PMID- 32664913 OWN - NLM STAT- MEDLINE DCOM- 20210428 LR - 20221216 IS - 1471-2466 (Electronic) IS - 1471-2466 (Linking) VI - 20 IP - 1 DP - 2020 Jul 14 TI - Expert consensus on the management of adverse events and prescribing practices associated with the treatment of patients taking pirfenidone for idiopathic pulmonary fibrosis: a Delphi consensus study. PG - 191 LID - 10.1186/s12890-020-01209-4 [doi] LID - 191 AB - BACKGROUND: In patients with idiopathic pulmonary fibrosis (IPF) treated with pirfenidone (Esbriet(R), Genentech USA, Inc. South San Francisco, CA.), effectively managing treatment-related adverse events (AEs) may improve adherence. Due to a lack of clinical evidence and expertise, managing these AEs can be challenging for patients and physicians alike. In the absence of evidence, consensus recommendations from physicians experienced in using pirfenidone to treat IPF are beneficial. METHODS: Using a modified Delphi process, expert recommendations were developed by a panel of physicians experienced with using pirfenidone for IPF. Over three iterations, panelists developed and refined a series of statements on the use of pirfenidone in IPF. Their agreement on each statement was ranked using a Likert scale. RESULTS: A panel of 12 physicians participated and developed a total of 286 statements on dosing and administration, special populations, drug-drug interactions, laboratory analysis, warnings and precautions, and AE management. Expert recommendations were achieved with regard to slower initial titrations and slower titrations for AEs, dosing with meal(s) or substantial meals, and adding other prescribed pharmacological agents for AEs. CONCLUSION: Until there is further clinical evidence, the resulting consensus recommendations are intended to provide direction on the practical management of IPF with pirfenidone, by encompassing a broad experience from the real world to complement data gleaned from clinical trials. FAU - Rahaghi, Franck F AU - Rahaghi FF AD - Department of Pulmonary and Critical Care Medicine, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA. rahaghf@ccf.org. FAU - Safdar, Zeenat AU - Safdar Z AD - Houston Methodist Lung Center, Houston, TX, USA. FAU - Brown, Anne Whitney AU - Brown AW AD - Inova Fairfax Hospital, Falls Church, VA, USA. FAU - de Andrade, Joao A AU - de Andrade JA AD - Birmingham VA Medical Center, Birmingham, AL, USA. FAU - Flaherty, Kevin R AU - Flaherty KR AD - Michigan Medicine Pulmonary Clinic, Ann Arbor, MI, USA. FAU - Kaner, Robert J AU - Kaner RJ AD - Weill Cornell Medicine Pulmonary & Critical Care Medicine, New York, NY, USA. FAU - King, Christopher S AU - King CS AD - Inova Fairfax Hospital, Falls Church, VA, USA. FAU - Padilla, Maria L AU - Padilla ML AD - The Mount Sinai Hospital, New York, NY, USA. FAU - Noth, Imre AU - Noth I AD - The University of Chicago Medicine, Chicago, IL, USA. FAU - Scholand, Mary Beth AU - Scholand MB AD - University of Utah School of Medicine, Salt Lake City, UT, USA. FAU - Shifren, Adrian AU - Shifren A AD - Washington University School of Medicine, St. Louis, MO, USA. FAU - Nathan, Steven D AU - Nathan SD AD - Inova Fairfax Hospital, Falls Church, VA, USA. LA - eng GR - R01 HL130796/HL/NHLBI NIH HHS/United States PT - Journal Article DEP - 20200714 PL - England TA - BMC Pulm Med JT - BMC pulmonary medicine JID - 100968563 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Pyridones) RN - D7NLD2JX7U (pirfenidone) SB - IM MH - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/therapeutic use MH - Consensus MH - Delphi Technique MH - Disease Management MH - Drug-Related Side Effects and Adverse Reactions/*etiology/prevention & control MH - Humans MH - Idiopathic Pulmonary Fibrosis/*drug therapy MH - *Practice Patterns, Physicians' MH - Pyridones/*adverse effects/*therapeutic use MH - Treatment Outcome PMC - PMC7362639 OTO - NOTNLM OT - Adverse events OT - Expert consensus OT - Idiopathic pulmonary fibrosis OT - Management OT - Pirfenidone COIS- FFR received support for the design and conduct of this study through an independent grant from Genentech, Inc. and is a consultant, speaker, and has received research funding from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., Lung Biotechnology, United Therapeutics Corporation, Bayer Corporation, and research funding from Bellerophon Therapeutics, Ikaria, Inc., and Eiger BioPharmaceuticals. ZS received support for the design and conduct of this study through an independent grant from Genentech, Inc. and is a consultant, speaker, and has received research funding from Actelion Pharmaceuticals US, Inc., Gilead Sciences, Inc., Lung Biotechnology, United Therapeutics Corporation, Bayer Corporation, Genetetech and Bohringer ingelheim. AWB is a consultant for Promedior, Genentech, and Theravance. She is on the speaker's bureau for Genentech. JAD is a consultant and received research funding (to his institution) from Genentech, and Boehringer Ingelheim. He also received research funding from GBT, Medscape, Fibrogen, and the NHLBI. KRF has received personal fees from Boehringer Ingelheim, Veracyte, Roche/Genentech, Fibrogen; and research funds from Roche/Genentech, Boehringer Ingelheim. RJK is a consultant for Roche-Genentech and Boehringer-Ingelheim. He is on the speaker's bureau for non-branded disease state lectures and has participated as an investigator in clinical trials for both Companies. CSK has served as a speaker for Genentech, Inc. He has also participated on a scientific advisory board for Boehringer Ingelheim Pharmaceuticals. MLP has served as Speaker Bureau Faculty (for non-branded IPF talks) from Genentech and serves as a Consultant for Boehringer Ingelheim. IN has served as a consultant for Genentech/HLR, Boehringer Ingelheim, Immuneworks, Sanofi Aventis, Global Blood Therapeutics. He has received research funding from Genentech and Boehringer Ingelheim. MBS has served on advisory boards, and investigator clinical trials with Genentech and Boehringer Ingelheim. MBS has patents issued for Apparatus, Compositions and Methods for Assessment of Chronic Obstructive Pulmonary Disease Progression among Rapid and Slow Decline Conditions. AS is a consultant for Roche-Genentech and Bellerophon. He is on the speaker's bureau for Roche-Genentech and Boerhinger Ingelheim. SDN is a consultant for Roche-Genentech and Boerhinger Ingelheim. He is on the speaker's bureau and has also received research funding from both Companies. He is also a consultant for United Therapeutics, Bellephoron, aTyr Pharma, and Galapogos. EDAT- 2020/07/16 06:00 MHDA- 2021/04/29 06:00 PMCR- 2020/07/14 CRDT- 2020/07/16 06:00 PHST- 2019/12/03 00:00 [received] PHST- 2020/06/03 00:00 [accepted] PHST- 2020/07/16 06:00 [entrez] PHST- 2020/07/16 06:00 [pubmed] PHST- 2021/04/29 06:00 [medline] PHST- 2020/07/14 00:00 [pmc-release] AID - 10.1186/s12890-020-01209-4 [pii] AID - 1209 [pii] AID - 10.1186/s12890-020-01209-4 [doi] PST - epublish SO - BMC Pulm Med. 2020 Jul 14;20(1):191. doi: 10.1186/s12890-020-01209-4.