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Highlights of Prescribing Information
HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------------WARNINGS AND PRECAUTIONS-------------------- These highlights do not include all the information needed to use • New onset or worsening renal impairment: Can include acute VIREAD safely and effectively. See full prescribing information renal failure and Fanconi syndrome. Assess creatinine clearance for VIREAD. (CrCl) before initiating treatment with VIREAD. Monitor CrCl and ® serum phosphorus in patients at risk. Avoid administering VIREAD (tenofovir disoproxil fumarate) tablets, for oral use VIREAD with concurrent or recent use of nephrotoxic drugs. (5.3) 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. WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH (5.4) STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS • HIV testing: HIV antibody testing should be offered to all HBV- 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 • Lactic acidosis and severe hepatomegaly with steatosis, combination regimen in HIV-infected patients with or without HBV including fatal cases, have been reported with the use of coinfection. (5.5) nucleoside analogs, including VIREAD. (5.1) • Decreases in bone mineral density (BMD): Consider assessment • Severe acute exacerbations of hepatitis have been reported of BMD in patients with a history of pathologic fracture or other in HBV-infected patients who have discontinued anti- risk factors for osteoporosis or bone loss. (5.6) hepatitis B therapy, including VIREAD. Hepatic function • Redistribution/accumulation of body fat: Observed in HIV-infected should be monitored closely in these patients. -
Novel Therapeutics for Epstein–Barr Virus
molecules Review Novel Therapeutics for Epstein–Barr Virus Graciela Andrei *, Erika Trompet and Robert Snoeck Laboratory of Virology and Chemotherapy, Department of Microbiology and Immunology, Rega Institute for Medical Research, KU Leuven, 3000 Leuven, Belgium; [email protected] (E.T.); [email protected] (R.S.) * Correspondence: [email protected]; Tel.: +32-16-321-915 Academic Editor: Stefano Aquaro Received: 15 February 2019; Accepted: 4 March 2019; Published: 12 March 2019 Abstract: Epstein–Barr virus (EBV) is a human γ-herpesvirus that infects up to 95% of the adult population. Primary EBV infection usually occurs during childhood and is generally asymptomatic, though the virus can cause infectious mononucleosis in 35–50% of the cases when infection occurs later in life. EBV infects mainly B-cells and epithelial cells, establishing latency in resting memory B-cells and possibly also in epithelial cells. EBV is recognized as an oncogenic virus but in immunocompetent hosts, EBV reactivation is controlled by the immune response preventing transformation in vivo. Under immunosuppression, regardless of the cause, the immune system can lose control of EBV replication, which may result in the appearance of neoplasms. The primary malignancies related to EBV are B-cell lymphomas and nasopharyngeal carcinoma, which reflects the primary cell targets of viral infection in vivo. Although a number of antivirals were proven to inhibit EBV replication in vitro, they had limited success in the clinic and to date no antiviral drug has been approved for the treatment of EBV infections. We review here the antiviral drugs that have been evaluated in the clinic to treat EBV infections and discuss novel molecules with anti-EBV activity under investigation as well as new strategies to treat EBV-related diseases. -
Treatment of Warts with Topical Cidofovir in a Pediatric Patient
Volume 25 Number 5| May 2019| Dermatology Online Journal || Case Report 25(5):6 Treatment of warts with topical cidofovir in a pediatric patient Melissa A Nickles BA, Artem Sergeyenko MD, Michelle Bain MD Affiliations: Department of Dermatology, University of Illinois at Chicago College of Medicine, Chicago, llinois, USA Corresponding Author: Artem Sergeyenko MD, 808 South Wood Street Suite 380, Chicago, IL 60612, Tel: 847-338-0037, Email: a.serge04@gmail topical cidofovir is effective in treating HPV lesions Abstract and molluscum contagiosum in adult patients with Cidofovir is an antiviral nucleotide analogue with HIV/AIDS [2]. Case reports have also found topical relatively new treatment capacities for cidofovir to effectively treat anogenital squamous dermatological conditions, specifically verruca cell carcinoma (SCC), bowenoid papulosis, vulgaris caused by human papilloma virus infection. condyloma acuminatum, Kaposi sarcoma, and HSV-II In a 10-year old boy with severe verruca vulgaris in adult patients with HIV/AIDS [3]. Cidofovir has recalcitrant to multiple therapies, topical 1% experimentally been shown to be effective in cidofovir applied daily for eight weeks proved to be an effective treatment with no adverse side effects. treating genital condyloma acuminata in adult This case report, in conjunction with multiple immunocompetent patients [4] and in a pediatric published reports, suggests that topical 1% cidofovir case [5]. is a safe and effective treatment for viral warts in Cidofovir has also been used in pediatric patients to pediatric patients. cure verruca vulgaris recalcitrant to traditional treatment therapies. There have been several reports Keywords: cidofovir, verruca vulgaris, human papilloma that topical 1-3% cidofovir cream applied once or virus twice daily is effective in treating verruca vulgaris with no systemic side effects and low rates of recurrence in immunocompetent children [6-8], as Introduction well as in immunocompromised children [9, 10]. -
Design and Evaluation of 5•²-O-Dicarboxylic And
University of Rhode Island DigitalCommons@URI Open Access Master's Theses 2014 DESIGN AND EVALUATION OF 5′-O-DICARBOXYLIC AND POLYARGININE FATTY ACYL DERIVATIVES OF ANTI-HIV NUCLEOSIDES Bhanu Priya Pemmaraju Venkata University of Rhode Island, [email protected] Follow this and additional works at: https://digitalcommons.uri.edu/theses Recommended Citation Pemmaraju Venkata, Bhanu Priya, "DESIGN AND EVALUATION OF 5′-O-DICARBOXYLIC AND POLYARGININE FATTY ACYL DERIVATIVES OF ANTI-HIV NUCLEOSIDES" (2014). Open Access Master's Theses. Paper 474. https://digitalcommons.uri.edu/theses/474 This Thesis is brought to you for free and open access by DigitalCommons@URI. It has been accepted for inclusion in Open Access Master's Theses by an authorized administrator of DigitalCommons@URI. For more information, please contact [email protected]. DESIGN AND EVALUATION OF 5′-O- DICARBOXYLIC AND POLYARGININE FATTY ACYL DERIVATIVES OF ANTI-HIV NUCLEOSIDES BY BHANU PRIYA, PEMMARAJU VENKATA A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE MASTER’S DEGREE IN BIOMEDICAL AND PHARMACEUTICAL SCIENCES UNIVERSITY OF RHODE ISLAND 2014 MASTER OF SCIENCE THESIS OF BHANU PRIYA, PEMMARAJU VENKATA APPROVED: Thesis Committee: Major Professor Keykavous Parang Roberta King Stephen Kogut Geoffrey D. Bothun Nasser H. Zawia DEAN OF THE GRADUATE SCHOOL UNIVERSITY OF RHODE ISLAND 2014 ABSTRACT 2′,3′-Dideoxynucleoside (ddNs) analogs are the most widely used anti-HIV drugs in the market. Even though these drugs display very potent activities, they have a number of limitations when are used as therapeutic agents. The primary problem associated with ddNs is significant toxicity, such as neuropathy and bone marrow suppression. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 4 1. NAME OF THE MEDICINAL PRODUCT VISTIDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cidofovir equivalent to 375 mg/5 ml (75 mg/ml) cidofovir anhydrous. The formulation is adjusted to pH 7.4. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion 4. CLINICAL PARTICULARS 4.1 Therapeutic Indication Cidofovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Until further experience is gained, cidofovir should be used only when other agents are considered unsuitable. 4.2 Posology and Method of Administration Before each administration of cidofovir, serum creatinine and urine protein levels should be investigated. The recommended dosage, frequency, or infusion rate must not be exceeded. Cidofovir must be diluted in 100 milliliters 0.9% (normal) saline prior to administration. To minimise potential nephrotoxicity, oral probenecid and intravenous saline prehydration must be administered with each cidofovir infusion. Dosage in Adults • Induction Treatment. The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once weekly for two consecutive weeks. • Maintenance Treatment. Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once every two weeks. Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by = 44 µmol/L (= 0.5 mg/dl), or if persistent proteinuria = 2+ develops. • Probenecid. -
Silibinin Component for the Treatment of Hepatitis Silbininkomponente Zur Behandlung Von Hepatitis Composant De Silibinine Pour Le Traitement De L’Hépatite
(19) & (11) EP 2 219 642 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/357 (2006.01) A61P 1/16 (2006.01) 21.09.2011 Bulletin 2011/38 A61P 31/12 (2006.01) (21) Application number: 08849759.9 (86) International application number: PCT/EP2008/009659 (22) Date of filing: 14.11.2008 (87) International publication number: WO 2009/062737 (22.05.2009 Gazette 2009/21) (54) SILIBININ COMPONENT FOR THE TREATMENT OF HEPATITIS SILBININKOMPONENTE ZUR BEHANDLUNG VON HEPATITIS COMPOSANT DE SILIBININE POUR LE TRAITEMENT DE L’HÉPATITE (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR WO-A-02/067853 GB-A- 2 167 414 HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR • POLYAK STEPHEN J ET AL: "Inhibition of T- cell inflammatory cytokines, hepatocyte NF-kappa B (30) Priority: 15.11.2007 EP 07022187 signaling, and HCV infection by standardized 15.11.2007 US 988168 P silymarin" GASTROENTEROLOGY, vol. 132, no. 25.03.2008 EP 08005459 5, May 2007 (2007-05), pages 1925-1936, XP002477920 ISSN: 0016-5085 (43) Date of publication of application: • MAYER K E ET AL: "Silymarin treatment of viral 25.08.2010 Bulletin 2010/34 hepatitis: A systematic review" JOURNAL OF VIRAL HEPATITIS 200511 GB, vol. 12, no. 6, (60) Divisional application: November 2005 (2005-11), pages 559-567, 11005445.9 XP002477921 ISSN: 1352-0504 1365-2893 • CHAVEZ M L: "TREATMENT OF HEPATITIS C (73) Proprietor: Madaus GmbH WITH MILK THISTLE?" JOURNAL OF HERBAL 51067 Köln (DE) PHARMACOTHERAPY, HAWORTH HERBAL PRESS, BINGHAMTON, US, vol. -
Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection
pharmaceuticals Review Tenofovir, Another Inexpensive, Well-Known and Widely Available Old Drug Repurposed for SARS-COV-2 Infection Isabella Zanella 1,2,* , Daniela Zizioli 1, Francesco Castelli 3 and Eugenia Quiros-Roldan 3 1 Department of Molecular and Translational Medicine, University of Brescia, 25123 Brescia, Italy; [email protected] 2 Clinical Chemistry Laboratory, Cytogenetics and Molecular Genetics Section, Diagnostic Department, ASST Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy 3 University Department of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili di Brescia, Piazzale Spedali Civili 1, 25123 Brescia, Italy; [email protected] (F.C.); [email protected] (E.Q.-R.) * Correspondence: [email protected]; Tel.: +39-030-399-6806 Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is spreading worldwide with different clinical manifestations. Age and comorbidities may explain severity in critical cases and people living with human immunodeficiency virus (HIV) might be at particularly high risk for severe progression. Nonetheless, current data, although sometimes contradictory, do not confirm higher morbidity, risk of more severe COVID-19 or higher mortality in HIV-infected people with complete access to antiretroviral therapy (ART). A possible protective role of ART has been hypothesized to explain these observations. Anti-viral drugs used to treat HIV infection have been repurposed for COVID-19 treatment; this is also based on previous studies on severe acute respiratory syndrome virus (SARS-CoV) and Middle East respiratory syndrome virus (MERS-CoV). Among Citation: Zanella, I.; Zizioli, D.; them, lopinavir/ritonavir, an inhibitor of viral protease, was extensively used early in the pandemic Castelli, F.; Quiros-Roldan, E. -
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Fixed-Dose Combination (Ftc/Rpv/Taf [F/R/Taf] Fdc)
SECTION 2.6.—NONCLINICAL SUMMARY SECTION 2.6.1—INTRODUCTION EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE FIXED-DOSE COMBINATION (FTC/RPV/TAF [F/R/TAF] FDC) Gilead Sciences 11 May 2015 CONFIDENTIAL AND PROPRIETARY INFORMATION FTC/RPV/Tenofovir alafenamide 2.6.1 Introduction Final TABLE OF CONTENTS SECTION 2.6.1—INTRODUCTION ...........................................................................................................................1 TABLE OF CONTENTS ..............................................................................................................................................2 GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS......................................................................3 NOTE TO REVIEWER.................................................................................................................................................4 1. NONCLINICAL SUMMARY..............................................................................................................................6 1.1. Introduction..............................................................................................................................................6 1.1.1. Emtricitabine ..........................................................................................................................6 1.1.2. Rilpivirine ..............................................................................................................................7 1.1.3. Tenofovir Alafenamide ..........................................................................................................7 -
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of -
Remdesivir Potently Inhibits SARS-Cov-2 in Human Lung Cells and Chimeric
bioRxiv preprint doi: https://doi.org/10.1101/2020.04.27.064279; this version posted April 27, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Remdesivir potently inhibits SARS-CoV-2 in human lung cells and chimeric SARS-CoV expressing the SARS-CoV-2 RNA polymerase in mice. Andrea J. Pruijssers1,2*, Amelia S. George1,2, Alexandra Schäfer3, Sarah R. Leist3, Lisa E. Gralinksi3, 3,4 3 1,2 1,2 1,2 Kenneth H. Dinnon III , Boyd L. Yount , Maria L. Agostini , Laura J. Stevens , James D. Chappell , Xiaotao Lu1,2, Tia M. Hughes1,2, Kendra Gully3, David R. Martinez3, Ariane J. Brown3, Rachel L. Graham3, Jason K. Perry5, Venice Du Pont5, Jared Pitts5, Bin Ma5, Darius Babusis5, Eisuke Murakami5, Joy Y. Feng5, John P. Bilello5, Danielle P. Porter5, Tomas Cihlar5, Ralph S. Baric3,4, Mark R. Denison1,2,6, and Timothy P. Sheahan3* 1Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA 2Vanderbilt Institute for Infection, Immunology, and Inflammation, Nashville, TN, 37232, USA 3Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA 4Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA 5Gilead Sciences, Inc, Foster City, CA, 94404, USA 6Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN, 37232, USA *Corresponding Authors: Andrea J. Pruijssers [email protected] and Timothy P. Sheahan [email protected] 1 SUMMARY 2 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in 2019 as the causative agent 3 of the novel pandemic viral disease COVID-19. -
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0 -
(12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr
US008158152B2 (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr. 17, 2012 (54) LYOPHILIZATION PROCESS AND 6,884,422 B1 4/2005 Liu et al. PRODUCTS OBTANED THEREBY 6,900, 184 B2 5/2005 Cohen et al. 2002fOO 10357 A1 1/2002 Stogniew etal. 2002/009 1270 A1 7, 2002 Wu et al. (75) Inventor: Nageswara R. Palepu. Mill Creek, WA 2002/0143038 A1 10/2002 Bandyopadhyay et al. (US) 2002fO155097 A1 10, 2002 Te 2003, OO68416 A1 4/2003 Burgess et al. 2003/0077321 A1 4/2003 Kiel et al. (73) Assignee: SciDose LLC, Amherst, MA (US) 2003, OO82236 A1 5/2003 Mathiowitz et al. 2003/0096378 A1 5/2003 Qiu et al. (*) Notice: Subject to any disclaimer, the term of this 2003/OO96797 A1 5/2003 Stogniew et al. patent is extended or adjusted under 35 2003.01.1331.6 A1 6/2003 Kaisheva et al. U.S.C. 154(b) by 1560 days. 2003. O191157 A1 10, 2003 Doen 2003/0202978 A1 10, 2003 Maa et al. 2003/0211042 A1 11/2003 Evans (21) Appl. No.: 11/282,507 2003/0229027 A1 12/2003 Eissens et al. 2004.0005351 A1 1/2004 Kwon (22) Filed: Nov. 18, 2005 2004/0042971 A1 3/2004 Truong-Le et al. 2004/0042972 A1 3/2004 Truong-Le et al. (65) Prior Publication Data 2004.0043042 A1 3/2004 Johnson et al. 2004/OO57927 A1 3/2004 Warne et al. US 2007/O116729 A1 May 24, 2007 2004, OO63792 A1 4/2004 Khera et al.