Rituximab 10mg/ml; 10ml & 50ml vial: i.v injection for infusion.

Ind: Treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP.

C/I: Known hypersensitivity to any component of this product or to murine proteins.

S/E: Monotherapy: Infusion related adverse reac¬tions occur in more than 50% of patients. These events mainly comprise fever, chills and rigors. Other symptoms include flushing, angioedema, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, vomiting and tumour pain. These symptoms accompanied by hypotension and bronchospasm in about 10% of the cases. Cardiovascular system: Severe cardiac events, including heart failure, cardiac arrhythmias and myocardial infarction have been observed, mainly in patients with prior cardiac disease and/or cardiotoxic chemotherapy and are mostly associated with infusion-related reactions. Respiratory system: Pulmonary adverse reactions include severe bronchoconstriction and rare fatalities.

Skin & appendages: Severe bullous skin reac¬tions, including fatal cases of toxic epidermal necrolysis, have been reported rarely.

Nervous system: Cranial neuropathy with or without peripheral neuropathy. Symptoms (e.g loss of senses and facial nerve palsy) can occur up to several months following completion of therapy.

Body as a whole: Serum sickness like reactions. Others: Serious or opportunistic infections were considerably less than reported with conventional chemotherapy. During treatment and up to one year following therapy, approximately 17% and 16% respectively, of patients developed infections which were usually common, non- opportunistic and mild. For additional adverse events which occurred in about 1% of patients please see full prescribing information. Severe adverse events occurring in <1% of patients were coagulation disorder, asthma and lung disorder. Precautions: Patients with a high number (>25,000 mm3) of circulating malignant cells or high tumour burden, are at a higher risk of severe cytokine release syndrome. These patients should be treated with caution and should be closely monitored during the first infusion. A reduced infusion rate should be considered for the first infusion. This syndrome may be associated with some features of tumour lysis syndrome. The syndrome frequently manifests itself within one or two hours of initiating the first infusion. Patients with a history of pulmonary insufficien¬cy, those with pulmonary tumour infiltration and patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be treated with caution. Further treatment of patients after com¬plete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syn¬drome. Anaphylactic and other hypersensitivity reactions have been reported. These may typical¬ly occur within minutes after starting the infu¬sion. Clinical manifestations of anaphylaxis may appear similar to clinical manfestations of the cytokine release syndrome. Since hypotension may occur, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the infusion. There is limited clini¬cal experience in patients with neutrophils <1.5 x 109/1 and/or platelet counts <75 x 1091. Periodic monitoring of a full blood count (including plate¬lets) should be considered during monotherapy.

When rituximab is given in combination with CHOP, regular lull blood counts should be performed.

Pregnancy & lactation: Rituximab should not be given to a pregnant women unless the potential benefit outweighs the potential risk. Rituximab may cause B-cell depletion in the foetus. Women of childbearing potential should use effective contraception both during and for up to 12 months following rituximab therapy. Rituximab should not be given to nursing women. Dosage & admin: Rituximab solution should be administered as an IV infusion through a delicated line. Premedication consisting of paracetamol and an antihistamine should be administered before each infusion. Premedication with corticosteroids should be considered. Patients should be closely monitored for the onset of cytokine release syndrome.

Follicular non-Hodgkin’s lymphoma: 375mg/m2, as an intravenous infusion once weekly for four weeks.

First infusion: The recommended initial rate for infusion is 50mg/hour; after the first 30 minutes, it can be escalated in 50mg/hour increments every 30 minutes to a maximum of 400mg/hour. If hypersensitivity or an infusion related event develops, the infusion should be temporarily slowed or interrupted and can continue at one half the previous rate upon improvement of symptoms. If the same adverse reactions occur severely for second time the decision to stop treatment should be considered. The infusion rate may be increased upon improvement of symptoms. Subsequent infusions: Infuse at initial rate of 100mg/hour and increase by 100mg/hour incr¬ements at 30 minute intervals, to a maximum of 400mg/hour. Patients who have responded to rituximab have been retreated with comparable response rates to first treatment. Children: Safety and efficacy of rituximab in children have not been established.

Drug inter: Currently, no data are available on possible drug interactions with rituximab.

Price:

500mg (50ml) vial x l's pack: 1,20,200.00 TP