Redditux

Redditux

rituximab

Manufacturer:

Dr Reddy's Lab

Distributor:

Dr Reddy's Lab
Concise Prescribing Info
Contents
Rituximab
Indications/Uses
Non-Hodgkin's lymphoma (NHL): previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy; maintenance therapy for follicular lymphoma patients responding to induction therapy; monotherapy in patients w/ stage III-IV follicular lymphoma who are chemoresistant or are in their 2nd or subsequent relapse after chemotherapy; patients w/ CD20 +ve diffuse large B cell NHL 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 granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA) in combination w/ glucocorticoids. Moderate to severe pemphigus vulgaris (PV) in adults.
Dosage/Direction for Use
1st IV infusion rate: Initially 50 mg/hr; after the 1st 30 min, can be escalated in 50 mg/hr increments every 30 min. Max: 400 mg/hr. Subsequent IV infusion rate: Initially 100 mg/hr, & increased by 100 mg/hr increments every 30 min. Max: 400 mg/hr. Premed & prophylactic medications Always give premed consisting of anti-pyretic (eg, paracetamol) & anti-histaminic drug (eg, diphenhydramine) before each infusion. NHL & CLL Premed w/ glucocorticoids if not to be given in combination w/ glucocorticoid-containing chemotherapy. CLL patient whose lymphocyte counts >25 x 109/L Administer prednisone/prednisolone 100 mg IV shortly before rituximab infusion. Patient w/ GPA or MPA in disease remission or PV Premed w/ methylprednisolone 100 mg IV completed in 30 min prior to infusions. Patient w/ GPA or MPA Methylprednisolone IV 1,000 mg daily for 1-3 days prior to 1st rituximab 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. Patient w/ GPA/MPA or PV Administer Pneumocystis jirovecii pneumonia prophylaxis during & following treatment, as appropriate according to local clinical practice guidelines. Follicular NHL: In combination w/ chemotherapy for induction treatment of previously untreated or relapsed/refractory patient w/ follicular NHL 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 patient w/ previously untreated follicular lymphoma who has 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. Maintenance treatment for patient w/ relapsed/refractory follicular lymphoma who has 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. Monotherapy as induction treatment for patient w/ stage III-IV follicular lymphoma who are chemoresistant or are in 2nd or subsequent relapse after chemotherapy 375 mg/m2 IV infusion once wkly for 4 wk. Retreatment w/ monotherapy for patient who has responded to previous treatment w/ monotherapy for relapsed/refractory follicular lymphoma 375 mg/m2 IV infusion once wkly for 4 wk. In combination w/ CHOP chemotherapy for 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 patient 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. GPA & MPA: Induction of remission therapy 375 mg/m2 IV infusion once wkly for 4 wk (4 infusions in total). Maintenance treatment Initiate no sooner than 16 wk after the last rituximab 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. PV: 1,000 mg IV infusion followed by a 2nd 1,000 mg IV infusion after 2 wk in combination w/ a tapering course of glucocorticoids. Maintenance treatment 500 mg IV at mth 12 & 18, & then every 6 mth thereafter. Relapse treatment 1,000 mg IV. 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.
Contraindications
Hypersensitivity to rituximab or murine proteins. Active, severe infections. Patients in a severely immunocompromised state. GPA, MPA & PV: Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.
Special Precautions
Do not use in MTX-naive patients. Increased 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 if a patient develops PML. Syndrome of cytokine release, tumour lysis syndrome & anaphylactic & hypersensitivity reactions. Higher risk of severe cytokine release syndrome in patients w/ high tumour burden or high number (≥25 x 109/L) of circulating malignant cells eg, patients w/ CLL; closely monitor throughout the 1st infusion. Reduce infusion rate or split dosing over 2 days during the 1st cycle & any subsequent cycles if the lymphocyte count is still >25 x 109/L. Severe, including fatal, renal toxicity may occur after administration in patients w/ NHL. History of pulmonary insufficiency or those w/ pulmonary tumour infiltration. Interrupt infusion immediately in patients who develop severe cytokine release syndrome. Closely monitor until tumour lysis syndrome & pulmonary infiltration have been resolved or ruled out. W/hold anti-hypertensive medicines 12 hr prior to 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. Perform regular FBC, including neutrophil & platelet counts during therapy. Do not use in patients w/ active, severe infection (eg, TB, sepsis & opportunistic infections); history of recurring or chronic infections or w/ underlying conditions which may further predispose patients to serious infection; w/ active hepatitis B disease. Perform HBV screening in all patients before initiation of treatment. Consult liver disease experts before start of treatment in patients w/ +ve hepatitis B serology. Vaccination w/ live virus vaccines is not recommended. Permanently discontinue if severe skin reactions eg, TEN (Lyell's syndrome) & SJS occur. Closely monitor patients w/ pre-existing cardiac conditions & those who experienced prior cardiopulmonary AR. Measure blood neutrophils prior to each course, & regularly up to 6 mth after cessation of treatment, & upon signs or symptoms of infection. Complete vaccination at least 4 wk prior to first administration. Patients on controlled Na diet. Use effective contraceptive methods during & for 12 mth following treatment in women of childbearing potential. Pregnancy. Do not breastfeed during & for 12 mth following treatment. Childn <18 yr.
Adverse Reactions
Bacterial infections, viral infections, bronchitis; neutropenia, leucopenia, febrile neutropenia, thrombocytopenia; infusion related reactions, angioedema; nausea; pruritus, rash, alopecia; fever, chills, asthenia, headache; decreased IgG levels. Sepsis, pneumonia, febrile infection, herpes zoster, resp tract infection, fungal infections, infections of unknown aetiology, acute bronchitis, sinusitis, hepatitis B; anaemia, pancytopenia, granulocytopenia; hypersensitivity; hyperglycaemia, decreased wt, peripheral oedema, face oedema, increased LDH, hypocalcaemia; paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety; lacrimation disorder, conjunctivitis; tinnitus, ear pain; MI, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder; HTN, orthostatic hypotension, hypotension; bronchospasm, resp disease, chest pain, dyspnoea, increased cough, rhinitis; vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation; urticaria, sweating, night sweats, skin disorder; hypertonia, myalgia, arthralgia, back pain, neck pain, pain; tumour pain, flushing, malaise, cold syndrome, fatigue, shivering, multi-organ failure.
Drug Interactions
Concomitant use w/ cisplatin may cause renal toxicity in patients who experience tumor lysis syndrome & in patients w/ NHL. Patients w/ human anti-mouse Ab (HAMA)/anti-drug Ab (ADA) titres may have allergic or hypersensitivity reactions when treated w/ other diagnostic or therapeutic monoclonal Abs.
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
Redditux conc for soln for infusion 10 mg/mL
Packing/Price
10 mL x 1's;50 mL x 1's
/philippines/image/info/redditux conc for soln for infusion 10 mg-ml/10 mg-ml x 10 ml?id=6e232f11-03fb-4751-8fb2-b0230098ef86
/philippines/image/info/redditux conc for soln for infusion 10 mg-ml/10 mg-ml x 50 ml?id=bdeee7ed-dc4b-4866-a4fe-b0230098ef86
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