Lek Pharma


Zuellig Pharma


Concise Prescribing Info
Relapsed or chemoresistant indolent B-cell non-Hodgkin's lymphoma (NHL). CD20 +ve diffuse large B-cell NHL in combination w/ cyclophosphamide, doxorubicin, vincristine & prednisone (CHOP). Stage III-IV follicular lymphoma in combination w/ cyclophosphamide, vincristine & prednisone (CVP) chemotherapy in previously untreated patient. Maintenance therapy for follicular lymphoma in patients responding to induction therapy. Chronic lymphocytic leukaemia (CLL) in combination w/ fludarabine & cyclophosphamide (FC) in previously untreated patient & previously treated CD20 +ve CLL. In combination w/ MTX for adult patients w/ severe active RA who have had inadequate response or intolerance to ≥1 tumour necrosis factor (TNF) inhibitor therapies.
Dosage/Direction for Use
Premed w/ analgesic/antipyretic (eg, paracetamol) & antihistamine (eg, diphenhydramine) before each infusion; may consider premed w/ corticosteroids if not given in combination w/ glucocorticoid-containing chemotherapy for NHL. IV infusion Low-grade/follicular NHL Adult Monotherapy: Initially 375 mg/m2 once wkly for 4 wk. In combination w/ CVP chemotherapy: 375 mg/m2 for 8 cycles (21 days/cycle) administered on day 1 of each cycle after corticosteroid IV. Re-treatment following relapse: 375 mg/m2 once wkly for 4 wk. Patient w/ previously untreated follicular lymphoma Maintenance: 375 mg/m2 once every 2 mth (starting 2 mth after the last dose of induction therapy) until disease progression. Max: 2 yr. Relapsed/refractory follicular lymphoma Maintenance: 375 mg/m2 once every 3 mth until disease progression. Max: 2 yr. Diffuse large B-cell NHL In combination w/ CHOP chemotherapy: 375 mg/m2 on day 1 of each cycle after corticosteroid IV. CLL 1st infusion: 375 mg/m2 in the 1st cycle. Initial infusion rate: 50 mg/hr, may increase by 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent infusions: 500 mg/m2 in cycles 2-6, in combination w/ FC, administered every 28 days. Infusion rate: 100 mg/hr may increase by 100 mg/hr increments every 30 min. Max: 400 mg/hr. Prophylaxis w/ adequate hydration & administer uricostatics 48 hr prior to start of therapy. Patient w/ lymphocyte count >25 x 109/L Administer prednisone/prednisolone 100 mg IV shortly before Rixathon infusion. RA 1,000 mg followed 2 wk later by 2nd 1,000 mg. Premed w/ methylprednisolone 100 mg IV 30 min prior to therapy. Alternative subsequent, faster, infusions schedule: 4 hr 15 min for the 1st infusion & 3 hr 15 min for the 2nd infusion. If patients did not experience a serious infusion-related adverse event, initiate at a rate of 250 mg/hr for the 1st 30 min & then 600 mg/hr for the next 90 min.
Hypersensitivity to rituximab or murine proteins. Active, severe infections. Severely immunocompromised patients.
Special Precautions
Not to be administered as an IV bolus or push. Possible severe infusion-related reactions (IRRs) w/ fatal outcome characterized by pulmonary events & features of tumour lysis syndrome (TLS) in addition to fever, chills, rigors, hypotension, urticaria, angioedema & other symptoms. Possible severe cytokine release syndrome w/ some features of TLS (eg, hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated LDH & may be associated w/ acute resp failure & death). Higher risk of IRRs in patients w/ high number (>25 x 109/L) of circulating malignant cells or high tumour burden (eg, patients w/ CLL & mantle cell lymphoma). Interrupt infusion to reverse IRRs; can be resumed at 50% reduction in rate when symptoms have been completely resolved. Patients w/ history of pulmonary insufficiency or those w/ pulmonary tumour infiltration. Consider prophylaxis for TLS in patients at risk of developing rapid tumour lysis; w/holding anti-hypertensives 12 hr prior to & throughout Rixathon infusion. Closely monitor patients w/ history of cardiac disease &/or cardiotoxic chemotherapy. Patients w/ neutrophils <1.5 x 109/L &/or platelet counts <75 x 109/L; regularly perform full blood counts including platelet counts during therapy. Do not administer in patients w/ active, severe infection (eg, TB, sepsis & opportunistic infections). History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infections. Possible hepatitis B reactivation including fulmitant hepatitis; perform HBV screening before initiation of therapy. May increase risk of progressive multifocal leukoencephalopathy (PML). Monitor patients at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML. Permanently discontinue use if patient develops PML; in cases of severe skin reactions (eg, TEN & SJS). Live viral vaccines are not recommended. Patients may receive non-live vaccinations; response rate to non-live vaccine may be reduced. Reduced IRRs in RA patients w/ premed glucocorticoid IV prior to therapy. Do not administer in patients w/ an active infection or severely immunocompromised (eg, CD4 or CD8 levels are very low). Not recommended in MTX-naïve patients; concomitant/sequential use of other DMARDs. Immunomodulatory drugs may increase risk of malignancy. Contains 2.3 mmol (52.6 mg) Na per 10 mL vial & 11.5 mmol (263.2 mg) Na per 50 mL vial. May have a minor influence on the ability to drive & use machines; dizziness may occur. Renal & hepatic impairment. Women of childbearing age should use effective contraceptive methods during & for 12 mth following treatment. Pregnancy. Not to be administered to nursing mothers. Possible hypogammaglobulinaemia in ped patients. Childn & adolescent <18 yr.
Adverse Reactions
Bronchitis; neutropenia; IRRs (HTN, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hypotension, rhinitis, fatigue, peripheral edema); alopecia; headache; decreased IgG levels. Sinusitis; paraesthesia, dizziness; anxiety; dyspepsia, diarrhoea; arthralgia. TEN. NHL & CLL: Bacterial & viral infections; leucopenia, febrile neutropenia, thrombocytopenia; angioedema; chills, asthenia. Sepsis, pneumonia, febrile infection, herpes zoster, resp tract & fungal infections, infections of unknown aetiology, acute bronchitis, hepatitis B; anaemia, pancytopenia, granulocytopenia; hypersensitivity; hyperglycaemia, decreased wt, face edema, increased LDH, hypocalcaemia; hypoaesthesia, agitation, insomnia, vasodilatation; lacrimation disorder, conjunctivitis; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder; orthostatic hypotension; bronchospasm, resp disease, chest pain, dyspnoea, increased cough; vomiting, abdominal pain, dysphagia, stomatitis, constipation, anorexia; sweating, night sweats, skin disorder; hypertonia, myalgia, back & neck pain, pain; tumour pain, flushing, malaise, cold syndrome, shivering, multi-organ failure. Interstitial lung disease; GI perforation. RA: Upper resp tract & urinary tract infection; hot flush, rigors, oropharyngeal pain, erythema; decreased IgM levels. Gastroenteritis, tinea pedis; hypercholesterolemia; migraine, sciatica; depression; gastro-oesophageal reflux, mouth ulceration, upper abdominal pain; musculoskeletal pain, osteoarthritis, bursitis.
Drug Interactions
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. DMARDs.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.
Rixathon conc for soln for infusion 100 mg/10 mL
2 × 1's
Rixathon conc for soln for infusion 500 mg/50 mL
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