Monitor patients during infusion and if serious reaction occurs, discontinue infusion. Administer with an in-line or syringe-tip sterile, disposable filter. Use the filter needle provided by the manufacturer during preparation; do not use an in-line filter during administration. Plasbumin [package insert]. Mylotarg [package insert]. Doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids must have been stable for 4 weeks prior to screening. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 m or less). If jaundice and/or marked liver enzyme elevations (eg, 5 times the upper limit of normal) develop, REMICADE should be discontinued, and a thorough investigation of the abnormality should be undertaken. What are current recommendations for filtering parenteral nutrition (PN TNF blockers, including REMICADE, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barr syndrome. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2014. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2014. Reopro [package insert]. SPIRIT evaluated 249 patients with plaque psoriasis. Aldurazyme [package insert]. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of either REMICADE or Infliximab. The supplied lyophilized powder must be reconstituted and diluted prior to administration. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Prior to infusion with REMICADE, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse). Bolus injection: Filter prior to administration using a sterile, nonpyrogenic, low proteinbinding syringe filter. Irvine, CA: Spectrum Pharmaceuticals, Inc; 2017. A system administrator can attach additional filters to a specific Dev Drive or all Dev Drives using an allow list. It's given as an infusion into your vein. Patients frequently presented with disseminated or extrapulmonary disease. Vimizim [package insert]. To update the chart, drugs approved from December 2011 to April 2019 were reviewed to determine if they require filtration and drugs included in the 2012 table were reviewed for accuracy. You can obtain a printable PDF of the full Prescribing Information and the Medication Guide here. Patients (N=1084) were randomized in a 1:1:1 ratio to 1 of 3 treatment groups: placebo infusions through Week 14, followed by REMICADE 3 mg/kg infusions every 8 weeks through Week 46 (Group 1, n=363); REMICADE 3 mg/kg infusions every 8 weeks through Week 46, with dose escalation from Week 22 to 46 by 1.5 mg/kg increments, if the patient had an inadequate response (Group 2, n=360); and REMICADE 10 mg/kg infusions every 8 weeks through Week 46 (Group 3, n=361). Whitehouse Station, NJ: Merck & Co. Inc; 2017. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse). It is from a group of drugs called cytokine inhibitors. Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Further management of reactions should be dictated by signs and symptoms. Pine Brook, NJ: Elusys Therapeutics, Inc; 2016. do not shake; mix gently to minimize bubbles and contact with stopper 10,000-5000 units/mL 15 min RT21 syringe 4 h RT21 - contact with the rubber stopper may denature the reconstituted drug, creating filaments of insoluble material; if present, administer with 5 micron filter21 - do not use sterile water for reconstitution as the resulting The primary endpoint of the study was the proportion of patients in corticosteroid-free remission at Week 26. Drugs to Be Used With a Filter for Preparation and/or Administration Patients randomized to REMICADE continued to receive REMICADE 5 mg/kg IV every 8 weeks through Week 46. Use the filter vial transfer device provided by the manufacturer. Secondary objectives included the evaluation of 2 REMICADE maintenance dosing regimens (every 8 weeks and every 12 weeks) in maintaining remission, as measured on the Pediatric Ulcerative Colitis Activity Index (PUCAI); the efficacy of a 3-dose regimen of REMICADE in the induction of clinical remission, as measured by the Mayo score; and the induction of remission, as measured on the PUCAI.1,5, All patients received induction dosing of REMICADE 5 mg/kg IV at Weeks 0, 2, and 6. Zinplava [package insert]. Before Thymoglobulin [package insert]. Patients should be tested for HBV infection before initiating REMICADE. Darzalex [package insert]. Administer with an in-line PES filter or an end-set PES filter if an in-line filter is not available. Skin cancer any changes in or growths on your skin. ; A new Generative Layer is created in the Layers panel. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder, which has a cake-like appearance. Drugs that require filtration to remove glass particles from an ampule are not included because this is a well-known standard of practice.5,158 In addition, medications for which filtration is optional, but not required, are not included in the chart. Plainsboro, NJ: Novo Nordisk Inc; 2018. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2014. At Week 54, clinical response, clinical remission, and change from baseline in average daily corticosteroid use were evaluated as secondary efficacy endpoints.5, Note: REMICADE 5 mg/kg IV every 12 weeks is not an approved maintenance dose for REMICADE.1, The safety and efficacy of REMICADE were evaluated in the Active Ulcerative Colitis Trial (ACT 1) (N=364), a randomized, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active ulcerative colitis who had an inadequate response or were intolerant to conventional therapy. At Week 16, the placebo group crossed over to REMICADE induction therapy (5 mg/kg IV), followed by a maintenance therapy every 8 weeks. If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) after starting Remicade (infliximab), go to the hospital right away so you can be tested for an infection. In clinical trials, other serious infections observed in patients treated with REMICADE included pneumonia, cellulitis, abscess, and skin ulceration. Infusions were administered at Weeks 0, 2, and 6, and every 8 weeks thereafter through Week 46.5, Final efficacy evaluations were completed 8 weeks following the last infusion. Why Infliximab | Patient | Infliximab Infliximab, a monoclonal antibody-binding tumor necrosis factor (anti-TNF) alpha, is the most commonly used first-line biological agent for treatment of inflammatory bowel disease (IBD), in both Crohn's disease and ulcerative colitis. Eatontown, NJ: West-Ward Pharmaceuticals Corporation; 2017. REMICADE and Infliximab have been associated with hypersensitivity reactions that differ in their time of onset. A causal relationship between REMICADE and cervical cancer cannot be excluded. weeks thereafter, The 5 mg/kg IV maintenance group received REMICADE 5 mg/kg IV at Weeks 2, 6, and every Prolastin-C: Administer with an infusion filter. REMICADE should be given in combination with methotrexate. Mannitol [package insert]. Patients were receiving MTX for 3 months before randomization and at a stable dose (25 mg/week) for 4 weeks before randomization. Remicade [package insert]. Westlake Village, CA: Baxalta US Inc; 2015. An air-eliminating in-line filter should be used when administering lipid emulsion, both alone and as part of an admixture. References: 1. In clinical trials of some TNF blockers, including either REMICADE or Infliximab, more cases of other malignancies were observed compared with controls. At Week 26, patients with a static physicians global assessment (sPGA) score of moderate or worse (3 on a scale of 0 to 5) received an additional dose of the randomized treatment. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. As the potential role of TNF blockers in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD). The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. Please see full Prescribing Information for TREMFYA. REMICADE is intended for use under the guidance and supervision of a healthcare provider. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 m or less). Deerfield, IL: Baxter Healthcare Corporation; 2016. mL reconstituted REMICADE = total dose/10 (rounded to nearest tenth). Administer with an infusion filter. This chart is an update to the 2012 article published in Hospital Pharmacy on injectable drugs to be used with a filter. New Haven, Ct: Alexion Pharmaceuticals Inc; 2015. PDF Chemo Stability Chart - BC Cancer Imfinzi [package insert]. Horsham, PA: Janssen Biotech Inc; 2018. At Week 24, all patients receiving placebo crossed over to active treatment and received REMICADE 5 mg/kg IV (n=91) at Weeks 24, 26, 30, 38, and 46. TNF blockers, including REMICADE, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Use a 19 gauge 1.5 in filter needle during preparation; use a nonfilter needle for the intravitreal injection. Infliximab (Intravenous Route) Side Effects - Mayo Clinic Exercise caution when considering either REMICADE or Infliximab in patients with these disorders and consider discontinuation if these disorders develop. The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. All rights reserved. I've chosen infliximab as my topic (espcially in relation to inflammatory bowel disease), and one of the objectives of our assignment is to discuss the nursing implications regarding our topic. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder, which has a cake-like appearance. Bridgewater, NJ: Sanofi-Aventis US LLC; 2016. Primary endpoints included the proportion of patients with ACR20 response at Week 14 and the change from baseline in total modified van der Heijde-Sharp (vdH-S) score at Week 24. Torisel [package insert]. to Schaumburg, IL: Fresenius Kabi USA, LLC; 2008. Improvement in Psoriasis Area and Severity Index (PASI) was evaluated in psoriatic arthritis patients with baseline body surface area (BSA) 3% (n=87, placebo; n=83, REMICADE). Waltham, MA: Sobi Inc; 2018. Last updated on Nov 26, 2022. Cyramza [package insert]. REMICADE and Infliximab are indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Patients were then randomized based on clinical response at Week 2 to 1 of 3 treatment groups through Week 541,6: The coprimary endpoints of the trial were the proportion of patients responding at Week 2 who were in remission at Week 30 and time to loss of response through Week 54.1,6. Newly approved drugs were identified by consulting the Food and Drug Administration (FDA) Purple Book, the Drugs@FDA database, the FDA Novel Drug Approvals Web site (included the years 2015-2019), and the CenterWatch Web site.154-157 Marketing status and filtration information for drugs included in the 2012 table were also reviewed for accuracy and updated as appropriate. Westlake Village, CA: Baxalta US Inc; 2015. Nuwiq [package insert]. Preventing TB in patients with Crohn's disease needing infliximab or Alphanate [package insert]. Octagam [package insert]. Hoboken, NJ: Octapharma USA Inc; 2018. Beleodaq [package insert]. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. The multilayer metal fiber felt of graded aperture, formed by layers with different fiber diameters, can realize higher filtration accuracy than single-deck felt. Administer with a sterile nonpyrogenic, low proteinbinding in-line filter. as a maintenance regimen REMICADE should be given in combination with methotrexate. For more information, please see the full Prescribing Information and Medication Guide for REMICADE. At Week 8, 45 patients were randomized to a maintenance regimen of REMICADE 5 mg/kg IV given either every 8 weeks through Week 46 or every 12 weeks through Week 42.1,5, Note: REMICADE 5 mg/kg IV every 12 weeks is not an FDA-approved maintenance dosing regimen for REMICADE in the treatment of pediatric patients with moderately to severely active UC.1. Some cases were fatal or required liver transplant. Lexington, MA: Baxalta US Inc; 2017. As the potential role of TNF blockers in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD). Provide the Medication Guide to your patients and encourage discussion. Moderately to severely active RA was defined as 10 swollen joints (out of 66 total) and 12 tender joints (out of 68 total) and 1 of the following: Concurrent stable treatment with corticosteroids (equivalent to 10 mg prednisone per day) and usual doses of nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted. ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy): a 2-year, multicenter, double-blind, placebo-controlled, randomized, phase 3 study of REMICADE with methotrexate (MTX) in 428 patients with moderately to severely active MTX-refractory established RA (MTX use 3 months). American Thoracic Society, Centers for Disease Control and Prevention. Thorough patient assessment and screening for hypersensitivity reactions are key to helping to prevent infusion-related events. The Infliximab infusion should begin within 3 hours of reconstitution and dilution. Infliximab [Prescribing Information]. Before infusing REMICADE, provide patients or their caregivers with the Medication Guide for REMICADE. Mannitol [package insert]. Kankakee, IL: CSL Behring LLC; 2014. IICan be used with or without methotrexate. ASPIRE (Active-controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset): a 54-week, multicenter, double-blind, active treatment-controlled, randomized, phase 3 study of REMICADE with methotrexate (MTX) in 1004 MTX-nave adult patients with moderately to severely active early RA (3 months and Patients were not permitted to be on any disease-modifying antirheumatic drugs (DMARDs) or systemic corticosteroids. Patients who did not respond to REMICADE at Week 8 received no further REMICADE and returned for safety follow-up. Use the 19 gauge 1.5 in filter needle provided by manufacturer during preparation; use a nonfilter needle for the intravitreal injection. New York, NY: Advanced Accelerator Applications USA Inc; 2018. In clinical trials, the most common adverse reactions occurring in >10% of REMICADE-treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. Whippany, NJ: Bayer HealthCare LLC; 2016. Patients who do not respond by Week 14 are unlikely to respond, and consideration should be given to discontinuing REMICADE in these patients1, 5 mg/kg IV given at 0, 2, and 6 weeks as an induction regimen, 5 mg/kg IV given every 8 weeks thereafter as a maintenance regimen. Experience the future of Photoshop with Generative Fill Dosing of. Aralast: Use the filter provided by the manufacturer during preparation. I've been told this is to prevent molecules that are too large from entering the blood stream, since it is a biologic medication. Deerfield, IL: Baxter Healthcare Corporation; 2018. Horsham, PA: Janssen Biotech Inc; 2018. Cases of transient visual loss have been reported during or within 2 hours of infusion of Infliximab. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE postmarketing. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Email: compounding, drug information, intravenous therapy, medication safety. Plainsboro, NJ: Novo Nordisk Inc; 2019. Vincasar PFS [package insert]. Novoeight [package insert]. Los Angeles, CA: Grifols Biologicals Inc; 2017. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Patients could continue receiving other conventional disease-modifying antirheumatic drugs (DMARDs) as long as doses had been stable for 4 weeks. Lexington, MA: Baxalta US Inc; 2017. Yes. Andexxa [package insert]. South San Francisco, CA: Portola Pharmaceuticals Inc; 2018. Most of the patients were receiving concomitant immunosuppressants. Humate-P [package insert]. Heather J. Ipema, Clinical Assistant Professor, College of Pharmacy, The University of Illinois at Chicago, 833 S. Wood Street, 164 PHARM (MC 886), Chicago, IL 60612, USA. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Provide the Medication Guide to your patients and encourage discussion. Horsham, PA: Janssen Biotech Inc; 2018. Generate variations. Rockland, MA: EMD Serono Inc; 2018. Secondary objectives measured the safety and efficacy of dose-escalation regimens in patients with an incomplete response to the initial dose of REMICADE 3 mg/kg every 8 weeks and the safety of REMICADE + MTX after 1 year. DO NOT SHAKE. The majority of reported REMICADE and Infliximab cases have occurred in patients with Crohns disease or ulcerative colitis and most were in adolescent and young adult males. Privigen [package insert]. Monoclate-P [package insert]. In the contextual taskbar, once your text prompt is complete, click Generate.. You can see thumbnail previews of the variations that get generated based on your text prompt in the Properties Panel and in the Generative Fill dialog if used. Omegaven [package insert]. Use a sterile PES syringe filter during preparation. At Week 26, Group 2 and Group 3 patients received a placebo infusion in order to maintain treatment blind. There were 4 REMICADE groups: 3 mg/kg IV q8 weeks + MTX (n=86), 3 mg/kg IV q4 weeks + MTX (n=86), 10 mg/kg IV q8 weeks + MTX (n=87), and 10 mg/kg IV q4 weeks + MTX (n=81); patients randomized to placebo + MTX (n=88). Zevalin [package insert]. Infliximab Uses, Dosage, Side Effects, Warnings. - Drugs.com The primary endpoint was clinical response at Week 4.5, Note: The recommended dose of REMICADE is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohns disease.1. Do Home Water Filters Work? What Experts Say - The New York Times Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. Remicade (Infliximab) - Side Effects, Interactions, Uses, Dosage, Warnings Berinert [package insert]. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Lumizyme [package insert]. Discontinue either REMICADE or Infliximab in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Xyntha [package insert]. Active tuberculosis (TB), including reactivation of latent TB. Horsham, PA: Janssen Biotech, Inc; 2018. https://orcid.org/0000-0002-0981-1358, National Library of Medicine Targeted tuberculin testing and treatment of latent tuberculosis infection. Dosing & Administration | REMICADE (infliximab) HCP Infliximab: Metabolic fate not fully characterized; the drug may be eliminated by the reticuloendothelial system. In clinical trials of all TNF blockers, more cases of lymphoma were observed compared with controls and the expected rate in the general population. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (10 mg/day) permitted at stable doses; no other disease-modifying antirheumatic drugs (DMARDs) allowed. Lymphoma, or any other cancers in adults and children. The causal relationship to REMICADE and Infliximab therapy remains unclear. Naglazyme [package insert]. Infliximab - Crohn's and Colitis UK Discontinue REMICADE if a patient develops a serious infection or sepsis. official website and that any information you provide is encrypted Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Nearly 50% of patients had advanced disease. The malignancies occurred after a median of 30 months after the first dose of therapy. This information is intended for the use of patients and caregivers in the United States and Puerto Rico Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article. All patients were to maintain a target MTX dose of 20 mg/week for the duration of the trial, whenever possible. Administer with a PES or equivalent low proteinbinding in-line filter. Further management of reactions should be dictated by signs and symptoms. Veletri [package insert]. Poteligeo [package insert]. Simponi aria [package insert]. Thousand Oaks, CA: Amgen Inc; 2018. Infliximab (Remicade), Infliximab-abda (Renflexis), Infliximab-dyyb (Inflectra). Biologic medications are engineered to treat inflammation and they are used to treat many conditions, including inflammatory bowel disease (IBD), rheumatoid arthritis, psoriasis, ankylosing spondylitis, and hidradenitis suppurativa. REMICADE should be given in combination with methotrexate. REMICADE can be used with or without methotrexate in active PsA. Esperoct [package insert]. Medications for the treatment of hypersensitivity reactions should be available. For more information, please see the full Prescribing Information, including Boxed Warning and Medication Guide for REMICADE and full Prescribing Information, including Boxed Warning and Medication Guide for Infliximab. The information contained in this section of the site is intended for US healthcare professionals only. Albuminar [package insert]. 2. All patients received induction dosing of 5 mg/kg IV REMICADE at Weeks 0, 2, and 6. Bedminster, NJ: Kyowa Kirin Inc; 2018. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE. Do not use if the lyophilized powder has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Figure 1. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Carefully assess the risks and benefits of treatment with either REMICADE or Infliximab, especially in these patient types. Prior to infusion with Infliximab, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. C1 esterase inhibitor (human) (Berinert, Cinryze. Serious infections may be more likely in adults who are 65 years or older. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of REMICADE with other agents. Patients were randomized to the following treatment groups: REMICADE 5 mg/kg IV (n=121), REMICADE 10 mg/kg IV (n=120), or placebo (n=123). Thank you for visiting www.infliximab.com. Novato, CA: BioMarin Pharmaceutical Inc; 2018. Discontinue treatment if symptoms of a lupus-like syndrome develop. Elimination Metabolism. Exercise caution when considering resumption of REMICADE and monitor patients closely. Frequently Asked Questions About RENFLEXIS (infliximab-abda) All patients received an initial dose of REMICADE 5 mg/kg IV. PDF Infliximab: Prescribing and Administering Bethlehem, PA: B. Braun Medical Inc; 2014. REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness). country. Whitehouse Station, NJ: Merck & Co. Inc; 2016. RENFLEXIS treatment Some cases were fatal or required liver transplant. REMICADE has been associated with hypersensitivity reactions that differ in their time of onset. The .gov means its official. Infusions every 6 weeks after 3 induction doses. 1. In clinical trials of some TNF blockers, including REMICADE, more cases of other malignancies were observed compared with controls. 3 years from date of diagnosis). government site. At baseline, mean CDAI score for all patients was 287; median duration of CD ranged from 2.2 to 2.4 years. Thiotepa [package insert]. Zemaira [package insert]. Inclusion in an NLM database does not imply endorsement of, or agreement with, However, patients with Crohns disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. Fabrazyme [package insert]. REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy. Glassia [package insert].