Rituximab

Active, severe infection (e.g. tuberculosis, sepsis, opportunistic infections), severely immunocompromised state; severe heart failure or severe, uncontrolled cardiac disease (in patients with rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris). Lactation.

Patient with evidence of previous hepatitis B virus (HBV) infection (e.g. hepatitis B surface antigen [HBsAg] positive regardless of antibody status, HBsAg negative but hepatitis B core antibody [anti-HBc] positive) or history of recurring or chronic infections, underlying conditions predisposing to serious infections (e.g. hypogammaglobulinaemia); history of cardiopulmonary reactions, pre-existing cardiac disease or pulmonary conditions (e.g. pulmonary tumour infiltration); high tumour burden or high numbers of circulating malignant cells (≥25,000/mm³); neutrophils <1.5 x 10⁹/L and/or platelet counts <75 x 10⁹/L. Children. Pregnancy. Not recommended for treatment of patients with rheumatoid arthritis who are methotrexate naive. Vaccination using live vaccines prior to or during therapy is not recommended. Different formulations (IV and SC inj) are not interchangeable; refer to specific product guideline. Monitoring Parameters Screen for HBV infection (including HBsAg and anti-HBc status) before treatment initiation; monitor for signs of reactivation during treatment and for up to 2 years after completion for carriers and patients with evidence of infection or recovery from prior HBV infection. Confirm pregnancy status in females of childbearing potential prior to initiation of treatment (SC inj). Monitor CBC with differential and platelets (before initial treatment, and before each treatment course, then at weekly to monthly intervals or as clinically indicated), and continue monitoring for cytopenias after the final dose and until resolution; electrolytes, renal function (in patients at risk for tumour lysis syndrome); fluid status balance, blood pressure, vital signs. Perform cardiac monitoring during and after infusion (in patients with rheumatoid arthritis or pre-existing cardiac disease, or those who developed arrhythmias during or after subsequent infusions). Assess for signs and symptoms of infusion-related reactions, bowel obstruction or perforation, progressive multifocal leucoencepalopathy, tumour lysis syndrome, mucocutaneous skin reactions.

Significant: CV reactions (e.g. ventricular fibrillation, MI, cardiogenic shock, angina pectoris, atrial flutter and fibrillation); lymphopenia, leucopenia, neutropenia, thrombocytopenia, anaemia; hypotension, hypersensitivity reactions. Blood and lymphatic system disorders: Pancytopenia, granulocytopenia. Ear and labyrinth disorders: Tinnitus, ear pain. Eye disorders: Conjunctivitis, lacrimation disorder. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, throat irritation, gastroentiritis, GERD. General disorders and administration site conditions: Fever, chills, asthenia, tumour pain, malaise, cold syndrome, fatigue, shivering, multi-organ failure; injection site reactions (SC). Immune system disorders: Angioedema. Infections and infestations: Febrile infection, herpes zoster. Investigations: Decreased weight, IgG or IgM levels; increased LDH, ALT. Metabolism and nutrition disorders: Hyperglycaemia, hypocalcaemia, hypercholesterolaemia, anorexia, peripheral oedema. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, back pain, neck pain, hypertonia, osteoarthritis, bursitis. Nervous system disorders: Paraesthesia, hypoaesthesia, dizziness, headache, migraine, sciatica. Psychiatric disorders: Depression, anxiety, agitation, insomnia, irritability. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Respiratory tract infection, bronchitis, rhinitis, sinusitis, bronchospasm, respiratory disease, dyspnoea, increased cough, nasopharyngitis, epistaxis. Skin and subcutaneous tissue disorders: Rash, pruritus, alopecia, urticaria, sweating or night sweats, skin disorder. Vascular disorders: Vasodilation, hypertension, orthostatic hypertension, flushing.
Potentially Fatal: Progressive multifocal leucoencepalopathy, HBV reactivation which may result in fulminant hepatitis or hepatic failure; infusion-related reactions (e.g. pulmonary infiltrates, anaphylactic events, hypoxia, acute respiratory syndrome); bacterial, fungal, viral infections (new or reactivated), mucocutaneous reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, lichenoid dermatitis, paraneoplastic pemphigus, vesiculobullous dermatitis); severe renal toxicity or tumour lysis syndrome leading to acute renal failure (in patients with NHL). Rarely, bowel obstruction and perforation.

Response rate to non-live vaccines may be reduced.

Targeted Cancer Therapy

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