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ARZERRA ® (ofatumumab) Indications. ARZERRA is a prescription medication used: With a chemotherapy drug called chlorambucil to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment and whose doctor has decided not to treat them with a chemotherapy drug called fludarabine
The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European Medicines Agency Committee for Medicinal Products for Human Use
Arzerra (ofatumumab) is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Arzerra is used to treat chronic lymphocytic leukemia (CLL).
Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a fully human monoclonal antibody to CD20, which appears to inhibit early-stage B lymphocyte activation.It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating follicular lymphoma, diffuse large B cell lymphoma, rheumatoid ...
Copenhagen, Denmark; January 22, 2018 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Novartis (SIX Swiss Exchange: NOVN) intends to transition Arzerra ® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia (CLL) indications from commercial availability to limited availability via compassionate use programs in all markets around the world except the United States.
Genmabs Arzerra slår konkurrerende middel i nye sklerosestudier fra Novartis. Genmabs Arzerra (ofatumumab), som bliver solgt af Novartis, har genereret positive resultater i et nyt skleroseforsøg med midlet, hvor det bliver testet overfor Sanofis Aubagio.
Arzerra should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product. Special populations. Paediatric. population. The safety and efficacy of Arzerra in children aged below 18 years have not been established. Arzerra is therefore not recommended for use in this patient population. Elderly
Administer ARZERRA in an environment where facilities to adequately monitor and treat infusion reactions are available. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Infusion reactions may occur despite premedication; Interrupt ARZERRA for infusion reactions of any severity and initiate appropriate medical treatment.
Ofatumumab is marketed and developed under a co-development and commercialization agreement with Novartis Pharma AG. Indication and safety Ofatumumab is approved as ARZERRA® in certain territories to treat certain chronic lymphocytic leukemia (CLL) indications.
Arzerra-koncentratet skal kontrolleres for fremmedlegemer og misfarvning inden fortyndingen. Ofatumumab bør være en farveløs til svagt gul opløsning. Arzerra-koncentratet må ikke anvendes, hvis det er misfarvet. Hætteglasset med ofatumumab må ikke rystes i forbindelse med denne inspektion. Fortynding af infusionsvæsken