It being investigated as a treatment for relapsingremitting. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use zinplavasafely and effectively. Ofatumumab binds effectively to both the small and large extracellular loops on cd20 and releases very slowly over time.
To potentially gain insight into outcomes in patients previously. However, instead of getting a pdf icon to click on in order to open the pdf file, i get a small copy of the pdf file. Tm ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. It would be expected that any safety concerns related to the much longer experience with rituximab and b cell depletion would apply to ofatumumab, although the use in cll would normally entail shorter periods than might be.
The recommended dosage for extended treatment in cll is 300 mg on day 1. Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Studies on expression of molecular targets bestows one disadvantage of. Efficacy and safety of ofatumumab compared to teriflunomide. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab. 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.
Monoclonal antibodies are made to target and destroy only certain cells in the body. See how to insert a file in pdf format into your office file as an attachment. Withdraw 5 ml from each of 3 ofatumumab vials and add to 0. Nov 09, 2018 ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. Full text infusion reactions associated with use of. This may help to protect healthy cells from damage. Ninlaro 4 mg capsules contain 4 mg of ixazomib equivalent to 5. Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. The treatment landscape for patients with chronic lymphocytic leukemia cll has changed considerably with the introduction of very effective oral targeted therapies such as ibrutinib, idelalisib. This emedtv resource further explains what ofatumumab is used for and explains whether there are any reasons this drug may be used for unapproved purposes. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively.
Prior therapies included a pi and an immunomodulatory agent or patients were doublerefractory to a pi and an immunomodulatory agent. Lymphoma burden was estimated by the sum of the product of the largest. 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. If youre looking to insert the contents of your pdf file into an office file, as opposed to simply inserting the pdf as an attachment, then your best bet is to open that pdf with word 20 or 2016.
Ofatumumab arzerra medical clinical policy bulletins aetna. Ofatumumab definition of ofatumumab by medical dictionary. Lartruvoolaratumabinjection, for intravenous use initial u. Bendamustine was approved by the united states fda in march 2008 for the treatment of cll, based on a phase iii study comparing bendamustine and chlorambucil as firstline therapy for cll. Ofatumumab trade name arzerra, also known as humaxcd20 is a fully human monoclonal antibody to cd20, which appears to inhibit earlystage b lymphocyte activation. Ofatumumab, the human cd20 monoclonal antibody that binds a distinct. Ofatumumab arzerra as maintenance therapy in patients with relapsed.
Highlights of prescribing information extended treatment. Withdraw 5 ml from each of 20 ofatumumab vials and add to 0. Arzerra ofatumumab injection side effects, images, uses. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. Depending on the types of formatting you used in preparing the original. Jun 20, 2019 not known whether ofatumumab is distributed into milk.
Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Uploaded in accordance with the publishers selfarchiving policy. Ofatumumab is used to treat chronic lymphocytic leukemia cll. Arzerra ofatumumab injection, for intravenous infusion. Formation of anti ofatumumab antibodies was observed in less than 1% of patients with cll after treatment with ofatumumab.
It is usually injected once a week for 8 weeks then once a month for 4 months. I want to embed the pdf file into the word document, so that it can be opened, and copied onto another location in its original form, not as a small picture of the original. Listing a study does not mean it has been evaluated by the u. Patients recruitment has been completed, and preliminary results are expected in 20. Ofatumumab as singleagent cd20 immunotherapy in fludarabine. First clinical use of ofatumumab, a novel fully human anticd20.
The recommended dosage and schedule is 12 doses administered as follows. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated. Ofatumumab all dosing groups combined resulted in significantly fewer new gdenhancing lesions compared with placebo. Jan 09, 2017 what other drugs will affect ofatumumab arzerra. Arzerra ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Select object action in the action settings window and select open. Highlights of prescribing information zinplavasafely and. Chronic lymphocytic leukemia treatment algorithm 2018. Ofatumumab is an antibody against a protein called cd20, which is found on the surface of certain types of immune cells called bcells. Premedicate before each infusion see dosage and administration 2. Ofatumumab side effects, dosage, interactions drugs. Resource links provided by the national library of. Prior therapies included lenalidomide and a proteasome inhibitor pi. The fdaapproved package insert updated september 2011 contains warnings regarding pml and reactivation of hepatitis b.
In fact, with ofatumumab, the risk for new gdenhancing lesions was reduced by 99% compared with placebo. Ofatumumab in children with drug resistant idiopathic. Xgevadenosumab injection, for subcutaneous use initial usapproval. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of. You can resize the object, but you cant edit it after you insert it. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively.
It is used in people who have not responded to or cannot take certain other chemotherapy treatment. For adults who have chronic lymphocytic leukemia cll. Bendamustine for treatment of chronic lymphocytic leukemia. Sep 06, 2011 ofatumumab ofa is the first fully human anticd20 mab approved by u. 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. Your doctor may need to interrupt your treatment if you experience certain side effects. The management of chronic lymphocytic leukemia cll has dramatically improved in the past decade with the addition of anticd20 monoclonal antibodies to the treatment armamentarium. 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.
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. How to import adobe pdf files to publisher on a pc small. Ofatumumab uses, dmf, dossier, manufacturer, supplier. Chronic lymphocytic leukemia cll is the most common leukemia in adults, with approximately 15,720 men and women expected to be diagnosed with cll in 2014 in the united states. 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. Fortunately, microsoft word can help you convert it into a format that publisher can read. Important safety information for arzerra ofatumumab warning. Ofatumumab is a medication prescribed for treating a certain type of cancer known as chronic lymphocytic leukemia cll. Subsequently, detection was performed by adding azino benzothiazoline sulphonic acid substrate resulting in a color.
The intravenous infusion is administered by a healthcare provider once every one to four weeks. 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 low blood cell counts may be severe and, in some cases, lead to death. Ofatumumab also resulted in similar significant reductions in mri t2 lesions compared with placebo. Please see complete indications and usage for more information.
Ofatumumab targets a novel epitope of the cd20 molecule on b cells and. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. Fda for patients with chronic lymphocytic leukemia cll. Ofatumumab is active in patients with fludarabinerefractory cll. Ofatumumab injection comes as a solution liquid to be added to fluid and injected intravenously into a vein by a doctor or nurse in a medical office or hospital. Arzerra ofatumumab injection, for intravenous use initial u. It has shown promising activity against a broad range of cd20. Official hcp website darzalex faspro daratumumab and. Biologic medicines, such as monoclonal antibodies are gaining popularity for prevention and treatment of diseases. Homepage darzalex faspro daratumumab and hyaluronidase. Other drugs may interact with ofatumumab, including prescription and overthecounter medicines, vitamins, and herbal products. In some patients, ofatumumab is given with another.
The effectiveness of arzerra is based on the demonstration of durable objective responses. A phase 2 study of ofatumumab as a treatment for waldenstrom macroglobulinemia, which is a rare form of nonhodgkin lymphoma, is also ongoing. Highlights of prescribing information these highlights do. The median age at diagnosis is 72 yrs and 10% of the patients are younger than 55 yrs. A doctor may prescribe ofatumumab to treat chronic lymphocytic leukemia in adults. Highlights of prescribing information these highlights do not. Your doctor will check your blood to see if you have low blood cell counts. Add a pdf to your office file office support microsoft office support. Withdraw and discard 15 ml from a 1,000ml polyolefin bag of 0. Link to the pdf file there and select the pdf file, then ok.
Jun 07, 2016 a randomized, doubleblind, doubledummy, parallelgroup study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis. May 01, 2009 ofatumumab doses were 300 mg, followed by five infusions of either 500 or 1,000 mg. 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. Ninlaro ixazomib capsules, for oral use hepatotoxicity. 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. Arzerra ofatumumab for previously untreated cll hcp. Arzerra ofatumumab plus chlorambucil demonstrated a statistically significant 71% improvement in median pfs 22. Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. Arzerra ofatumumab injection, for intravenous infusion initial u. Cytokine release syndrome and neurological toxicities see full prescribing information for complete boxed warning. Ketamine hydrochloride ketamine hydrochloride this product information is intended only for residents of the united states. Find info for hcps about arzerra, a monoclonal antibody for 4 cll treatment indications. Zinplavabezlotoxumabinjection,for intravenous use initial u. Blincyto blinatumomab for injection, for intravenous use initial u.
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