Dr. Reddy's


Zuellig Pharma


Dr. Reddy's
Concise Prescribing Info
Previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy; maintenance therapy for follicular lymphoma patients responding to induction therapy; monotherapy for stage III-IV follicular lymphoma in patients that are chemo-resistant or in 2nd or subsequent relapse after chemotherapy; patients w/ CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination w/ cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) chemotherapy. In combination w/ chemotherapy, for previously untreated & relapsed/refractory chronic lymphocytic leukemia. In combination w/ methotrexate, to reduce signs & symptoms in adults w/ moderately to severely active RA who had an inadequate response or intolerance to ≥1 TNF antagonist therapies.
Dosage/Direction for Use
1st infusion: Recommended initial rate: 50 mg/hr; after first 30 min, it can be escalated in 50 mg/hr increments every 30 min to a max of 400 mg/hr. Subsequent infusion: Initial rate: 100 mg/hr, & increased by 100 mg/hr increments every 30 min interval to a max of 400 mg/hr. Always administer premedication consisting of an anti-pyretic & antihistaminic eg, paracetamol & diphenhydramine prior to each infusion. Patients w/ RA Premedication w/ 100 mg methylprednisolone IV should be completed 30 min prior to infusion. Follicular non-Hodgkin's lymphoma Previously untreated or relapsed/refractory 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 of the chemotherapy. Previously untreated follicular lymphoma Responded to induction treatment Maintenance: 375 mg/m2 once every 2 mth (starting 2 mth after the last dose of induction therapy) until disease progression or for a max period of 2 yr. Relapsed/refractory follicular lymphoma Responded to induction treatment Maintenance: 375 mg/m2 once every 3 mth (starting 3 mth after the last dose of induction therapy) until disease progression or for a max period of 2 yr. Patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy Monotherapy (as induction treatment): 375 mg/m2 as IV infusion once wkly for 4 wk. Diffuse large B cell non-Hodgkin's lymphoma In combination w/ CHOP chemotherapy: 375 mg/m2 administered on day 1 of each chemotherapy cycle for 8 cycles after IV infusion of the glucocorticoid component of CHOP. Chronic lymphocytic leukemia Prophylaxis w/ adequate hydration & administer uricostatics starting 48 hr prior to start of therapy. Patients w/ >25 x 109/L lymphocyte counts Administer prednisone/prednisolone 100 mg IV shortly before rituximab infusion. Previously untreated & relapsed/refractory patients Recommended dose in combination w/ chemotherapy: 375 mg/m2 administered on day 0 of the 1st treatment cycle followed by 500 mg/m2 administered on day 1 of each subsequent cycle for 6 cycles. Chemotherapy should be given after rituximab infusion. RA 1,000 mg IV infusion followed by a second 1,000 mg IV infusion 2 wk later. Further courses should be evaluated 24 wk following previous course.
Hypersensitivity to rituximab or murine proteins. Active, severe infections. Patients in severely immunocompromised state. RA: Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.
Special Precautions
Do not administer as IV push or bolus. Monitor patients at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of progressive multifocal leukoencephalopathy (PML). Permanently discontinue dosing if PML develops. Patients w/ high tumour burden or w/ high number (≥25 x 109/L) of circulating malignant cells eg, patients w/ chronic lymphocytic leukemia, who may be at higher risk of especially severe cytokine release syndrome. History of pulmonary insufficiency or those w/ pulmonary tumour infiltration. Interrupt infusion immediately & institute aggressive symptomatic treatment in patients who develop severe cytokine release syndrome. Anaphylactic & other hypersensitivity reactions. Consider withholding antihypertensive medicines 12 hr prior to infusion. Closely monitor patients w/ history of cardiac disease &/or cardiotoxic chemotherapy; those who experienced prior cardiopulmonary adverse reactions; known cardiac history, & consider risk of CV complications resulting from infusion reactions. Patients w/ neutrophils <1.5 x 109/L &/or platelet counts <75 x 109/L. Perform regular full blood counts including neutrophil & platelet counts during therapy. Active, severe infection (eg, TB, sepsis & opportunistic infections) & severely immunocompromised patients (eg, those w/ very low CD4 or CD8 levels). History of recurring or chronic infections or w/ underlying conditions which may further predispose to serious infections (eg, hypogammaglobulinaemia). Perform HBV screening (including HBsAg- & HBcAb-status) before treatment initiation. Active hepatitis B disease; monitor patients w/ positive hepatitis B serology. Permanently discontinue in case of severe skin reactions eg, toxic epidermal necrolysis (Lyell's syndrome), & Stevens-Johnson syndrome. Not recommended in methotrexate-naïve patients. Patients w/ multiple PML risk factors including underlying disease & long-term immunosuppressive therapy or chemotherapy. Measure blood neutrophils prior to each course of treatment & regularly up to 6 mth after treatment cessation. Complete vaccination at least 4 wk prior to 1st rituximab administration. Concomitant use w/ live virus vaccine & anti-rheumatic therapies other than those specified under RA indication & dosage are not recommended; DMARDs. Risk of malignancy. Women of childbearing potential should use effective contraceptive methods during & for 12 mth following therapy. Pregnancy. Should not breastfeed during therapy & for 12 mth following treatment.
Adverse Reactions
Bacterial & viral infections, bronchitis, upper resp tract infection, UTI; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; infusion-related reactions (eg, 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; headache. 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, hypercholesterolemia; depression; paraesthesia, hypoesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety, migraine, sciatica; lacrimation disorder, conjunctivitis; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder; HTN, orthostatic hypotension, hypotension; bronchospasm, resp disease, chest disease, dyspnoea, increased cough, rhinitis; vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation, gastro-oesophageal reflux, mouth ulceration, upper abdominal pain; urticaria, sweating, night sweats, skin disorder; hypertonia, myalgia, arthralgia, back, neck & musculoskeletal pain, pain, OA, bursitis; tumour pain, flushing, malaise, cold syndrome, fatigue, shivering, multi-organ failure.
Drug Interactions
ATC Classification
L01XC02 - rituximab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Redditux soln for infusion 500 mg/50 mL
Redditux soln for infusion 100 mg/10 mL
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