سعر جازيفارو 1000 مجم / 40 مل فيال 2025

Obinutuzumab 1,000 mg/40 ml concentrate for solution for intravenous infusion (one vial), a glycoengineered type II anti-CD20 monoclonal antibody by Roche used for CLL, follicular lymphoma and lupus nephritis.

• In combination with chlorambucil for adults with previously untreated chronic lymphocytic leukaemia (CLL) and comorbidities making them unsuitable for full-dose fludarabine-based therapy.Population: Adults with CLLEuropean Medicines Agency (EMA)
• In combination with chemotherapy, followed by Gazyvaro maintenance in responders, for adults with previously untreated advanced follicular lymphoma (FL).Population: Adults with advanced FLEuropean Medicines Agency (EMA)
• In combination with bendamustine, followed by Gazyvaro maintenance, for adults with follicular lymphoma who did not respond or progressed during or up to 6 months after rituximab or a rituximab-containing regimen.Population: Adults with rituximab-refractory FLEuropean Medicines Agency (EMA)

• Most common (CLL): infusion-related reactions and neutropenia. Most common (NHL): infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections and musculoskeletal pain.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Hypersensitivity to obinutuzumab or to any of the excipients.International label, same product · European Medicines Agency (EMA)
• Known hypersensitivity reactions (e.g. anaphylaxis) to obinutuzumab or any excipient, including serum sickness with prior obinutuzumab use.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Boxed warning: hepatitis B virus reactivation (sometimes fulminant hepatitis, hepatic failure and death) - screen all patients for HBV before starting and monitor HBV-positive patients; progressive multifocal leukoencephalopathy (PML), including fatal cases.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Infusion-related reactions (premedicate, monitor closely, interrupt or slow the infusion); hypersensitivity reactions including serum sickness (discontinue permanently); tumour lysis syndrome (anti-hyperuricaemics and hydration in high tumour burden).International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Serious, including fatal, infections; neutropenia (including late-onset); thrombocytopenia; disseminated intravascular coagulation.International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Based on animal data and mechanism of action, obinutuzumab can cause fetal B-cell depletion; there are no data in pregnant women; monoclonal antibodies cross the placenta. Advise pregnant women of the potential risk.International label, same formulation · DailyMed (U.S. National Library of Medicine)
• Gazyvaro should be avoided during pregnancy unless the possible benefit outweighs the potential risk; postpone live vaccines in infants exposed in utero until B-cell levels recover.International label, same product · European Medicines Agency (EMA)
• Advise women not to breastfeed during treatment and for 6 months after the last dose (US label).International label, same formulation · DailyMed (U.S. National Library of Medicine)

• Obinutuzumab: Binds CD20 on B cells and causes B-cell lysis through antibody-dependent cellular cytotoxicity and phagocytosis, direct cell death and complement activation.