{"id":9759,"date":"2025-04-14T08:06:06","date_gmt":"2025-04-14T08:06:06","guid":{"rendered":"https:\/\/organonpro.com\/en-us\/product\/tofidence\/dosing\/"},"modified":"2026-01-14T11:48:38","modified_gmt":"2026-01-14T11:48:38","slug":"dosing","status":"publish","type":"product","link":"https:\/\/organonpro.com\/en-us\/product\/tofidence\/dosing\/","title":{"rendered":"Dosing"},"content":{"rendered":"\n<h1 class=\"wp-block-heading seo-heading-two-title\" id=\"h-renflexis-same-dosing-as-remicade-infliximab\"><br>TOFIDENCE is approved for the same arthritic indications as ACTEMRA and has the same dosing as the IV product presentation<sup>1<\/sup><\/h1>\n\n\n\n<p>Scroll to view the recommended dosing regimens below. Please see the Prescribing Information for full details on dosing and administration.<\/p>\n\n\n\n<p><strong>TOFIDENCE injection, for intravenous use, is an FDA-approved biosimilar to ACTEMRA based on data demonstrating that it is highly similar and that there are no clinically meaningful differences in safety and effectiveness between the two tocilizumab products.<strong><sup>2<\/sup><\/strong><\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity is-style-wide\"\/>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-top is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:30%\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/organonpro.com\/en-us\/wp-content\/uploads\/sites\/6\/2025\/07\/tofidence-dosing.png\" alt=\"\"\/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<h2 class=\"wp-block-heading\" id=\"h-general-information\"><strong>General dosing and administration information<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>For RA, PJIA, and SJIA, TOFIDENCE may be used alone or in combination with methotrexate, and in RA, TOFIDENCE may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs.<\/li>\n\n\n\n<li>For GCA, TOFIDENCE is recommended to be used in combination with a tapering course of glucocorticoids. It can also be used alone following discontinuation of glucocorticoids.<\/li>\n\n\n\n<li>Obtain and assess baseline complete blood count (CBC) and liver function tests prior to treatment.\n<ul class=\"wp-block-list\">\n<li>Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory changes in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>RA, GCA, PJIA, and SJIA\u2014It is recommended that TOFIDENCE not be initiated in patients with an absolute blood count (ANC) below 2000 per mm<sup>3<\/sup>, platelet count below 100,000 per mm<sup>3<\/sup>, or ALT or AST above 1.5 times the upper limit of normal (ULN).<\/li>\n\n\n\n<li>COVID-19\u2014It is recommended that TOFIDENCE not be initiated in patients with an ANC below 1000 per mm<sup>3<\/sup>, platelet count below 50,000 mm<sup>3<\/sup>, or ALT or AST above 10 times ULN.<\/li>\n\n\n\n<li>TOFIDENCE is administered as a 60-minute intravenous infusion. Do not administer as an intravenous push or bolus.<\/li>\n\n\n\n<li>TOFIDENCE solutions do not contain preservatives; therefore, unused product remaining in the vial should not be used.<\/li>\n\n\n\n<li>For patients with RA or COVID-19, TOFIDENCE doses exceeding 800&nbsp;mg\/infusion are not recommended.<\/li>\n\n\n\n<li>For&nbsp;patients with GCA, TOFIDENCE doses exceeding 600&nbsp;mg\/infusion are not recommended.<\/li>\n\n\n\n<li>For&nbsp;patients with RA, GCA, COVID-19, PJIA, and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.<\/li>\n\n\n\n<li>For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Hold TOFIDENCE treatment if a patient develops a serious infection until the infection is controlled.<\/strong><\/p>\n\n\n\n<p>Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory changes in neutrophils, platelets, lipids, and liver function tests. Please consult the Prescribing Information for guidance on dosage modifications\/interruptions based on changes in laboratory parameters.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-background has-fixed-layout\" style=\"background-color:#9dc31a33\"><thead><tr><th class=\"has-text-align-center\" data-align=\"center\"><strong>Indication<\/strong><\/th><th class=\"has-text-align-center\" data-align=\"center\"><strong>Dosag<\/strong>e<\/th><th class=\"has-text-align-center\" data-align=\"center\">Dosing Schedule<\/th><\/tr><\/thead><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Moderately to severely active RA <\/strong><br>(Adult patients who have had an inadequate response to one or more DMARDs)<\/td><td class=\"has-text-align-center\" data-align=\"center\">Starting at 4 mg\/kg followed by an increase to 8 mg\/kg based on clinical response<\/td><td class=\"has-text-align-center\" data-align=\"center\">Every 4 weeks<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong><strong>SJIA<\/strong><\/strong> (active)<br>(Patients 2 years of age and older)<\/td><td class=\"has-text-align-center\" data-align=\"center\">8 mg\/kg for weights \u226530kg<br>12 mg\/kg for weights &lt;30kg<\/td><td class=\"has-text-align-center\" data-align=\"center\">Every 2 weeks<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong><strong>PJIA<\/strong><\/strong> (active)<br>(Patients 2 years of age and older)<\/td><td class=\"has-text-align-center\" data-align=\"center\">8 mg\/kg for weights \u226530kg<br>10 mg\/kg for weights &lt;30kg<\/td><td class=\"has-text-align-center\" data-align=\"center\">Every 4 weeks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p class=\"has-small-font-size\">Refer to Prescribing Information for full indications and dosing.<br>TOFIDENCE is not approved for the following indications: Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) and Cytokine Release Syndrome (CRS).<\/p>\n\n\n\n<p class=\"has-small-font-size\">ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; COVID-19=coronavirus disease 2019; DMARD=disease-modifying anti-rheumatic drug; GCA=giant cell arteritis; PJIA=polyarticular juvenile idiopathic arthritis; RA=rheumatoid arthritis; SJIA=systemic juvenile idiopathic arthritis; ULN=upper limit of normal.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:100%\"><\/div>\n<\/div>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n","protected":false},"author":116,"featured_media":0,"parent":9756,"menu_order":1,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"product_categories":[],"product_specialization":[],"customer_type":[],"class_list":["post-9759","product","type-product","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.11 (Yoast SEO v26.6) - 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