Truxima

Rituximab

Relapsed or chemoresistant low-grade or follicular, CD20 +ve, B-cell non-Hodgkin's lymphoma. In combination w/ chemotherapy for previously untreated patients w/ stage III-IV follicular lymphoma; ped patients ≥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). Maintenance treatment of follicular lymphoma after response to induction therapy. In combination w/ cyclophosphamide, doxorubicin, vincristine & prednisone (CHOP) chemotherapy for CD20 +ve diffuse large B-cell non-Hodgkin's lymphoma. In combination w/ chemotherapy for previously untreated & relapsed/refractory chronic lymphocytic leukemia (CLL). In combination w/ MTX in adults w/ moderate to severe, active RA w/ inadequate response to DMARDs or inadequate response or intolerance to ≥1 tumour necrosis factor inhibitor therapies. Reduces rate of progression of joint damage as measured by X-ray, to improve physical function & induce major clinical response in combination w/ MTX. In combination w/ glucocorticoids in adults w/ severe active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA); for induction of remission in ped patients ≥2 to <18 yr w/ severe, active GPA & MPA. Moderate to severe pemphigus vulgaris (PV).

IV infusion Premed: Analgesic/antipyretic & antihistamine. Consider glucocorticoids if Truxima is not given in combination w/ glucocorticoid-containing chemotherapy. Adult Low-grade or follicular non-Hodgkin's lymphoma Initial treatment: Monotherapy: 375 mg/m² once wkly for 4 wk. Combination therapy (w/ any chemotherapy): 375 mg/m²/cycle for total of 8 cycles w/ R-CVP (21 days/cycle); 8 cycles w/ R-MCP (28 days/cycle); 8 cycles w/ R-CHOP (21 days/cycle); 6 cycles if complete remission is achieved after 4 cycles; 6 cycles w/ R-CHVP-Interferon (21 days/cycle). Administer on day 1 of each cycle after IV administration of glucocorticoid component of chemotherapy if applicable. Re-treatment following relapse: Initially 375 mg/m² once wkly for 4 wk. Maintenance treatment: Previously untreated patients after response to induction treatment 375 mg/m² once every 2 mth until disease progression or max period of 2 yr (total: 12 infusions). Relapsed/refractory patients after response to induction treatment 375 mg/m² once every 3 mth until disease progression or max period of 2 yr (total: 8 infusions). Diffuse large B-cell non-Hodgkin's lymphoma In combination w/ CHOP: 375 mg/m² administered on day 1 of each cycle for 8 cycles after IV glucocorticoid component of CHOP. 1st infusion: Initial rate 50 mg/hr, may subsequently escalate in 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusion: Initial rate 100 mg/hr & increased by 100 mg/hr increments every 30 min. Max: 400 mg/hr. CLL Prophylaxis w/ adequate hydration & administration of uricostatics 48 hr prior to start of therapy. Patients whose lymphocyte counts are >25 x10⁹/L Administer prednisone/prednisolone 100 mg IV shortly before infusion w/ Truxima. Previously untreated & relapsed/refractory patients In combination w/ chemotherapy: 375 mg/m² administer on day 1 of 1st cycle followed by 500 mg/m² on day 1 of each subsequent cycle for 6 cycles in total. Chemotherapy should be given after Truxima infusion. 1st infusion: Initial infusion rate 50 mg/hr, subsequently, can be escalated in 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusions: Initially 100 mg/hr & increased by 100 mg/hr increments every 30 min. Max: 400 mg/hr. RA Premed: Methylprednisolone 100 mg IV 30 min prior to both Truxima infusions. 1,000 mg followed 2 wk later by 2nd 1,000 mg IV infusion. 1st infusion: Initial rate 50 mg/hr; after 1st 30 min, it can be escalated in 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusions: Initial rate 100 mg/hr & increased by 100 mg/hr increments at 30 min intervals. Max: 400 mg/hr. Alternative rapid infusion: Initially 250 mg/hr for 1st 30 min, then 600 mg/hr for next 90 min. GPA & MPA Premed: Methylprednisolone 100 mg IV 30 min prior to each Truxima infusions. Induction of remission: 375 mg/m² once wkly for 4 wk (total: 4 infusions). In combination w/ methylprednisolone given IV for 1-3 days & 1,000 mg daily for severe vasculitis symptoms, followed by oral prednisone 1 mg/kg (max: 80 mg daily) during & after 4 wk induction course of treatment. Maintenance treatment: Following induction of remission, initiate no sooner than 16 wk after last infusion. Following induction of remission w/ other standard of care immunosuppressants, initiate maintenance treatment during 4-wk period that follows disease remission. Administer as two 500 mg separated by 2 wk, followed by 500 mg at 6, 12 & 18 mth & then every 6 mth thereafter for at least 24 mth after achievement of remission. 1st infusion: Initial rate 50 mg/hr; after 1st 30 min, it can be escalated in 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusion: Initial infusion rate 100 mg/hr, & increased by 100 mg/hr increments at 30 min intervals. Max: 400 mg/hr. PV 1,000 mg followed 2 wk later by 2nd 1,000 mg in combination w/ tapering course of glucocorticoids. Maintenance treatment: 500 mg at mth 12 & then every 6 mth thereafter. Treatment of relapse: 1,000 mg IV. Administer subsequent infusions no sooner than 16 wk following the previous infusion. Ped patients Non-Hodgkin's lymphoma 375 mg/m² in combination w/ systemic Lymphome Malin B chemotherapy for ped patients ≥6 mth to <18 yr w/ previously untreated, advanced stage CD20 +ve DLBCL/BL/BAL/BLL. 1st infusion: Initial infusion rate 0.5 mg/kg/hr (max: 50 mg/hr), can be escalated in 0.5 mg/kg/hr every 30 min. Max: 400 mg/hr. Subsequent infusions: Initially 1 mg/kg/hr (max: 50 mg/hr), increased by 1 mg/kg/hr every 30 min. Max: 400 mg/hr. Severe, active GPA & MPA Induction of remission: 375 mg/m² once wkly for 4 wk. Prior to 1st Truxima infusion, administer methylprednisolone IV for 3 daily doses of 30 mg/kg daily (max: 1 g daily) for severe vasculitis symptoms. May give up to 3 additional daily doses of methylprednisolone 30 mg/kg IV prior to 1st Truxima infusion. Following completion of methylprednisolone IV, administer oral prednisone 1 mg/kg daily (max: 60 mg daily).

Hypersensitivity to rituximab or murine proteins. Active, severe infections; severe heart failure (NYHA class IV) or uncontrolled cardiac disease. Severely immunocompromised patients.

Anaphylactic & other hypersensitivity reactions. Not to be administered as IV push or bolus. Permanently discontinue in severe skin reactions eg, TEN & SJS. Interrupt treatment immediately in severe pulmonary events. Not to be initiated in patients w/ severe active infections. Not to be administered in patients w/ active hepatitis B or severely immunocompromised. Not recommended in MTX-naïve patients. Progressive multifocal leukoencephalopathy. Patients w/ high tumour burden or high number (>25 x 10⁹/L) of circulating malignant cells eg, patients w/ CLL & mantle cell lymphoma; history of pulmonary insufficiency or pulmonary tumour infiltration, cardiac disease; neutrophil counts <1.5 x10⁹/L &/or platelet counts <75 x 10⁹/L; history of recurring or chronic infections or w/ underlying conditions predisposing to serious infection. Closely monitor patients experiencing pulmonary events or other severe infusion-related symptoms; w/ history of cardiac disease; w/ preexisting cardiac conditions & those who experienced prior cardiopulmonary adverse reactions. Perform lab monitoring in patients who develop signs & symptoms consistent w/ rapid tumor lysis; regular FBC including platelet counts during monotherapy & in combination w/ CHOP or CVP chemotherapy; HBV screening before initiation of treatment. Complete vaccination at least 4 wk prior to 1st administration of therapy. Withhold antihypertensive medications 12 hr prior to & throughout infusion. Not recommended in concomitant use w/ live viral vaccines. Renal & hepatic impairment. Women of childbearing age should employ effective contraceptive methods during & for up to 12 mth after treatment. Not to be administered during pregnancy & lactation. Not to be used from birth to <6 mth w/ CD20 +ve DLBCL, in ped patients w/ severe, active GPA/MPA <2 yr. Ped patients <3 yr.

Bacterial & viral infections, bronchitis, URTI, UTI; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; angioedema, infusion-related reactions; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG levels; persistent depressive disorder. Sepsis, pneumonia, febrile, resp tract & fungal infections, herpes zoster, infections of unknown aetiology, acute bronchitis, sinusitis, hepatitis B, gastroenteritis, tinea pedis, herpes virus infection, oral herpes, nasopharyngitis, oral candidiasis; anaemia, pancytopenia, granulocytopenia; hypersensitivity, pyrexia, urticaria, hot flush, rigors, oropharyngeal pain, peripheral oedema, erythema; hyperglycaemia, decreased wt, peripheral & face edema, increased LDH, hypocalcaemia, hypercholesterolaemia; paresthesia, hypoesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety, migraine, sciatica; lacrimation disorder, conjunctivitis; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder; HTN, orthostatic hypotension, hypotension; bronchospasm, resp disease, chest pain, dyspnoea, cough, rhinitis; vomiting, diarrhea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation, gastroesophageal reflux, mouth ulceration, upper abdominal pain; urticaria, sweating, night sweats, skin disorder; hypertonia, myalgia, arthralgia, back, neck & musculoskeletal pain, pain, OA, bursitis; tumour pain, flushing, malaise, cold syndrome, fatigue, shivering; depression, irritability; skin papilloma.

May develop allergic or hypersensitivity reactions w/ other diagnostic or therapeutic monoclonal Abs.

Targeted Cancer Therapy

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

S