Cytokine release syndrome and neurological toxicities see full prescribing information for complete boxed warning. Your doctor will check your blood to see if you have low blood cell counts. Arzerra from approval to post marketing surveillance slideshare. A phase 2 study of ofatumumab as a treatment for waldenstrom macroglobulinemia, which is a rare form of nonhodgkin lymphoma, is also ongoing. The use of ofatumumab in combination with chemotherapy fludarabine f and cyclophosphamide c in fit, treatmentnaive cll patients has been discouraging, represented by a lower orr than its counterpart monoclonal anticd20 antibody, rituximab, in combination with the same chemotherapy fcr. The overall rate of irrs to first exposure of ofatumumab has been shown to. Prior therapies included a pi and an immunomodulatory agent or patients were doublerefractory to a pi and an immunomodulatory agent. Ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. The quality of the pdf file is reduced with this method, but you can open the full pdf file by doubleclicking the image when viewing or editing in normal view. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. Request permission export citation add to favorites track citation. Insert pdf file content into a powerpoint presentation. Ofatumumab is a medication prescribed for treating a certain type of cancer known as chronic lymphocytic leukemia cll.
This may help to protect healthy cells from damage. Now you can find the tools you need to help manage. It is used alone as extended treatment in patients with recurrent or progressive disease who are in complete or partial response after at least two other types of treatment. Insert pdf content into your presentation either as a picture that shows on your slide, or as a document that you can open during your slide show. Arzerra ofatumumab injection, for intravenous infusion. The fdaapproved package insert updated september 2011 contains warnings regarding pml and reactivation of hepatitis b. Xgevadenosumab injection, for subcutaneous use initial usapproval. Arzerratm ofatumumab from approval to postmarketing compliance by.
Ofatumumab is used to treat a certain type of cancer chronic lymphocytic leukemia cll. Ofatumumab in children with drug resistant idiopathic nephrotic syndrome the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Withdraw and discard 15 ml from a 1,000ml bag of 0. Arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. We assessed the efficacy and safety of ofatumumab maintenance. Ofatumumab doses were 300 mg, followed by five infusions of either 500 or 1,000 mg. Ofatumumab is used to treat chronic lymphocytic leukemia cll.
Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults primary progressive ms, in adults 2 dosage and administration. Jan 19, 2016 the fda has approved arzerra ofatumumab for the extended treatment of patients with recurrent or progressive chronic lymphocytic leukemia cll who are in complete or partial response following two or more lines of therapy. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. These low blood cell counts may be severe and, in some cases, lead to death. Fda for use in combination with fludarabine and cyclophosphamide in relapsed cll approval based on data from phase iii complement 2 study. Ofatumumab genmabnovartis is a fully human immunoglobulin g1 and highaffinity antibody that targets a novel epitope on cluster of differentiation cd20 on the bcell membrane. Arzerra ofatumumab is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia cll for whom fludarabine based therapy is considered inappropriate see clinical studies 14. Prior therapies included lenalidomide and a proteasome inhibitor pi. Arzerra ofatumumab dosing, indications, interactions. Highlights of prescribing information these highlights do. Jul 09, 2015 arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. In fact, with ofatumumab, the risk for new gdenhancing lesions was reduced by 99% compared with placebo. The intravenous infusion is administered by a healthcare provider once every one to four weeks. Ofatumumab is approved to be used alone or with other drugs to treat.
Duvelisib in haematological malignancies the lancet oncology. Arzerra ofatumumab plus chlorambucil demonstrated a statistically significant 71% improvement in median pfs 22. Patients recruitment has been completed, and preliminary results are expected in 20. Dermatologic toxicities occurred in 90% of patients and were severe ncictc grade 3 and higher in. 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. This medication works by stopping the growth of cancer cells.
Nov 09, 2018 ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. A missed dose should not be taken within 72 hours of the next scheduled dose. Ofatumumab also resulted in similar significant reductions in mri t2 lesions compared with placebo. If a ninlaro dose is delayed or missed, the dose should be taken only if the next scheduled dose is. Cytokine release syndrome and neurological toxicities see full prescribing information for. Open powerpoint and display the slide where you want to insert the pdf text. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsing. It is used in people who have not responded to or cannot take certain other chemotherapy treatment. Open your powerpoint presentation on the page you want to insert the pdf within. In fact, with ofatumumab, the risk for new gdenhancing lesions was reduced. Ofatumumab side effects, dosage, interactions drugs. Ofatumumab has also been shown to induce cell lysis in both high and low cd20 expressing cells and in rituximabresistant cells.
Ofatumumab definition of ofatumumab by medical dictionary. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Ofatumumab in firstline treatment for chronic lymphocytic leukemia. 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. We report updated results for the phase 3 resonatetm pcyc1112 study of ibrutinib ibr vs ofatumumab ofa in previouslytreated patients with cllsll.
May 01, 2009 ofatumumab doses were 300 mg, followed by five infusions of either 500 or 1,000 mg. The effectiveness of arzerra is based on the demonstration of durable objective responses see clinical studies 14. Ofatumumab and its role as immunotherapy in chronic. For decades, the regulation and control of new drugs in the united states has been based on the new drug application nda. Homepage darzalex faspro daratumumab and hyaluronidase. It is used in people who have not responded to or cannot take certain. Ofatumumab is an antibody against a protein called cd20, which is found on the surface of certain types of immune cells called bcells. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Highlights of prescribing information zinplavasafely and. Lartruvoolaratumabinjection, for intravenous use initial u.
Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of. The pdf file should be the first option within the insert dialog window. In addition, the binding of ofatumumab allows the recruitment of natural killer. New brain mri lesion activity was suppressed greater than 99 % in the first 24 weeks after ofatumumab administration all doses, with statistically significant reductions p ofatumumab found in new t1 gadoliniumenhancing lesions, total enhancing t1 lesions, and new andor enlarging t2 lesions. It being investigated as a treatment for relapsingremitting. Highlights of prescribing information these highlights do not. Ofatumumab, a fully human anticd20 monoclonal antibody, in.
Jan 29, 2020 ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab. Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. Highlights of prescribing information extended treatment. Tm ofatumumab is a cd20directed cytolytic monoclonal antibody. Arzerra ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Now you can find the tools you need to help manage your patients, all in one place. It would be expected that any safety concerns related to the much longer.
All three doses were found to reduce the number of cumulative lesions, total number of lesions and newenlarging t2 lesions. Insert pdf file content into a powerpoint presentation powerpoint. Please see complete indications and usage for more information. Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy hepatitis b virus hbv reactivation can occur in patients receiving cd20directed cytolytic antibodies, including arzerra, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Jun 20, 2019 not known whether ofatumumab is distributed into milk.
Efficacy and safety in genetic and clinical subgroups. Ofatumumab in children with drug resistant idiopathic. Fda for use in combination with fludarabine and cyclophosphamide in relapsed cll approval based on data from phase iii. Blincyto blinatumomab for injection, for intravenous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively. Zinplavabezlotoxumabinjection,for intravenous use initial u. Youll have access to the site in a moment, or click continue to close this message and advance directly to the site. The nda application is the vehicle through which drug sponsors formally. Arzerra ofatumumab for previously untreated cll hcp.
It is used to treat chronic lymphocytic leukemia cll in patients who have further disease after. Ofatumumab belongs to a class of drugs known as monoclonal antibodies. No data demonstrate an improvement in diseaserelated symptoms or. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. 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. Click the image and it will be inserted into the slide. Ofatumumab arzerra medical clinical policy bulletins aetna. Aug 31, 2016 company announcement arzerra now approved by u. Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Ofatumumab maintenance versus observation in relapsed chronic. The binding of ofatumumab to the membraneproximal epitope of the cd20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complementdependent cytotoxicity cdc and resultant lysis of tumour cells. Fda approves extended therapy with arzerra for chronic.
Tm ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Monoclonal antibodies are made to target and destroy only certain cells in the body. Ofatumumab arzerra medical clinical policy bulletins. Ofatumumab trade name arzerra, also known as humaxcd20 is a fully human monoclonal antibody to cd20, which appears to inhibit earlystage b lymphocyte activation.
Ninlaro ixazomib capsules, for oral use hepatotoxicity. In some patients, ofatumumab is given with another. A phase ii study examining the efficacy of subcutaneous injections of ofatumumab 3mg, 30mg, and 60mg is underway in rrms patients. Listing a study does not mean it has been evaluated by the u. It is used to treat chronic lymphocytic leukemia cll in patients who have further disease. Ofatumumab is a fully human monoclonal antibody that may have the advantage of improved efficacy and pharmacokinetics with fewer adverse effects compared to chimeric antibodies. Serious allergic reactions and other severe injectionrelated reactions. Ofatumumab treatment was associated with a significant reduction of b cells. Serious allergic reactions and reactions due to release of certain substances by your body systemic that can lead to death, can. Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy hepatitis b virus hbv reactivation can occur in patients receiving cd20directed cytolytic antibodies, including arzerra, in some cases resulting in fulminant hepatitis, hepatic failure, and death see warnings and precautions 5. In the insert object box, select create from file, and then enter the pdf file location. Ofatumumab all dosing groups combined resulted in significantly fewer new gdenhancing lesions compared with placebo.
Prior therapies included a pi and an immunomodulatory agent or patients were doublerefractory to a pi and. Darzalex faspro is a prescription medicine used to treat adult patients with multiple myeloma. Pneumocystis jirovecii prophylaxis concomitant with study drug treatment was required for. Official hcp website darzalex faspro daratumumab and. Highlights of prescribing information these highlights.
1049 1139 765 1518 335 282 858 1368 607 431 1313 1347 1277 1065 1290 1265 351 163 1256 294 1222 927 1408 804 1214 961 1372 1056 70 829 624 535 1047 318 1179 947 943 1101 1169 1469 777 940 1395 498 1379 1486