Ruxience

Ruxience

rituximab

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

Pfizer
Concise Prescribing Info
Contents
Rituximab
Indications/Uses
Previously untreated adults w/ stage III-IV follicular lymphoma in combination w/ chemotherapy. Maintenance therapy for adult follicular lymphoma patients responding to induction therapy. Monotherapy in adults w/ stage III-IV follicular lymphoma who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy. Adults w/ CD20 +ve diffuse large B cell non-Hodgkin's lymphoma in combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. In combination w/ chemotherapy in paed 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); in patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukaemia (CLL). In combination w/ MTX in adults w/ severe active RA who have had inadequate response or intolerance to other DMARDs including ≥1 tumour necrosis factor inhibitor therapies; w/ glucocorticoids in adults w/ severe, active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA) & for induction of remission in paed patients (≥2 to <18 yr) w/ severe, active GPA (Wegener's) & MPA. Moderate to severe pemphigus vulgaris (PV).
Dosage/Direction for Use
IV infusion 1st infusion: 50 mg/hr. May be escalated in 50 mg/hr increments every 30 min after 1st 30 min. Max: 400 mg/hr. Subsequent infusion: Initially 100 mg/hr & increased by 100 mg/hr increments at 30 min intervals. Max: 400 mg/hr. Premed: Anti-pyretic & antihistaminic eg, paracetamol & diphenhydramine, or glucocorticoids if not given in combination w/ glucocorticoid-containing chemotherapy. Follicular non-Hodgkin's lymphoma Combination therapy: 375 mg/m2 per cycle in combination w/ chemotherapy for up to 8 cycles. Administer on day 1 of each chemotherapy cycle. Maintenance: Previously untreated patient after response to induction treatment 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 (total: 12 infusions). Relapsed/refractory patient after response to induction treatment 375 mg/m2 once every 3 mth (starting 3 mth after last dose of induction therapy) until disease progression or for max of 2 yr (total: 8 infusions). Stage III-IV follicular lymphoma & chemoresistant or who are in their 2nd or subsequent relapse after chemotherapy, & retreatment for patients who have responded to previous treatment for relapsed/refractory follicular lymphoma Monotherapy: 375 mg/m2 once wkly for 4 wk. Adult diffuse large B cell non-Hodgkin's lymphoma Combination w/ CHOP: 375 mg/m2 on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of glucocorticoid component of CHOP. CLL Prophylaxis w/ adequate hydration & administer uricostatics 48 hr prior to start of therapy. Patients whose lymphocyte counts are >25 x 109/L Administer prednisone/prednisolone 100 mg IV shortly before infusion w/ Ruxience. Previously untreated & relapsed/refractory patient Combination w/ chemotherapy: 375 mg/m2 on day 0 of 1st treatment cycle followed by 500 mg/m2 on day 1 of each subsequent cycle (total: 6 cycles). Give chemotherapy after Ruxience infusion. RA Premed: Methylprednisolone 100 mg IV 30 min prior to each Ruxience infusion. 1,000 mg followed by 2nd 1,000 mg after 2 wk. 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 Ruxience infusion. Induction of remission: 375 mg/m2 once wkly for 4 wk (total: 4 infusions). Administer prior to infusion methylprednisolone 1,000 mg IV daily for 1-3 days followed by oral prednisone 1 mg/kg daily (max: 80 mg daily) during & after 4 wk induction course of treatment. Maintenance: Initiate no sooner than 16 wk after last infusion. Two 500 mg separated by 2 wk, followed by 500 mg every 6 mth. PV 1,000 mg followed 2 wk later by 2nd 1,000 mg in combination w/ tapering course of glucocorticoids. Maintenance: At 12 & 18 mth, then every 6 mth if needed. In case of relapse, administer 1,000 mg. Administer subsequent infusions no sooner than 16 wk following previous infusion. Paed 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: Initially 0.5 mg/kg/hr (max: 50 mg/hr). May be escalated by 0.5 mg/kg/hr every 30 min if no hypersensitivity or infusion-related reactions. Max: 400 mg/hr. Subsequent infusions: Initially 1 mg/kg/hr (max: 50 mg/hr). May be 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 Ruxience 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. Followed by oral prednisone 1 mg/kg daily (max: 60 mg daily).
Contraindications
Hypersensitivity to rituximab or murine proteins. Active, severe infections. Severely immunocompromised patients. RA, GPA, MPA & PV: Severe heart failure (NYHA class IV) or severe, uncontrolled cardiac disease.
Special Precautions
Discontinue permanently if patient develops progressive multifocal leukoencephalopathy (PML); in case of SJS & TEN. Interrupt infusion immediately in patients who develop severe cytokine release syndrome. Potential increased risk of infections, including PML. Infusion-related adverse reactions including cytokine release & tumour lysis syndrome, anaphylactic & hypersensitivity reactions. Pulmonary oedema & acute reversible thrombocytopenia. Angina pectoris, cardiac arrhythmias eg, atrial flutter & fibrillation, heart failure &/or MI. Hepatitis B reactivation. Not to be administered in patients w/ active, severe infection (eg, TB, sepsis & opportunistic infections) or severely immunocompromised patients (eg, very low CD4 or CD8); active hepatitis B disease. Not recommended in MTX-naïve patients. Patients w/ history of pulmonary insufficiency or w/ pulmonary tumour infiltration; cardiac disease &/or cardiotoxic chemotherapy; recurring or chronic infections or w/ underlying conditions which may further predispose patients to serious infection eg, hypogammaglobulinaemia. Patients w/ high tumour burden or high number (≥25 x 109/L) of circulating malignant cells; neutrophils <1.5 x 109/L &/or platelet counts <75 x 109/L; moderate heart failure (NYHA class III) or severe, uncontrolled CV disease. Monitor at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML; patients w/ +ve hepatitis B serology (either HBsAg or HBcAb). Perform regular FBC including neutrophil (prior to each course of treatment & regularly up to 6 mth after cessation of treatment & upon signs or symptoms of infection) & platelet counts during therapy; HBV screening before treatment initiation. Closely monitor patients w/ pre-existing cardiac conditions & who experienced prior cardiopulmonary adverse reactions. Determine Ig levels prior to treatment. Re-evaluate patients for potential risk of infection before giving subsequent course of treatment. Closely observe for signs of infection if biologic agents &/or DMARDs are used following therapy. Complete vaccination at least 4 wk prior to 1st administration. Consider withholding anti-hypertensive medicines for 12 hr prior to infusion. Not recommended in combination w/ vaccination w/ live virus vaccines; anti-rheumatic therapies. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Not to be administered during pregnancy. Not recommended during lactation while on treatment & optimally for 12 mth following treatment. Not to be used from birth to <6 mth w/ CD20 +ve DLBCL; ped patients w/ severe, active GPA/MPA <2 yr. Paed <3 yr.
Adverse Reactions
Bronchitis, URTI, UTI; neutropenia; infusion-related reactions; nausea; pruritus, rash, alopecia; headache; decreased IgG levels; sinusitis. HTN, hypotension; urticaria, skin disorder; rhinitis; tachycardia; fatigue, asthenia, pyrexia; peripheral oedema; anxiety; paraesthesia, dizziness; throat irritation, dyspepsia, diarrhoea, upper abdominal pain; arthralgia/musculoskeletal pain, back pain; herpes zoster; conjunctivitis. SJS, TEN. Non-Hodgkin's lymphoma & CLL: Bacterial & viral infections; leucopenia, febrile neutropenia, thrombocytopenia; angioedema; fever, chills. Sepsis, pneumonia, febrile infection, resp tract & fungal infections, infections of unknown aetiology, acute bronchitis, hepatitis B1; anaemia, pancytopenia, granulocytopenia; hypersensitivity; hyperglycaemia, decreased wt, face oedema, increased LDH, hypocalcaemia; hypoaesthesia, agitation, insomnia, vasodilatation; lacrimation disorder; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, cardiac disorder; orthostatic hypotension; bronchospasm, resp disease, chest pain, dyspnoea, increased cough, vomiting, abdominal pain, dysphagia, stomatitis, constipation, anorexia; sweating, night sweats; hypertonia, myalgia, neck pain, pain; tumour pain, flushing, malaise, cold syndrome, shivering, multi-organ failure. RA: Hot flush, rigors, oropharyngeal pain, erythema; decreased IgM levels. Gastroenteritis, tinea pedis; hypercholesterolemia; depression; migraine, sciatica; gastro-oesophageal reflux, mouth ulceration; OA, bursitis. GPA/MPA: Persistent depressive disorder. Herpes virus infection, oral herpes & candidiasis, nasopharyngitis; skin papilloma; major depression, irritability.
MIMS Class
Targeted Cancer Therapy / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Ruxience conc for soln for infusion 100 mg/10mL
Packing/Price
1's
Form
Ruxience conc for soln for infusion 500 mg/50 mL
Packing/Price
1's
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