Download File

Total Page:16

File Type:pdf, Size:1020Kb

Download File Presentation Supplier Name Product Adult Antiretroviral Medicine 2017 2018 2019 2020 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 30 6.50 5.60 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 30 ,Cartonless 6.45 5.50 Aurobindo Pharma Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 90 ,Cartonless 19.00 16.25 Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300mg/300mg tablet, Pack of 30 7.30 6.75 6.75 6.75 Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg tablet, Pack of 60 7.10 6.70 6.70 6.70 Cipla Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300mg/300mg tablet, Pack of 30 7.25 7.00 5.75 5.75 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 30 6.25 6.25 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 90 ,Cartonless 18.60 18.60 Hetero Labs Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600mg/200mg/300mg tablet, Pack of 30 7.05 6.35 6.55 6.55 Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300mg/300mg tablet, Pack of 30 6.42 6.10 5.59 5.59 Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg tablet, Pack of 60 6.16 6.16 7.50 7.50 Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600mg/200mg/300mg tablet, Pack of 30 7.50 7.50 6.50 6.50 Adult Macleods Pharmaceuticals Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300mg/300mg tablet, Pack of 30 7.25 5.75 5.75 5.75 Triple Fixed Dose Combination Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg tablet, Pack of 60 6.80 7.25 7.25 8.25 Abacavir/Lamivudine/Zidovudine 300mg/150mg/300mg tablet, Pack of 60 21.00 21.00 21.00 21.00 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 30 6.00 6.00 Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 30 ,Cartonless 6.00 6.00 Mylan Laboratories Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300/300 mg Tablet, Pack of 90 ,Cartonless 17.80 17.80 Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600mg/200mg/300mg tablet, Pack of 30 7.99 6.25 6.25 6.25 Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300mg/300mg tablet, Pack of 30 7.99 6.25 6.25 6.25 Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600mg/200mg/300mg tablet, Pack of 30 7.00 7.00 7.00 7.00 Strides Shasun Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg tablet, Pack of 60 6.40 6.40 6.40 6.40 Abacavir/Lamivudine/Zidovudine 300mg/150mg/300mg tablet, Pack of 60 20.00 20.00 Sun Pharmaceutical Industries Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600mg/200mg/300mg tablet, Pack of 30 7.16 7.16 Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg tablet, Pack of 60 6.88 6.80 AbbVie Logistics Lopinavir/Ritonavir 200mg/50mg Heat stable tablet, Pack of 120 19.31 19.31 19.31 19.31 Abacavir/Lamivudine 600mg/300mg tablet, Pack of 30 13.00 12.00 12.00 12.00 Aurobindo Pharma Lamivudine/Zidovudine 150mg/300mg tablet, Pack of 60 6.00 6.00 6.00 6.00 Lopinavir/Ritonavir 200mg/50mg Heat stable tablet, Pack of 120 18.00 18.00 18.00 19.00 Abacavir/Lamivudine 600mg/300mg tablet, Pack of 30 13.49 13.49 12.35 12.35 Cipla Atazanavir/Ritonavir 300mg/100mg tablet, Pack of 30 20.00 17.00 17.00 16.75 Lamivudine/Zidovudine 150mg/300mg tablet, Pack of 60 6.10 5.25 5.25 5.25 Emcure Pharmaceuticals Atazanavir/Ritonavir 300mg/100mg tablet, Pack of 30 16.20 14.90 14.90 14.90 Abacavir/Lamivudine 600mg/300mg tablet, Pack of 30 10.50 9.80 9.20 9.20 Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300mg tablet, Pack of 30 4.45 4.24 4.59 4.59 Adult Hetero Labs Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg tablet, Pack of 30 2.93 3.16 3.16 3.16 Dual Fixed Dose Combination Lamivudine/Zidovudine 150mg/300mg tablet, Pack of 60 4.93 5.16 6.25 6.25 Lopinavir/Ritonavir 200mg/50mg Heat stable tablet, Pack of 120 16.45 18.45 25.00 25.00 Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300mg tablet, Pack of 30 4.85 4.85 4.85 4.50 Macleods Pharmaceuticals Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg tablet, Pack of 30 3.50 3.23 3.50 3.50 Lamivudine/Zidovudine 150mg/300mg tablet, Pack of 60 5.50 5.70 5.70 6.75 Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300mg tablet, Pack of 30 3.91 4.60 4.60 4.60 Micro Labs Lamivudine/Tenofovir Disoproxil Fumarate 300mg/300mg tablet, Pack of 30 3.10 3.28 3.28 3.28 Abacavir/Lamivudine 600mg/300mg tablet, Pack of 30 11.88 9.50 9.50 9.50 Mylan Laboratories Atazanavir/Ritonavir 300mg/100mg tablet, Pack of 30 16.50 15.00 15.00 15.00 Lopinavir/Ritonavir 200mg/50mg Heat stable tablet, Pack of 120 18.00 17.50 17.50 17.50 Sun Pharmaceutical Industries Emtricitabine/Tenofovir Disoproxil Fumarate 200mg/300mg tablet, Pack of 30 4.40 4.45 4.45 4.45 AbbVie Logistics Ritonavir 100mg heat stable tablet, Pack of 60 6.85 6.85 6.85 6.85 Abacavir 300mg tablet, Pack of 60 11.20 10.70 10.70 10.70 Dolutegravir 50mg tablet, Pack of 30 3.67 3.20 Aurobindo Pharma Efavirenz 600mg tablet, Pack of 30 2.90 2.90 2.90 2.55 Nevirapine 200mg tablet, Pack of 60 2.00 2.00 2.00 2.00 Darunavir 400mg tablet, Pack of 60 40.00 40.00 40.00 40.00 Darunavir 600mg tablet, Pack of 60 60.00 60.00 60.00 60.00 Darunavir 75mg tablet, Pack of 480 60.00 60.00 60.00 60.00 Cipla Dolutegravir 50mg tablet, Pack of 30 4.00 4.00 3.38 3.38 Efavirenz 600mg tablet, Pack of 30 3.25 3.15 3.15 3.15 Ritonavir 100mg heat stable tablet, Pack of 30 7.50 7.50 7.50 7.50 Tenofovir Disoproxil Fumarate 300mg tablet, Pack of 30 3.40 3.00 3.00 3.00 Emcure Pharmaceuticals Atazanavir 300mg capsule, Pack of 30 17.00 17.00 17.00 17.00 Abacavir 300mg tablet, Pack of 60 9.10 9.10 9.10 9.10 Darunavir 400mg tablet, Pack of 60 65.00 56.00 52.50 52.50 Darunavir 600mg tablet, Pack of 60 70.00 58.00 53.80 53.80 Dolutegravir 50mg tablet, Pack of 30 3.75 3.75 Adult Hetero Labs Efavirenz 600mg tablet, Pack of 30 2.39 2.46 2.75 2.75 Single Formulation Lamivudine 150mg tablet, Pack of 60 1.65 1.80 2.40 2.40 Nevirapine 200mg tablet, Pack of 60 1.74 1.82 2.30 2.30 Tenofovir Disoproxil Fumarate 300mg tablet, Pack of 30 2.44 2.30 2.60 2.60 Zidovudine 300mg tablet, Pack of 60 4.35 4.35 5.05 5.05 Darunavir 400mg tablet, Pack of 60 36.00 36.00 36.00 36.00 Janssen Pharmaceutica NV Darunavir 600mg tablet, Pack of 60 54.00 54.00 54.00 54.00 Etravirine 100mg tablet, Pack of 120 36.00 36.00 36.00 36.00 Macleods Pharmaceuticals Efavirenz 600mg tablet, Pack of 30 2.75 2.61 2.61 2.61 Lamivudine 150mg tablet, Pack of 60 1.54 1.72 1.72 1.90 Micro Labs Nevirapine 200mg tablet, Pack of 60 1.93 1.93 1.93 2.11 Zidovudine 300mg tablet, Pack of 60 4.72 4.72 4.72 4.72 Abacavir 300mg tablet, Pack of 60 9.50 8.75 8.75 8.75 Atazanavir 300mg capsule, Pack of 30 15.00 14.75 14.75 14.75 Dolutegravir 50mg tablet, Pack of 30 4.50 4.50 Mylan Laboratories Nevirapine 200mg tablet, Pack of 60 2.00 2.00 2.00 2.00 Ritonavir 100mg heat stable tablet, Pack of 30 7.28 7.28 7.28 7.28 Tenofovir Disoproxil Fumarate 300mg tablet, Pack of 30 3.50 3.20 3.20 3.20 Presentation Supplier Name Product Paediatric Antiretroviral Medicine 2017 2018 2019 2020 Cipla Lamivudine/Nevirapine/Zidovudine 30mg/50mg/60mg dispersible tablet, Pack of 60 3.40 3.40 3.00 3.00 Paediatric Mylan Laboratories Lamivudine/Nevirapine/Zidovudine 30mg/50mg/60mg dispersible tablet, Pack of 60 3.00 3.00 3.00 3.00 Triple Fixed Dose Combination Strides Shasun Lamivudine/Nevirapine/Zidovudine 30mg/50mg/60mg dispersible tablet, Pack of 60 3.20 3.00 3.00 3.00 Lopinavir/Ritonavir 100mg/25mg Heat stable tablet, Pack of 60 5.94 5.94 5.94 5.94 AbbVie Logistics Lopinavir/Ritonavir 80mg/20mg/ml oral solution, Pack of 5x60ml Bottle 30.82 30.82 30.82 30.82 Aurobindo Pharma Lopinavir/Ritonavir 100mg/25mg Heat stable tablet, Pack of 60 7.70 7.70 7.70 8.00 Abacavir/Lamivudine 120mg/60mg dispersible tablet, Pack of 60 7.75 7.75 7.10 7.10 Abacavir/Lamivudine 60mg/30mg dispersible tablet, Pack of 60 4.25 4.00 4.00 4.00 Cipla Paediatric Lamivudine/Zidovudine 30mg/60mg dispersible tablet, Pack of 60 1.90 1.90 1.90 1.90 Dual Fixed Dose Combination Lopinavir/Ritonavir 40mg/10mg heat stable pellets in a capsule, Pack of 120 19.20 19.20 19.20 15.00 Hetero Labs Lopinavir/Ritonavir 100mg/25mg Heat stable tablet, Pack of 120 11.00 11.00 19.00 19.00 Macleods Pharmaceuticals Lopinavir/Ritonavir 100mg/25mg Heat stable tablet, Pack of 60 9.00 6.50 7.25 8.50 Abacavir/Lamivudine 120mg/60mg dispersible tablet, Pack of 30 3.60 3.60 3.60 3.60 Mylan Laboratories Abacavir/Lamivudine 60mg/30mg dispersible tablet, Pack of 60 3.60 3.50 3.50 3.50 Lamivudine/Zidovudine 30mg/60mg dispersible tablet, Pack of 60 1.90 1.90 1.90 1.90 Abacavir 20mg/ml oral solution, Bottle of 240ml 6.83 6.83 6.83 6.83 Lamivudine 10mg/ml oral solution, Bottle of 240ml 1.43 1.51 2.00 2.00 Nevirapine 10mg/ml oral suspension, Bottle of 100ml 1.30 1.43 2.00 2.00 Aurobindo Pharma Nevirapine 10mg/ml oral suspension, Bottle of 240ml 1.51 1.51 2.50 2.50 Nevirapine 50mg dispersible tablet, Pack fo 30 1.25 1.25 2.00 2.00 Zidovudine 50mg/5ml Oral solution, Bottle of 240ml 2.00 2.00 2.00 2.00 Abacavir 60mg dispersible tablet, Pack of 60 4.00 3.80 3.80 3.80 Lamivudine 10mg/ml oral solution, Bottle of 100ml 1.20 1.20 1.20 1.20 Cipla Nevirapine 10mg/ml oral suspension, Bottle of 100ml 1.25 1.25 1.25 1.25 Paediatric Nevirapine 50mg dispersible tablet, Pack fo 60 1.25 1.25 1.25 1.25 Single Formulation Zidovudine 50mg/5ml Oral solution, Bottle of 100ml 1.20 1.20 Abacavir 20mg/ml oral solution, Bottle of 240ml 6.35 6.45 7.25 7.25 Hetero Labs Zidovudine 50mg/5ml Oral solution, Bottle of 240ml 1.95 1.95 2.15 2.15 Darunavir 150mg tablet, Pack of 240 54.00 54.00 54.00 54.00 Janssen Pharmaceutica NV Darunavir 75mg tablet, Pack of 480 54.00 54.00 54.00 54.00 Etravirine 25mg tablet, Pack of 120 9.00 9.00 9.00 9.00 Macleods Pharmaceuticals Zidovudine 50mg/5ml Oral solution, Bottle of 240ml 2.00 2.50 3.00 3.00 Micro Labs Abacavir 60mg dispersible tablet, Pack of 60 3.25 3.25 3.25 3.25 Strides Shasun Efavirenz 200mg scored tablet, Pack of 90 9.30 9.30 9.30 9.30 Data shows the ceiling price (in USD) per product per supplier per calendar year, based on a multi year supply agreement.
Recommended publications
  • KALETRA (Lopinavir/Ritonavir)
    HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use • Hypersensitivity to KALETRA (e.g., toxic epidermal necrolysis, Stevens- KALETRA safely and effectively. See full prescribing information for Johnson syndrome, erythema multiforme, urticaria, angioedema) or any of KALETRA. its ingredients, including ritonavir. (4) • Co-administration with drugs highly dependent on CYP3A for clearance KALETRA (lopinavir and ritonavir) tablet, for oral use and for which elevated plasma levels may result in serious and/or life- KALETRA (lopinavir and ritonavir) oral solution threatening events. (4) Initial U.S. Approval: 2000 • Co-administration with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for RECENT MAJOR CHANGES loss of virologic response and possible resistance and cross resistance. (4) Contraindications (4) 12/2019 WARNINGS AND PRECAUTIONS The following have been observed in patients receiving KALETRA: INDICATIONS AND USAGE • The concomitant use of KALETRA and certain other drugs may result in KALETRA is an HIV-1 protease inhibitor indicated in combination with other known or potentially significant drug interactions. Consult the full antiretroviral agents for the treatment of HIV-1 infection in adults and prescribing information prior to and during treatment for potential drug pediatric patients (14 days and older). (1) interactions. (5.1, 7.3) • Toxicity in preterm neonates: KALETRA oral solution should not be used DOSAGE AND ADMINISTRATION in preterm neonates in the immediate postnatal period because of possible Tablets: May be taken with or without food, swallowed whole and not toxicities. A safe and effective dose of KALETRA oral solution in this chewed, broken, or crushed.
    [Show full text]
  • TRIZIVIR® (Abacavir Sulfate, Lamivudine, and Zidovudine) Tablets
    NDA 21-205/S-011 Page 4 PRESCRIBING INFORMATION TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine) Tablets WARNINGS TRIZIVIR contains 3 nucleoside analogues (abacavir sulfate, lamivudine, and zidovudine) and is intended only for patients whose regimen would otherwise include these 3 components. Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of TRIZIVIR. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue TRIZIVIR as soon as a hypersensitivity reaction is suspected. Permanently discontinue TRIZIVIR if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Following a hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Reintroduction of TRIZIVIR or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours (see WARNINGS and PRECAUTIONS: Information
    [Show full text]
  • Recommendations on First and Second Line Antiretroviral Regimens
    POLICY BRIEF UPDATE OF RECOMMENDATIONS ON FIRST- AND SECOND-LINE ANTIRETROVIRAL REGIMENS JULY 2019 HIV TREATMENT WHO/CDS/HIV/19.15 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/ licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Update of recommendations on first- and second-line antiretroviral regimens. Geneva, Switzerland: World Health Organization; 2019 (WHO/CDS/HIV/19.15). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing.
    [Show full text]
  • ZIAGEN Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients With Hepatic Impairment: Mild hepatic impairment – 200 mg These highlights do not include all the information needed to use twice daily; moderate/severe hepatic impairment – contraindicated. (2.3) ZIAGEN safely and effectively. See full prescribing information for --------------------- DOSAGE FORMS AND STRENGTHS -------------- ZIAGEN. Tablets: 300 mg; Oral Solution: 20 mg/mL (3) ZIAGEN® (abacavir sulfate) Tablets and Oral Solution -------------------------------CONTRAINDICATIONS------------------------ Initial U.S. Approval: 1998 • Previously demonstrated hypersensitivity to abacavir. (4, 5.1) • Moderate or severe hepatic impairment. (4) WARNING: HYPERSENSITIVITY REACTIONS/LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY ----------------------- WARNINGS AND PRECAUTIONS ---------------- • Hypersensitivity: Serious and sometime fatal hypersensitivity reactions See full prescribing information for complete boxed warning. have been associated with ZIAGEN and other abacavir-containing • Serious and sometimes fatal hypersensitivity reactions have been products. Read full prescribing information section 5.1 before associated with ZIAGEN (abacavir sulfate). (5.1) prescribing ZIAGEN. (5.1) • Hypersensitivity to abacavir is a multi-organ clinical syndrome. • Lactic acidosis and severe hepatomegaly with steatosis have been (5.1) reported with the use of nucleoside analogues. (5.2) • Patients who carry the HLA-B*5701 allele are at high risk for • Immune reconstitution syndrome (5.3) and redistribution/accumulation
    [Show full text]
  • Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis
    Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis Centers for Disease Control and Prevention Office of Infectious Diseases National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of Tuberculosis Elimination June 2013 This document is accessible online at http://www.cdc.gov/tb/TB_HIV_Drugs/default.htm Suggested citation: CDC. Managing Drug Interactions in the Treatment of HIV-Related Tuberculosis [online]. 2013. Available from URL: http://www.cdc.gov/tb/TB_HIV_Drugs/default.htm Table of Contents Introduction 1 Methodology for Preparation of these Guidelines 2 The Role of Rifamycins in Tuberculosis Treatment 4 Managing Drug Interactions with Antivirals and Rifampin 5 Managing Drug Interactions with Antivirals and Rifabutin 9 Treatment of Latent TB Infection with Rifampin or Rifapentine 10 Treating Pregnant Women with Tuberculosis and HIV Co-infection 10 Treating Children with HIV-associated Tuberculosis 12 Co-treatment of Multidrug-resistant Tuberculosis and HIV 14 Limitations of these Guidelines 14 HIV-TB Drug Interaction Guideline Development Group 15 References 17 Table 1a. Recommendations for regimens for the concomitant treatment of tuberculosis and HIV infection in adults 21 Table 1b. Recommendations for regimens for the concomitant treatment of tuberculosis and HIV infection in children 22 Table 2a. Recommendations for co-administering antiretroviral drugs with RIFAMPIN in adults 23 Table 2b. Recommendations for co-administering antiretroviral drugs with RIFAMPIN in children 25 Table 3. Recommendations for co-administering antiretroviral drugs with RIFABUTIN in adults 26 ii Introduction Worldwide, tuberculosis is the most common serious opportunistic infection among people with HIV infection.
    [Show full text]
  • DESCOVY, and Upon Diagnosis of These Highlights Do Not Include All the Information Needed to Use Any Other Sexually Transmitted Infections (Stis)
    HIGHLIGHTS OF PRESCRIBING INFORMATION once every 3 months while taking DESCOVY, and upon diagnosis of These highlights do not include all the information needed to use any other sexually transmitted infections (STIs). (2.2) DESCOVY safely and effectively. See full prescribing information • Recommended dosage: for DESCOVY. • Treatment of HIV-1 Infection: One tablet taken once daily with or ® without food in patients with body weight at least 25 kg. (2.3) DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for • HIV-1 PrEP: One tablet taken once daily with or without food in oral use individuals with body weight at least 35 kg. (2.4) Initial U.S. Approval: 2015 • Renal impairment: DESCOVY is not recommended in individuals with WARNING: POST-TREATMENT ACUTE EXACERBATION OF estimated creatinine clearance below 30 mL per minute. (2.5) HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS Tablets: 200 mg of FTC and 25 mg of TAF (3) (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. -------------------------------CONTRAINDICATIONS------------------------------­ DESCOVY for HIV-1 PrEP is contraindicated in individuals with Severe acute exacerbations of hepatitis B (HBV) have been unknown or positive HIV-1 status. (4) reported in HBV-infected individuals who have discontinued products containing emtricitabine (FTC) and/or tenofovir -----------------------WARNINGS AND PRECAUTIONS-----------------------­ disoproxil fumarate (TDF), and may occur with • Comprehensive management to reduce the risk of sexually discontinuation of DESCOVY. Hepatic function should be transmitted infections (STIs), including HIV-1, when DESCOVY is monitored closely in these individuals.
    [Show full text]
  • KALETRA® (Lopinavir/Ritonavir) Capsules (Lopinavir/Ritonavir) Oral Solution
    1 of 57 KALETRA® (lopinavir/ritonavir) capsules (lopinavir/ritonavir) oral solution DESCRIPTION Proprietary name: Kaletra Established name: lopinavir and ritonavir Route of administration: ORAL (C38288) Active ingredients (moiety): Lopinavir (Lopinavir), Ritonavir (Ritonavir) # Strength Form Inactive ingredients 1 133.3 MILLIGRAM, CAPSULE, FD&C Yellow No. 6, gelatin, glycerin, oleic acid, polyoxyl 35 castor oil, 33.3 MILLIGRAM LIQUID FILLED propylene glycol, sorbitol special, titanium dioxide, water (C42954) 2 80 MILLIGRAM, SOLUTION Acesulfame potassium, alcohol, artificial cotton candy flavor, citric acid, 20 MILLIGRAM (C42986) glycerin, high fructose corn syrup, Magnasweet-110 flavor, menthol, natural & artificial vanilla flavor, peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, saccharin sodium, sodium chloride, sodium citrate, water KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A- mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6- dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro- alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir has the following structural formula: 2 of 57 Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1- methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir has the following structural formula: Lopinavir is a white to light tan powder.
    [Show full text]
  • Dolutegravir-Abacavir-Lamivudine (Triumeq)
    © National HIV Curriculum PDF created September 24, 2021, 7:23 pm Dolutegravir-Abacavir-Lamivudine (Triumeq) Table of Contents Dolutegravir-Abacavir-Lamivudine Triumeq Summary Drug Summary Key Clinical Trials Resistance Key Drug Interactions Drug Summary Dolutegravir-abacavir-lamivudine is a single-tablet regimen that is used primarily for treatment-naïve individuals. It has high potency, a relatively robust barrier to resistance (due to the dolutegravir component), and few drug interactions. It may be especially advantageous for individuals with renal insufficiency or risk factors for renal disease or osteoporosis, as it avoids the use of tenofovir DF. In certain treatment- experienced individuals, dolutegravir-abacavir-lamivudine may provide an option for switch or simplification of therapy. Abacavir can cause a life-threatening hypersensitivity reaction in individuals who are HLA-B*5701 positive; all patients need to undergo testing for HLA-B*5701 prior to receiving dolutegravir-abacavir- lamivudine and those who test positive for HLA-B*5701 should not receive this single tablet regimen. Dolutegravir blocks tubular secretion of creatinine and therefore causes a small increase in serum creatinine in the first 4 to 8 weeks of use; this increase is benign and does not indicate a change in true creatinine clearance. Key Clinical Trials In antiretroviral-naïve individuals, dolutegravir plus abacavir-lamivudine demonstrated superior virologic responses when compared with efavirenz-tenofovir disoproxil fumarate (DF)-emtricitabine [SINGLE], with superiority largely driven by the greater tolerability of the dolutegravir plus abacavir-lamivudine regimen. In a comparison of 2 NRTIs plus either dolutegravir or raltegravir in treatment-naïve patients, virologic responses in the subset of patients who received dolutegravir plus abacavir-lamivudine were equivalent to those receiving raltegravir plus either tenofovir DF-emtricitabine or abacavir-lamivudine [SPRING-2].
    [Show full text]
  • Of 43 Reference ID: 4711890 FULL PRESCRIBING INFORMATION: CONTENTS*
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR -----------------------WARNINGS AND PRECAUTIONS------------------------ ALAFENAMIDE TABLETS safely and effectively. See full prescribing • Hypersensitivity reactions characterized by rash, constitutional findings, information for DOLUTEGRAVIR, EMTRICITABINE and and sometimes organ dysfunction, including liver injury have been TENOFOVIR ALAFENAMIDE TABLETS. reported. Discontinue dolutegravir, emtricitabine and tenofovir alafenamide tablets and other suspect agents immediately if signs or DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR symptoms of hypersensitivity reactions develop. (5.2) ALAFENAMIDE tablets, for oral use • Hepatotoxicity has been reported in patients receiving a dolutegravir- containing regimen. Monitoring for hepatotoxicity is recommended. WARNING: POST-TREATMENT ACUTE EXACERBATION OF (5.3) HEPATITIS B • Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy. An alternative treatment to dolutegravir, See full prescribing information for complete boxed warning. emtricitabine and tenofovir alafenamide tablets should be considered at the time of conception through the first trimester of pregnancy due to the Severe acute exacerbations of hepatitis B virus (HBV) have been reported risk of neural tube defects. Counsel adolescents and adults of in HBV-infected patients who have discontinued products containing childbearing potential to use effective contraception.
    [Show full text]
  • Bictegravir-Tenofovir Alafenamide-Emtricitabine (Biktarvy)
    © National HIV Curriculum PDF created September 25, 2021, 12:10 pm Bictegravir-Tenofovir alafenamide-Emtricitabine (Biktarvy) Table of Contents Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy Summary Drug Summary Key Clinical Trials Key Drug Interactions Figures Drug Summary Bictegravir-tenofovir alafenamide-emtricitabine is a single-tablet regimen that is comprised of an integrase strand transfer inhibitor (bictegravir) combined with two nucleoside reverse transcriptase inhibitors (tenofovir alafenamide and emtricitabine). Bictegravir, which is not FDA-approved as an individual antiretroviral medication, has a high barrier to resistance, is well tolerated, and, extrapolating from the phase 3 data, has virologic efficacy comparable to dolutegravir. Bictegravir levels can be reduced with medications or oral supplement that contain polyvalent cations (e.g. Ca, Mg, Al, Fe). Bictegravir blocks tubular secretion of creatinine and typically raises serum creatinine by about 0.1 mg/dL, but without affecting renal glomerular function. Phase 3 trials in antiretroviral-naïve persons as well as switch trials in persons with virologic suppression have shown excellent efficacy with bictegravir-tenofovir alafenamide-emtricitabine. Available data suggest that bictegravir has a high genetic barrier to resistance. Key Clinical Trials In a phase 3 trial, 629 antiretroviral-naïve adults were randomized to receive bictegravir-tenofovir alafenamide-emtricitabine or dolutegravir-abacavir-lamivudine; after 48 weeks, there was no significant difference
    [Show full text]
  • 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.
    [Show full text]
  • Estonian Statistics on Medicines 2016 1/41
    Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole
    [Show full text]