{"id":24,"date":"2019-04-23T00:02:31","date_gmt":"2019-04-23T00:02:31","guid":{"rendered":"https:\/\/www.cutaquigus.com\/hcp\/evidence\/safety-tolerability\/"},"modified":"2025-01-29T00:32:31","modified_gmt":"2025-01-29T00:32:31","slug":"safety-tolerability","status":"publish","type":"page","link":"https:\/\/cutaquigusa.com\/hcp\/evidence\/safety-tolerability\/","title":{"rendered":"Cutaquig SCIg Therapy | Proven Safety &#038; Tolerability"},"content":{"rendered":"\n<h2>For Both Adults and Pediatric Patients 2 Years of Age and Older, Most Local Infusion Site Reactions were Mild or Moderate<\/h2>\n<section id=\"block-1a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<h3>98% of Infusion Site Reactions Were Mild (88%) or Moderate (10%)<sup>1*<\/sup><\/h3>\n<div class=\"content-column two_third\">\n<ul class=\"slick arrow-v2\">\n<li>Across all infusion, ZERO infusions site reactions were observed for over 85% of infusions (6151 or 7239)<sup>1<\/sup><\/li>\n<li>73% of adult and pediatric patients experienced at least once infusion site reaction<sup>1<\/sup><\/li>\n<li>The most frequent infusion site reactions were redness, swelling, and itching<sup>1<\/sup><\/li>\n<\/ul>\n<p class=\"small\"><sup>*<\/sup> Mild local reaction was defined as a transient adverse reaction causing discomfort but not interfering with routine activities; moderate local reaction was defined as an adverse reaction causing sufficient discomfort to interfere with routine activities.<\/p>\n<\/div>\n<div class=\"content-column one_third last-column\">\n<img alt=\"Of 7,239 total infusions, there were only 0.15 local reactions per infusion\" width=\"900\" height=\"900\" class=\"alignnone size-full wp-image-420\" data-original=\"https:\/\/cutaquigusa.com\/hcp\/wp-content\/uploads\/sites\/2\/2022\/04\/abdomen2.png\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-2a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<h3>The Incident of Local Reactions Decreased Over Time<sup>1,2,3<\/sup><\/h3>\n<p><a class=\"enlarge\" href=\"https:\/\/cutaquigusa.com\/hcp\/wp-content\/uploads\/sites\/2\/2022\/04\/Infusion-Site-Reactions_v5.png\"><br>\n<img alt=\"\" width=\"550\" height=\"303\" class=\"block__img initial loaded aligncenter wp-image-421\" data-original=\"https:\/\/cutaquigusa.com\/hcp\/wp-content\/uploads\/sites\/2\/2022\/04\/Infusion-Site-Reactions_v5.png\"><\/a><\/p>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-3a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide\">\n<div class=\"aligndefault\">\n<h3>Adverse Reactions (ARs) in &ge;5% of Patients and Rate Per Infusion in the Pivotal and Extension Trials<sup>1,4&dagger;<\/sup><\/h3>\n<table class=\"inset-2-col\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th style=\"width: 25%;\"><\/th>\n<th colspan=\"2\">Adults (N=43) Who Received 3956 Infusions<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<th style=\"width: 25%;\">ARs<\/th>\n<td>% Patients with ARs<\/td>\n<td>% ARs Per Infusion<sup>&dagger;<\/sup><\/td>\n<\/tr>\n<tr>\n<th>Local<br>\n<span class=\"desc\">(infusion site)<\/span><\/th>\n<td>72.1%<\/td>\n<td>16.4%<\/td>\n<\/tr>\n<tr>\n<th colspan=\"3\">Systemic<\/th>\n<\/tr>\n<tr>\n<th>Headache<\/th>\n<td>18.6%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Dermatitis<\/th>\n<td>11.6%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Fever<\/th>\n<td>11.6%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Diarrhea<\/th>\n<td>11.6%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Muscle Spasms<\/th>\n<td>9.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Back Pain<\/th>\n<td>9.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Arthralgia<\/th>\n<td>7.0%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-3b\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<table class=\"inset-2-col\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr>\n<th style=\"width: 25%!important;\"><\/th>\n<th colspan=\"2\">Children\/Adolescents (N=38) Who Received 3282 Infusions<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<th style=\"width: 25%!important;\">ARs<\/th>\n<td>% Patients with ARs<\/td>\n<td>% ARs Per Infusion<sup>&dagger;<\/sup><\/td>\n<\/tr>\n<tr>\n<th>Local<br>\n<span class=\"desc\">(infusion site)<\/span><\/th>\n<td>73.7%<\/td>\n<td>16.4%<\/td>\n<\/tr>\n<tr>\n<th colspan=\"3\">Systemic<\/th>\n<\/tr>\n<tr>\n<th>Asthma<\/th>\n<td>10.5%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Cough<\/th>\n<td>10.5%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Vomiting<\/th>\n<td>10.5%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Nasal Congestion<\/th>\n<td>7.9%<\/td>\n<td>0.20%<\/td>\n<\/tr>\n<tr>\n<th>Fever<\/th>\n<td>7.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Headache<\/th>\n<td>7.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>ALT Increased<\/th>\n<td>7.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Leukopenia<\/th>\n<td>7.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Neutropenia<\/th>\n<td>7.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Dermatitis<\/th>\n<td>5.9%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Oropharyngeal Pain<\/th>\n<td>5.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Urticaria<\/th>\n<td>5.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>AST Increased<\/th>\n<td>5.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Abdominal Pain<\/th>\n<td>5.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<tr>\n<th>Ear Pain<\/th>\n<td>5.3%<\/td>\n<td>0.10%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"small\">ALT: alanine aminotransferase; AST: aspartate aminotransferase<\/p>\n<p class=\"small\"><sup>&dagger;<\/sup>Excluding infections, defined as ARs occurring during or within 72 hours of infusion or any ARs otherwise causally related.<\/p>\n<p class=\"small\"><sup>*<\/sup>Rate = total number of ARs divided by total number of infusions.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-3a\" class=\"block block--content alignfull highlight-bar\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\" style=\"font-size: 1.25em; color: #fff;\">\n<h3 style=\"color: #fff; margin-bottom: 0; padding-bottom: 0;\"><b>ZERO WITHDRAWLS<\/b><\/h3>\n<div>Due to adverse reactions in the phase 3 pivotal and extension studies<sup>1,2<\/sup><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-5a\" class=\"block block--cta-with-wysiwyg-and-image alignfull\">\n<div class=\"alignwide\">\n<div class=\"cta-banner cta-banner--fallback-bg\">\n<div class=\"cta-banner__body\">\n<div class=\"cta-banner__body-inner\">\n<div class=\"cta-banner__icon\"><img width=\"45\" data-original=\"https:\/\/cutaquigusa.com\/wp-content\/uploads\/2019\/12\/notepad-pink.png\"><\/div>\n<h3 class=\"h3\">Review the recommended dosing, administration and usage of cutaquig.<\/h3>\n<p><a class=\"action action--fa-angle-right\" href=\"https:\/\/cutaquigusa.com\/hcp\/usage\/\">Learn More <i class=\"fa fa-angle-right\"><\/i><\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"block-6a\" class=\"block block--content alignfull\">\n<div class=\"block__content-wrapper alignwide \">\n<div class=\"aligndefault\">\n<h5>References:<\/h5>\n<ol>\n<li class=\"small\">Kobayashi RH, Gupta S, Melamed I, et al. Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (octanorm [cutaquig<sup>&reg;<\/sup>]) in the Treatment of Patients with Primary Immunodeficiencies. Front Immunol. February 2019 | Volume 10 | Article 40.<\/li>\n<li class=\"small\">Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.<\/li>\n<li class=\"small\">Kobayashi RH, et al. Immunotherapy. 2021;13(10):813&ndash;824.<\/li>\n<li class=\"small\">Kobayashi RH, et al., Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig<sup>&reg;<\/sup>) in the treatment of patients with primary immunodeficiencies, Clinical and Experimental Immunology. 2022; 210: 91&ndash;103.<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/section>\n\n","protected":false},"excerpt":{"rendered":"<p>For Both Adults and Pediatric Patients 2 Years of Age and Older, Most Local Infusion Site Reactions were Mild or&#8230;<\/p>\n","protected":false},"author":29,"featured_media":0,"parent":22,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-24","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SCIg Infusion Site Safety &amp; Tolerability | cutaquig\u00ae<\/title>\n<meta name=\"description\" content=\"Learn about the safety and tolerability of cutaquig\u00ae (Immune Globulin Subcutaneous [Human]-hipp, 16.5% solution), including SCIg infusion site reactions. 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