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Successful Treatment of Rifampicin Resistant Case of Leprosy by WHO Recommended Ofloxacin and Minocycline Regimen
Lepr Rev (2019) 90, 456–459 CASE REPORT Successful treatment of rifampicin resistant case of leprosy by WHO recommended ofloxacin and minocycline regimen MALLIKA LAVANIAa, JOYDEEPA DARLONGb, ABHISHEK REDDYb, MADHVI AHUJAa, ITU SINGHa, R.P. TURANKARa & U. SENGUPTAa aStanley Browne Laboratory, The Leprosy Mission Community Hospital, Nand Nagri, New Delhi 110093, India bThe Leprosy Mission Hospital, Purulia, West Bengal 723101, India Accepted for publication 15 July 2019 Summary A 25-year-old male treated for leprosy at the age of 15, with MDT, visited TLM Purulia Hospital in July 2017. He was provisionally diagnosed as a lepromatous relapse with ENL reaction. A biopsy was done to test for drug resistance. Drug resistance testing showed resistance to rifampicin. Second line drug regimen recommended by WHO for rifampicin-resistance was started. Within 6 months of taking medication the clinical signs and symptoms improved rapidly and the BI dropped by 1·66 log within 6 months. This case highlights the need for investigations in cases of relapse and the efficacy of WHO recommended second line drug regimen treatment in rifampicin-resistant leprosy cases. Keywords: leprosy, rifampicin-resistance, second-line treatment Introduction Leprosy, also known as Hansen’s disease (HD), is a chronic infectious disease caused by the bacterium Mycobacterium leprae or Mycobacterium lepromatosis.1,2 Leprosy is curable with administration of a rifampicin, clofazimine and dapsone known as multidrug therapy (MDT). Since the introduction of MDT in 1983 the prevalence -
WO 2017/048702 Al
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2017/048702 A l 2 3 March 2017 (23.03.2017) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 487/04 (2006.01) A61P 35/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/519 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) International Application Number: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US20 16/05 1490 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (22) International Filing Date: KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 13 September 2016 (13.09.201 6) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (25) Filing Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (26) Publication Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 62/218,493 14 September 2015 (14.09.2015) US (84) Designated States (unless otherwise indicated, for every 62/218,486 14 September 2015 (14.09.2015) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (71) Applicant: INFINITY PHARMACEUTICALS, INC. -
Sofosbuvir/Ledipasvir for HIV •
Hepatitis C: Drugs and Combinations Melissa Osborn MD Associate Professor MetroHealth Medical Center Case Western Reserve University Cleveland, OH Faculty and Planning Committee Disclosures Please consult your program book. Off-Label Disclosure The following off-label/investigational uses will be discussed in this presentation: • Sofosbuvir/ledipasvir for HIV •. Investigational agents for hepatitis C will be mentioned – Asunaprevir – Daclatasvir – Beclabuvir – Grazoprevir – Elbasvir – GS-5816 Learning Objectives Upon completion of this presentation, learners should be better able to: • apply clinical trial data on new hepatitis C therapies to their patient population. • select which new hepatitis C therapies are appropriate to use with common antiretrovirals. Evolution of interferon-based therapy in HCV-monoinfected genotype 1 patients Sustained Virologic Response 100% 90% 80% 80% 75% 67% 60% 42% 46% 40% 28% 20% 7% 0% Std interferon-alfa IFN + RBV Peg-alfa-2b+RBV Peg-alfa-2a +RBV P/R/Telaprevir P/R/Boceprevir P/R/Simeprevir P/R/Sofosbuvir McHutchison, NEJM 1998; 339: 1485-92 Jacobson, NEJM 2011; 364:2405-16 Fried, NEJM 2002; 347: 975-82 Poordad, NEJM 2011; 364: 1195-206 Manns, Lancet 2001; 358:958-65 Jacobson, AASLD 2013 #1122 Lawitz, NEJM 2013 Evolution of HCV Therapy: Genotype 1 Patients Naïve to Therapy: HIV-HCV coinfection Sustained Virologic Response 80% 75% 74% 67% 61% 60% 46% 42% 40% 28% 29% 20% 17% 7% 7% 0% Std interferon-alfa IFN + RBV Peg-alfa-2b+RBV Peg-alfa-2a +RBV P/R/Telaprevir P/R/Boceprevir Torriani, NEJM, 2004 351:438-50 -
Hepatitis C Agents Therapeutic Class Review
Hepatitis C Agents Therapeutic Class Review (TCR) November 2, 2018 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2018 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Mfr FDA-Approved Indications Interferons peginterferon alfa-2a Genentech Chronic hepatitis C (CHC) 1 (Pegasys®) . -
Clofazimine As a Treatment for Multidrug-Resistant Tuberculosis: a Review
Scientia Pharmaceutica Review Clofazimine as a Treatment for Multidrug-Resistant Tuberculosis: A Review Rhea Veda Nugraha 1 , Vycke Yunivita 2 , Prayudi Santoso 3, Rob E. Aarnoutse 4 and Rovina Ruslami 2,* 1 Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, Indonesia; [email protected] 2 Division of Pharmacology and Therapy, Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran, Bandung 40161, Indonesia; [email protected] 3 Department of Internal Medicine, Faculty of Medicine, Universitas Padjadjaran—Hasan Sadikin Hospital, Bandung 40161, Indonesia; [email protected] 4 Department of Pharmacy, Radboud University Medical Center, Radboud Institute for Health Sciences, 6255HB Nijmegen, The Netherlands; [email protected] * Correspondence: [email protected] Abstract: Multidrug-resistant tuberculosis (MDR-TB) is an infectious disease caused by Mycobac- terium tuberculosis which is resistant to at least isoniazid and rifampicin. This disease is a worldwide threat and complicates the control of tuberculosis (TB). Long treatment duration, a combination of several drugs, and the adverse effects of these drugs are the factors that play a role in the poor outcomes of MDR-TB patients. There have been many studies with repurposed drugs to improve MDR-TB outcomes, including clofazimine. Clofazimine recently moved from group 5 to group B of drugs that are used to treat MDR-TB. This drug belongs to the riminophenazine class, which has lipophilic characteristics and was previously discovered to treat TB and approved for leprosy. This review discusses the role of clofazimine as a treatment component in patients with MDR-TB, and Citation: Nugraha, R.V.; Yunivita, V.; the drug’s properties. -
AHFS Pharmacologic-Therapeutic Classification System
AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective -
Where Do Novel Drugs of 2016 Fit In?
FORMULARY JEOPARDY: WHERE DO NOVEL DRUGS OF 2016 FIT IN? Maabo Kludze, PharmD, MBA, CDE, BCPS, Associate Director Elizabeth A. Shlom, PharmD, BCPS, SVP & Director Clinical Pharmacy Program Acurity, Inc. Privileged and Confidential August 15, 2017 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ◆ Identify orphan drugs and first-in-class medications approved by the FDA in 2016. ◆ Describe the role of new agents approved for use in oncology patients. ◆ Identify and discuss the role of novel monoclonal antibodies. ◆ Discuss at least two new medications that address public health concerns. Neither Dr. Kludze nor Dr. Shlom have any conflicts of interest in regards to this presentation. Privileged and Confidential 2016 NDA Approvals (NMEs/BLAs) ◆ Nuplazid (primavanserin) P ◆ Adlyxin (lixisenatide) ◆ Ocaliva (obeticholic acid) P, O ◆ Anthim (obitoxaximab) O ◆ Rubraca (rucaparib camsylate) P, O ◆ Axumin (fluciclovive F18) P ◆ Spinraza (nusinersen sodium) P, O ◆ Briviact (brivaracetam) ◆ Taltz (ixekizumab) ◆ Cinqair (reslizumab) ◆ Tecentriq (atezolizumab) P ◆ Defitelio (defibrotide sodium) P, O ◆ Venclexta (venetoclax) P, O ◆ Epclusa (sofosburvir and velpatasvir) P ◆ Xiidra (lifitigrast) P ◆ Eucrisa (crisaborole) ◆ Zepatier (elbasvir and grazoprevir) P ◆ Exondys 51 (eteplirsen) P, O ◆ Zinbyrta (daclizumab) ◆ Lartruvo (olaratumab) P, O ◆ Zinplava (bezlotoxumab) P ◆ NETSTPOT (gallium Ga 68 dotatate) P, O O = Orphan; P = Priority Review; Red = BLA Privileged and Confidential History of FDA Approvals Privileged and Confidential Orphan Drugs ◆FDA Office of Orphan Products Development • Orphan Drug Act (1983) – drugs and biologics . “intended for safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. -
WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization I International Bureau (10) International Publication Number (43) International Publication Date WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, C12N 9/26 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (21) International Application Number: KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, PCT/US20 17/024981 MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, (22) International Filing Date: NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, 30 March 2017 (30.03.2017) RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, (25) Filing Language: English ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/3 15,400 30 March 2016 (30.03.2016) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/457,584 10 February 2017 (10.02.2017) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 15/473,994 30 March 2017 (30.03.2017) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: AMICUS THERAPEUTICS, INC. -
Enzyme Replacement Therapy Srx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment
MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/15/2011 03/15/2017 10/04/2016 Policy Name Policy Number Enzyme Replacement Therapy SRx-0019 Policy Type ☒ Medical ☐ Administrative ☐ Payment Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. -
Combination Therapy for Peptic Ulcer Treatment
Office europeen des brevets © Publication number: 0 480 691 A2 © EUROPEAN PATENT APPLICATION © Application number : 91309249.0 © int. ci.5: A61K 33/24, A61K 31/60, A61K 31/44, A61K 31/425, © Date of filing : 09.10.91 //(A61K33/24, 31:44, 31:425), (A61K31/60, 31:44, 31:425), (A61K31/44, 31:195), (A61K31/425, 31:195) © Priority: 11.10.90 US 595908 © Inventor: Berlin, Roger G. 519 Mulberry Lane Haverford, PA 19041 (US) (43) Date of publication of application : 15.04.92 Bulletin 92/16 @ Representative : Thompson, John Dr. et al Merck & Co., Inc. European Patent @) Designated Contracting States : Department Terlings Park Eastwick Road CH DE FR GB IT LI NL Harlow, Essex CM20 2QR (GB) © Applicant : MERCK & CO. INC. 126, East Lincoln Avenue P.O. Box 2000 Rahway New Jersey 07065-0900 (US) © Combination therapy for peptic ulcer treatment. © Peptic ulcer disease is treated with a combination therapy of famotidine or omeprazole plus a bismuth salt. CM < CO o 00 LU Jouve, 18, rue Saint-Denis, 75001 PARIS EP 0 480 691 A2 BACKGROUND OF THE INVENTION In the past, treatment of peptic ulcer disease was based on either neutralization of intragastric acidity with antacids or the inhibition of production of acid secretion by H2-receptor antagonists or by proton pump inhibition 5 among others. Using bismuth salts alone to heal ulcers has been shown to be effective presumably because of its effect on Helicobacter pylori. Relapse of Helicobacter positivity, however, has been a problem as has relapse of ulcer disease in patients treated with antisecretory therapy. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT NutropinAq 10 mg/2 ml (30 IU) solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. NutropinAq is a solution for subcutaneous use. The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4). 4.2 Posology and method of administration Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use. The NutropinAq dosage and administration schedule should be individualised for each patient. Dosage Growth failure in children due to inadequate growth hormone secretion: 0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed. -
Penile Injection Therapy | Memorial Sloan Kettering Cancer Center
PATIENT & CAREGIVER EDUCATION Penile Injection Therapy This information will help you learn to inject medication into your penis. This is called penile injection therapy. Penile injections can help you achieve an erection if you have erectile dysfunction (ED). Read this resource carefully before starting injection therapy. If you do not follow the instructions in this resource, your doctor or APP may stop prescribing your penile injection medications and supplies. About Penile Injection Therapy The tissue that causes you to get an erection (erectile tissue) is a muscle. Going long periods of time without an erection is unhealthy for erectile tissue and may damage it. We believe having erections keeps erectile tissue healthy. A penile injection helps you have an erection. It works best if it’s given about 5 to 15 minutes before you want an erection. Penile Injection Therapy 1/19 Giving Yourself the Injection Your advanced practice provider (APP) will review the instructions below with you. Generally, the training for the injections takes 2 office visits. Please be aware that each visit may take up to 1 hour, so you should plan your schedule on the day of your appointment. Use this resource to help you the first few times you inject on your own. Do not take the following medications within 18 hours of injecting (before or after): Sildenafil (Viagra®) - 20 mg to 100 mg Vardenafil (Levitra®) - 10 mg to 20 mg Avanafil (Stendra®) - 50 mg to 200 mg If you take tadalafil (Cialis®) 10 mg or 20 mg, do not inject within 72 hours (3 days) of taking the medication.