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The Clinical Insight The Clinical InSight March 2018 800.361.4542 | envisionrx.com Recent FDA Approvals New Medications Trade Name Dosage Form Manufacturer Indication(s) Approval Date (generic name) Strength For use in combination with other antiretroviral(s) for the treatment of human immunodeficiency virus type 1 Trogarzo TaiMed Biologics Injection, (HIV-1) infection in heavily March 3, 2018 (ibalizumab-uiyk) USA 150 mg/mL treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. For the treatment of adults Ilumya with moderate-to-severe Merck Sharp & Injection, (tildrakizumab- plaque psoriasis who are March 20, 2018 Dohme 100 mg/mL asmn) candidates for systemic therapy or phototherapy. New Combinations and Formulations Trade Name Dosage Form Manufacturer Indication(s) Approval Date (generic name) Strength For use as a complete Symfi regimen for the treatment of (efavirenz; Tablet, human immunodeficiency lamivudine; Mylan Specialty 600 mg; 300 mg; virus type 1 (HIV-1) infection March 22, 2018 tenofovir L.P. 300 mg in adult and pediatric disoproxil patients weighing at least 40 fumarate) kg. New Generics Generic Name Trade Name Dosage Form Manufacturer(s) Approval Date Cinacalcet Cipla Ltd.; Aurobindo Sensipar Tablets March 8, 2018 Hydrochloride Pharma Limited Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 2 form or medium, without EnvisionRxOptions’ prior written consent. Pipeline New Medication Pipeline Anticipated Mechanism of Drug Name Generic Name Route Indication(s) Approval Action Date Jatenzo Testosterone Oral Androgens Hypogonadism 1Q 2018 Undecanoate Ryplazim Plasminogen Intravenous Enzyme Hypoplasminogenemia 04/14/2018 replacement therapy KRN23 Burosumab Subcutaneous Fibroblast growth Familial 04/17/2018 factor inhibitor hypophosphatemia Tavalisse Fostamatinib Oral Syk kinase inhibitor Immune 04/17/2018 thrombocytopenic purpura AndexXa Andexanet Alfa Intravenous Antidote for oral Reversal of 05/04/2018 anticoagulants anticoagulation by FXa inhibitors Plenvu Polyethylene Oral Osmotic laxative Bowel cleansing 05/13/2018 Glycol Aimovig Erenumab Subcutaneous Calcitonin gene- Migraine 05/17/2018 related peptide (CGRP) inhibitor Avatrombopag Avatrombopag Oral Thrombopoietin Thrombocytopenia 05/21/2018 Receptor Agonists Methylene Methylene Blue Oral Imaging For diagnostic imaging 05/21/2018 Blue MMX of colorectal cancers BMN 165 Pegvaliase Subcutaneous Enzyme Phenylketonuria 05/25/2018 replacement therapy Yuvvexy Estradiol Other Estrogens Vaginal atrophy 05/29/2018 Evosyal Botulinum Toxin Injectable Neurotoxins Glabellar frown lines 05/2018 (Branded Type A Competitor of Botox (cosmetic), Xeomin, Dysport) KW-0761 Mogamulizumab Intravenous Anti-CCR4 antibody Cutaneous T-cell 06/04/2018 lymphoma Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 3 form or medium, without EnvisionRxOptions’ prior written consent. Anticipated Mechanism of Drug Name Generic Name Route Indication(s) Approval Action Date Epidiolex Epidiolex Oral Cannabinoid Dravet syndrome; 06/27/2018 Lennox-Gastaut syndrome; Infantile spasms; Epilepsy Aripiprazole Aripiprazole Intramuscular Atypical Schizophrenia 06/30/2018 Lauroxil Lauroxil antipsychotic NanoCrystal Dispersion Binimetinib Binimetinib Oral MEK inhibitor BRAF-mutant 06/30/2018 melanoma LGX818 Encorafenib Oral B-RAF kinase BRAF-mutant 06/30/2018 inhibitor melanoma TEV-48125 Fremanezumab Subcutaneous Calcitonin gene- Migraine 06/2018 related peptide (CGRP) inhibitor Alicaforsen Alicaforsen Rectal Antisense Pouchitis 2Q 2018 oligonucleotide Elagolix Elagolix Oral Luteinizing Endometriosis 2Q 2018 hormone releasing hormone (LHRH) antagonist Lofexidine Lofexidine Oral Alpha adrenergic Symptoms associated 2Q 2018 agonist with acute opioid withdrawal Olumiant Baricitinib Oral Janus Kinase (JAK) Rheumatoid arthritis 2Q 2018 inhibitor IONIS-TTRRx Inotersen Subcutaneous Protein synthesis Familial amyloid 07/06/2018 inhibitor polyneuropathy Azedra Ultratrace Injectable Electron transport Neuroendocrine 07/30/2018 Iobenguane I- inhibitor tumors 131 Tpoxx Tecovirimat Oral Orthopoxvirus Smallpox 08/08/2018 Intravenous egress inhibitor ALN-TTR02 Patisiran Intravenous Antisense Familial amyloid 08/11/2018 oligonucleotide polyneuropathy Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 4 form or medium, without EnvisionRxOptions’ prior written consent. Anticipated Mechanism of Drug Name Generic Name Route Indication(s) Approval Action Date AG-120 Ivosidenib Oral Isocitrate Acute myeloid 08/21/2018 dehydrogenase 1 leukemia (IDH1) inhibitor Stannsoporfin Stannsoporfin Intramuscular Heme oxygenase Hyperbilirubinemia 08/22/2018 inhibitors S-888711 Lusutrombopag Oral Thrombopoietin Thrombocytopenia 08/26/2018 Receptor Agonists SHP643 Lanadelumab Subcutaneous Plasma kallikrein Prophylaxis in 08/26/2018 inhibitor hereditary angioedema Volanesorsen Volanesorsen Subcutaneous Antisense Familial 08/30/2018 apolipoprotein chylomicronemia inhibitor syndrome PF-06463922 Lorlatinib Oral Tyrosine kinase Non-small cell lung 08/2018 inhibitor cancer Tafenoquine Tafenoquine Oral Antimalarials Prophylaxis; treatment 08/2018; of malaria 4Q 2018 BAY 94-9027 Coagulation Intravenous Coagulation factor Hemophilia A 3Q 2018 Factor VIII VIII (recombinant) IDP-118 Halobetasol Topical Corticosteroid Moderate to severe 3Q 2018 Propionate; Retinoids chronic plaque Tazarotene psoriasis Symtuza Darunavir; Oral Protease inhibitor; HIV-1 infection 3Q 2018 Cobicistat; Nucleoside Emtricitabine; analogue reverse Tenofovir transcriptase Alafenamide inhibitor; Pharmacokinetic enhancer Baremsis Amisulpride Intravenous Atypical Postoperative nausea 10/05/2018 antipsychotic and vomiting Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 5 form or medium, without EnvisionRxOptions’ prior written consent. Anticipated Mechanism of Drug Name Generic Name Route Indication(s) Approval Action Date DOR/3TC/TDF Doravirine; Oral Nucleoside HIV-1 infection 10/23/2018 Lamivudine; analogue reverse Tenofovir transcriptase Disoproxil inhibitor; Non- Fumarate nucleoside reverse transcriptase inhibitor MK-1439 Doravirine Oral Non-nucleoside HIV infection 10/23/2018 reverse transcriptase inhibitor LY2951742 Galcanezumab Subcutaneous Calcitonin gene- Migraine 10/2018 related peptide (CGRP) inhibitor TD-4208 Revefenacin Inhaled Long-acting Chronic obstructive 11/13/2018 muscarinic pulmonary disease antagonist Olinvo Oliceridine Intravenous Opioid agonist Acute pain 12/02/2018 JZP-110 Solriamfetol Oral CNS stimulant Narcolepsy; Daytime 12/20/2018 sleepiness in obstructive sleep apnea Resolor Prucalopride Oral 5-HT4 serotonin Chronic idiopathic 12/21/2018 receptor agonist constipation Calaspargase Calaspargase Intravenous Antineoplastic Acute lymphocytic 12/22/2018 pegol Pegol enzymes leukemia CL-108 Acetaminophen; Oral COX inhibitor; H1 Symptoms associated 4Q 2018 Hydrocodone; histamine receptor with acute opioid Promethazine antagonist; Opioid withdrawal agonist Galafold Migalastat Oral Chemical Fabry disease 4Q 2018 chaperone LOXO-101 Larotrectinib Oral Tropomyosin Solid tumors 4Q 2018 receptor kinases (TRK) inhibitor Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 6 form or medium, without EnvisionRxOptions’ prior written consent. Anticipated Mechanism of Drug Name Generic Name Route Indication(s) Approval Action Date VivaGel BV Astodrimer Intravaginal Anti-infective Bacterial vaginosis 4Q 2018 Sodium Seysara Sarecycline Oral Tetracycline Acne vulgaris 2H 2018 antibiotic ALKS 5461 Buprenorphine; Oral Opioid antagonist; Major depressive 1Q 2019 Samidorphan Opioid partial disorder agonist Arikayce Liposomal Inhaled Aminoglycoside Nontuberculous 1Q 2019 amikacin antibiotic mycobacteria lung infections Eravacycline Eravacycline Oral Fluorocycline Complicated intra- 1Q 2019 Intravenous antibiotic abdominal infections Firdapse Amifampridine Oral Potassium Channel Lambert-Eaton 1Q 2019 Phosphate Inhibitor myasthenic syndrome N8-GP Coagulation Intravenous Coagulation factor Hemophilia A 1Q 2019 Factor VIII VIII (recombinant) (Recombinant) PTK 0796 Omadacycline Oral Aminomethylcycline Acute Bacterial Skin 1Q 2019 Intravenous antibiotic and Skin Structure Infections; Community-acquired bacterial pneumonia Rekynda Bremelanotide Injectable Peptide Female sexual 1Q 2019 melanocortin dysfunction receptor agonist Zemcolo Rifamycin-SV Oral Rifamycin Diarrhea caused by 1Q 2019 antibacterial certain organisms Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any 800.361.4542 | envisionrx.com 7 form or medium, without EnvisionRxOptions’ prior written consent. 2018 New Generic Pipeline Anticipated Brand 2016 U.S. Brand Name Generic Name Indication(s) Launch Date Manufacturer(s) Sales 1Q 2018 ISTODAX Romidepsin Celgene Non-Hodgkin's $65M Lymphoma (2015) 04/08/2018 NUVARING Ethinyl Estradiol; Organon; Merck & Contraception $773M Etonogestrel Co 05/18/2018 INVEGA Paliperidone Janssen Schizophrenia $256M TRINZA Palmitate 05/22/2018 ADCIRCA
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  • Addiction Pharmacy
    Presented by the Student College of Clinical Pharmacy — UGA College of Pharmacy, a student chapter of ACCP Clinical Pharmacist Spotlight: Addiction Pharmacy What is the role of a pharmacist in addiction pharmacy? Addiction Pharmacy is the study of three separate distinct, but closely connected areas of pharmacotherapy in a patient that is diagnosed with an addictive disease and the co-occurring disease states of mental illness and/or acute/chronic pain. This patient is particularly difficult to manage due to the vast complexities of the multiple disease states and needs continual evaluation of pharmacotherapies and other treatment modalities (psychotherapy, pain management, etc.). What types of things do you do at your practice site? I encounter a variety of disease states in this clinic so I provide evaluation, assessment, intervention and treatment strategies to the patient’s treatment team for the following: Substance Use Disorders (Chemical and Behavioral) - ambulatory detoxification of alcohol Dr. Merrill Norton, and withdrawal, benzodiazepine withdrawal, and opioid withdrawal; PharmD, PhD, ICCDP-D Anxiety (assessment and screening); Bipolar Disorder (assessment and screening); Depression (assessment and screening) Inside this issue: Tobacco Use Disorder (interventions and pharmacotherapy); Acute/chronic pain (assessment and follow-up); Clinical Pharmacist 1 I also provide ongoing drug information lectures on the neurobiology and Spotlight pharmacogenomics of addiction, and the appropriate use of medications in recovery to patients and their families. Other disease states that are commonly encountered are Levaquin ADR 2 metabolic syndrome, insomnia, liver disease, and GERD. Update New Rheumatoid What do you think should change in the field of addiction pharmacy? 2 Arthritis Treatment Simply to educate all pharmacists to the basics of addiction pharmacy.
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