Injection, for Intravenous Use. Benlysta (Belimumab)
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BAFF-Neutralizing Interaction of Belimumab Related to Its Therapeutic Efficacy for Treating Systemic Lupus Erythematosus
ARTICLE DOI: 10.1038/s41467-018-03620-2 OPEN BAFF-neutralizing interaction of belimumab related to its therapeutic efficacy for treating systemic lupus erythematosus Woori Shin1, Hyun Tae Lee1, Heejin Lim1, Sang Hyung Lee1, Ji Young Son1, Jee Un Lee1, Ki-Young Yoo1, Seong Eon Ryu2, Jaejun Rhie1, Ju Yeon Lee1 & Yong-Seok Heo1 1234567890():,; BAFF, a member of the TNF superfamily, has been recognized as a good target for auto- immune diseases. Belimumab, an anti-BAFF monoclonal antibody, was approved by the FDA for use in treating systemic lupus erythematosus. However, the molecular basis of BAFF neutralization by belimumab remains unclear. Here our crystal structure of the BAFF–belimumab Fab complex shows the precise epitope and the BAFF-neutralizing mechanism of belimumab, and demonstrates that the therapeutic activity of belimumab involves not only antagonizing the BAFF–receptor interaction, but also disrupting the for- mation of the more active BAFF 60-mer to favor the induction of the less active BAFF trimer through interaction with the flap region of BAFF. In addition, the belimumab HCDR3 loop mimics the DxL(V/L) motif of BAFF receptors, thereby binding to BAFF in a similar manner as endogenous BAFF receptors. Our data thus provides insights for the design of new drugs targeting BAFF for the treatment of autoimmune diseases. 1 Department of Chemistry, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Republic of Korea. 2 Department of Bio Engineering, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. These authors contributed equally: Woori Shin, Hyun Tae Lee, Heejin Lim, Sang Hyung Lee. -
Using Rheology Measurement As a Potentially Predictive Tool for Solder Paste Transfer Efficiency and Print Volume Consistency
USING RHEOLOGY MEASUREMENT AS A POTENTIALLY PREDICTIVE TOOL FOR SOLDER PASTE TRANSFER EFFICIENCY AND PRINT VOLUME CONSISTENCY Mitch Holtzer, Karen Tellefsen and Westin Bent Alpha Assembly Solutions South Plainfield, NJ, USA [email protected] ABSTRACT Commercially available solder pastes use an upper and Industry standards such as J-STD-005 and JIS Z 3284-1994 lower limit for viscosity. Generally, this viscosity is call for the use of viscosity measurement(s) as a quality measured at one shear rate, typically the shear associated assurance test method for solder paste. Almost all solder with a spiral viscometer rotating at 10 revolutions per paste produced and sold use a viscosity range at a single minute (RPM). If the powder contained in solder paste is shear rate as part of the pass fail criteria for shipment and dissolved by the acid activator in the solder paste flux, the customer acceptance respectively. viscosity of the solder paste will quickly increase. If the viscosity increases more than 20 to 30% above the upper As had been reported many times, an estimated 80% of the limit of the specification, poor printing results will be highly defects associated with the surface mount technology likely. The solder paste will not roll evenly over the stencil process involve defects created during the printing process. and apertures in the stencil will remain unfilled, causing Viscosity at a single shear rate could predict a fatal flaw in skips in the paste printing pattern. the printability of a solder paste sample. However, false positive single shear rate viscosity readings are not The purpose of the study was to determine if there is a unknown. -
Differentiating Between Anxiety, Syncope & Anaphylaxis
Differentiating between anxiety, syncope & anaphylaxis Dr. Réka Gustafson Medical Health Officer Vancouver Coastal Health Introduction Anaphylaxis is a rare but much feared side-effect of vaccination. Most vaccine providers will never see a case of true anaphylaxis due to vaccination, but need to be prepared to diagnose and respond to this medical emergency. Since anaphylaxis is so rare, most of us rely on guidelines to assist us in assessment and response. Due to the highly variable presentation, and absence of clinical trials, guidelines are by necessity often vague and very conservative. Guidelines are no substitute for good clinical judgment. Anaphylaxis Guidelines • “Anaphylaxis is a potentially life-threatening IgE mediated allergic reaction” – How many people die or have died from anaphylaxis after immunization? Can we predict who is likely to die from anaphylaxis? • “Anaphylaxis is one of the rarer events reported in the post-marketing surveillance” – How rare? Will I or my colleagues ever see a case? • “Changes develop over several minutes” – What is “several”? 1, 2, 10, 20 minutes? • “Even when there are mild symptoms initially, there is a potential for progression to a severe and even irreversible outcome” – Do I park my clinical judgment at the door? What do I look for in my clinical assessment? • “Fatalities during anaphylaxis usually result from delayed administration of epinephrine and from severe cardiac and respiratory complications. “ – What is delayed? How much time do I have? What is anaphylaxis? •an acute, potentially -
Ocrevus (Ocrelizumab) Policy Number: C11250-A
Prior Authorization Criteria Ocrevus (ocrelizumab) Policy Number: C11250-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 8/1/2017 2/17/2021 4/26/2022 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION J2350-injection,ocrelizumab, Q2 2021 RxPA 1mg 20200428C11250-A PRODUCTS AFFECTED: Ocrevus (ocrelizumab) DRUG CLASS: Multiple Sclerosis Agents - Monoclonal Antibodies ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and the IV infusion products administered in a place of service that is a non-hospital facility-based location (i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) AVAILABLE DOSAGE FORMS: Ocrevus SOLN 300MG/10ML FDA-APPROVED USES: Indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. RELAPSING FORMS OF MULTIPLE SCLEROSIS: 1. Documentation of a definitive diagnosis of a relapsing form of multiple sclerosis as defined by the McDonald criteria (see Appendix), including: Relapsing- remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive- relapsing multiple sclerosis [PRMS] or First clinical episode with MRI features consistent with multiple sclerosis Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. -
Intravenous Therapy Procedure Manual
INTRAVENOUS THERAPY PROCEDURE MANUAL - 1 - LETTER OF ACCEPTANCE __________________________________________ hereby approves (Facility) the attached Reference Manual as of _____________________. (Date) The Intravenous Therapy Procedure Manual will be reviewed at least annually or more often when deemed appropriate. Revisions will be reviewed as they occur. Current copies of the Intravenous Therapy Procedure Manual shall be maintained at each appropriate nursing station. I have reviewed this manual and agree to its approval. __________________________ (Administrator) __________________________ (Director of Nursing) __________________________ (Medical Director) - 2 - TABLE OF CONTENTS TABLE OF CONTENTS INTRODUCTION A. Purpose 1 B. Local Standard of Practice 1 RESPONSIBILITIES A. Responsibilities: M Chest Pharmacy 1 B. Responsibilities: Administrator 1 C. Responsibilities: Director of Nursing Services (DON/DNS) 1 D. Skills Validation 2 AMENDMENTS GUIDELINES A. Resident Candidacy for IV Therapy 1 B. Excluded IV Medications and Therapies 1 C. Processing the IV Order 1 D. IV Solutions/Medications: Storage 2 E. IV Solutions/Medications: Handling 3 F. IV Solutions and Supplies: Destroying and Returning 4 G. IV Tubing 5 H. Peripheral IV Catheters and Needles 6 I. Central Venous Devices 7 J. Documentation and Monitoring 8 K. IV Medication Administration Times 9 L. Emergency IV Supplies 10 I TABLE OF CONTENTS PROTOCOLS A. IV Antibiotic 1 1. Purpose 2. Guidelines 3. Nursing Responsibilities B. IV Push 2 1. Purpose 2. Guidelines C. Anaphylaxis Allergic Reaction 4 1. Purpose 2. Guidelines 3. Nursing Responsibilities and Interventions 4. Signs and Symptoms of Anaphylaxis 5. Drugs Used to Treat Anaphylaxis 6. Physician Protocol PRACTICE GUIDELINES A. Purpose 1 B. Personnel 1 C. Competencies 1 D. -
Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0). -
Curriculum Vitae: Daniel J
CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR) -
Migraine Specialty Care Program Tm
MIGRAINE SPECIALTY CARE PROGRAM TM Phone: 833-796-6470 • Fax: 844-841-3401 Community Led Specialty Pharmacy Care 1 PATIENT INFORMATION: 2 PRESCRIBER INFORMATION: Name: ___________________________________________________ Name: ___________________________________________________ Address: _________________________________________________ Address: _________________________________________________ City: _________________________ State: ____ Zip: ____________ City: _________________________ State: ____ Zip: ____________ Phone: ___________________ Alt. Phone: ____________________ Phone: _____________________ Fax: _______________________ Email: ____________________________________________________ NPI: ________________________ DEA: _______________________ DOB: ___________ Gender: M F Caregiver: _____________ Tax I.D.: __________________________________________________ Height: ________ Weight: ________ Allergies: ________________ Office Contact: __________________ Phone: __________________ 3 STATEMENT OF MEDICAL NECESSITY: (Please Attach All Medical Documentation) Prior Failed Indicate Drug Name v10.0_060821 Length of Symptoms: ___________________________ ICD-10: _________________________ Treatments: and Length of Treatment: Other diagnosis _______________ Number of Migraine Days per month: ________________ Preventative: Headache Days per month: _________________ Migraine Hours per day: __________________ ACE-I/ARBs ___________________ Patient has been evaluated and does not have medication overuse headache? No Yes Antiepileptics ___________________ -
Orally Inhaled & Nasal Drug Products
ORALLY INHALED & NASAL DRUG PRODUCTS: INNOVATIONS FROM MAJOR DELIVERY SYSTEM DEVELOPERS www.ondrugdelivery.com 00349_GF_OnDrugDelivery349_GF_OnDrugDelivery PulmonaryPulmonary NasalNasal NovemberNovember 2010.indd2010.indd 1 330/11/100/11/10 111:32:331:32:33 “Orally Inhaled & Nasal Drug Products: Innovations from Major Delivery CONTENTS System Developers” This edition is one in the ONdrugDelivery series of pub- Innovation in Drug Delivery by Inhalation lications from Frederick Furness Publishing. Each issue focuses on a specific topic within the field of drug deliv- Andrea Leone-Bay, Vice-President, Pharmaceutical ery, and is supported by industry leaders in that field. Development, Dr Robert Baughman, Vice-President, Clinical Pharmacology & Bioanalytics, Mr Chad EDITORIAL CALENDAR 2011: Smutney, Senior Director, Device Technology, February: Prefilled Syringes Mr Joseph Kocinsky, Senior Vice-President, March: Oral Drug Delivery & Advanced Excipients Pharmaceutical Technology Development April: Pulmonary & Nasal Drug Delivery (OINDP) MannKind Corporation 4-7 May: Injectable Drug Delivery (Devices Focus) June: Injectable Drug Delivery (Formulations Focus) Current Innovations in Dry Powder Inhalers September: Prefilled Syringes Richard Sitz, Technical Manager, DPI Technology October: Oral Drug Delivery Platform Leader November: Pulmonary & Nasal Drug Delivery (OINDP) 3M Drug Delivery Systems 10-12 December: Delivering Biologics (Proteins, Peptides & Nucleotides) Pulmonary Delivery & Dry-Powder Inhalers: SUBSCRIPTIONS: Advances in Hard-Capsule -
An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: a Review
Muthadi Radhika Reddy /J. Pharm. Sci. & Res. Vol. 12(7), 2020, 925-940 An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: A Review Muthadi Radhika Reddy1* 1School of pharmacy, Gurunanak Institute of Technical Campus, Hyderabad, Telangana, India and Department of Pharmacy, Gandhi Institute of Technology and Management University, Vizag, Andhra Pradesh, India INTRODUCTION 2. Useful in situations where rapid onset of action Fast dissolving drug delivery systems were first developed required such as in motion sickness, allergic attack, in the late 1970s as an alternative to conventional dosage coughing or asthma forms. These systems consist of solid dosage forms that 3. Has wide range of applications in pharmaceuticals, Rx disintegrate and dissolve quickly in the oral cavity without Prescriptions and OTC medications for treating pain, the need of water [1]. Fast dissolving drug delivery cough/cold, gastro-esophageal reflux disease,erectile systems include orally disintegrating tablets (ODTs) and dysfunction, sleep disorders, dietary supplements, etc oral thin films (OTFs). The Centre for Drug Evaluation [4] and Research (CDER) defines ODTs as,“a solid dosage 4. No water is required for the administration and hence form containing medicinal substances which disintegrates suitable during travelling rapidly, usually within a matter of seconds, when placed 5. Some drugs are absorbed from the mouth, pharynx upon the tongue” [2]. USFDA defines OTFs as, “a thin, and esophagus as the saliva passes down into the flexible, non-friable polymeric film strip containing one or stomach, enhancing bioavailability of drugs more dispersed active pharmaceutical ingredients which is 6. May offer improved bioavailability for poorly water intended to be placed on the tongue for rapid soluble drugs by offering large surface area as it disintegration or dissolution in the saliva prior to disintegrates and dissolves rapidly swallowing for delivery into the gastrointestinal tract” [3]. -
Attachment 3
CURRICULUM CLINICAL BASE / CA-1 / CA-2 / CA-3 ANESTHESIOLOGY RESIDENCY PROGRAM GOALS AND OBJECTIVES AND CORE COMPETENCIES Department of Anesthesiology University of Missouri at Kansas City School of Medicine Saint Luke’s Hospital Truman Medical Center Children’s Mercy Hospital Revised 2011 Table of Contents Pages Introduction – Statement of Curriculum ................................................................................................................... 3 I. Rendering Patient Insensible to Pain ............................................................................................................. 4-10 II. Support of Life Functions ............................................................................................................................. 11-16 III. Clinical Base Year A. Cardiology ................................................................................................................................................. 17-32 B. Emergency Medicine ................................................................................................................................. 33-44 C. General Medicine ....................................................................................................................................... 45-49 D. Infectious Disease ...................................................................................................................................... 50-59 E. Nephrology .............................................................................................................................................. -
DDT Cover/Back April 2006.Qx
March 2007 Vol 7 No 3 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH DPT’S PRESIDENT MR. PAUL JOHNSON In Situ Gel Systems 30 Mitan Gokulgandhi, BPharm Dharmesh M. Modi, MPharm COX-II Microspheres 38 Lakshmi Sivasubramanian Madhumathi Seshadri Undermining CEO’s 82 John A. Bermingham FEATURING Parkinson’s Disease 59 Steven Damon Yogi R. Patel The science & business of specialty pharma, biotechnology, and drug delivery Specialty Pharma Indices 64 Dr. Barath Christopher Avani Amin, Josef Bossart, PhD Shankar Robinson, PhD Drug Delivery’s PhD Current Status of Clinical Trials Increasing New Ways to Non-Invasive In Asia 68 Importance to Partner With Insulin Delivery Ames Gross, MBA Big Pharma & the Federal Technologies Specialty Pharma Government Momoko Hirose March 2007 Vol 7 No 3 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren