Humulin n is an intermediateacting human insulin indicated to improve glycemic control in adult and pediatric patientswith diabetes mellitus. A consumer medicine information leaflet for baraclude is available for patient information. Labeling package insert label is not available on this site. Nulojix is contraindicated in patients who are ebv seronegative or with unknown serostatus because the risk of ptld is particularly increased in patients who are ebv seronegative. Side effects of baraclude entecavir, warnings, uses rxlist. Severe acute exacerbations of hepatitis b have been reported in patients who have discontinued antihepatitis b therapy, including entecavir see adverse reactions 6. Lactic acidosis is a serious medical emergency that can cause death. Its molecular formula is c 12 h 15 n 5 o 3 h 2 o, which corresponds to a molecular weight of 295. Over 350 million people worldwide are chronically infected with hbv. Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablets, for oral use. Dose adjustments needed for individuals with kidney disease. Unitedhealthcare pharmacy clinical pharmacy programs program. Welcome to the leading independent provider of fda approved medication information, delivering the latest package inserts and product labels directly from the fda repository in an easytoread format. Labeling package insert, labelingpatient package insert label is not available on this site.
Warnings and precautions severe acute exacerbations of hepatitis b. Fda recently approved revisions in the labeling for baraclude entecavir 0. Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms. Welcome to the bristolmyers squibb safety data sheet sds locator. However, longer duration of treatment has shown that adding adefovir on. A more current version may be available on the manufacturers web site. Entecavir versus other oral antiviral drugs for chronic. Vemlidy is a hbv nucleoside analogue reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis b virus infection in adults with compensated liver disease.
Safety and efficacy of entecavir for the treatment of. Taltz ixekizumab injection, for subcutaneous use initial u. One 10 mg tablet once per day, with or without food. A patient package insert ppi for baraclude is available for patient information. Program step therapy vemlidy tenofovir alafenamide change control. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Baraclude is an antiviral medicine that is used to treat chronic hepatitis b virus hbv in adults and children who are at least 2 years old and weigh at least 22 pounds 10 kilograms baraclude is not a cure for hepatitis. Prescription treatment with zytiga abiraterone acetate. Baraclude should be administered on an empty stomach at least 2 hours after a meal and 2 hours before the next meal. Higher than recommended doses or more frequent dosing of. Patient information baraclude entecavir tablets baraclude. Hepatotoxicity see full prescribing information for complete boxed warning.
Severe acute exacerbations of hepatitis b, patients coinfected with hiv and hbv, and lactic acidosis and hepatomegaly see full prescribing information for complete boxed warning. Limited data are available on the safety and efficacy of baraclude in liver transplant recipients. Highlights of prescribing information platinumresistant. Use of nulojix for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. Actemra can be used alone following discontinuation of glucocorticoids. Lift the package away from the adapter and discard the package. Dec 17, 2018 baraclude entecavir is an antiviral nucleoside drug indicated for the treatment of chronic hepatitis b virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases alt or ast or histologically active disease. Refer to the full prescribing information of coadministeredpalbociclib, abemaciclib, or ribociclib for dose modification guidelines in the event of toxicities, for use with concomitant medications, and other relevant safety information. Viread is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 hiv1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. Drug information on entecavir for health care professionals. Baraclude entecavir tablets, for oral use baraclude entecavir oral solution initial u. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 0.
Place thumb and index finger on the outside of the package, on top of the ends. Pdf analysis of minimum target prices for production of entecavir. See full prescribing information for complete boxed warning. The role of entecavir in the treatment of chronic hepatitis b ncbi. Lactic acidosissevere hepatomegaly with steatosis and post treatment severe acute exacerbation of hepatitis b lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs see warnings and precautions 5. Download product insert pdfdownload safety data sheet sds pdf. Call the merck national service center at 18778884231 if you have any questions. See drug page and consult a medical provider for more detail. These supplemental applications propose changes to the clinical pharmacology, microbiology section of the package insert to include results from the longterm rollover. Entecavir prevents certain virus cells from multiplying in your body.
Fda hepatitis update revised baraclude entecavir label. Videos demonstrating insertion and removal are available online for trained healthcare providers. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. If you are unsure of the necessary steps to safely insert andor remove nexplanon, do not attempt the procedure. The chemical name for entecavir is 2amino1,9dihydro91s,3r,4s4hydroxy3 hydroxymethyl2methylenecyclopentyl6hpurin6one, monohydrate. Each tablet contains 1 mg entecavir as monohydrate. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Highlights of prescribing information baraclude see full. Neither the information presented in the sds nor the package insert should be used as a substitute for the advice of a health care professional or as a recommendation for any treatment plan. Patients should remain under the care of a physician while taking. Dose adjustments needed for individuals with kidney disease, hepatic impairment, or significant toxicity. Highlights of prescribing information marked bradycardia. Unitedhealthcare pharmacy clinical pharmacy programs.
Baraclude entecavir is an antiviral nucleoside drug indicated for the treatment of chronic hepatitis b virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases alt or ast or histologically active disease. List of products click on the product to find the authorized distributors and click on bms logo to return to this page. Read this patient information before you start taking baraclude and each time you get a refill. In a small pilot study of entecavir use in hbvinfected liver transplant recipients on a stable dose of cyclosporine a n5 or tacrolimus n4, entecavir exposure was approximately 2fold the exposure in healthy subjects. Baraclude is an antiviral medicine that is used to treat chronic hepatitis b virus hbv in adults and children who are at least 2 years old and weigh at least 22 pounds 10 kilograms. Baraclude is indicated for the treatment of chronic hepatitis b virus hbv infection see section 5. Hypersensitivity to any component of paragard including. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Baraclude can cause serious side effects including. Serious infections and malignancies 1 indications and usage 1. Vemlidy tenofovir alafenamide step therapy unitedhealthcare commercial plans author. Dec 17, 2018 baraclude can cause serious side effects including. Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with. Calculation of treatment cost we estimated a reasonable market demand for generic entecavir to provide incentive for effective competition to reach low production costs. Baraclude is indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. 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. Baraclude is a nucleoside analogue indicated for the treatment of chronic hepatitis b virus. It is not known if zytiga is safe and effective in females or children. Analysis of minimum target prices for production of. Baraclude filmcoated tablets are available for oral administration in strengths of 0. For the 2 x 5 ml syringe package, the contents of both syringes must be injected to receive the 500 mg.
Apr 16, 2020 a dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for baraclude entecavir. Highlights of prescribing information these highlights do not. Highlights of prescribing information nexplanon safely and. Some people who have taken baraclude or medicines like baraclude a nucleoside analogue have developed a serious condition called lactic acidosis. Highlights of prescribing information these highlights do not include all the information needed to use taltz safely and effectively. Page 2 of 21 full prescribing information 1 indications and usage 1. Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. You should get an hiv test before you start taking baraclude and anytime after that when there is a chance you were exposed to hiv.
Highlights of prescribing information for psoriatic. Sections or subsections omitted from the full prescribing information are not listed. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. The specific populations section of the package insert sections 8. Pull the solid white rod from the package and put it back in the package laying it carefully alongside the insertion tube, making sure the distal end of the rod remains sterile. Highlights of prescribing information these highlights do not include all the information needed to use genvoya safely and effectively. In conclusion, etv is a very potent antihbv drug with a high genetic barrier to. Baraclude 1mg filmcoated tablets are pink, triangularshaped, and debossed with bms on one side and 1612 on the other side. Baraclude entecavir is indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of. Each 1 mg filmcoated tablet contains 241 mg lactose.
Entecavir mylan can be used in children whose liver is damaged but still functions properly compensated liver disease. Baraclude prescribing information from the fda web site. If you have any questions concerning our products, or your treatment, you should. Use nulojix only in patients who are epsteinbarr virus ebv seropositive. Actemra subcutaneous formulation is not intended for intravenous administration. Deplin tablets folic acid, when administered in daily doses above 800 mcg, may increase the amount of unmetabolized folic description less likely than folic acid to accelerate the growth of existing neoplasms. See package insert and consult a medical provider for more detail. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for baraclude entecavir skip to. Any linked documents and websites are intended only for u. Qtern dapagliflozin and saxagliptin is indicated as an adjunct to diet and exercise to. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. Read all of this leaflet carefully before you start taking this medicine.
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