PMID- 28326906 OWN - NLM STAT- MEDLINE DCOM- 20170807 LR - 20170807 IS - 1941-9260 (Electronic) IS - 0032-5481 (Linking) VI - 129 IP - 6 DP - 2017 Aug TI - A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice. PG - 590-597 LID - 10.1080/00325481.2017.1302306 [doi] AB - OBJECTIVES: Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them. METHODS: Pooled analyses of safety data from completed randomized, multicenter, double-blind, placebo-controlled phase 2 and phase 3 US and EU trials of timothy grass, short ragweed, and SQ house dust mite SLIT-tablets were conducted to characterize safety and tolerability. RESULTS: SLIT-tablets are generally well tolerated. No life-threatening events, serious systemic allergic reactions, or events that compromised the airway have been reported. The most common treatment-related adverse events (AEs) are oral site reactions, most of which begin on day 1 of treatment, recur for less than 2 weeks, and resolve after approximately 30-60 minutes. Systemic allergic reactions have been managed with conventional pharmacotherapy. Reactions treated with epinephrine are uncommon, but have been reported. Treatment of AEs, treatment discontinuation considerations, and patient FAQs regarding SLIT-tablet safety/tolerability are discussed. CONCLUSIONS: This report gives healthcare providers valuable information to educate patients regarding what to expect in terms of SLIT-tablet safety and tolerability. Practical guidance is also provided to ensure proper treatment of any adverse reactions. FAU - Bernstein, David I AU - Bernstein DI AD - a Bernstein Clinical Research Center and Department of Medicine and Environmental Health , University of Cincinnati , Cincinnati , OH , USA. FAU - Bardelas, Jose A Jr AU - Bardelas JA Jr AD - b Allergy and Asthma Center of North Carolina , High Point , NC , USA. FAU - Svanholm Fogh, Bodil AU - Svanholm Fogh B AD - c ALK , Horsholm , Denmark. FAU - Kaur, Amarjot AU - Kaur A AD - d Merck & Co., Inc. , Kenilworth , NJ , USA. FAU - Li, Ziliang AU - Li Z AD - d Merck & Co., Inc. , Kenilworth , NJ , USA. FAU - Nolte, Hendrik AU - Nolte H AD - d Merck & Co., Inc. , Kenilworth , NJ , USA. LA - eng PT - Clinical Trial, Phase II PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170322 PL - England TA - Postgrad Med JT - Postgraduate medicine JID - 0401147 RN - 0 (Tablets) SB - IM MH - Adolescent MH - Adult MH - Ambrosia MH - Animals MH - Child MH - Child, Preschool MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Poaceae MH - Pyroglyphidae MH - Rhinitis, Allergic/*drug therapy/*immunology MH - Self Care MH - Sublingual Immunotherapy/*adverse effects MH - Tablets MH - Treatment Outcome OTO - NOTNLM OT - Adverse events OT - allergy immunotherapy OT - clinical practice OT - safety OT - sublingual immunotherapy OT - tablets EDAT- 2017/03/23 06:00 MHDA- 2017/08/08 06:00 CRDT- 2017/03/23 06:00 PHST- 2017/03/23 06:00 [pubmed] PHST- 2017/08/08 06:00 [medline] PHST- 2017/03/23 06:00 [entrez] AID - 10.1080/00325481.2017.1302306 [doi] PST - ppublish SO - Postgrad Med. 2017 Aug;129(6):590-597. doi: 10.1080/00325481.2017.1302306. Epub 2017 Mar 22.