Ruxience

Rituximab

Previously untreated adults w/ stage III-IV follicular lymphoma (FL) in combination w/ chemotherapy; stage III-IV FL who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy; CD20 +ve diffuse large B-cell non-Hodgkin's lymphoma (NHL) in combination w/ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy; ped patients (≥6 mth to <18 yr) w/ previously untreated advanced stage CD20 +ve diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukemia (mature B-cell acute leukemia) (BAL) or Burkitt-like lymphoma (BLL) in combination w/ chemotherapy; maintenance therapy for adult FL patients responding to induction therapy. In combination w/ chemotherapy for patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukemia (CLL). In combination w/ MTX for adults w/ moderate to severe active RA who have had an inadequate response or intolerance to other DMARD including ≥1 tumor necrosis factor (TNF) inhibitor therapies. In combination w/ glucocorticoids for adult patients w/ severe, active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA); induction of remission in ped patients (≥2 to <18 yr) w/ severe, active GPA (Wegener's) & MPA. Moderate to severe pemphigus vulgaris (PV).

Premed: Anti-pyretic & antihistaminic eg, paracetamol & diphenhydramine before each administration. Patient w/ NHL & CLL Premed w/ glucocorticoids if therapy is not in combination w/ glucocorticoid-containing chemotherapy. CLL patient Prophylaxis w/ adequate hydration & administration of uricostatics starting 48 hr prior to start of therapy to reduce the risk of tumor lysis syndrome. CLL patient whose lymphocyte counts are >25 x 10⁹/L Administer prednisone/prednisolone 100 mg IV shortly before infusion to decrease the rate & severity of acute infusion. Patient w/ RA, GPA, MPA, PV Premed w/ 100 mg IV methylprednisolone 30 min prior to each infusion. Adult patient w/ GPA or MPA Administer 1,000 mg methylprednisolone IV for 1-3 days prior to the 1st infusion. Last dose may be given on the same day as the 1st infusion. Followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, & tapered as rapidly as possible based on clinical need) during & after the 4-wk induction course of treatment. Adult patient w/ GPA, MPA, PV Administer prophylaxis for Pneumocystis jirovecii pneumonia during & following treatment, as appropriate according to local clinical practice guidelines. Ped patient w/ NHL Premed: Paracetamol & H₁ antihistamine 30-60 min before the start of the infusion. Ped patient w/ GPA or MPA Administer 30 mg/kg/day (not to exceed 1 g/day) methylprednisolone IV up to 3 additional daily dose of 30 mg/kg prior to the 1st IV infusion. Followed by oral prednisone 1 mg/kg/day (not to exceed 60 mg/day) & taper as rapidly as possible per clinical need. Administer prophylaxis for Pneumocystis jirovecii pneumonia during & following treatment. Adult Infusion rate: 1st infusion: Initially, 50 mg/hr, after the 1st 30 min, may be escalated to 50 mg/hr increments every 30 min to max of 400 mg/hr. Subsequent infusion: Initially, 100 mg/hr & increased by 100 mg/hr increments at 30 min intervals to max of 400 mg/hr. NHL: In combination w/ chemotherapy for induction treatment of previously untreated or relapsed/refractory patients w/ FL 375 mg/m²/cycle for up to 8 cycles. Administer on day 1 of each chemotherapy cycle after IV administration of the glucocorticoid component of the chemotherapy if applicable. Maintenance treatment for patients w/ previously untreated FL who have responded to induction treatment 375 mg/m² once every 2 mth (starting 2 mth after the last dose of induction therapy) until disease progression or max period of 2 yr (12 infusions in total). Maintenance treatment for patients w/ relapsed refractory FL who have responded to induction treatment 375 mg/m² once every 3 mth (starting 3 mth after the last dose of induction therapy) until disease progression or max period of 2 yr (8 infusions in total). Monotherapy induction treatment for patients w/ stage III-IV FL who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy 375 mg/m² once wkly for 4 wk. Retreatment of monotherapy for patients who have responded to previous treatment w/ monotherapy for relapsed/refractory FL 375 mg/m² once wkly for 4 wk. In combination w/ CHOP chemotherapy for adult diffuse large B-cell NHL 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 administered on day 1 of each subsequent cycle for 6 cycles in total. RA 1,000 mg followed by 2nd 1,000 mg IV infusion after 2 wk. Evaluate 24 wk following previous course w/ retreatment should be given based on residual disease or disease activity. GPA, MPA: Induction of remission therapy 375 mg/m² once wkly for 4 wk (4 infusions in total). Maintenance therapy: Initiate not sooner than 16 wk after the last infusion. Following induction of remission w/ other standard of care immunosuppressants, initiate during the 4-wk period that follows disease remission. Administer as two 500 mg IV infusions separated by 2 wk, followed by a 500 mg IV infusion every 6 mth thereafter. Continue treatment at least 24 mth after achievement of remission. Consider longer duration maintenance therapy (up to 5 yr) for higher risk of relapse. PV 1,000 mg followed by a 2nd 1,000 mg IV infusion after 2 wk in combination w/ a tapering course of glucocorticoids. Maintenance: 500 mg IV at mth 12 & 18, & then every 6 mth thereafter. Relapsed PV 1,000 mg. Consider resuming or increasing the glucocorticoid dose based on clinical evaluation. Subsequent infusions may be administered no sooner than 16 wk following the previous infusion. Ped patient ≥6 mth to <18 yr previously untreated, advanced stage CD20 +ve DLBCL/BL/BAL/BLL In combination w/ systemic Lymphome Malin B (LMB) chemotherapy: 375 mg/m². Infusion rate: 1st infusion: 0.5 mg/kg/hr (max 50 mg/hr); may be increased by 0.5 mg/kg/hr every 30 min if there is no hypersensitivity or infusion-related reactions to a max of 400 mg/hr. Subsequent infusions: 1 mg/kg/hr (max 50 mg/hr); may be increased by 1 mg/kg/hr every 30 min to a max of 400 mg/hr. Induction of remission therapy w/ severe, active GPA or MPA 375 mg/m² once wkly for 4 wk.

Hypersensitivity to rituximab or murine proteins. Active, severe infections; patients in a severely immunocompromised state. RA, GPA, MPA & PV: Severe heart failure (NYHA class IV) or severe, uncontrolled cardiac disease.

Do not administer as IV push or bolus. Infusion-related reactions. Monitor at regular intervals for any new or worsening neurological symptoms, or signs that may be suggestive of progressive multifocal leukoencephalopathy (PML); permanently discontinue if patient develops PML. Do not administer to patients w/ an active, severe infection (eg, TB, sepsis, & opportunistic infections) or severely immunocompromised patients (eg, where levels of CD4 or CD8 are very low). Patients w/ a history of recurring or chronic infections, or w/ underlying conditions which may further predispose to serious infections. Hepatitis B reactivation; perform HBV screening in all patients before initiation of treatment. Do not use in patients w/ active hepatitis B. Severe skin reactions eg, TEN & SJS. Avoid vaccination w/ live virus vaccines. NHL & CLL: Interrupt the infusion immediately in patients who develop severe cytokine release syndrome. Patients w/ a high tumor burden or w/ a high number (≥25 x 10⁹/L) of circulating malignant cells eg, patients w/ CLL, who may be at higher risk of especially severe cytokine release syndrome. May cause angina pectoris, cardiac arrhythmias eg, atrial flutter & fibrillation, heart failure &/or MI. Patients w/ a history of cardiac disease &/or cardiotoxic chemotherapy; neutrophils <1.5 x 10⁹/L &/or platelet counts <75 x 10⁹/L. Perform regular CBC including neutrophil & platelet counts during therapy. RA, GPA, MPA & PV: Not recommended in MTX-naïve patients. Measure blood neutrophils prior to each course, & regularly up to 6 mth after cessation of treatment, & upon signs or symptoms of infection. Vaccination should be completed at least 4 wk prior to 1st administration. Avoid concomitant use w/ anti-rheumatic therapies eg, DMARDs. Concomitant use w/ immunomodulatory drugs. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following treatment. Pregnancy. Do not breastfeed during treatment & for at least 6 mth after the last dose. Childn <3 yr. Do not use in ped patients from birth to <6 mth w/ CD20 +ve diffuse large B-cell lymphoma. Do not use in ped patients <2 yr w/ severe active GPA or MPA.

Infusion-related reactions including cytokine-release syndrome & tumor-lysis syndrome, infections, CV events. Hepatitis B reactivation & PML. Bronchitis, sinusitis; neutropenia, late neutropenia; depression, anxiety; paresthesia, dizziness, headache; heart failure, MI, atrial fibrillation; dyspepsia, diarrhea; SJS, TEN, alopecia; arthralgia, decreased IgG levels. UTI, herpes zoster; thrombocytopenia; cytokine release syndrome, insomnia; HTN, flushing; cough, dyspnea, constipation, back pain; peripheral edema; rhinitis; upper resp tract infection; conjunctivitis; tachycardia, abdominal pain; urticaria, skin disorder, pruritus; musculoskeletal pain; pyrexia; fatigue, asthenia. NHL, CLL: Progressive multifocal leukoencephalopathy, serious viral infection, Pneumocystis jirovecii, sepsis, pneumonia, febrile infection, resp tract infection, fungal infections of unknown etiology, acute bronchitis, hepatitis B, bacterial infections, viral infections; coagulation disorders, aplastic anemia, hemolytic anemia, febrile neutropenia, anemia, pancytopenia, granulocytopenia, leukopenia, lymphadenopathy, transient increase in serum IgM levels; tumor lysis syndrome, serum sickness, anaphylaxis, hypersensitivity, angioedema, infusion-related acute reversible thrombocytopenia; hyperglycemia, wt decrease, face edema, increased blood LDH, hypocalcemia; nervousness; cranial neuropathy, peripheral neuropathy, facial nerve palsy, loss of other senses, hypoesthesia, agitation, vasodilatation, dysgeusia; severe vision loss, lacrimation disorder; hearing loss, tinnitus, ear pain; severe cardiac disorders, left ventricular failure, SVT, ventricular tachycardia, angina, myocardial ischemia, arrhythmia, bradycardia, cardiac disorder; vasculitis (predominately cutaneous), leukocytoclastic vasculitis, orthostatic hypotension, hypotension; resp failure, ILD, lung infiltration, asthma, bronchiolitis obliterans, lung disorder, hypoxia, bronchospasm, resp disease, chest pain; GI perforation, abdominal enlargement, vomiting, dysphagia, stomatitis, anorexia, throat irritation, nausea; severe bullous skin reactions, sweating, night sweats, rash; hypertonia, myalgia, neck pain, pain; renal failure; multi-organ failure, tumor pain, malaise, cold syndrome, shivering, infusion site pain, fever, chills. RA: Gastroenteritis, tinea pedis; serum sickness-like syndrome; hypercholesterolemia; sciatica; angina pectoris; GERD, mouth ulceration, OA, bursitis; decreased IgM levels. GPA, MPA: Nasopharyngitis; hyperkalemia; tremor; epistaxis, nasal congestion; acne; muscle spasms, muscle weakness, pain in extremities; decreased Hb; flu-like illness. PV: Herpes virus infection, oral herpes, oral candidiasis, nasopharyngitis; skin papilloma; persistent depressive disorder, irritability; tachycardia.

Anti-rituximab Abs (human anti-mouse Ab or anti-drug Ab) titres may develop allergic or hypersensitivity reactions w/ other diagnostic or therapeutic monoclonal Abs.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Targeted Cancer Therapy

L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.

Rx