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