Outline. References. Marshall,1

Similar documents
Multiple Sclerosis Agents Drug Class Prior Authorization Protocol

Clinical Policy: Multiple Sclerosis Reference Number: CP.CPA.206 Effective Date: Last Review Date: Line of Business: Commercial

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

The Cost-Effectiveness of Treatment Options for Relapsing-Remitting and Primary Progressive Multiple Sclerosis: Modeling Analysis Plan

LEMTRADA (ALEMTUZUMAB)

A Multiple Treatment Comparison of Eleven Disease- Modifying Drugs Used for Multiple Sclerosis

There are currently 4 US Food and Drug

National MS Society Information Sourcebook

Form 2043 R3.0: Multiple Sclerosis Pre-HSCT data

Tysedmus, a Registry of Multiple Sclerosis patients exposed to Natalizumab

Timing is Everything: The Importance of Early Intervention in Multiple Sclerosis

Clinical Utility of Glatiramer Acetate in the Management of Relapse Frequency in Multiple Sclerosis

Emerging Therapies for the Management of Multiple Sclerosis

The Latest Innovations in the Drug Pipeline for Multiple Sclerosis

MEDICATION GUIDE RIBAVIRIN TABLETS Rx Only Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication

As the disease progresses, patients may experience suboptimal response to their current therapy, necessitating a treatment switch.

Current and Emerging Therapies in Multiple Sclerosis: A Systematic Review

Advances in Immunomodulatory Therapy for Multiple Sclerosis

AVONEX (Interferon beta-1a) IM Injection DESCRIPTION

AVONEX. What is in this Leaflet. What AVONEX is used for. Before you use AVONEX. Interferon beta-1a. Consumer Medicine Information

Injection Guide for Treatment with the AVONEX Prefilled Syringe

Injection Guide for Treatment with the AVONEX PEN

Dirucotide (MBP8298) for the treatment of multiple sclerosis

Document number (version): RMP.NUS (3.0) Page 63 of 95

Credit Suisse 7 th Annual European Large Cap Pharmaceutical Conference. November 6, 2007

Guideline on similar biological medicinal products containing interferon beta

Patient Case and Question

A BS TR AC T. n engl j med 367;12 nejm.org september 20,

Dimethyl Fumarate and Peginterferon β-1a: New Insights Into the Pivotal Trials

Heparin Induced Thrombocytopenia. Heparin Induced Thrombocytopenia. Heparin Induced Thrombocytopenia. Temporal Aspects.

Treatment: Nutrition and Medication

ACTELION TRANSFORMATION ON THE WAY. Jean-Paul Clozel Chief Executive Officer. Copyright 2016 Actelion Pharmaceuticals Ltd

Material Safety data sheet

Sovaldi Pegasys Ribavirin

Clinical Policy: Eculizumab (Soliris) Reference Number: ERX.SPMN.225

Ebola Facts. October 14, 2014

Mapi Pharma Value-Added High-Barrier to Entry Pharmaceuticals Q4 2014

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph. PART III: CONSUMER INFORMATION

Clinical Policy: Octreotide Acetate (Sandostatin Injection, Sandostatin LAR Depot) Reference Number: CP.PHAR.40

Emerging Medical Therapies in Inflammatory Bowel Disease

PHYSICIAN OFFICE BILLING INFORMATION SHEET FOR IMLYGIC (talimogene laherparepvec)

The Economics of New Drug Development: Costs, Risks, and Returns

WHAT S IN A NAME? The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation

Adherence to glatiramer acetate treatment for multiple sclerosis: the Brazilian experience

FDA Just Approved Some Highly Anticipated Specialty Drugs; Payers Must Prepare Now

BETRIXABAN TO PREVENT PE, DVT, STROKE: MEDICALLY ILL PATIENTS Samuel Z. Goldhaber, MD Director, Thrombosis Research Group Section Head, Vascular

Biomarkers: Physiological & Laboratory Markers of Drug Effect

What do you do, with an M protein?

B Lymphocytes In The Brains Of Multiple Sclerosis Patients Mature In Peripheral Lymph Nodes

Understanding the roots of `electrical pollution`

Specialty Drug Spending

9/7/17. Implementing the ARK Immunoassay for Therapeutic Drug Monitoring of High-Dose Methotrexate. Disclosure. Learning Objectives

Technology Overview. 1. Background of Technology. (1) Regulatory Status

TITLE OF PRESENTATION SECOND QUARTER 2014 FINANCIAL RESULTS & BUSINESS UPDATE

Peter A. McCroskery, M.D., M.S.

A Phase I/IIa Study of Human Anti-CD38 Antibody MOR03087 in Relapsed/Refractory Multiple Myeloma

Professor Ahmed H Al-jedai, PharmD, MBA, BCPS, FCCP, FAST, Saudi Arabia

Penicillin. Introduction:

Guidelines for the Medical Clearance of Designated Ebola Caregivers in US Hospitals

Safety Data Sheet European Format

Journal of Interferon & Cytokine Research The Official Publication of the International Society for Interferon and Cytokine Research

Biogen Idec Synergy Creation in the move to the Big League. Activities, Assets and Sales Figures

Clinical Trials in Multiple Sclerosis 2007: Planned, In Progress, Recently Completed

NEW ZEALAND DATA SHEET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Doctor of Pharmacy Course Descriptions

Developing Therapeutics for the Treatment of Multiple Sclerosis

UNIT PRICING INFORMATION 1

Daniel Harari 1, *, Irit Orr 2, Ron Rotkopf 2, Sergio E. Baranzini 3 and Gideon Schreiber 1, * Abstract. Introduction ORIGINAL ARTICLE

Investigator Guide Reporting of Unanticipated Problems to the IRB

Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER

Introduction to Pharmacogenetics Competency

ANAPROX(R) Tablets (550 mg)

Medical History Questionnaire

Elevated Immunoglobulins and Paraproteins

and What Can Be Done About It

FREQUENTLY ASKED QUESTIONS

Communicating Emerging Drug Therapies Prior to FDA Approval. May 4, 2017

Package leaflet: Information for the user. HUMAN ALBUMIN BAXALTA 200 g/l Solution for Infusion. Human albumin

Treatment strategies for relapsing and refractory myeloma

BIOLOGIC MEDICATIONS IN THE TREATMENT OF IBD. crohnsandcolitis.ca

Regulatory hurdles and opportunities

HIGHLIGHTS OF PRESCRIBING INFORMATION REMICADE

MATERIAL SAFETY DATA SHEET

Brincidofovir (CMX001) is Well Tolerated in Highly Immunocompromised Pediatric Patients

NEUTRALIZING ANTIBODY TESTS FOR INTERFERON

MSDS for Dry Charged Motorcycle Batteries

KLONOPIN(R) Tablets (2 mg)

Antisense Therapeutics Ltd ASX:ANP January 2017

REFCTRI/2010/ CTRI Website URL -

Anti- THrombosis with Enoxaparin in intubated Adolescents

Denosumab for the prevention of skeletal related events in patients with multiple myeloma first line

RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLATIRAMER ACETATE FOR INJECTION IN PHARMACEUTICAL DOSAGE FORMS

RITUXAN(R) Vials (100 mg/10 ml)

The quality of reports of randomized trials in multiple sclerosis: a review

The New News in Stem Cell Research Andrés Bratt-Leal, PhD 12/1/2017

Dr Guy Pratt Consultant Haematologist, Heart of England NHS Foundation Trust. Natural course of myeloma. Some definitions. First relapse.

Transcription:

Outline Multiple Sclerosis: More Than Your ABC s Janene L. Marshall, PharmD, BCPS Clinical Associate Professor Internal Medicine Clinical Pharmacist Chicago State University College of Pharmacy J-marshall@csu.edu 1. Epidemiology of 2. Etiology 3. Pathophysiology 4. Signs and Symptoms 5. Diagnosis 6. Subtypes a. Primary Progressive b. Remitting c. Secondary Progressive d. Progressive relapsing 7. Treatment a. Exacerbation Treatment b. Disease Modifying Therapy 8. Related Illnesses 9. CAM 10. Pharmacist and Technician Role 11. Resources References 1. Olek, Michael J. Clinically isolated syndromes suggestive of multiple sclerosis. UpToDate. Accessed: October 2015. 2. Marshall JL. Multiple Sclerosis Treatment Update: Current and Emerging Therapies. 2013. Power Pak CE. 3. Comer G, et al. Phase III dose-comparison study of glatiramer acetate for multiple sclerosis. Ann Neurol.2011;69(1):75-82. 4. Gold R, et al. Placebo-Controlled Phase 3 Study of Oral BG-12 for Multiple Sclerosis. N Engl J Med 2012;367:1098-107. 5. Fox, et al. Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis. N Engl J Med 2012;367:1087-97. 6. Habibi, et al. Management of multiple sclerosis and the integration of related specialty pharmacy programs within health systems. AJHP. 2016;73:811-19. 7. Ayzenberg, et al. Fingolimod for multiple sclerosis and emerging indications: appropriate patient selection safety precautions, and special considerations. Ther Clin Risk Manag. 2016;12:261-272. Marshall,1

FDA approved Pharmacotherapy Table Generic Name Brand Name Indication Treatment Common Adverse Effects Dose Interferon beta-1a Avonex Rebif Peginterferon beta- 1a Interferon beta-1b Glatitramer (Glatopa), Dimethyl fumerate (BG-12) CIS 30mcg IM q week 44mcg SQ three times weekly Plegridy RR 125mg q 2 weeks Betaseron Extavia CIS 0.25mg SQ every other day Copaxone CIS, RR 20mg SQ daily 40mg SQ TIW Tecfidera 240 mg PO twice daily injection site reactions (SQ>IM), depression, liver abnormality, leukopenia injection site reactions, depression, liver abnormality, leukopenia injection site reactions, depression, liver abnormality, leukopenia Injection site reaction, transient immediate post injection reaction Flushing, GI side effects Terifluonmide Aubagio Alemtuzumab Lemtrada B-cell chronic lymphocytic leukemia, Fingolimod Gilenya 7 or 14mg PO daily 12 mg IV daily for 5 consecutive days, followed 12 months later by 12 mg daily for 3 consecutive days 0.5mg PO daily Daclizumab Zinbryta RR 150mg SQ monthly Hair loss/thinning, liver abnormality, *liver toxicity, GI side effects, infection, pregnancy category X Headache, fatigue, urticarial, UTI, candidiasis, arthralgia, URI, fever, thyroid disease Headache, diarrhea, influenza, back pain, liver abnormality, macular edema, *decreased HR and BP with first dose *severe liver injury, lymphadenopathy, skin reactions, nasopharyngitis, URI, depression Marshall,2

Natalizumab Tysabri Mitoxantrone Novantrone SP, worsening forms of relapsing Abbreviations: *Black box warning 300mg IV q4weeks 12mg/m 2 IV over 5-15 minutes q 3 months Lifetime maximum: 140mg/m 2 *PML, suppression of immune system, infections Blue-green urine for 24 hours, nausea, menstrual disorders, *cardiotoxicity, *liver toxicity, leukopenia, leukemia, infections CIS- Clinically Isolated Syndrome, PML Progressive multifocal leukoencephalopathy, SP- secondary progressive, RRrelapsing remitting Marshall,3

National Society Resources Avonex Rebif Copaxone http://www.nationalmssociety.org/multimedia-library/index.aspx Knowledge is Power (KIP) ActiveSource avonex.com msactivesource.com 800-456-2255 LifeLinesTM rebif.com mslifelines.com 877-447-3243 Shared Solutions sharedsolutions.com 800-887-8100 Plegridy/Tecfidera ABOVE 800-456-2255 Betaseron/Extavia betaseron.com 800-788-1467 extavia.com Extavia Go Program 866-398-2842 Novantrone Tysabari 888-275-7376 tysabri.com 800-456-2255 Marshall,4

Gilenya gilenya.com Go Program 800-445-3692 Aubagio one to one, www.aubagio.com/ms-one-to-one 1-855-One2One Marshall,5