Rixathon

Rituximab

In combination w/ chemotherapy for previously untreated stage III-IV follicular lymphoma; previously untreated & relapsed/refractory chronic lymphocytic leukaemia (CLL). Maintenance treatment of follicular lymphoma after response to induction therapy. Monotherapy for patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy. In combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for CD20 +ve diffuse large B cell non-Hodgkin's lymphoma (NHL). In combination w/ MTX for severe active RA in adults who have had inadequate response or intolerance to other DMARDS including ≥1 tumour necrosis factor (TNF) inhibitor therapies. In combination w/ glucocorticoids for induction of remission of severely active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA).

Always give premed consisting of antipyretic & antihistaminic (eg, paracetamol & diphenhydramine) before each administration of Rixathon. 1st IV infusion: Initially 50 mg/hr; may be escalated after 30 min in 50 mg/hr increments every 30 min to max of 400 mg/hr. Subsequent IV infusions: Initially 100 mg/hr & increased by 100 mg/hr increments every 30 min to max of 400 mg/hr. Patients w/ RA Administer 100 mg IV methylprednisolone to be completed 30 min prior to each infusion. Patients w/ GPA or MPA Administer 1,000 mg IV methylprednisolone daily for 1-3 days prior to 1st infusion of Rixathon (last dose of methylprednisolone may be given on the same day as 1st infusion of Rixathon). Should be followed by oral prednisolone 1 mg/kg daily (max of 80 mg daily & tapered as rapidly as possible) during & after treatment. Patients w/ CLL Administer uricostatics starting 48 hr prior to initiation of therapy w/ prophylaxis w/ adequate hydration. Patients w/ CLL whose lymphocyte count >25 x 10⁹ L Administer 100 mg prednisone/prednisolone IV shortly before administration w/ Rixathon. Follicular NHL Previously untreated 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. Maintenance therapy (responded to induction treatment): 375 mg/m² once every 2 mth (starting 2 mth after last dose of induction therapy) until disease progression or max of 2 yr. Relapsed/refractory patients responded to induction treatment 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. Maintenance therapy: 375 mg/m² once every 3 mth (starting 3 mth after last dose of induction therapy) until disease progression or max of 2 yr. Adult w/ stage III-IV follicular lymphoma who are chemoresistant or in 2nd or subsequent relapse after chemotherapy Monotherapy: 375 mg/m² as IV infusion once wkly for 4 wk. Diffuse large B cell NHL 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. CLL Previously untreated & relapsed/refractory patients 375 mg/m² 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. RA 1,000 mg IV infusion followed by 2nd 1,000 mg IV infusion 2 wk after. Patients who do not experience serious infusion-related reaction w/ 1st or subsequent infusions Initiate at rate of 250 mg/hr for 1st 30 min & then 600 mg/hr for the next 90 min. GPA & MPA 375 mg/m² administered as IV infusion once wkly for 4 wk (4 infusions in total). Pneumocystis jiroveci pneumonia prophylaxis is recommended during & following rituximab treatment.

Hypersensitivity to rituximab or murine proteins. Active, severe infections. Severely immunocompromised patients. RA, GPA & MPA: Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.

Infusion-related reactions. Monitor patients at regular intervals for any new or worsening neurological symptoms & signs of progressive multifocal leukoencephalopathy (PML). Patients w/ history of pulmonary insufficiency, pulmonary tumour infiltration; recurring or chronic infections or w/ underlying conditions; neutrophils <1.5 x 10⁹/L &/or platelet counts <75 x 10⁹/L; high tumour burden or high number (>25 x 10⁹/L) of circulating malignant cells. Consider withholding of antihypertensives 12 hr prior to infusion. Closely monitor patients w/ history of cardiac disease &/or cardiotoxic chemotherapy; prior cardiopulmonary adverse reactions. Perform regular full blood counts including neutrophil & platelet counts. Do not administer in patients w/ active, severe infections (eg, TB, sepsis, & opportunistic infections); severely immunocompromised patients (eg, very low CD4 or CD8 levels); active hepatitis B. Perform HBV screening before initiation of therapy. Determine Ig levels prior to start of therapy. Live virus vaccines & MTX-naive patients are not recommended. Permanently discontinue treatment if severe skin reactions eg, TEN (Lyell's syndrome) & SJS occur. Measure blood neutrophils prior to each course & regularly up to 6 mth after cessation of treatment. Complete vaccination at least 4 wk prior to 1st administration. Concomitant use w/ anti-rheumatic therapies. Increased risk of malignancy. Controlled Na diet. Minor influence on the ability to drive & use machines. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Pregnancy & lactation (during & for 12 mth following treatment). Patients w/ human anti-mouse Ab or human anti-chimeric Ab (HAMA/HACA) titres.

Bacterial & viral infections, bronchitis, URTI, UTI; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; infusion-related reactions (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. 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; paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety, migraine, sciatia; 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, GERD, mouth ulceration, urticaria, sweating, night sweats, skin disorder; hypertonia, myalgia, arthralgia, back & neck pain, pain; tumour pain, flushing, malaise, cold syndrome, fatigue, shivering, multi-organ failure.

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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