Ofatumumab as singleagent cd20 immunotherapy in fludarabine. Listing a study does not mean it has been evaluated by the u. Resource links provided by the national library of. Ofatumumab arzerra as maintenance therapy in patients with relapsed. Bendamustine for treatment of chronic lymphocytic leukemia. Arzerra ofatumumab plus chlorambucil demonstrated a statistically significant 71% improvement in median pfs 22.
To potentially gain insight into outcomes in patients previously. The recommended dosage and schedule is 12 doses administered as follows. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Nov 09, 2018 ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. In some patients, ofatumumab is given with another. It is used in people who have not responded to or cannot take certain other chemotherapy treatment. Lartruvoolaratumabinjection, for intravenous use initial u. 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. It is usually injected once a week for 8 weeks then once a month for 4 months. For adults who have chronic lymphocytic leukemia cll. May 01, 2009 ofatumumab doses were 300 mg, followed by five infusions of either 500 or 1,000 mg.
The recommended dosage for extended treatment in cll is 300 mg on day 1. 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. Arzerra ofatumumab injection, for intravenous use initial u. 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.
It being investigated as a treatment for relapsingremitting. Full text infusion reactions associated with use of. The median age at diagnosis is 72 yrs and 10% of the patients are younger than 55 yrs. 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. Link to the pdf file there and select the pdf file, then ok. Original package inserts for 25 specific new molecular entities approved from 19951997. Blincyto blinatumomab for injection, for intravenous use initial u. Due to their binding specificity for the molecular target of interest, or other biochemical pathways in human system, they provide benefits of lowering the unwanted systemic effects with an increasein efficacy. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab. Ofatumumab in children with drug resistant idiopathic. Fda for patients with chronic lymphocytic leukemia cll.
Monoclonal antibodies are made to target and destroy only certain cells in the body. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. Withdraw 5 ml from each of 20 ofatumumab vials and add to 0. 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. 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. Darzalex faspro is a prescription medicine used to treat adult patients with multiple myeloma. Highlights of prescribing information extended treatment. Efficacy and safety of ofatumumab compared to teriflunomide.
Find info for hcps about arzerra, a monoclonal antibody for 4 cll treatment indications. Ofatumumab arzerra medical clinical policy bulletins aetna. Lymphoma burden was estimated by the sum of the product of the largest. Premedicate before each infusion see dosage and administration 2. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. It has shown promising activity against a broad range of cd20. Please see complete indications and usage for more information. Arzerra ofatumumab for previously untreated cll hcp. In fact, with ofatumumab, the risk for new gdenhancing lesions was reduced by 99% compared with placebo. Ofatumumab binds effectively to both the small and large extracellular loops on cd20 and releases very slowly over time.
Prior therapies included a pi and an immunomodulatory agent or patients were doublerefractory to a pi and an immunomodulatory agent. Ofatumumab targets a novel epitope of the cd20 molecule on b cells and. 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. Highlights of prescribing information these highlights do. 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 zinplavasafely and. 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.
Cytokine release syndrome crs, which may be lifethreatening or fatal, occurred in patients receiving blincyto. The intravenous infusion is administered by a healthcare provider once every one to four weeks. 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. These low blood cell counts may be severe and, in some cases, lead to death.
Zinplavabezlotoxumabinjection,for intravenous use initial u. 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. See how to insert a file in pdf format into your office file as an attachment. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Prior therapies included lenalidomide and a proteasome inhibitor pi. The effectiveness of arzerra is based on the demonstration of durable objective responses. Ofatumumab trade name arzerra, also known as humaxcd20 is a fully human monoclonal antibody to cd20, which appears to inhibit earlystage b lymphocyte activation. Chronic lymphocytic leukemia treatment algorithm 2018. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
A phase 2 study of ofatumumab as a treatment for waldenstrom macroglobulinemia, which is a rare form of nonhodgkin lymphoma, is also ongoing. Ofatumumab is an antibody against a protein called cd20, which is found on the surface of certain types of immune cells called bcells. Fortunately, microsoft word can help you convert it into a format that publisher can read. Ofatumumab all dosing groups combined resulted in significantly fewer new gdenhancing lesions compared with placebo. How to import adobe pdf files to publisher on a pc small. Patients recruitment has been completed, and preliminary results are expected in 20. Depending on the types of formatting you used in preparing the original. Do not administer as an intravenous push or bolus or as a subcutaneous injection. 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 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. The fdaapproved package insert updated september 2011 contains warnings regarding pml and reactivation of hepatitis b.
Add a pdf to your office file office support microsoft office support. 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. Your doctor may need to interrupt your treatment if you experience certain side effects. Arzerra ofatumumab injection side effects, images, uses. 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. Important safety information for arzerra ofatumumab warning. 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. Highlights of prescribing information these highlights do not. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. Xgevadenosumab injection, for subcutaneous use initial usapproval.
Homepage darzalex faspro daratumumab and hyaluronidase. Ofatumumab is used to treat chronic lymphocytic leukemia cll. Ofatumumab also resulted in similar significant reductions in mri t2 lesions compared with placebo. 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. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated. Subsequently, detection was performed by adding azino benzothiazoline sulphonic acid substrate resulting in a color. Ofatumumab side effects, dosage, interactions drugs. Ofatumumab is active in patients with fludarabinerefractory cll.
Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Jan 09, 2017 what other drugs will affect ofatumumab arzerra. Select object action in the action settings window and select open. You can resize the object, but you cant edit it after you insert it. Light orange gelatin capsule imprinted with takeda on the cap and 4 mg on the body in black ink. Ninlaro 4 mg capsules contain 4 mg of ixazomib equivalent to 5. Other drugs may interact with ofatumumab, including prescription and overthecounter medicines, vitamins, and herbal products. Ofatumumab is a medication prescribed for treating a certain type of cancer known as chronic lymphocytic leukemia cll. Biologic medicines, such as monoclonal antibodies are gaining popularity for prevention and treatment of diseases. Ofatumumab uses, dmf, dossier, manufacturer, supplier. 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. 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.
Ofatumumab definition of ofatumumab by medical dictionary. This may help to protect healthy cells from damage. First clinical use of ofatumumab, a novel fully human anticd20. Arzerra ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Uploaded in accordance with the publishers selfarchiving policy. Withdraw and discard 15 ml from a 1,000ml polyolefin bag of 0.
A doctor may prescribe ofatumumab to treat chronic lymphocytic leukemia in adults. Sep 06, 2011 ofatumumab ofa is the first fully human anticd20 mab approved by u. Highlights of prescribing information these highlights do not include all the information needed to use lartruvosafely and effectively. 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 injection, for intravenous infusion. 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. Studies on expression of molecular targets bestows one disadvantage of. Formation of anti ofatumumab antibodies was observed in less than 1% of patients with cll after treatment with ofatumumab. Arzerra ofatumumab injection, for intravenous infusion initial u. Ketamine hydrochloride ketamine hydrochloride this product information is intended only for residents of the united states. Tm ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Ofatumumab, the human cd20 monoclonal antibody that binds a distinct. Highlights of prescribing information these highlights do not include all the information needed to use zinplavasafely and effectively.
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