Arzerra is an antibody that is made in a laboratory rather than a naturally occurring antibody. Dosage adjustment should be guided by the clinical response 2. 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. The following table lists the ndcs and labelers of arzerra. Arzerra is also approved for firstline use in russia.
Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cellsmm3. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of arzerra while maintaining optimal therapeutic outcomes. Get emergency medical help if you have signs of an allergic reaction. Patients with a history of a clinically significant low white blood cell count wbc or a druginduced leukopenianeutropenia should have their complete blood count cbc monitored frequently during the first few months of therapy and discontinuation of abilify should be considered at the first sign of a. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Your doctor will check your blood to see if you have low blood cell counts. Accelerated approval was granted for this indication based on overall response rate. Tell your caregiver right away if you feel dizzy, nauseated, lightheaded, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble. Monoclonal antibodies are made to target and destroy only certain cells in the body.
About goodrx prices and arzerra coupons goodrx s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. Highlights of prescribing information these highlights do not include all the information needed to use jadenu safely and effectively. Arzerra ofatumumab injection, for intravenous infusion initial u. Gsk and genmab receive fda approval for arzerra ofatumumab. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia cll 1. Arzerra should be limited to use in patients who are refractory to fludarabine andor alemtuzumab or rituximab and have been heavily pretreated 12.
Description azactam aztreonam injection contains the active ingredient aztreonam, a monobactam. Ofatumumab omb157 ectrims data investor call novartis. Highlights of prescribing information these highlights do not include all the information needed to use complera safely and effectively. All reported events are included except those already listed above, events unlikely to be drugrelated, and those too general to be informative. Highlights of prescribing information these highlights do not include all the information needed to use afrezza safely and effectively.
Venclexta may be considered medically necessary in patients that are 18 years of age and. Sirturo bedaquiline official website about sirturo. Jul 09, 2015 arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. Administer arzerra in an environment where facilities to adequately monitor and treat infusion reactions are available see warnings and precautions 5. Highlights of prescribing information these highlights do not. Ofatumumab arzerra medical clinical policy bulletins. Calan sr is available for oral administration as light green, capsule. The effectiveness of arzerra is based on the demonstration of durable objective responses. Highlights of prescribing information extended treatment. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. Control and prevention of bleeding in patients with hemophilia a or acquired factor viii fviii deficiency 1. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline skip to. Please also see full prescribing information for azactam. Sep 16, 2019 administer arzerra in an environment where facilities to adequately monitor and treat infusion reactions are available see warnings and precautions 5.
Tsai, head global drug development and chief medical officer, novartis. Arzerra ofatumumab is a human monoclonal antibody that is designed to target the cd20 molecule found on the surface of chronic lymphocytic leukemia cll. Aliqopa was evaluated in a singlearm, multicenter, phase ii clinical trial, chronos1, in a total of 142 subjects, which included 104 subjects with follicular bcell nonhodgkin lymphoma who had relapsed disease following at least 2 prior treatments. Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, and decrease the risk of bleeding. In some patients, ofatumumab is given with another medicine called chlorambucil. Novartis ofatumumab demonstrates superiority versus aubagio in. Ofatumumab was granted orphan drug designation in november 2008 for the. The solution 115 should not be used if discolored or cloudy, or if foreign particulate matter is present. Antitumor activity was also observed in additional patients in study 1 and in a multicenter, openlabel, doseescalation study study 2 conducted in patients with relapsed or refractory cll smithkline beecham corporation product insert for arzerra, 2009. In both headtohead studies, ofatumumab demonstrated superiority over. Aliqopa copanlisib is indicated for the treatment of adult patients with relapsed follicular lymphoma fl who have received at least two prior systemic therapies.
The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. Congestive heart failure thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients see warnings and precautions 5. Arzerra is used to treat chronic lymphocytic leukemia cll. Ofatumumab may also be used for purposes not listed in this medication guide. Risk of acute bronchospasm in patients with chronic lung disease acute bronchospasm has been observed in patients with asthma and copd using afrezza. Continued approval for this indication may be contingent upon verification and description of. This will insert the pdf first page only as objects cannot span pages just as in earlier versions, without converting the pdf. Complera emtricitabine, rilpivirine, tenofovir disoproxil fumarate tablets, for oral use initial u. Food and drug administration fda to treat chronic lymphocytic leukemia cll either as a single therapy or in combination with other treatments. Ofatumumab human monoclonal antibody was provided in prefilled glass syringes initial syringes contained 0. Arzerra ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of.
Many programs are available from federal and state governments, nonprofits, manufacturers, and other organizations to help you get the drugs you need at a reduced cost. It was developed and is marketed by genmab under a codevelopment and commercialization agreement with novartis. Arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. Food and drug administration fda to treat chronic lymphocytic leukemia cll either as a single therapy or in combination with other treatments it was developed and is marketed by genmab under a codevelopment and commercialization agreement with novartis. Our discount and coupon prices are based on contracts between a pharmacy or pharmacy purchasing group and a pharmacy benefit manager pbm, who provides. Arzerra ofatumumab is the generic name for the trade chemotherapy drug arzerra. Patient assistance program from pan foundation learn more about this tip on our blog. It works by binding to cd20, a specific antigen found on the surface of healthy cells and leukemia b cells a type of white blood cell. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. Sirturo is the first antitb drug to interfere with bacterial energy metabolism. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zithromax azithromycin. After initiation of avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure.
It is used to treat chronic lymphocytic leukemia cll in patients who have further disease after. For full us prescribing information, including boxed warning, please. Forward looking statements can generally be identified by words. Ofatumumab arzerra medical clinical policy bulletins aetna. Graham mayor microsoft word mvp 20022019 for more word tips and downloads visit my web site. Highlights of prescribing information patients with high. It is given once a week for eight weeks, followed by a dose once every four weeks for four doses. Initiation of avandia in patients with established nyha class iii or iv heart failure is contraindicated.
Corticorelin ovine has an amino acid sequence identical to ovine corticotropinreleasing hormone ocrh. Ofatumumab is sometimes given after other medications have been tried without success. Jadenu deferasirox tablets, for oral use jadenu sprinkledeferasirox granules, for oral use initial u. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes such as cold. First quarter 2015 net sales figures for arzerra ofatumumab. May 06, 2015 arzerra ofatumumab is a human monoclonal antibody that is designed to target the cd20 molecule found on the surface of chronic lymphocytic leukemia cll cells and normal b lymphocytes. Glaxosmithkline is a human monoclonal antibody therapy that targets the protein cd20 on the surface of bcells a type of lymphocyte that plays a key role in immune response. For outlook, click inside of the body of an item, such as an email message or calendar event. Avandia is not recommended in patients with symptomatic heart failure. Efficacy and safety of ofatumumab in treatment of pemphigus. Highlights of prescribing information these highlights do not include all the information needed to use alimta safely and effectively. Highlights of prescribing information these highlights. In some cases, health care professionals may use the trade name arzerra when referring to the generic drug name ofatumumab. The words believe, expect, anticipate, intend and plan and.
Arzerra should be a clear to opalescent, colorless solution. To report suspected adverse reactions, contact glaxosmithkline at 18888255249 or fda at 1800fda1088 or. Study 970034, a randomized, doubleblind, comparative multicenter trial, evaluated the safety of ambisome 3 and 5 mgkgday compared with amphotericin b lipid complex 5 mgkgday in the empirical treatment of 202 adult and 42 pediatric neutropenic patients. Sirturo is the first medication for pulmonary mdrtb with a novel mechanism of action in over 40 years. Sirturo specifically inhibits mycobacterial atp adenosine 5triphosphate synthase, by binding to subunit c of the enzyme that is. 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. Arzerra is indicated for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive cll see clinical studies 14. Ofatumumab was administered per the approved product label for monotherapy in. Resume abraxane and carboplatin at reduced doses see table 2 when peripheral neuropathy improves to grade 1 or completely resolves see warnings and precautions 5. This medication comes as an intravenous iv infusion that is given by a healthcare provider. The recommended dose of alimtafor treatment of recurrent nonsquamous nsclcinpatients with a creatinine clearance calculated by cockcroftgault equation of 45mlmin or greateris 500mgm2 as an intravenous infusion over 10minutes on day 1 of each 21day cycle until disease progression or unacceptable toxicity. Withhold abraxane for grade 34 peripheral neuropathy. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections.
It works by binding to cd20, a specific antigen found on the surface of. It was originally isolated from chromobacterium violaceum. Mar 01, 2018 product approval information is indicated for. Ofatumumab package insert keyword found websites listing.
Efficacy and safety of duvelisib following disease progression on. Arzerra ofatumumab is a human, anticd20 monoclonal antibody approved by the u. Refractory cll arzerra is indicated for the treatment of patients with cll refractory to fludarabine and alemtuzumab see clinical studies 14. Withdraw 5 ml from each of 3 singleuse 100mg vials of. Withdraw and discard 15 ml from a 1,000ml bag of 0. Arzerra ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. These low blood cell counts may be severe and, in some cases, lead to death. Highlights of prescribing information these highlights do. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which.
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