Inserting pdf files into an existing pdf using adobe acrobat pro. Neulasta pegfilgrastim injection,for subcutaneous use initial u. This reimbursement policy is intended to ensure that you are reimbursed based on the code or codes that correctly describe the. The product is available in singleuse vials and prefilled syringes. Efficacy and safety of lipegfilgrastim versus pegfilgrastim. Pegfilgrastim is in a class of medications called colony stimulating factors.
You can resize the object, but you cant edit it after you insert it. Then, pull back the plunger and draw air into the syringe. Filgrastim zarxio is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions. It is given either by injection into a vein or under the skin.
Check to make sure that the plastic transparent needle guard is covering the barrel of the glass syringe. Filgrastim, sold under the brand name neupogen among others, is a medication used to treat low neutrophil count. Jan 01, 1990 we only accepted studies in which filgrastim 5 microgkgday and pegfilgrastim 100 microgkg or a fixed dose of 6 mg were administered at approved doses indicated on the package insert. Nitro pro enables you to combine pages from multiple pdfs into a single file. This package simplifies the inclusion of external multipage pdf documents in. The report provides key statistics on the market status of the filgrastim manufacturers and is a valuable source of guidance and direction for. Package insert lists common adverse reactions from reference labeling.
For evidence, tools, and resources related to covid19, visit our covid19 evidence portal. Giving yourself an injection of filgrastim neupogen or. If you have a multipage pdf from another division, you may need to extract some of the pages in order to insert them where they need to be. How to insert a pdf file into another pdf file using. Learn more at these data are based on paid claims data from national data providers for the period 11201812312018. With filgrastim, its important to watch for potentially dangerous drug interactions and take blood tests regularly to measure neutrophil levels in your blood. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. White blood cells are important to help you fight off. Read more i understand that some in australia are getting subsidized filgrastim neupogen, hopefully you wont need it but id be discussing with my specialist so you. Low neutrophil counts may occur with hivaids, following chemotherapy or radiation poisoning, or be of an unknown cause. Filgrastim, lenograstim, nartograstim, pegfilgrastim. A total of 4 cases associated with anaphylaxis has been reported including a case for which a causal relationship to the product could not be ruled out. It is used to help your body make more white blood cells.
Fluid therapy and sodium bicarbonate administration are potential supportive therapies. To enter and activate the submenu links, hit the down arrow. Pegfilgrastim is a form of a protein that stimulates the growth of white blood cells that help your body fight against infection. Use your thumb whichever thumb is more comfortable to slowly push the plunger all the way down.
Jul 27, 2009 antizol fomepizole injection is a competitive inhibitor of alcohol dehydrogenase. Precautions and warnings with filgrastim before starting a new medication, make sure you are aware of the drugs precautions and warnings. Jul 24, 2014 this filing acceptance represents a significant step toward making highquality biologics more accessible in the us and we applaud fda for its progress in making this a reality, said mark mccamish, m. We only accepted studies in which filgrastim 5 microgkgday and pegfilgrastim 100 microgkg or a fixed dose of 6 mg were administered at approved doses indicated on the package insert. It has the molecular formula c 4 h 6 n 2 and a molecular weight of 82. Va17jul19p this document contains confidential and proprietary. You are responsible for submission of accurate claims. The approval of the first biosimilar for market in the u. Highlights of prescribing information acute respiratory. Administer neupogenat least 24 hours aftercytotoxic chemotherapy. Bmt recommended dose following bmt is 10 mcgkgday given as an iv infusion of 4 or 24 hours or sc. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for granix tbo filgrastim. The following is the recommended dosage and frequency when administering this drug.
It is usually given once a day, but filgrastim injection products neupogen, nivestym, zarxio may be given twice a day when it is used to treat severe chronic neutropenia. If you add a folder that contains files other than pdfs, the nonpdf files are not added. Other considerations do not administer to patients with latex allergy. Filgrastim dosing during chemotherapy the recommended starting filgrastim dose for preventing infections during chemotherapy is based on body weight filgrastim 5 mcg per kg each day about 2. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Dispose of that syringe in the punctureproof disposal container. This document contains c onfidential and proprietary information of cvs caremark and. Webmd provides common contraindications for filgrastim injection.
Filgrastim injection products come as a solution liquid in vials and prefilled syringes to inject under the skin or into a vein. Pegfilgrastim pegfilgrastim is a covalent conjugate of recombinant methionyl human gcsf filgrastim and monomethoxypolyethylene glycol. Pegfilgrastim injection neulasta is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and lifethreatening damage to bone marrow. Cber, approval, label, filgrastim, neupogen, amgen. Pune, india may 5, 2017 marketersmedia the global and chinese filgrastim market, 20122022 industry research report is a professional and indepth study on the current state of the global filgrastim market with a focus on the chinese market. It may also be used to increase white blood cells for gathering during leukapheresis. Filgrastim is a manmade version of a certain natural substance made in your body. The chemical name of fomepizole is 4methylpyrazole.
Do not use a zarxio prefilled syringe if it is broken. Neulasta pegfilgrastiminjection,for subcutaneous use initial u. Aug 12, 2015 cadth is committed to supporting canadas health care decisionmakers through this challenging and uncertain time. These highlights do not include all the information needed to use cuvitru safely and effectively. Cadth is committed to supporting canadas health care decisionmakers through this challenging and uncertain time. Pegfilgrastim side effects, dosage, interactions drugs. Local coverage determination for gcsf filgrastim, neupogen. Pooled relative risk rr was estimated using the conservative random effects, empirical bayesian method of hedges and olkin. Projected place in therapy product licensed filgrastimsndz has been. Highlights of prescribing information neulasta safely and.
Do not administer neupogen within the 24hour period prior to chemotherapy see warnings and precautions 5. The amgen first step program can help commercially insured patients reduce outofpocket costs for neulasta or neulasta onpro. Highlights of prescribing information these highlights do not include all the information needed to use neulasta safely and effectively. The labeler code, product code, and package code segments of the national drug code number, separated by hyphens. The package insert instructions for dosage and duration of treatment should not be exceeded. Insert the needle into your skin in one quick motion at a 90degree straight up and down angle see figure 3. Pegfilgrastim may also be used for purposes not listed in this medication guide. Compendial uses neupogengranixzarxio treatment of chemotherapy induced febrile neutropenia in patients with nonmyeloid malignancies treatment of symptomatic anemia in patients with myelodysplastic syndromes mds, in combination with epoetin or darbepoetin treatment of neutropenia in patients with mds and recurrent or resistant infections. If the syringe package is undamaged, open the package and remove the syringe. The singleuse vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1. The amount of air drawn into the syringe should be the same amount ml or cc as the dose of neupogen that your doctor prescribed. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for granix tbofilgrastim.
Call your doctor right away if you have signs of this condition, which may. Patient package insert 29 may 2002 neupogen filgrastim. Return the broken prefilled syringe and the package it came in to your pharmacy. Hit enter to expand a main menu option health, benefits, etc. The pdf file will then be placed onto your word document. You will now be able to tab or arrow up or down through the submenu options to accessactivate the submenu links. The package insert for ribavirin recommends reducing the ribavirin dose at hemoglobin levels less than 10 gdl and permanently discontinuing the drug at levels less than 8.
Nov 09, 2018 pegfilgrastim is a manmade form of a protein that stimulates the growth of white blood cells in your body. Get emergency medical help if you have signs of an allergic reaction. Low neutrophil counts may occur with hivaids, following chemotherapy or radiation poisoning, or be of an unknown cause, it may be used to increase white blood cells for gathering during leukapheresis. Zarxio filgrastimsndz is a 175 amino acid human granulocyte colonystimulating factor gcsf manufactured by recombinant dna technology zarxio is produced by escherichia coli e coli bacteria into which has been inserted the human granulocyte colonystimulating factor gene. It works by helping the body make more neutrophils. When inserting pages, you can choose whether to insert an entire document or just. Pegfilgrastim is a manmade form of a protein that stimulates the growth of white blood cells in your body. Csf, a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow. Return the zarxio prefilled syringe and the package it came in to your pharmacy. If the package has been opened or damaged, do not use that syringe. This phase iii, doubleblind, randomized, activecontrolled, noninferiority trial compared the efficacy and safety of lipegfilgrastim versus pegfilgrastim in chemotherapynaive breast cancer patients receiving doxorubicin.
Neulasta pegfilgrastim cost assistance, tools, and resources. Nov 09, 2018 filgrastim zarxio is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions. Compendial uses neupogengranixzarxio treatment of chemotherapy induced febrile neutropenia in patients with nonmyeloid malignancies treatment of symptomatic anemia in patients with myelodysplastic syndromes mds, in combination with. Projected place in therapy product licensed filgrastim sndz has been shown to be biosimilar the reference filgrastim in the u. A onepage pdf is relatively simple to insert while the process for inserting. The active substance in lonquex, lipegfilgrastim, is similar to granulocytecolonystimulating factor g. White blood cells help your body fight against infection.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the ndc. Filgrastim zarxio side effects, dosage, interactions. A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of neupogen therapy. Fda accepts sandoz application biosimilar filgrastim sandoz. Comparison of ep2006, a filgrastim biosimilar, to the. Find out what health conditions may be a health risk when taken with filgrastim injection. Read the patient information leaflet and instructions for use if available from your pharmacist before you start using filgrastim and. Lipegfilgrastim is a novel glycopegylated granulocytecolony stimulating factor in development for neutropenia prophylaxis in cancer patients receiving chemotherapy. Choose the pdf file from the popup window and press insert. Combine or merge files into a single pdf, adobe acrobat dc. Filgrastim market 2017 analysis, company profiles, trends.
Pegfilgrastim uses, dmf, dossier, manufacturer, supplier. This filing acceptance represents a significant step toward making highquality biologics more accessible in the us and we applaud fda for its progress in making this a reality, said mark mccamish, m. Filgrastimsndz zarxio national drug monograph september 2016. If you only have the free reader, you can subscribe to the pdf pack service to combine files or download a 30day trial of acrobat xi pro. The number of reported adverse reactions and fatal cases in the last 3 fiscal years in japan 1. Neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresissee clinical studies 14. Filgrastim is a watersoluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons kd.954 1392 504 1253 1279 1021 71 208 503 45 408 974 571 299 1335 653 1268 821 913 245 647 637 760 1149 1298 1479 755 1009 1288 906 360 38 533 1398