Gammaked, immune globulin injection human, 10% caprylatechromatography purified initial u. Ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. Ofatumumab is an antibody against a protein called cd20, which is found on the surface of certain types of immune cells called bcells. In combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed cll. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated. Ofatumumab also resulted in similar significant reductions in mri t2 lesions compared with placebo. Patients should be closely monitored during administration of ofatumumab for the.
The effectiveness of arzerra is based on the demonstration of durable objective responses. In ms, the drug entered phase iii development in september 2016. In fact, with ofatumumab, the risk for new gdenhancing lesions was reduced by 99% compared with placebo. Withdraw and discard 15 ml from a 1,000ml bag of 0. These low blood cell counts may be severe and, in some cases, lead to death. It is strongly recommended you download this document to your own computer and open from there. Lartruvoolaratumabinjection, for intravenous use initial u. These highlights do not include all the information needed to use.
For adults who have chronic lymphocytic leukemia cll. For a complete list of excipients see the dosage forms, composition and. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. Novartis is conducting ofatumumabs pivotal studies in relapsing ms, and the company plans to file for approval in 2019. These highlights do not include all the information needed to use advate safely and effectively.
Ofatumumab is already approved for the treatment of chronic lymphocytic leukemia in both the us and europe, where it is marketed as arzerra. Monoclonal antibodies are made to target and destroy only certain cells in the body. Chronic lymphocytic leukemia arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic. Ofatumumab is used to treat chronic lymphocytic leukemia cll. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia cll 1. For previously untreated cll, the recommended dosage and schedule is. These highlights do not include all the information needed to use cuvitru safely and effectively. Ofatumumab all dosing groups combined resulted in significantly fewer new gdenhancing lesions compared with placebo. Prolonged neutropenia was reported in 6% of the ofatumumabchlorambucil arm. Indications for arzerra ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia cll for whom fludarabinebased therapy is considered inappropriate. Highlights of prescribing information extended treatment.
Now you can find the tools you need to help manage your patients, all in one place. Highlights of prescribing information these highlights do. Arzerra is indicated for the treatment of patients with cll refractory to fludarabine and. Ofatumumab is highly potent in lysing b cells, and this appears to stem from its binding site on the short extracellular loop of the target cd20 protein and its slow. Ofatumumab is a fully human anticd20 monoclonal antibody that induces antibodydependent cellmediated cytotoxicity and complementdependent cytotoxicity in cd20expressing b lymphocytes. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. Companyfunded, randomized, doubleblind, parallelgroup, placebocontrolled, multinational study to evaluate whether subcutaneous ofatumumab 3 mg, 30 mg, or 60 mg given every 12 weeks. Youll have access to the site in a moment, or click continue to close this message and advance directly to the site.
Attempting to open large files over the internet within the browser window may cause problems. Novartis announces fourth quarter and full year financial results for 2019 at 07. Find info for hcps about arzerra, a monoclonal antibody for 4 cll treatment indications. Ofatumumab is a cd20directed cytolytic monoclonal antibody that is fda approved for the treatment of previously untreated patients with chronic lymphocytic leukemia cll in combination with chlorambucil and patients with cll refractory to fludarabine and alemtuzumab. These effects were not noted to be clinically important, therefore no dosage. There is a black box warning for this drug as shown here. Your doctor will check your blood to see if you have low blood cell counts.
Tm ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Arzerra ofatumumab injection, for intravenous infusion. This may help to protect healthy cells from damage. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively.