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Rituximab

Previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy; maintenance therapy for follicular lymphoma patients responding to induction therapy; monotherapy for stage III-IV follicular lymphoma in patients that are chemo-resistant or in 2nd or subsequent relapse after chemotherapy; patients w/ CD20 +ve diffuse large B cell non-Hodgkin's lymphoma in combination w/ cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) chemotherapy. In combination w/ chemotherapy, for previously untreated & relapsed/refractory chronic lymphocytic leukemia. In combination w/ MTX, to reduce signs & symptoms in adults w/ moderately to severely active RA who had inadequate response or intolerance to ≥1 TNF antagonist therapies.

1st infusion: Recommended initial rate: 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 infusion: Initial rate: 100 mg/hr, & increased by 100 mg/hr increments every 30 min interval to max of 400 mg/hr. Always administer premed consisting of antipyretic & antihistamine eg, paracetamol & diphenhydramine prior to each infusion. Patient w/ RA Premed w/ 100 mg methylprednisolone IV should be completed 30 min prior to infusion. Follicular non-Hodgkin's lymphoma Previously untreated or relapsed/refractory patients In combination w/ chemotherapy: 375 mg/m²/cycle for up to 8 cycles. Administer on day 1 of each chemotherapy cycle after IV administration of glucocorticoid component of the chemotherapy. Previously untreated follicular lymphoma Responded to induction treatment Maintenance: 375 mg/m² once every 2 mth (starting 2 mth after last dose of induction therapy) until disease progression or for max period of 2 yr. Relapsed/refractory follicular lymphoma Responded to induction treatment Maintenance: 375 mg/m² once every 3 mth (starting 3 mth after last dose of induction therapy) until disease progression or for max period of 2 yr. Patients w/ stage III-IV follicular lymphoma who are chemoresistant or in 2nd or subsequent relapse after chemotherapy Monotherapy (as induction treatment): 375 mg/m² as IV infusion once wkly for 4 wk. Diffuse large B cell non-Hodgkin's lymphoma In combination w/ CHOP chemotherapy: 375 mg/m² administered on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of glucocorticoid component of CHOP. Chronic lymphocytic leukemia Prophylaxis w/ adequate hydration & administer uricostatics starting 48 hr prior to start of therapy. Patients w/ >25 x 10⁹/L lymphocyte counts Administer prednisone/prednisolone 100 mg IV shortly before rituximab infusion. Previously untreated & relapsed/refractory patients Recommended dose in combination w/ chemotherapy: 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. Chemotherapy should be given after rituximab infusion. RA 1,000 mg IV infusion followed by a second 1,000 mg IV infusion 2 wk later. Further courses should be evaluated 24 wk following previous course.

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

Anaphylactic & other hypersensitivity reactions. Permanently discontinue dosing if progressive multifocal leukoencephalopathy (PML) develops; in case of severe skin reactions eg, TEN (Lyell's syndrome) & SJS. Interrupt infusion immediately & institute aggressive symptomatic treatment in patients who develop severe cytokine release syndrome. Not to administer as IV push or bolus. Not recommended in MTX-naïve patients w/ RA. Patients w/ high tumour burden or w/ high number (≥25 x 10⁹/L) of circulating malignant cells eg, patients w/ chronic lymphocytic leukemia, who may be at higher risk of especially severe cytokine release syndrome; neutrophils <1.5 x 10⁹/L &/or platelet counts <75 x 10⁹/L; multiple PML risk factors including underlying disease & long-term immunosuppressive therapy or chemotherapy. History of pulmonary insufficiency or those w/ pulmonary tumour infiltration; recurring or chronic infections or w/ underlying conditions which may further predispose to serious infections (eg, hypogammaglobulinaemia). Active, severe infection (eg, TB, sepsis & opportunistic infections) & severely immunocompromised patients (eg, those w/ very low CD4 or CD8 levels). Active hepatitis B disease. Risk of malignancy. Monitor patients at regular intervals for any new or worsening neurological symptoms or signs suggestive of PML; w/ +ve hepatitis B serology. Closely monitor patients w/ history of cardiac disease &/or cardiotoxic chemotherapy; those who experienced prior cardiopulmonary adverse reactions; known cardiac history, & consider risk of CV complications resulting from infusion reactions. Perform regular FBC including neutrophil & platelet counts during therapy; HBV screening (including HBsAg- & HBcAb-status) before treatment initiation. Measure blood neutrophils prior to each course of treatment & regularly up to 6 mth after treatment cessation. Consider withholding antihypertensives 12 hr prior to infusion. Complete vaccination at least 4 wk prior to 1st rituximab administration. Concomitant use w/ live virus vaccine & anti-rheumatic therapies other than those specified under RA indication & dosage are not recommended; DMARDs. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following therapy. Pregnancy. Should not breastfeed during therapy & for 12 mth following treatment.

Bacterial & viral infections, bronchitis, URTI, UTI; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; infusion-related reactions (eg, HTN, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema), angioedema; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG & IgM levels; headache. Sepsis, pneumonia, febrile infection, herpes zoster, resp tract infection, fungal infections, infections of unknown aetiology, acute bronchitis, sinusitis, hepatitis B, gastroenteritis, tinea pedis; anaemia, pancytopenia, granulocytopenia; hypersensitivity; hyperglycaemia, decreased wt, peripheral & face oedema, increased LDH, hypocalcaemia, hypercholesterolemia; depression; paraesthesia, 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 & chest disease, dyspnoea, increased cough, rhinitis; vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation, gastro-oesophageal 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, multi-organ failure.

Concomitant cisplatin therapy.

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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