Harvoni may be given with pglycoprotein inhibitors. Harvoni and certain medicines may affect each other, or cause side effects. Real world analysis of ledipasvirsofosbuvir harvoni. Pharmaceuticals and medical devices agency this english version is intended to be a reference material for the convenience of users. No dose adjustment of harvoni is required for patients with mild, moderate, or severe hepatic impairment childpugh class a, b or c hepatitis b coinfection in october 2016, the fda placed a boxed warning on all new hepatitis c drugs about the possible reactivation of hepatitis b infection in coinfected patients who are taking directacting. 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. Package, are files created in the linuxbased autopackage program, a program used by developers to make installation packages for linux programs. Harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog ns5b polymerase inhibitor, and is indicated with or without ribavirin for. The addition of instructions for use ifu for the oral pellets. Harvoni is a prescription medicine used to treat adults with chronic lasting a long time hepatitis c hep c genotype gt 1, 4, 5 or 6 infection. Information on submitting spl files using elist may be found in the guidance for industry.
Some dosages and delivery methods may not reflect package insert information, due to the clinical experience of the. Sofosbuvir, ribavirin, ledipasvir acetonatesofosbuvir. Harvoni is indicated for the treatment of chronic hepatitis c chc infection in. Before taking harvoni this is only a brief summary of important information about harvoni.
Apr 19, 2019 patient readiness has been assessed and patient attestation of compliance is submitted and on file in the pa. Faqs harvoni ledipasvir 90 mgsofosbuvir 400 mg tablets. Official site harvoni ledipasvir 90 mgsofosbuvir 400 mg. Fdca for harvoni ledipasvir and sofosbuvir tablets, 90 mg400mg. I paid for a pro membership specifically to enable this feature. These prior approval supplemental new drug applications provide for the following. To combine pdf files into a single pdf document is easier than it looks. Harvoni is a twodrug fixeddose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet. Highlights of prescribing information zepatier is recommended. Several different methods to choose from since 1983 when it was first developed, microsoft word. Using adobe acrobat, you can create pdf documents with editable fields, secure pdfs and more. References to examine the real world hepatitis c svr rate among commercially insured members completing at least eight weeks of ledipasvirsofosbuvir therapy. Sep 16, 2020 harvoni pellets can be taken in pediatric patients who cannot swallow the tablet formulation. Ledipasvirsofosbuvir harvoni package insert daids regulatory.
Read on to find out just how to combine multiple pdf files on macos and windows 10. Harvoni is used with ribavirin in gt 1 patients with decompensated cirrhosis and in gt 1 or 4 liver transplant recipients without cirrhosis or with compensated cirrhosis. Carefully pour the entire contents of the prescribed number of harvoni oral pellet packets onto the food in the bowl and gently mix with a spoon see figure f. Pdf files can contain text, images and hyperlinks packed into the same document. Louisiana medicaid hepatitis c directacting antiviral daa agents. Jun 22, 2020 harvoni ledipasvirsofosbuvir package insert. This article explains what pdfs are, how to open one, all the different ways. Depending on the type of scanner you have, you might only be able to scan one page of a document at a time. The pregnancy risk summary information in the package insert for ledpasvirsofosbuvir harvoni states. Highlights of prescribing information these highlights do not include all the information needed to use zepatiersafely and effectively.
Harvoni should not be given with pglycoprotein inducers ex. Not just in the number of versions but also in how much you can do with it. Highlights of prescribing information these highlights do not. Direct acting antiviral agents for hepatitis c virus hcv page 8 of 8. Ledipasvirsofosbuvir harvoni pharmacy benefits management.
By michelle rae uy 24 january 2020 knowing how to combine pdf files isnt reserved. Fdaapproved indications harvoni is indicated for the treatment of. Content of labeling o prescribing information o patient package insert or medication guide. Easily edit documents and add text, shapes, comments and highlights to a pdf file. Jun 24, 2019 harvoni 12 weeks treatmentexperienced without cirrhosis harvoni 12 weeks treatmentexperienced with compensated cirrhosis childpugh a harvoni 24 weeks genotype 4, 5, or 6 treatmentnaive and treatmentexperienced, without cirrhosis or with compensated cirrhosis childpugh a harvoni 12 weeks. Criteria for prior approval of harvoni sofosbuvirledipasvir 1. Package files, which actually use the the long extension.
Recommended dosage of harvoni in pediatric patients 3 years of is based on weight. The recommended dosage of harvoni in adults with genotype 1, 4, 5, or 6 hcv is one tablet 90 mg ledipasvir and 400 mg sofosbuvir taken orally once daily. In those with gt 1 and advanced cirrhosis decompensated or with gt 1 or 4 with or without cirrhosis compensated who have had a liver transplant, harvoni. To learn about potential savings, call 18557mypath or go to. When used in combination with ribavirin, refer also to the summary of product. If you require further assistance, speak with a harvoni educator at 1844ready41 18447323941, or contact your hep c specialist harvoni is a prescription medicine used to treat adults with chronic lasting a long time hepatitis c hep c genotype gt 1, 4, 5 or 6 infection with or without. Scroll to discover harvoni in a study of 865 patients with genotype 1 hep c and no prior hep c treatment, with or without cirrhosis compensated, 99% 210 out of 2 of those who. Please see harvoni package insert pdf for further information. The fda approved ledipasvir combined with sofosbuvir in one tablet harvoni for the. Protonpump inhibitors if coadministration required, doses comparable to omeprazole 20 mg or lower. Harvoni 12 weeks treatmentexperienced without cirrhosis harvoni 12 weeks treatmentexperienced with compensated cirrhosis childpugh a harvoni 24 weeks genotype 4, 5, or 6 treatmentnaive and treatmentexperienced, without cirrhosis or with compensated cirrhosis childpugh a harvoni 12 weeks.
If the patient is male and using harvoni in combination with ribavirin, he must not have a female partner who is currently pregnant, and he must agree to use adequate contraception to avoid pregnancy during treatment. Pdf file or convert a pdf file to docx, jpg, or other file format. Dailymed harvoni ledipasvir and sofosbuvir tablet, film. Direct acting antivirals f or hepatitis c hcv therapeutic. The patient does not have end stage renal disease requiring dialysis or a glomerular filtration rate package information data. That is one of my denial reasonsi dont know if it says that. Fill out pdf forms and modify your pdf by adding annotations. If patient is female she must not currently be pregnant and may not become pregnant while taking above combination. A pdf file is a portable document format file, developed by adobe systems. Highlights of prescribing information thereafter or as. Luckily, there are lots of free and paid tools that can compress a pdf file in just a few easy steps. Harvoni is indicated for the treatment of adults and children 3 years of age and older with chronic hepatitis c virus hcv. Aetna better health pharmacy prior authorization hepatitis c.
Harvoni is a prescription medicine used to treat adults with chronic hepatitis c hep c genotype 1, 4, 5, or 6 infection with or without cirrhosis compensated. Harvoni is a prescription medicine used to treat adults with chronic lasting a long time hepatitis c hep c genotype gt 1, 4, 5 or 6 infection with or without cirrhosis compensated. Csl behring immune globulin intravenous human, 10% liquid. H2receptor antagonists administer simultaneously with or 12 hours apart from ledipasvirsofosbuvir. Ledipasvirsofosbuvir authorized generic of hharvoni package insert. Harvoni is indicated for the treatment of chronic hepatitis c chc in adults see. Gilead report on ims national prescription audit december 20 through september 2019. Harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog ns5b polymerase. Background of the revision and investigation results cases of severe hypertension in patients concomitantly administered sofosbuvir and. Strategy rems, contraindications, minimum age requirements, recommended dosing, and prior treatment requirements.
The content on this site is presented in a summary fashion, and is intended to be used for educational and entertainment purposes only. Consult the full prescribing information for harvoni for more information on potentially significant drug interactions, including clinical comments. Do not use harvoni tablets if the seal over the bottle opening is broken or missing. Read below for answers to faqs about hepatitis c and harvoni. It is not intended to be and should not be interpreted as medical advice or a diagnosis of any health or fitness problem, condition or disease. Harvoni is indicated for the treatment of chronic hepatitis c chc genotype 1 infection in adults.
Objective hepatitis c members receiving specialty pharmacy drug management through. Criteria for prior approval of harvoni sofosbuvirledipasvir. The recommended dose of harvoni in adults is 90 mg400 mg once. Do not exceed doses comparable to famotidine 40 mg twice daily. Harvoni ledipasvir and sofosbuvir for hepatitis c genotype 1 treatment ranged 8 to 12 weeks. Let your provider know if you are taking any acidreducing medicationseither prescribed to you or purchased over. Direct acting antivirals for hepatitis c hcv therapeutic class. If you require further assistance, speak with a harvoni educator at 1844ready41 18447323941, or contact your hep c specialist. Real world analysis of ledipasvirsofosbuvir harvoni therapy. Safety information harvoni ledipasvir 90 mgsofosbuvir. Keep harvoni and all medicines out of the reach of children. Cut the packet along the cut line with scissors see figure c, or fold the packet back at the tear line see figure d and tear open see figure e. Please see full prescribing information for harvoni, including boxed warning.
Harvoni in combination with ribavirin is contraindicated in pregnancy. Harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog ns5b polymerase inhibitor, and is indicated with or without ribavirin for the treatment of chronic hepatitis c virus hcv genotype 1, 4, 5 or 6. An oversized pdf file can be hard to send through email and may not upload onto certain file managers. Harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus hcv genotype gt 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. And all laboratory testing and clinical monitoring recommended in the prescribing information have been completed as of the date of the request and will be repeated as recommended including renal function, hepatic state and monitoring for reactivation of hepatitis b. Chronic hepatitis c virus hcv infection should not be considered a contraindication to treatment with statins 3hydroxy3methylglutaryl coenzyme a reductase inhibitors. Do not use harvoni pellets if the carton tamperevident seal, or the pellets packet seal, is broken or damaged.
Reference numbers 2184h specialty quantity limit hepatitis c medications 2184h p2019. The recommended dosage of harvoni in pediatric patients 12 years of age. The pdf, or portable document format, was created by adobe to allow users to read formatted documents on a variety of devices. Since 1983 when it was first developed, microsoft word has evolved.
Harvoni 8 weeks genotype 1 treatmentnaive, baseline hcv rna level of greater than or equal to 6 million iuml, without compensated cirrhosis harvoni 12 weeks genotype 1 treatmentnaive, with compensated cirrhosis harvoni 12 weeks genotype 1 dual or triple treatmentexperienced, without compensated cirrhosis harvoni 12 weeks. Csl behring immune globulin intravenous human, 10%. Harvoni is a two drug fixeddose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet. This means it can be viewed across multiple devices, regardless of the underlying operating system. Direct acting antivirals for hepatitis c hcv therapeutic. Does anybody have the package insert that comes with harvoni section 8. Sep 22, 2017 patient readiness has been assessed and patient attestation of compliance is submitted and on file in the pa. Ledipasvirsofosbuvir harvoni drug interactions a quick. Highlights of prescribing information thereafter or. The daily dosage of ribavirin is weightbased and administered orally in. One tablet 90 mg of ledipasvir and 400 mg of sofosbuvir taken orally once daily with or without food. In this new clinically significant adverse reaction subsection, cerebrovascular disorder should be added. Highlights of prescribing information these highlights do. Pdf is a hugely popular format for documents simply because it is independent of the hardware or application used to create that file.
Dec 14, 2020 harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog ns5b polymerase inhibitor, and is indicated for the treatment of chronic hepatitis c virus hcv in adults and pediatric patients 3 years of age and older. Talk to your healthcare provider or pharmacist to learn more. Spl standard for content of labeling technical qs and as, available at. Read all of this leaflet carefully before you start taking this medicine because it contains important. The patient must meet all general criteria for newer direct acting antivirals. The authorized generic ag of epclusa is preferred and does. Jun 08, 2020 previously treated with a nonstructural protein 5a ns5a inhibitor for example, harvoni, daklinza, and not a nonstructural protein s34a ns34a inhibitor no cirrhosis or compensated cirrhosis childpugh a. Ledipasvirsofosbuvir harvoni acidreducing medications can decrease the effectiveness of harvoni and epclusa and could prevent successful cure.
Harvoni, innledispavirsofosbuvir european medicines agency. If your scanner saves files as pdf portbale document format files, the potential exists to merge the individual files into one doc. Harvoni ledipasvir sofosbuvir tablets 90400 mg 90400 mg once daily 28 per 28 days mavyret glecaprevir. Aetna better health pharmacy prior authorization hepatitis. Prescribing information and patient package insert, with the addition of any labeling changes in pending changes being effected cbe supplements, as well as annual reportable changes not included in the enclosed labeling. The fda approval of ledipasvirsofosbuvir was based on three pivotal phase 3 randomized. Background package for nda 204671 sofosbuvir gs7977.
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