Medi-Cal DHCS Carve out Medication List the Drugs Shown Below

Total Page:16

File Type:pdf, Size:1020Kb

Medi-Cal DHCS Carve out Medication List the Drugs Shown Below Medi-Cal DHCS Carve Out Medication List The drugs shown below are non-capitated or carved-out of IEHP. This means they are not reimbursed by IEHP except where indicated and they should be billed to Fee-For-Service (FFS) Medi-Cal for payment. Please note that this list is frequently updated by Medi-Cal with additions and deletions of drugs. For questions about a benefit or service listed here, please call Medi-Cal Support at 1-800-541-5555. Psychiatric Drugs Drug Name (Brand Name) Amantadine HCl Amantadine HCl ER Aripiprazole Aripiprazole lauroxil (Aristada Initio) Asenapine (Saphris) Benztropine Mesylate Brexpiprazole Cariprazine Chlorpromazine HCl Clozapine Fluphenazine Decanoate Fluphenazine HCl Haloperidol Haloperidol Decanoate Haloperidol Lactate Iloperidone (Fanapt) Isocarboxazid Lithium Carbonate Lithium Citrate Loxapine Succinate Loxapine Aerosol Powder Breath Activated (Adasuve) Lurasidone Hydrochloride Molindone HCl Olanzapine Olanzapine Fluoxetine HCl Olanzapine Pamoate Monohydrate (Zyprexa Relprevv) Paliperidone (Invega) Paliperidone Palmitate (Invega Sustenna) Paliperidone Palmitate (Invega Trinza) Perphenazine Phenelzine Sulfate Pimavanserin (Nuplazid) Pimozide Quetiapine Risperidone 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org Updated 01/07/2020 (v14) A Public Entity 1 Drug Name (Brand Name) Risperidone ER injectable suspension (Perseris) Risperidone Microspheres Selegiline (transdermal only) Thioridazine HCl Thiothixene Thiothixene HCl Tranylcypromine Sulfate Trifluoperazine HCl Trihexyphenidyl Ziprasidone HCl Ziprasidone Mesylate AIDS Drugs Drug Name (Brand Name) Abacavir/Lamivudine Abacavir Sulfate Abacavir Sulfate/Dolutegravir/Lamivudine (Triumeq) Atazanavir Sulfate Atazanavir/Cobicistat (Evotaz) Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Cobicistat (Tybost) Darunavir Ethanolate Darunavir/Cobicistat (Prezcobix) Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Symtuza) Delavirdine Mesylate Dolutegravir (Tivicay) Dolutegravir/Lamivudine (Dovato) Dolutegravir/ Rilpivirine (Juluca) Doravine (Pifeltro) Doravirine/ Lamivudine/ Tenofovir disoproxil fumarate (Delstrigo) Efavirenz Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (Atripla) Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate (Symfi LO) Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate (Symfi) Elvitegravir (Vitekta) Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (Stribild) Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (Genvoya) Emtricitabine/Rilpivirine/Tenofovir Alafenamide (Odefsey) Emtricitabine/Rilpivirine/ Tenofovir Disoproxil Fumarate (Complera) Emtricitabine/Tenofovir Alafenamide (Descovy) Emtricitabine Enfuvirtide Etravirine 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org Updated 01/07/2020 (v14) A Public Entity 2 Drug Name (Brand Name) Fosamprenavir Calcium Ibalizumab-uiyk (Trogarzo) Indinavir Sulfate Lamivudine Lamivudine/Tenofovir Disoproxil Fumarate (Cimduo) Lamivudine/ Tenofovir Disoproxil Fumarate (Temixys) Lopinavir/Ritonavir Maraviroc Nelfinavir Mesylate Nevirapine Raltegravir Potassium Rilpivirine Hydrochloride Ritonavir Saquinavir Saquinavir Mesylate Stavudine Tenofovir Alafenamide (Vemlidy) Tenofovir Disoproxil-Emtricitabine Tenofovir Disoproxil Fumarate Tipranavir Zidovudine/Lamivudine Zidovudine/Lamivudine/ Abacavir Sulfate Alcohol, Heroin Detoxification, and Dependency Treatment Drugs Drug Name (Brand Name) Acamprosate Calcium Buprenorphine HCl Buprenorphine Extended-Release Inj (Sublocade) Buprenorphine HCl (Belbuca) Buprenorphine Implant (Probuphine) Buprenorphine/Naloxone HCl Disulfiram (Antabuse) Lofexidine Hydrochloride (Lucemyra) Naloxone HCl Naltrexone (oral) Naltrexone Microsphere Injectable Suspension (Vivitrol) Blood Factor Products Drug Name (Brand Name) Antihemophilic factor VIII/von Willebrand factor complex (human) Anti-inhibitor 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org Updated 01/07/2020 (v14) A Public Entity 3 Drug Name (Brand Name) Coagulation factor X (human) Factor VIIa (antihemophilic factor, recombinant) Factor VIII (antihemophilic factor, human) Factor VIII (antihemophilic factor, recombinant) Factor VIII (antihemophilic factor, recombinant) (Novoeight) Factor IX (antihemophilic factor, purified, nonrecombinant) Factor IX (antihemophilic factor, recombinant) Factor IX (antihemophilic factor, recombinant) (Rixubis) Factor IX (antihemophilic factor, recombinant), glycopegylated, (Rebinyn), Per IU Factor IX complex Factor XIII (antihemophilic factor, human) Factor XIII A-Subunit (recombinant) Hemlibra Hemophilia clotting factor, not otherwise classified Injection, factor VIII (antihemophilic factor, recombinant) (Obizur) Injection, factor VIII, fc fusion (recombinant) Injection, factor VIII, fc fusion protein (recombinant) Injection, factor IX fusion protein (recombinant) Von Willebrand factor complex (human), Wilate Von Willebrand factor complex (Humate-P) 10801 6th St., Suite 120, Rancho Cucamonga, CA 91730 Tel (909) 890-2049 Fax (909) 890-2058 Visit our web site at: www.iehp.org Updated 01/07/2020 (v14) A Public Entity 4 .
Recommended publications
  • Effects of Enzyme Inducers Efavirenz and Tipranavir/Ritonavir on the Pharmacokinetics of the HIV Integrase Inhibitor Dolutegravir
    Eur J Clin Pharmacol (2014) 70:1173–1179 DOI 10.1007/s00228-014-1732-8 CLINICAL TRIAL Effects of enzyme inducers efavirenz and tipranavir/ritonavir on the pharmacokinetics of the HIV integrase inhibitor dolutegravir Ivy Song & Julie Borland & Shuguang Chen & Phyllis Guta & Yu Lou & David Wilfret & Toshihiro Wajima & Paul Savina & Amanda Peppercorn & Stephen Castellino & David Wagner & Louise Hosking & Michael Mosteller & Justin P.Rubio & Stephen C. Piscitelli Received: 7 May 2014 /Accepted: 11 August 2014 /Published online: 23 August 2014 # The Author(s) 2014. This article is published with open access at Springerlink.com Abstract study due to increases in alanine aminotransferase that were Purpose Dolutegravir (DTG) is an unboosted, integrase in- considered related to TPV/r. Co-administration with EFV hibitor for the treatment of HIV infection. Two studies evalu- resulted in decreases of 57, 39 and 75 % in DTG AUC(0–τ), ated the effects of efavirenz (EFV) and tipranavir/ritonavir Cmax and Cτ, respectively. Co-administration with TPV/r re- (TPV/r) on DTG pharmacokinetics (PK) in healthy subjects. sulted in decreases of 59, 46 and 76 % in DTG AUC(0–τ), Cmax Methods The first study was an open-label crossover where and Cτ, respectively. 12 subjects received DTG 50 mg every 24 hours (q24h) for Conclusions Given the reductions in exposure and PK/ 5 days, followed by DTG 50 mg and EFV 600 mg q24h for pharmacodynamic relationships in phase II/III trials, DTG 14 days. The second study was an open-label crossover where should be given at an increased dose of 50 mg twice daily 18 subjects received DTG 50 mg q24h for 5 days followed by when co-administered with EFV or TPV/r, and alternative TPV/r 500/200 mg every 12 hours (q12h) for 7 days and then regimens without inducers should be considered in integrase DTG 50 mg q24h and TPV/r 500/200 mg q12h for a further inhibitor-resistant patients.
    [Show full text]
  • Revised 4/1/2021 GEORGIA MEDICAID FEE-FOR-SERVICE HIV
    GEORGIA MEDICAID FEE-FOR-SERVICE HIV-AIDS PA SUMMARY Preferred (may not be all inclusive) Non-Preferred Abacavir generic Abacavir/lamivudine/zidovudine generic Abacavir/lamivudine generic Aptivus (tipranavir) Complera (emtricitabine/rilpivirine/tenofovir disoproxil Atazanavir capsules generic fumarate) Atripla (efavirenz/emtricitabine/tenofovir disoproxil Crixivan (indinavir) fumarate) Biktarvy (bictegravir/emtricitabine/tenofovir Delstrigo (doravirine/lamivudine/tenofovir disoproxil alafenamide) fumarate) Cimduo (lamivudine/tenofovir disoproxil fumarate) Fuzeon (enfuvirtide) Descovy (emtricitabine/tenofovir alafenamide) Intelence (etravirine) Dovato Invirase (saquinavir) Edurant (rilpivirine)* Lexiva (fosamprenavir) Efavirenz tablets generic Nevirapine extended-release generic Emtriva (emtricitabine) Norvir Powder (ritonavir) Epivir solution (lamivudine) Pifeltro (doravirine) Evotaz (atazanavir/cobicistat)* Reyataz Powder (atazanavir) Genvoya (elvitegravir/cobicistat/emtricitabine/ Ritonavir tablets generic tenofovir alafenamide) Isentress and Isentress HD (raltegravir)* Rukobia (fostemsavir) Juluca (dolutegravir/rilpivirine) Selzentry (maraviroc) Kaletra (lopinavir/ritonavir) Stavudine generic^ Stribild (elvitegravir/cobicistat/emtricitabine/ tenofovir Lamivudine generic disoproxil fumarate) Symfi (efavirenz 600 mg/lamivudine/tenofovir Lamivudine/zidovudine generic disoproxil fumarate) Symfi Lo (efavirenz 400 mg/lamivudine/tenofovir Nevirapine immediate-release tablets generic disoproxil fumarate) Norvir (ritonavir) Temixys (lamivudine/tenofovir
    [Show full text]
  • Truvada (Emtricitabine / Tenofovir Disoproxil)
    Pre-exposure Prophylaxis (2.3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Recommended dose in HIV-1 uninfected adults: One tablet TRUVADA safely and effectively. See full prescribing information (containing 200 mg/300 mg of emtricitabine and tenofovir for TRUVADA. disoproxil fumarate) once daily taken orally with or without food. (2.3) TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Recommended dose in renally impaired HIV-uninfected Initial U.S. Approval: 2004 individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH uninfected individuals while using TRUVADA for PrEP, evaluate STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF potential causes and re-assess potential risks and benefits of HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF continued use. (2.4) TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION -----------------------DOSAGE FORMS AND STRENGTHS-------------------­ See full prescribing information for complete boxed warning. Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 Lactic acidosis and severe hepatomegaly with steatosis, mg/150 mg of emtricitabine and tenofovir disoproxil fumarate . (3) including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. (5.1) --------------------------------CONTRAINDICATIONS-----------------------------­ TRUVADA is not approved for the treatment of chronic Do not use TRUVADA for pre-exposure prophylaxis in individuals with hepatitis B virus (HBV) infection. Severe acute unknown or positive HIV-1 status. TRUVADA should be used in exacerbations of hepatitis B have been reported in patients HIV-infected patients only in combination with other antiretroviral coinfected with HIV-1 and HBV who have discontinued agents.
    [Show full text]
  • United States Patent (19) 11 Patent Number: 5,993,812 Tsoukas Et Al
    USOO5993812A United States Patent (19) 11 Patent Number: 5,993,812 TSOukas et al. (45) Date of Patent: Nov.30, 1999 54 METHOD OF DELAYING THE Brunkhorst et al., Infection 18:28-32, 1990. PROGRESSION OF AN INFECTION WITH Coyle et al., Changes in the Lymphocyte Count and Lym THE HUMAN IMMUNODEFICIENCY VIRUS phocyte Subsets After Splenectomy in Human Immunode ficiency Virus Infection, Letters and Correspondence, pp. 75 Inventors: Christos M. Tsoukas, Montreal; Barry 144-146. Michael Woloski, Winnipeg, both of DeSimone et al., Immunopharma. and Immunotoxic., Canada 13:447-458, 1991. Gringeri et al., British Journal of Haemotology, 80:337-340, 73 Assignee: Cangene Corporation, Winnipeg, 1992. Canada Gingör et al., Eur. J. Pediatr., 152:650–654, 1993. Mofenson and Moye, Pediatric Research, 33:80-S89, 1993. 21 Appl. No.: 08/835,400 Mofenson et al., Journal of Acquired Immune Deficiency 22 Filed: Apr. 7, 1997 Syndrome, 6:1103-1113, 1993. Schrappe-Bächer et al., Vox Sang, 59:3-14, 1990. Related U.S. Application Data Shearer et al., Ann. N.Y. Acad. Sci., pp. 35-51. Wagner et al., Arch. of Disease in Childhood., 63 Continuation-in-part of application No. 08/713,765, Sep. 13, 67:1267-1271, 1992. 1996, abandoned. Watson, et al., “Recombinant DNA”, Scientific American 60 Provisional application No. 60/003,756, Sep. 14, 1995. Books, Chapter 25. 51) Int. Cl. ............................ A61K 39/395; CO7K 1/00 Okesenhendeler, et al., “Anti-RH immunoglobulin therapy 52 U.S. Cl. ................... 424/130.1; 530/350, 530/388.7; for human immunodeficiency virus-related immune throm 424/142.1; 424/141.1; 424/153.1 bocytopenic purpura’, Blood, 71 (5) 1499-502.
    [Show full text]
  • Download Article PDF/Slides
    New Antiretrovirals in Development: Reprinted from The PRN Notebook,™ june 2002. Dr. James F. Braun, Editor-in-Chief. Tim Horn, Executive Editor. Published in New York City by the Physicians’ Research Network, Inc.,® John Graham Brown, Executive Director. For further information and other articles The View in 2002 available online, visit http://www.PRN.org All rights reserved. © june 2002. Roy “Trip” Gulick, md, mph Associate Professor of Medicine, Weill Medical College of Cornell University Director, Cornell Clinical Trials Unit, New York, New York Summary by Tim Horn Edited by Scott Hammer, md espite the fact that 16 antiretro- tiviral activity of emtricitabine was estab- Preliminary results from two random- virals are approved for use in the lished, with total daily doses of 200 mg or ized studies—FTC-302 and FTC-303—were United States, there is an indis- more producing the greatest median viral reported by Dr. Charles van der Horst and putable need for new anti-hiv com- load suppression: 1.72-1.92 log. Based on his colleagues at the 8th croi, held in Feb- pounds that have potent and these data, a once-daily dose of 200 mg ruary 2001 in Chicago (van der Horst, durable efficacy profiles, unique re- was selected for further long-term clinical 2001). FTC-302 was a blinded comparison sistance patterns, patient-friendly dosing study. “This is what we’re looking forward of emtricitabine and lamivudine, both in schedules, and minimal toxicities. To pro- to with emtricitabine,” commented Dr. combination with stavudine (Zerit) and vide prn with a glimpse of drugs current- Gulick.
    [Show full text]
  • VIDEX (Didanosine) Chewable/Dispersible Buffered Tablets
    Rx only VIDEXâ (didanosine) â VIDEX (didanosine) Chewable/Dispersible Buffered Tablets â VIDEX (didanosine) Buffered Powder for Oral Solution â VIDEX (didanosine) Pediatric Powder for Oral Solution (Patient Information Leaflet Included) WARNING FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION. VIDEX SHOULD BE SUSPENDED IN PATIENTS WITH SUSPECTED PANCREATITIS AND DISCONTINUED IN PATIENTS WITH CONFIRMED PANCREATITIS (SEE WARNINGS). LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING DIDANOSINE AND OTHER ANTIRETROVIRALS. FATAL LACTIC ACIDOSIS HAS BEEN REPORTED IN PREGNANT WOMEN WHO RECEIVED THE COMBINATION OF DIDANOSINE AND STAVUDINE WITH OTHER ANTIRETROVIRAL AGENTS. THE COMBINATION OF DIDANOSINE AND STAVUDINE SHOULD BE USED WITH CAUTION DURING PREGNANCY AND IS RECOMMENDED ONLY IF THE POTENTIAL BENEFIT CLEARLY OUTWEIGHS THE POTENTIAL RISK. (SEE WARNINGS AND PRECAUTIONS: PREGNANCY.) Page 4 of 39 DESCRIPTION â VIDEX (didanosine) is a brand name for didanosine (ddI), a synthetic purine nucleoside analogue active against the Human Immunodeficiency Virus (HIV). VIDEX Chewable/Dispersible Buffered Tablets are available for oral administration in strengths of 25, 50, 100, 150, and 200 mg of didanosine. Each tablet is buffered with calcium carbonate and magnesium hydroxide. VIDEX tablets also contain aspartame, sorbitol, microcrystalline cellulose, polyplasdone, mandarin-orange flavor, and magnesium stearate. VIDEX Buffered Powder for Oral Solution is supplied for oral administration in single- dose packets containing 100, 167, or 250 mg of didanosine. Packets of each product strength also contain a citrate-phosphate buffer (composed of dibasic sodium phosphate, sodium citrate, and citric acid) and sucrose.
    [Show full text]
  • Recommendations for the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Table of Contents Table 1
    Recommendations for the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection Table of Contents Table 1. Outline of the Guidelines Development Process..........................................................................................................................1 Table 2. Rating Scheme for Recommendations........................................................................................................................................3 Table 3. Sample Schedule for Clinical and Laboratory Monitoring of Children Before and After Initiation of Combination Antiretroviral Therapy .................................................................................................................4 Table 4. Primary FDA-Approved Assays for Monitoring Viral Load D-8 Table 5. HIV Infection Stage Based on Age-Specific CD4 Count or Percentage ........................................................................................4 Table 6. HIV-Related Symptoms and Conditions ......................................................................................................................................5 Table 7. Antiretroviral Regimens Recommended for Initial Therapy for HIV Infection in Children ...........................................................................................................................................................................................7 Table 8. Advantages and Disadvantages of Antiretroviral Components Recommended for Initial Therapy in Children ............................................................................................................................................................10
    [Show full text]
  • Fee-For-Service Preferred Drug List
    Prescription Drug Program Apple Health Medicaid: Fee-for-Service Preferred Drug List What is new in this version of the preferred drug list? Effective for dates of service on and after January 1, 2018, the Health Care Authority will make the following changes: Unless otherwise indicated in the drug class information, the authorization criteria is that the client must have tried and failed, or is intolerant to, at least two or more preferred drugs within the drug class unless contraindicated, not clinically appropriate, or only one drug is preferred. Drugs may have criteria that go beyond these basic criteria. Drug classes that are subject to the Therapeutic Interchange Program (TIP), are noted in the drug class information. For more information on TIP, see Theraputic Interchange Program in the Prescription Drug Program Medicaid Billing Guide. Drug Class Drug Name Change ACE Inhibitors Univasc Removed, no longer manufactured Galantamine Removed, no longer manufactured Alzheimer’s Drugs Aricept ODT Removed, no longer manufactured Exelon solution Removed, no longer manufactured Adrenaclick Non-Preferred, PA required Anaphylaxis Agents: Adrenalin Non-Preferred, PA required Epinephrine, Self Epinephrine Non-Preferred, PA required Injectable (new drug class) Epinephrine (Mylan only) Preferred Epipen 2-Pak/ JR 2-Pak Non-Preferred, PA required (Rev. 12/28/2017)(Eff. 1/1/2018) – 1 – Apple Health Medicaid PDL Prescription Drug Program Renamed drug class “Anticoagulants: Anticoagulants Entire class Factor XA and Thrombin Inhibitors.” Anticoagulants:
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 7,732,399 B2 Goldenberg Et Al
    US007732399B2 (12) United States Patent (10) Patent No.: US 7,732,399 B2 Goldenberg et al. (45) Date of Patent: *Jun. 8, 2010 (54) SUSTAINED RELEASE FORMULATIONS 2002fO151582 A1 10, 2002 Dou et al. 2003/O190307 A1* 10, 2003 DiBiase et al. ............. 424,856 (75) Inventors: Merrill S. Goldenberg, Thousand Oaks, 2004/0142048 A1 7/2004 Moore et al. CA (US); Jian Hua Gu, Thousand Oaks 2005/0180925 A1* 8/2005 Chaudry ...................... 424/46 CA (US s s 2005/0215470 A1 9/2005 Ng et al. FOREIGN PATENT DOCUMENTS (73) Assignee: Amgen Inc., Thousand Oaks, CA (US) GB 92.9405 A 6, 1963 (*) Notice: Subject to any disclaimer, the term of this GB 1234.805. A 6, 1971 patent is extended or adjusted under 35 W W 3. t E. U.S.C. 154(b) by 193 days. WO WO99,04764 2, 1999 This patent is Subject to a terminal dis- W W 995, 239, claimer. WO WO 2004/O12522 2, 2004 (21) Appl. No.: 11/847,984 OTHER PUBLICATIONS 1-1. Yan et al. Identification of histatins as tannin-binding proteins in (22) Filed: Aug. 30, 2007 human saliva. Biochemical Journal. 1995, vol. 311, pp. 341-347.* O O Charlton, A. J. et al., “Polyphenol/Peptide Binding and Precipita (65) Prior Publication Data tion.” J. Agric. Food Chem. 50, pp. 1593-1601 (2002); published by US 2007/0292506 A1 Dec. 20, 2007 Chasin,American M.. Chemical “Biodegradable Society. Polymers for Controlled Drug Deliv O O ery,” J.O. Hollinger Editor, Biomedical Applications of Synthetic Related U.S. Application Data Biodegradable Polymers CRC, Boca Raton, FL (1995), pp.
    [Show full text]
  • Minutes of PRAC Meeting on 09-12 July 2018
    6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018.
    [Show full text]
  • EVOTAZ (Atazanavir Or Cobicistat) to Pregnant Rats and Rabbits (See Data)
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Assess creatinine clearance (CLcr) before initiating treatment. Consider These highlights do not include all the information needed to use EVOTAZ alternative medications that do not require dosage adjustments in patients safely and effectively. See full prescribing information for EVOTAZ. with renal impairment. (5.3) • When cobicistat, a component of EVOTAZ, is used in combination with a EVOTAZ (atazanavir and cobicistat) tablet, for oral use tenofovir disoproxil fumarate (tenofovir DF)-containing regimen, cases of Initial U.S. Approval: 2015 acute renal failure and Fanconi syndrome have been reported. (5.4) • When used with tenofovir DF, assess urine glucose and urine protein at ---------------------------RECENT MAJOR CHANGES--------------------------­ baseline and monitor CLcr, urine glucose, and urine protein. Monitor serum Indications and Usage phosphorus in patients with or at risk for renal impairment. Coadministration Indications (1.1) 07/2020 with tenofovir DF is not recommended in patients with CLcr below 70 Dosage and Administration mL/min or in patients also receiving a nephrotoxic agent. (5.4) Laboratory Testing Prior to Initiation and During • Chronic kidney disease has been reported during postmarketing surveillance Treatment with EVOTAZ (2.1) 04/2020 in patients with HIV-1 infection treated with atazanavir, with or without Recommended Dosage (2.2) 07/2020 ritonavir. Consider alternatives in patients at high risk for renal disease or Not Recommended During Pregnancy (2.5) 04/2020 with preexisting renal disease. Monitor renal laboratory tests prior to therapy Contraindications (4) 04/2020 and during treatment with EVOTAZ. Consider discontinuation of EVOTAZ Warnings and Precautions in patients with progressive renal disease. (5.5) Immune Reconstitution Syndrome (5.11) 07/2020 • Nephrolithiasis and cholelithiasis have been reported.
    [Show full text]
  • Non-Anntoated Product Monograph
    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrTRIUMEQ dolutegravir, abacavir, and lamivudine tablets 50 mg dolutegravir (as dolutegravir sodium), 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine Antiretroviral Agent ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: January 31, 2020 Submission Control No: 233245 © 2020 ViiV Healthcare group of companies or its licensor Trademarks are owned by or licensed to the ViiV Healthcare group of companies Page 1 of 61 TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS............................................................................ 4 ADVERSE REACTIONS.......................................................................................... 11 DRUG INTERACTIONS .......................................................................................... 19 DOSAGE AND ADMINISTRATION ........................................................................ 24 OVERDOSAGE....................................................................................................... 26 ACTION AND CLINICAL PHARMACOLOGY........................................................
    [Show full text]