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Rituxell

Rituxell

rituximab

Manufacturer:

BIOCAD

Distributor:

Qualimed
Concise Prescribing Info
Contents
Rituximab
Indications/Uses
Previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy. Maintenance therapy for the treatment of follicular lymphoma patients responding to induction therapy. Monotherapy for treatment of patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in the 2nd or subsequent relapse after chemotherapy. Patients w/ CD20 +ve di-use large B cell non-Hodgkin's lymphoma in combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination w/ chemotherapy. Adults w/ severe active RA who have had an inadequate response or intolerance to other DMARDs including ≥1 tumour necrosis factor (TNF) inhibitor therapies in combination w/ MTX. Induction of remission in adults w/ severe, active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA) in combination w/ glucocorticoids.
Dosage/Direction for Use
Premed & prophylactic medications Anti-pyretic & antihistamine, eg, paracetamol & diphenhydramine, should be given before each administration of Rituximab. Patient w/ non-Hodgkin's lymphoma & CLL Premed w/ glucocorticoids should be considered if Rituximab is not given in combination w/ glucocorticoid-containing chemotherapy. Prophylaxis w/ adequate hydration & administration of uricostatics 48 hr prior to start of therapy is recommended for CLL patient. CLL patient whose lymphocyte counts are >25 x 109/L Administer prednisone/prednisolone 100 mg IV shortly before infusion w/ Rituximab. Patient w/ RA, GPA or MPA Premed w/ 100 mg IV methylprednisolone should be completed 30 min prior to Rituximab infusions. Patient w/ granulomatosis w/ polyangiitis (Wegener's) or microscopic polyangiitis Methylprednisolone given intravenously for 1-3 days at a dose of 1,000 mg daily is recommended prior to the 1st infusion of Rituximab (the last dose of methylprednisolone may be given on the same day as the 1st infusion of Rituximab). This should be followed by oral prednisone 1 mg/kg daily (not to exceed 80 mg daily, & tapered as rapidly as possible based on clinical need) during & after 4 wk induction course of Rituximab treatment. Pneumocystis jirovecii pneumonia (PJP) Prophylaxis is recommended for adult w/ GPA/MPA during & following Rituximab treatment, as appropriate according to local clinical practice guidelines. Follicular non-Hodgkin's lymphoma in combination w/ chemotherapy for induction treatment of previously untreated or relapsed/refractory patient w/ follicular lymphoma 375 mg/m2/cycle, for up to 8 cycles, on day 1 of each chemotherapy cycle, after IV administration of the glucocorticoid component. Maintenance therapy in previously untreated follicular lymphoma 375 mg/m2 once every 2 mth (starting 2 mth after the last dose of induction therapy) until disease progression or for max period of 2 yr (12 infusions in total). Relapsed/refractory follicular lymphoma 375 mg/m2 once every 3 mth (starting 3 mth after the last dose of induction therapy) until disease progression or for max period of 2 yr (8 infusions in total). Monotherapy in relapsed/refractory follicular lymphoma 375 mg/m2 IV infusion once wkly for 4 wk. Retreatment w/ monotherapy for patient who have responded to previous treatment w/ rituximab monotherapy for relapsed/refractory follicular lymphoma 375 mg/m2 administered as IV infusion once wkly for 4 wk. Di-use large B cell non-Hodgkin's lymphoma in combination w/ CHOP chemotherapy 375 mg/m2 on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP. CLL in combination w/ chemotherapy for previously untreated & relapsed/refractory patients 375 mg/m2 on day 0 of the 1st treatment cycle followed by 500 mg/m2 on day 1 of each subsequent cycle for 6 cycles in total. RA Patient treated w/ Rituximab must be given patient alert card w/ each infusion. Course of Rituximab consists of 2 (1,000 mg) IV infusions. Recommended dosage: 1,000 mg by IV infusion followed by 2nd 1,000 mg IV infusion 2 wk later. Need for further courses should be evaluated 24 wk following the previous course. Retreatment should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns. Granulomatosis w/ polyangiitis (GPA) & microscopic polyangiitis (MPA) Patient treated w/ Rituximab must be given patient alert card w/ each infusion. Induction of remission 375 mg/m2 administered as IV infusion once wkly for 4 wk (4 infusions in total). Maintenance treatment Following induction of remission in adult w/ GPA & MPA should be initiated no sooner than 16 wk after the last infusion. Following induction of remission w/ other standard of care immunosuppressants, maintenance treatment should be initiated during 4 wk period that follows disease remission. Rituximab should be administered as 2 (500 mg) IV infusions separated by 2 wk, followed by 500 mg IV infusion every 6 mth thereafter. Patient should receive Rituximab for at least 24 mth after achievement of remission (absence of clinical signs & symptoms). Patient who may be at higher risk for relapse Physician should consider a longer duration of Rituximab maintenance therapy, up to 5 yr. Mild or moderate infusion-related reactions (IRR) Usually respond to a reduction in the rate of infusion. Infusion rate may be increased upon improvement of symptoms. 1st infusion: Initially 50 mg/hr; after the 1st 30 min. Can be escalated in 50 mg/hr increments every 30 min, max of 400 mg/hr. Subsequent infusions (all indications): Initially 100 mg/hr, & increased by 100 mg/hr increments at 30 min intervals, max of 400 mg/hr. RA only (alternative subsequent, faster, infusion schedule) If patient did not experience serious IRR w/ the 1st or subsequent infusions of dose of 1,000 mg Rituximab administered over the standard infusion schedule, a more rapid infusion can be administered for 2nd & subsequent infusions using the same conc as in previous infusions (4 mg/mL in 250 mL). Initiate at a rate of 250 mg/hr for the 1st 30 min & then 600 mg/hr for the next 90 min. If the more rapid infusion is tolerated, this infusion schedule can be used when administering subsequent infusions.
Contraindications
Non-Hodgkin's lymphoma, CLL RA, granulomatosis w/ polyangiitis & microscopic polyangiitis: Hypersensitivity to rituximab or to murine proteins. Active, severe infections. Patients in a severely immunocompromised state. RA, granulomatosis w/ polyangiitis & microscopic polyangiitis: Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.
Special Precautions
Do not administer as IV push/bolus. Premed should always be given before each administration of Rituximab. Do not administer more rapid infusion in patient w/ significant CV disease including arrhythmias or previous serious infusion reaction to any prior biologic therapy or to Rituximab. Patients treated w/ Rituximab for RA, granulomatosis w/ polyangiitis & microscopic polyangiitis must be given a patient alert card; contains safety information regarding potential increased risk of infections including progressive multifocal leukoencephalopathy (PML). Permanently discontinue therapy if PML develops. Consider withholding anti-hypertensive medicines 12 hr prior to infusion (hypotension may occur). Cardiac disorders. Caution in patients w/ history of recurring or chronic infections or w/ underlying conditions. HBV screening in all patients before initiation of treatment. Patients w/ active hepatitis B disease should not be treated w/ rituximab. Permanently discontinue treatment if severe skin reactions occur. Vaccination w/ live virus vaccine is not recommended; non-live vaccine (response rates may be reduced). Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Pregnancy & lactation. Childn <18 yr. Non-Hodgkin's lymphoma & CLL: IRR. Patient who develops severe cytokine release syndrome should have the infusion interrupted immediately & should receive aggressive symptomatic treatment. Caution in patients w/ a high tumuor burden or high number of circulating malignant cells; closely monitor throughout 1st infusion. Anaphylactic & other hypersensitivity reactions following IV administration of proteins. Haematological toxicities; caution in patients w/ neutrophils <1.5 x 109/L &/or platelet count <75 x 109/L. Perform regular FBCs. RA, granulomatosis w/ polyangiitis & microscopic polyangiitis: Not recommended in MTX-naïve patient. IRR. Patients w/ moderate heart failure (NYHA class III) or severe, uncontrolled CV disease. Late neutropenia. Concomitant use of other DMARDs in RA. Malignancy. Contains Na.
Adverse Reactions
Non-Hodgkin's lymphoma & CLL: Bacterial & viral infections, bronchitis; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; IRR, angioedema; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG levels. RA: URTI, UTI; IRR (HTN, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythema); headache; decreased IgM levels. Granulomatosis w/ polyangiitis & microscopic polyangiitis: UTI, bronchitis, herpes zoster, nasopharyngitis; thrombocytopenia; cytokine release syndrome; hyperkalaemia; insomnia; dizziness, tremor; HTN, flushing; cough, dyspnoea, epistaxis, nasal congestion; diarrhea, dyspepsia, constipation; acne; muscle spasms, arthralgia, back pain, muscle weakness, musculoskeletal pain, pain in extremities; peripheral oedema; decreased Hb. Adult maintenance treatment (GPA/MPA): Bronchitis, rhinitis; dyspnoea; diarrhea; pyrexia, flu-like illness, oedema peripheral; IRR.
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.
Presentation/Packing
Form
Rituxell conc for soln for infusion 100 mg/10 mL
Packing/Price
1 × 2's
Form
Rituxell conc for soln for infusion 500 mg/50 mL
Packing/Price
1's
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