w/ MTX for treatment of adults w/ severe active RA who have had inadequate response or intolerance to other DMARDs including ≥1 tumour necrosis factor (TNF) inhibitor therapies. Granulomatosis w/ polyangiitis (GPA) & microscopic polyangiitis (MPA): Combination w/ glucocorticoids for treatment of adults w/ severe, active GPA (Wegener's) & MPA; for induction of remission in paed patients (aged ≥2 to <18 yr) w/ severe, active GPA (Wegener's) & MPA. Pemphigus vulgaris: Treatment of moderate to severe pemphigus vulgaris (PV).

IV infusion Adult 1st infusion: Initially 50 mg/hr; after 1st 30 min, it can be escalated in 50 mg/hr increments every 30 min to max of 400 mg/hr. Subsequent infusions: Initially 100 mg/hr, & increased by 100 mg/hr increments at 30 min intervals to max of 400 mg/hr. Alternative subsequent, faster infusion schedule for RA: Initially 250 mg/hr for the 1st 30 min & then 600 mg/hr for the next 90 min. If tolerated, this infusion schedule can be used when administering subsequent infusions. Combination therapy for induction treatment of previously untreated or relapsed/refractory follicular NHL 375 mg/m² per cycle for up to 8 cycles, administered on day 1 of each chemotherapy cycle, after IV administration of glucocorticoid component. Maintenance therapy of previously untreated follicular lymphoma 375 mg/m² once every 2 mth (starting 2 mth after last dose of induction therapy) until disease progression or max period of 2 yr (12 infusions in total). Maintenance therapy of relapsed/refractory follicular lymphoma 375 mg/m² once every 3 mth (starting 3 mth after last dose of induction therapy) until disease progression or max period of 2 yr (8 infusions in total). Monotherapy for induction treatment of stage III-IV follicular lymphoma that is chemoresistant or in 2nd or subsequent relapse after chemotherapy 375 mg/m² once wkly for 4 wk. Retreatment w/ rituximab monotherapy for relapsed/refractory follicular lymphoma 375 mg/m² once wkly for 4 wk. DLBCL in combination w/ CHOP chemotherapy 375 mg/m² on day 1 of each cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP. Combination therapy for previously untreated & relapsed/refractory CLL 375 mg/m² administered on day 0 of 1st treatment cycle followed by 500 mg/m² administered on day 1 of each subsequent cycle for 6 cycles in total. Chemotherapy should be given after rituximab infusion. RA 1,000 mg followed by a 2nd 1,000 mg 2 wk later. The need for further courses should be evaluated 24 wk following the previous course. Induction of remission therapy for GPA & MPA 375 mg/m² once wkly for 4 wk (4 infusions in total). Maintenance treatment of GPA & MPA Initiate no sooner than 16 wk after last rituximab infusion. If following induction of remission w/ other standard of care immunosuppressants, initiate during the 4 wk period that follows disease remission. Rituximab should be administered as two 500-mg IV infusions separated by 2 wk, followed by 500 mg every 6 mth thereafter. Patient should receive rituximab for at least 24 mth after achievement of remission (absence of clinical signs & symptoms). Consider longer duration of rituximab maintenance therapy, up to 5 yr for patient who may be at higher risk for relapse. PV 1,000 mg followed 2 wk later by 2nd 1,000 mg in combination w/ tapering course of glucocorticoids. Maintenance: 500 mg administered at mth 12 & 18, & then every 6 mth thereafter if needed. Treatment of relapse: 1,000 mg. Subsequent infusions may be administered no sooner than 16 wk following previous infusion. Paed patient ≥6 mth to <18 yr Previously untreated, advanced stage CD20 +ve DLBCL/BL/BAL/BLL 1st infusion: Initially 0.5 mg/kg/hr (max 50 mg/hr), can be escalated by 0.5 mg/kg/hr every 30 min to max of 400 mg/hr. Subsequent infusions: Initially 1 mg/kg/hr (max 50 mg/hr), can be increased by 1 mg/kg/hr every 30 min to max of 400 mg/hr. Recommended dose: 375 mg/m² in combination w/ systemic Lymphome Malin B (LMB) chemotherapy. Paed patient ≥2 to <18 yr Severe, active GPA or MPA 375 mg/m² once wkly for 4 wk.

Hypersensitivity to rituximab or murine proteins. Active, severe infections. Patients in a severely immunocompromised state. RA, GPA, MPA & PV: Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.

Should not be administered as IV push or bolus. Monitor patients at regular intervals for any new or worsening neurological symptoms or signs suggestive of progressive multifocal leukoencephalopathy (PML). Permanently discontinue if PML develops. Associated w/ infusion-related reactions including syndrome of cytokine release, tumour lysis syndrome & anaphylactic & hypersensitivity reactions. Risk of angina pectoris, cardiac arrhythmias eg, atrial flutter & fibrillation, heart failure &/or MI; serious infections; hepatitis B reactivation. Caution in patients w/ neutrophils <1.5 x 10⁹/L &/or platelet counts <75 x 10⁹/L. Perform regular FBC, including neutrophil & platelet counts. Permanently discontinue in case of severe skin reactions eg, TEN (Lyell's syndrome) & SJS. Vaccination w/ live virus vaccines is not recommended. Contains 2.3 mmol Na per 10 mL vial & 11.5 mmol Na per 50 mL vial. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Should not be administered to pregnant women unless possible benefit outweighs the potential risk. Breast-feeding is not recommended while on treatment & for 12 mth following rituximab treatment. Limited data are available for patients <3 yr. RA, GPA, MPA, PV: Rituximab is not recommended in MTX-naïve RA patients. Measure blood neutrophils prior to each course of rituximab, & regularly up to 6 mth after cessation of treatment, & upon signs or symptoms of infection. Concomitant use of rituximab & anti-rheumatic therapies other than those specified under RA indication & posology is not recommended.

Infusion-related reactions. NHL & CLL: Bacterial & viral infections, bronchitis; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; angioedema; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG levels. Sepsis, pneumonia, febrile infection, herpes zoster, resp tract infection, fungal infections, infections of unknown aetiology, acute bronchitis, sinusitis, hepatitis B; anaemia, pancytopenia, granulocytopenia; hypersensitivity; hyperglycaemia, decreased wt, peripheral & face oedema, increased LDH, hypocalcaemia; paraesthesia, hypoaesthesia, 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, dyspnoea, increased cough, rhinitis; vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation; urticaria, sweating, night sweats, skin disorder; hypertonia, myalgia, arthralgia, back & neck pain, pain; tumour pain, flushing, malaise, cold syndrome, fatigue, shivering, multi-organ failure. RA: URTI, UTI; headache; decreased IgM levels. Bronchitis, sinusitis, gastroenteritis, tinea pedis; neutropenia; hypercholesterolemia; depression, anxiety; paraesthesia, migraine, dizziness, sciatica; dyspepsia, diarrhoea, GERD, mouth ulceration, upper abdominal pain; alopecia; arthralgia/musculoskeletal pain, OA, bursitis, decreased IgG levels. GPA & MPA: UTI, bronchitis, herpes zoster, nasopharyngitis, rhinitis; thrombocytopenia; cytokine release syndrome; hyperkalemia; insomnia; dizziness, tremor; HTN, flushing; cough, dyspnoea, epistaxis, nasal congestion; diarrhoea, dyspepsia, constipation; acne; muscle spasms, arthralgia, back pain, muscle weakness, musculoskeletal pain, pain in extremities; peripheral oedema, pyrexia, flu-like illness; decreased Hb. PV: URTI; persistent depressive disorder; headache; alopecia. Herpes virus infection, herpes zoster, oral herpes, conjunctivitis, nasopharyngitis, oral candidiasis, UTI; skin papilloma; major depression, irritability; dizziness; tachycardia; upper abdominal pain; pruritus, urticaria, skin disorder; musculoskeletal pain, arthralgia, back pain; fatigue, asthenia, pyrexia.

Patients w/ human anti-mouse Ab (HAMA) or anti-drug Ab (ADA) titres may have allergic or hypersensitivity reactions when treated w/ other diagnostic or therapeutic monoclonal Ab. Closely observe for signs of infection if biologic agents &/or DMARDs are used following rituximab therapy in RA patients.

Targeted Cancer Therapy / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

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

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