ADEFOVIR What Should You Do If You FORGET a and Decreases in Kidney Function

Total Page:16

File Type:pdf, Size:1020Kb

ADEFOVIR What Should You Do If You FORGET a and Decreases in Kidney Function ADEFOVIR What should you do if you FORGET a and decreases in kidney function. Blood dose? tests must be done regularly to look for these adverse effects. Other NAMES: Hepsera If you miss a dose of adefovir, take it as soon as possible. However, if it is time Kidney failure has occurred with WHY is this drug prescribed? for your next dose, do not double the patients who have received very high dose, just carry on with your regular doses of adefovir (ten times the dose Adefovir is an antiviral drug that is part schedule. that you will be receiving). of the nucleotide reverse transcriptase inhibitor family. It is used to treat Why should you not forget to take Rarely, some people can develop a skin hepatitis B infection (a type of liver this drug? rash and itchiness. Please consult with disease caused by the hepatitis B virus). a doctor if this occurs. It acts by decreasing hepatitis B virus If you miss doses of adefovir, the replication. This then decreases amount of hepatitis B virus in your blood It is important that you keep your damage to the liver. (known as the HBV viral load) will start doctor appointments and come for increasing again and your liver can be your laboratory tests so that your Adefovir was previously used at much further damaged. Missing doses can progress can be followed. higher doses to manage HIV. It is no stop adefovir from being active. A longer suggested for the treatment of phenomenon known as resistance . As What other PRECAUTIONS should HIV as the high doses necessary can be much as possible, try to take all the you follow while using this drug? toxic to the kidneys. doses of adefovir. Please do not stop adefovir without talking to your doctor Before starting adefovir, please inform HOW should this drug be taken? first. your doctor if you have kidney problems or if you are infected by HIV. For the treatment of hepatitis B, the What ADVERSE EFFECTS can this usual dose is 10 mg (1 tablet) once a drug cause? What should you do You must make sure that you are taking day. The dosage may need to be about them? the right dose. If you take higher doses adjusted if you have kidney problems. of adefovir than what is prescribed, you Adefovir can be taken with or without Most adverse effects reported with may increase the chance of having food. adefovir are mild and uncommon. adverse effects. If you take lower doses These may include headache, fatigue, of adefovir than what is prescribed, the Your dosage is: diarrhea, intestinal gas, nausea and hepatitis B virus may become resistant vomiting. If these effects occur and are to adefovir. 10 mg tablet bothersome, please discuss this with your doctor or pharmacist. Adefovir should not be taken together ____ tablet (____mg) once a day with tenofovir (Viread ), or products Other adverse effects that have been that contain tenofovir including observed are increases in liver enzymes Truvada and Atripla . As adefovir is eliminated by the kidneys, Write questions or concerns down to it is possible that it may interfere with ensure they are addressed. other drugs that are also eliminated by the kidneys (eg. didanosine (Videx ), The following pharmacist is available to probenecid (Benuryl )). Inform your answer questions: doctor and pharmacist of all prescribed ADEFOVIR and non-prescribed drugs you are Pharmacist: __________________ taking. As well, you should inform them of natural products you are taking. If you Telephone: __________________ wish to start a new drug or natural product, please consult with your pharmacist before doing so. The safety of adefovir during pregnancy MEDICATION or breastfeeding has not yet been established. Please discuss this with your doctor if this is a concern. FACT SHEET How should this drug be STORED? Adefovir tablets should be stored in their original container in a cool (15-30 °C) dry place, protected from light and well out of the reach of children. Ensure that the drug has not expired by checking the expiry date (“EXP”) shown on the outside of the package. Do not store in your bathroom or kitchen, as heat and moisture may cause the drug to be less active. If you have any questions or Reference: Adefovir (Hepsera ) Product Monograph. concerns about this drug or if you Gilead Sciences Canada Inc. Mississauga, ON, Canada, are experiencing adverse effects, 2009. Prepared by the Ontario HIV Pharmacy Professional Specialty Group, 2003. Reviewed 2009. please discuss them with your pharmacist, doctor or nurse. Additional medication fact sheets and updates may be found at: www.hivclinic.ca .
Recommended publications
  • Injectable PLGA Adefovir Microspheres; the Way for Long Term Therapy of T Chronic Hepatitis-B ⁎ Margrit M
    European Journal of Pharmaceutical Sciences 118 (2018) 24–31 Contents lists available at ScienceDirect European Journal of Pharmaceutical Sciences journal homepage: www.elsevier.com/locate/ejps Injectable PLGA Adefovir microspheres; the way for long term therapy of T chronic hepatitis-B ⁎ Margrit M. Ayouba, , Neveen G. Elantounyb, Hanan M. El-Nahasa, Fakhr El-Din S. Ghazya a Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt b Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt ARTICLE INFO ABSTRACT Keywords: For patient convenience, sustained release Adefovir Poly-d,l-lactic-co-glycolic acid (PLGA) microspheres were Adefovir formulated to relieve the daily use of the drug which is a problem for patients treated from chronic hepatitis-B. Biodegradable microspheres PLGA microspheres were prepared and characterized by entrapment efficiency, particle size distribution and Poly-lactic-co-glycolic acid scanning electron microscopy (SEM). In-vitro release and in-vivo studies were carried out. Factors such as drug: Entrapment efficiency polymer ratio, polymer viscosity and polymer lactide content were found to be important variables for the preparation of PLGA Adefovir microspheres. Fourier transform infrared (FTIR) analysis and differential scanning calorimetry (DSC) were performed to determine any drug-polymer interactions. One way analysis of variance (ANOVA) was employed to analyze the pharmacokinetic parameters after intramuscular injection of the pure drug and the selected PLGA microspheres into rats. FTIR and DSC revealed a significant interaction between the drug and the polymer. Reports of SEM before and after 1 and 24 h release showed that the microspheres had nonporous smooth surface even after 24 h release.
    [Show full text]
  • Hepsera, INN- Defovir Dipivoxil
    SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Hepsera. For information on changes after approvalplease refer to module 8B 1. Chemical, pharmaceutical and biological aspects Composition Hepsera is presented as an immediate release tablet containing 10 mg of adefovir dipivoxil, as active substance. The other ingredients in this formulation are commonly used in tablets Hepsera is supplied in high-density polyethylene bottle (HDPE), with silica gel desiccant canisters or sachets, and polyester fiber packing material. The closure system consists of a child-resistant polypropylene screw cap lined with an induction activated aluminium foil liner. Active substance Adefovir dipivoxil is an ester prodrug of the nucleotide analogue, adefovir. A structural modification of the parent drug has been carried out in order to increase the lipophilicity and to enhance the oral bioavailability of adefovir. The active substance is a white to off-white crystalline powder. It is soluble in ethanol, sparingly soluble in 0.1N HCl and very slightly soluble in water adjusted to pH 7.2 but relatively highly soluble at physiological pH. The active substance does not contain any chiral center and does not exhibit any optical isomerism. In laboratory studies the anhydrate crystal form has been observed to convert gradually into a dihydrate crystal form when adefovir dipivoxil was exposed to high humidity conditions (75% R.H., 25ºC) over an approximately one-month period. However, the only crystal form produced during the active substance synthesis and utilised in non-clinical and clinical studies has been the anhydrous crystal form. Adefovir dipivoxil undergoes also hydrolysis in aqueous solution and to a smaller degree in the solid state after exposure to humidity and heat for extended periods.
    [Show full text]
  • COVID-19) Pandemic on National Antimicrobial Consumption in Jordan
    antibiotics Article An Assessment of the Impact of Coronavirus Disease (COVID-19) Pandemic on National Antimicrobial Consumption in Jordan Sayer Al-Azzam 1, Nizar Mahmoud Mhaidat 1, Hayaa A. Banat 2, Mohammad Alfaour 2, Dana Samih Ahmad 2, Arno Muller 3, Adi Al-Nuseirat 4 , Elizabeth A. Lattyak 5, Barbara R. Conway 6,7 and Mamoon A. Aldeyab 6,* 1 Clinical Pharmacy Department, Jordan University of Science and Technology, Irbid 22110, Jordan; [email protected] (S.A.-A.); [email protected] (N.M.M.) 2 Jordan Food and Drug Administration (JFDA), Amman 11181, Jordan; [email protected] (H.A.B.); [email protected] (M.A.); [email protected] (D.S.A.) 3 Antimicrobial Resistance Division, World Health Organization, Avenue Appia 20, 1211 Geneva, Switzerland; [email protected] 4 World Health Organization Regional Office for the Eastern Mediterranean, Cairo 11371, Egypt; [email protected] 5 Scientific Computing Associates Corp., River Forest, IL 60305, USA; [email protected] 6 Department of Pharmacy, School of Applied Sciences, University of Huddersfield, Huddersfield HD1 3DH, UK; [email protected] 7 Institute of Skin Integrity and Infection Prevention, University of Huddersfield, Huddersfield HD1 3DH, UK * Correspondence: [email protected] Citation: Al-Azzam, S.; Mhaidat, N.M.; Banat, H.A.; Alfaour, M.; Abstract: Coronavirus disease 2019 (COVID-19) has overlapping clinical characteristics with bacterial Ahmad, D.S.; Muller, A.; Al-Nuseirat, respiratory tract infection, leading to the prescription of potentially unnecessary antibiotics. This A.; Lattyak, E.A.; Conway, B.R.; study aimed at measuring changes and patterns of national antimicrobial use for one year preceding Aldeyab, M.A.
    [Show full text]
  • Enhancing the Antihepatitis B Virus Immune Response by Adefovir Dipivoxil and Entecavir Therapies
    Cellular & Molecular Immunology (2011) 8, 75–82 ß 2011 CSI and USTC. All rights reserved 1672-7681/11 $32.00 www.nature.com/cmi RESEARCH ARTICLE Enhancing the antihepatitis B virus immune response by adefovir dipivoxil and entecavir therapies Yanfang Jiang1,4, Wanyu Li1,4, Lei Yu1, Jingjing Liu1, Guijie Xin1, Hongqing Yan1, Pinghui Sun2, Hong Zhang1, Damo Xu3 and Junqi Niu1 Chronicity of hepatitis B (CHB) infection is characterized by a weak immune response to the virus. Entecavir (ETV) and adefovir dipivoxil (ADV) are effective in suppressing hepatitis B virus (HBV) replication. However, the underlying immune mechanism in the antiviral response of patients treated with nucleoside or nucleotide analogs is not clearly understood. In this study, regulatory T cells (Tregs) and intracellular cytokines, including IL-2, interferon (IFN)-c, tumor-necrosis factor (TNF)-a and IL-4, were measured prior to and at 12, 24, 36 and 48 weeks after treatment with ETV or ADV. The cytokines were increased from 24 to 48 weeks after treatment. Higher levels of Th1 cytokines were observed with ETV (n529) versus ADV (n528) treatment. By contrast, the numbers of Tregs in both groups were decreased. The altered cytokine profile and cellular component was accompanied by a decrease in HBV DNA levels in both groups, which may contribute to their therapeutic effect in CHB infection. Our findings suggest that the antiviral effect of the drugs may be attributed not only to their direct effect on virus suppression but also to their immunoregulatory capabilities. Cellular
    [Show full text]
  • Tenofovir Alafenamide Rescues Renal Tubules in Patients with Chronic Hepatitis B
    life Communication Tenofovir Alafenamide Rescues Renal Tubules in Patients with Chronic Hepatitis B Tomoya Sano * , Takumi Kawaguchi , Tatsuya Ide, Keisuke Amano, Reiichiro Kuwahara, Teruko Arinaga-Hino and Takuji Torimura Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan; [email protected] (T.K.); [email protected] (T.I.); [email protected] (K.A.); [email protected] (R.K.); [email protected] (T.A.-H.); [email protected] (T.T.) * Correspondence: [email protected]; Tel.: +81-942-31-7627 Abstract: Nucles(t)ide analogs (NAs) are effective for chronic hepatitis B (CHB). NAs suppress hepatic decompensation and hepatocarcinogenesis, leading to a dramatic improvement of the natural course of patients with CHB. However, renal dysfunction is becoming an important issue for the management of CHB. Renal dysfunction develops in patients with the long-term treatment of NAs including adefovir dipivoxil and tenofovir disoproxil fumarate. Recently, several studies have reported that the newly approved tenofovir alafenamide (TAF) has a safe profile for the kidney due to greater plasma stability. In this mini-review, we discuss the effectiveness of switching to TAF for NAs-related renal tubular dysfunction in patients with CHB. Keywords: adefovir dipivoxil (ADV); Fanconi syndrome; hepatitis B virus (HBV); renal tubular Citation: Sano, T.; Kawaguchi, T.; dysfunction; tenofovir alafenamide (TAF); tenofovir disoproxil fumarate (TDF); β2-microglobulin Ide, T.; Amano, K.; Kuwahara, R.; Arinaga-Hino, T.; Torimura, T. Tenofovir Alafenamide Rescues Renal Tubules in Patients with Chronic 1.
    [Show full text]
  • Study of Serious Adverse Drug Reactions Using FDA-Approved Drug Labeling and Meddra
    Wu et al. BMC Bioinformatics 2019, 20(Suppl 2):97 https://doi.org/10.1186/s12859-019-2628-5 RESEARCH Open Access Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA Leihong Wu1, Taylor Ingle1, Zhichao Liu1, Anna Zhao-Wong2, Stephen Harris1, Shraddha Thakkar1, Guangxu Zhou1, Junshuang Yang1, Joshua Xu1, Darshan Mehta1, Weigong Ge1, Weida Tong1* and Hong Fang1* From The 15th Annual MCBIOS Conference Starkville, MS, USA. March 29 - 31 2018 Abstract Background: Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern. Results: This study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents.
    [Show full text]
  • ARTICLES J Am Soc Nephrol 11: 383–393, 2000
    ARTICLES J Am Soc Nephrol 11: 383–393, 2000 Cytotoxicity of Antiviral Nucleotides Adefovir and Cidofovir Is Induced by the Expression of Human Renal Organic Anion Transporter 1 EDMUND S. HO, DEBORAH C. LIN, DIRK B. MENDEL, and TOMAS CIHLAR Gilead Sciences, Foster City, California. ␮ ϭ 6 ⅐ Abstract. The transport of organic anions in proximal convo- 58.0 M, Vmax 103 pmol/10 cells min) such that the levels luted tubules plays an essential role in the active secretion of a of intracellular metabolites of both nucleotides were Ͼ100-fold variety of small molecules by the kidney. In addition to other higher in CHOhOAT cells than in parental CHO. Consequently, anionic substrates, the human renal organic anion transporter 1 adefovir and cidofovir were approximately 500-fold and 400- (hOAT1) is capable of transporting the nucleotide analogs fold more cytotoxic, respectively, in CHOhOAT cells compared adefovir and cidofovir. To investigate the involvement of to CHO. The cytotoxicity of both drugs in CHOhOAT cells was hOAT1 in the mechanism of nephrotoxicity associated with markedly reduced in the presence of hOAT1 inhibitors. The these two clinically important antiviral agents, Chinese ham- cyclic prodrug of cidofovir, which exhibits reduced in vivo ster ovary (CHO) cells were stably transfected with hOAT1 nephrotoxicity, was a poor substrate for hOAT1 and showed cDNA. The resulting CHOhOAT cells showed probenecid-sen- only marginally increased cytotoxicity in CHOhOAT cells. In ϭ sitive and pH-dependent uptake of p-aminohippurate (Km conclusion, these studies demonstrate that hOAT1 plays a ␮ ϭ 6 ⅐ 15.4 M, Vmax 20.6 pmol/10 cells min), a prototypical critical role in the organ-specific toxicity of adefovir and organic anion substrate.
    [Show full text]
  • VEMLIDY Is Not Recommended in Patients with These Highlights Do Not Include All the Information Needed to Use Estimated Creatinine Clearance Below 15 Ml Per Minute
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Renal Impairment: VEMLIDY is not recommended in patients with These highlights do not include all the information needed to use estimated creatinine clearance below 15 mL per minute. (2.3) VEMLIDY safely and effectively. See full prescribing information • Hepatic Impairment: VEMLIDY is not recommended in patients with for VEMLIDY. decompensated (Child-Pugh B or C) hepatic impairment. (2.4) ® VEMLIDY (tenofovir alafenamide) tablets, for oral use --------------------- DOSAGE FORMS AND STRENGTHS --------------------­ Initial U.S. Approval: 2015 Tablets: 25 mg of tenofovir alafenamide. (3) ------------------------------- CONTRAINDICATIONS ------------------------------­ WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH None. (4) STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B ----------------------- WARNINGS AND PRECAUTIONS ----------------------­ • HBV and HIV-1 coinfection: VEMLIDY alone is not recommended for See full prescribing information for complete boxed warning. the treatment of HIV-1 infection. HIV-1 resistance may develop in • Lactic acidosis and severe hepatomegaly with steatosis, these patients. (5.3) including fatal cases, have been reported with the use of • New onset or worsening renal impairment: Assessment of serum nucleoside analogs. (5.1) creatinine, serum phosphorus, estimated creatinine clearance, urine • Discontinuation of anti-hepatitis B therapy may result in glucose, and urine protein is recommended before initiating severe acute exacerbations of hepatitis
    [Show full text]
  • Viread Label
    --------------------------WARNINGS AND PRECAUTIONS--------------------- HIGHLIGHTS OF PRESCRIBING INFORMATION • New onset or worsening renal impairment: Can include acute These highlights do not include all the information needed to use renal failure and Fanconi syndrome. Assess creatinine clearance VIREAD safely and effectively. See full prescribing information (CrCl) before initiating treatment with VIREAD. Monitor CrCl and for VIREAD. serum phosphorus in patients at risk. Avoid administering ® VIREAD with concurrent or recent use of nephrotoxic drugs. (5.3) VIREAD (tenofovir disoproxil fumarate) tablets, for oral use ® VIREAD (tenofovir disoproxil fumarate) powder, for oral use • Coadministration with Other Products: Do not use with other Initial U.S. Approval: 2001 tenofovir-containing products (e.g., ATRIPLA, COMPLERA, and TRUVADA). Do not administer in combination with HEPSERA. WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY (5.4) WITH STEATOSIS and POST TREATMENT EXACERBATION OF • HIV testing: HIV antibody testing should be offered to all HBV- HEPATITIS infected patients before initiating therapy with VIREAD. VIREAD See full prescribing information for complete boxed warning. should only be used as part of an appropriate antiretroviral combination regimen in HIV-infected patients with or without HBV • Lactic acidosis and severe hepatomegaly with steatosis, coinfection. (5.5) including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD. (5.1) • Decreases in bone mineral density (BMD): Observed in HIV- infected patients. Consider assessment of BMD in patients with a • Severe acute exacerbations of hepatitis have been reported history of pathologic fracture or other risk factors for osteoporosis in HBV-infected patients who have discontinued anti- or bone loss. (5.6) hepatitis B therapy, including VIREAD.
    [Show full text]
  • Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018
    REPORT 2019 Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018 RAVN Resistensovervåking av virus i Norge Resistance against Antivirals in Norway Usage of Antivirals and the Occurrence of Antiviral resistance in Norway 2018 RAVN Resistensovervåkning av virus i Norge Resistance against antivirals in Norway 2 Published by the Norwegian Institute of Public Health Division of Infection Control and Environmental Health Department for Infectious Disease registries October 2019 Title: Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018. RAVN Ordering: The report can be downloaded as a pdf at www.fhi.no Graphic design cover: Fete Typer ISBN nr: 978-82-8406-032-3 Emneord (MeSH): Antiviral resistance Any usage of data from this report should include a specific reference to RAVN. Suggested citation: RAVN. Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018. Norwegian Institute of Public Health, Oslo 2019 Resistance against antivirals in Norway • Norwegian Institute of Public Health 3 Table of contents Introduction _________________________________________________________________________ 4 Contributors and participants __________________________________________________________ 5 Sammendrag ________________________________________________________________________ 6 Summary ___________________________________________________________________________ 8 1 Antivirals and development of drug resistance ______________________________________ 10 2 The usage of antivirals in Norway
    [Show full text]
  • Drug Consumption at Wholesale Prices in 2017 - 2020
    Page 1 Drug consumption at wholesale prices in 2017 - 2020 2020 2019 2018 2017 Wholesale Hospit. Wholesale Hospit. Wholesale Hospit. Wholesale Hospit. ATC code Subgroup or chemical substance price/1000 € % price/1000 € % price/1000 € % price/1000 € % A ALIMENTARY TRACT AND METABOLISM 321 590 7 309 580 7 300 278 7 295 060 8 A01 STOMATOLOGICAL PREPARATIONS 2 090 9 1 937 7 1 910 7 2 128 8 A01A STOMATOLOGICAL PREPARATIONS 2 090 9 1 937 7 1 910 7 2 128 8 A01AA Caries prophylactic agents 663 8 611 11 619 12 1 042 11 A01AA01 sodium fluoride 610 8 557 12 498 15 787 14 A01AA03 olaflur 53 1 54 1 50 1 48 1 A01AA51 sodium fluoride, combinations - - - - 71 1 206 1 A01AB Antiinfectives for local oral treatment 1 266 10 1 101 6 1 052 6 944 6 A01AB03 chlorhexidine 930 6 885 7 825 7 706 7 A01AB11 various 335 21 216 0 227 0 238 0 A01AB22 doxycycline - - 0 100 0 100 - - A01AC Corticosteroids for local oral treatment 113 1 153 1 135 1 143 1 A01AC01 triamcinolone 113 1 153 1 135 1 143 1 A01AD Other agents for local oral treatment 49 0 72 0 104 0 - - A01AD02 benzydamine 49 0 72 0 104 0 - - A02 DRUGS FOR ACID RELATED DISORDERS 30 885 4 32 677 4 35 102 5 37 644 7 A02A ANTACIDS 3 681 1 3 565 1 3 357 1 3 385 1 A02AA Magnesium compounds 141 22 151 22 172 22 155 19 A02AA04 magnesium hydroxide 141 22 151 22 172 22 155 19 A02AD Combinations and complexes of aluminium, 3 539 0 3 414 0 3 185 0 3 231 0 calcium and magnesium compounds A02AD01 ordinary salt combinations 3 539 0 3 414 0 3 185 0 3 231 0 A02B DRUGS FOR PEPTIC ULCER AND 27 205 5 29 112 4 31 746 5 34 258 8
    [Show full text]
  • NEW ZEALAND DATA SHEET 1 VEMLIDY (TENOFOVIR ALAFENAMIDE 25 MG) TABLETS 2 QUALITATIVE and QUANTITATIVE COMPOSITION Tenofovir
    NEW ZEALAND DATA SHEET 1 VEMLIDY (TENOFOVIR ALAFENAMIDE 25 MG) TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tenofovir alafenamide 25 mg. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. VEMLIDY tablets are yellow, round, film-coated, debossed with “GSI” on one side and “25” on the other side. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications VEMLIDY is indicated for the treatment of chronic hepatitis B in adults. 4.2 Dose and method of administration The recommended dose of VEMLIDY is one tablet once daily, with or without food. Special populations Children and Adolescents up to 18 Years of Age No data are available on which to make a dose recommendation for patients younger than 18 years. Elderly No dose adjustment is required in patients age of 65 years and older. In clinical trials, 89 HBV-infected patients aged 65 years and over received VEMLIDY. No differences in safety or efficacy have been observed between elderly patients and those between 18 and less than 65 years of age (see Section 5.2). Renal Impairment No dose adjustment of VEMLIDY is required in patients with renal impairment. VEMLIDY is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute) (see Section 5.2). Hepatic Impairment No dose adjustment of VEMLIDY is required in patients with hepatic impairment (see Section 5.2). 4.3 Contraindications VEMLIDY tablets are contraindicated in patients with known hypersensitivity to the active substance or to any other component of the tablets listed in section 6.1.
    [Show full text]