Arzerra is an antibody that is made in a laboratory rather than a naturally occurring antibody. Control and prevention of bleeding in patients with hemophilia a or acquired factor viii fviii deficiency 1. The effectiveness of arzerra is based on the demonstration of durable objective responses. 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. It is used to treat chronic lymphocytic leukemia cll in patients who have further disease after. 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.
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. 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. Efficacy and safety of ofatumumab in treatment of pemphigus. This medication comes as an intravenous iv infusion that is given by a healthcare provider. Patient assistance program from pan foundation learn more about this tip on our blog. Highlights of prescribing information these highlights do not include all the information needed to use alimta safely and effectively. Sirturo is the first medication for pulmonary mdrtb with a novel mechanism of action in over 40 years. Highlights of prescribing information these highlights do not. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of. Your doctor will check your blood to see if you have low blood cell counts. The solution 115 should not be used if discolored or cloudy, or if foreign particulate matter is present.
Our discount and coupon prices are based on contracts between a pharmacy or pharmacy purchasing group and a pharmacy benefit manager pbm, who provides. Ofatumumab was granted orphan drug designation in november 2008 for the. In some cases, health care professionals may use the trade name arzerra when referring to the generic drug name ofatumumab. Accelerated approval was granted for this indication based on overall response rate. This will insert the pdf first page only as objects cannot span pages just as in earlier versions, without converting the pdf. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline. 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. Highlights of prescribing information these highlights do not include all the information needed to use afrezza safely and effectively. Withhold abraxane for grade 34 peripheral neuropathy. Food and drug administration fda to treat chronic lymphocytic leukemia cll either as a single therapy or in combination with other treatments.
First quarter 2015 net sales figures for arzerra ofatumumab. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present. These low blood cell counts may be severe and, in some cases, lead to death. Ofatumumab package insert keyword found websites listing. 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. Aliqopa copanlisib is indicated for the treatment of adult patients with relapsed follicular lymphoma fl who have received at least two prior systemic therapies. 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.
Risk of acute bronchospasm in patients with chronic lung disease acute bronchospasm has been observed in patients with asthma and copd using afrezza. Tsai, head global drug development and chief medical officer, novartis. Arzerra ofatumumab is a monoclonal antibody that affects the actions of the bodys immune system. Complera emtricitabine, rilpivirine, tenofovir disoproxil fumarate tablets, for oral use initial u. It is given once a week for eight weeks, followed by a dose once every four weeks for four doses. Arzerra ofatumumab is 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. 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. Ofatumumab is sometimes given after other medications have been tried without success. 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.
Graham mayor microsoft word mvp 20022019 for more word tips and downloads visit my web site. Corticorelin ovine has an amino acid sequence identical to ovine corticotropinreleasing hormone ocrh. Withdraw 5 ml from each of 3 singleuse 100mg vials of. 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. Sep 16, 2019 administer arzerra in an environment where facilities to adequately monitor and treat infusion reactions are available see warnings and precautions 5.
Congestive heart failure thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients see warnings and precautions 5. Ofatumumab is used to treat 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. For full us prescribing information, including boxed warning, please. Arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. Sirturo bedaquiline official website about sirturo. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for afrin oxymetazoline skip to.
Arzerra ofatumumab is a human monoclonal antibody that is designed to target the cd20 molecule found on the surface of chronic lymphocytic leukemia cll. Highlights of prescribing information these highlights do. Arzerra is used to treat chronic lymphocytic leukemia cll. Venclexta may be considered medically necessary in patients that are 18 years of age and. Highlights of prescribing information extended treatment. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cellsmm3. Please also see full prescribing information for azactam. Avandia is not recommended in patients with symptomatic heart failure. This may help to protect healthy cells from damage. Ofatumumab was administered per the approved product label for monotherapy in. For outlook, click inside of the body of an item, such as an email message or calendar event.
Jul 09, 2015 arzerra ofatumumab is in a class of drugs called anticd20directed monoclonal antibodies. Highlights of prescribing information these highlights. Jadenu deferasirox tablets, for oral use jadenu sprinkledeferasirox granules, for oral use initial u. Description azactam aztreonam injection contains the active ingredient aztreonam, a monobactam. Forward looking statements can generally be identified by words.
It was developed and is marketed by genmab under a codevelopment and commercialization agreement with novartis. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which. 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. Highlights of prescribing information these highlights do not include all the information needed to use complera safely and effectively. Ofatumumab omb157 ectrims data investor call novartis. 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. Efficacy and safety of duvelisib following disease progression on. 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. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia cll 1. Initiation of avandia in patients with established nyha class iii or iv heart failure is contraindicated. The words believe, expect, anticipate, intend and plan and.
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. Withdraw and discard 15 ml from a 1,000ml bag of 0. Calan sr is available for oral administration as light green, capsule. Arzerra may cause low blood cell counts white blood cells, platelets, and red blood cells. Dosage adjustment should be guided by the clinical response 2. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Arzerra should be limited to use in patients who are refractory to fludarabine andor alemtuzumab or rituximab and have been heavily pretreated 12. Mar 01, 2018 product approval information is indicated for. 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 zithromax azithromycin. Arzerra is also approved for firstline use in russia. Gsk and genmab receive fda approval for arzerra ofatumumab. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections.
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of arzerra while maintaining optimal therapeutic outcomes. It was originally isolated from chromobacterium violaceum. Refractory cll arzerra is indicated for the treatment of patients with cll refractory to fludarabine and alemtuzumab see clinical studies 14. To report suspected adverse reactions, contact glaxosmithkline at 18888255249 or fda at 1800fda1088 or. Highlights of prescribing information these highlights do not include all the information needed to use jadenu safely and effectively. 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. Arzerra ofatumumab is a cd20directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia cll refractory to fludarabine and alemtuzumab. Arzerra should be a clear to opalescent, colorless solution. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. Highlights of prescribing information patients with high. In some patients, ofatumumab is given with another medicine called chlorambucil. Sirturo specifically inhibits mycobacterial atp adenosine 5triphosphate synthase, by binding to subunit c of the enzyme that is.
Administer arzerra in an environment where facilities to adequately monitor and treat infusion reactions are available see warnings and precautions 5. Ofatumumab arzerra medical clinical policy bulletins aetna. Low white blood cell count, also called neutropenia, may happen during treatment or even weeks later. All reported events are included except those already listed above, events unlikely to be drugrelated, and those too general to be informative. It works by binding to cd20, a specific antigen found on the surface of. Ofatumumab arzerra medical clinical policy bulletins. After initiation of avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure. 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. Ofatumumab human monoclonal antibody was provided in prefilled glass syringes initial syringes contained 0.
1456 312 638 1104 438 152 882 636 1346 178 1449 314 125 268 928 402 519 7 681 1365 1522 1275 1413 1210 404 366 1072 1231 115 427 805 1326 357 190 210 129 285 1134 396 1354 777 716