DO NOT SHAKE. Administer with an in-line or syringe-tip sterile, disposable filter. Westlake Village, CA: Baxalta US Inc; 2016. The primary data source for each drug was the prescribing information. Maintenance visits occurred monthly. Bedminster, NJ: Kyowa Kirin Inc; 2018. Gorski L, Hadaway L, Hagle ME, McGoldrick M, Orr M, Doellman D. Orencia [package insert]. RadioGenix System [package insert]. Infliximab is administered by intravenous (IV) infusion over a period of not less than 2 hours. REMICADE is a medicine that affects your immune system. Amino acids, electrolytes, dextrose, and lipid injectable (Kabiven, Perikabiven). RENFLEXIS can make you more likely to get an infection or make any infection that you have worse. IICan be used with or without methotrexate. Generate variations. Third-party trademarks used herein are trademarks of their respective owners. New York, NY: Stemline Therapeutics, Inc; 2018. 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 CD who have had an inadequate response to conventional therapy. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Gamunex [package insert]. Monitor patients during infusion and if serious reactions occur, discontinue infusion. You can always select this layer to bring up the Properties panel to show your . For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg IV or treating as often as every 4 weeks, bearing in mind that risk of serious infections is increased at higher doses. Readers are urged to review national standards of practice for information about clinical situations that warrant the use of a filter for medication preparation or administration, independent of the drug being given (eg, intraspinal injection, amino acidcontaining parenteral nutrition solutions).5 Although every effort has been made to ensure the accuracy and completeness of the information presented in this chart, the reader is advised that the authors, Hospital Pharmacy, or SAGE cannot be held responsible for the currency of the information, for any errors or omissions, or for any consequences that may arise. 1The University of Illinois at Chicago, USA. Periodic screening should continue in women treated with either REMICADE or Infliximab. Gammaplex 10% [package insert]. 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). REMICADE is intended for use under the guidance and supervision of a healthcare provider. Glassia: Use the sterile filter needle provided by the manufacturer to transfer the solution to the infusion container. Skin cancer any changes in or growths on your skin. weeks thereafter, The 5 mg/kg IV maintenance group received REMICADE 5 mg/kg IV at Weeks 2, 6, and every These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Princeton, NJ: Bristol-Myers Squibb Company; 2018. Indianapolis, IN: Exelead Inc; 2017. Administer with a PES or equivalent low proteinbinding in-line filter. Most of these reactions were manageable and responded to appropriate treatment steps. Targeted tuberculin testing and treatment of latent tuberculosis infection. Novato, CA: BioMarin Pharmaceutical Inc; 2018. The supplied lyophilized powder must be reconstituted and diluted prior to administration. 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. To be cautious, drug companies state that infliximab should only be used during pregnancy if needed to keep your condition under control. Administer conventional paclitaxel with an in-line filter. on this site is intended only as informational or as an educational aid and it is not intended to be taken A causal relationship between REMICADE and cervical cancer cannot be excluded. Hoboken, NJ: Octapharma USA Inc; 2018. 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. Exercise caution when considering REMICADE in patients with these disorders and consider discontinuation if these disorders develop. Kadcyla [package insert]. Thousand Oaks, CA: Amgen Inc; 2017. 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. Infliximab is administered by IV infusion over a period of not less than 2 hours. The Elelyso [package insert]. Carefully assess the risks and benefits of treatment with REMICADE, especially in these patient types. Cambridge, MA: Genzyme Corporation; 2010. Octagam [package insert]. REMICADE is administered by intravenous (IV) infusion over a period of not less than 2 hours.1, 5 mg/kg IV given every 6 weeks thereafter as a maintenance regimen, REMICADE4. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. In clinical trials of Infliximab, the majority of infusion reactions were mild to moderate. Cambridge, MA: Biogen Inc; 2017. Slowly add the total volume of reconstituted Infliximab solution from the vial(s) to the 250-mL infusion bottle or bag, Discard any unused portion of the reconstituted Infliximab solution remaining in the vial(s), Gently invert the bag to mix the solution. States REMICADE and Infliximab are indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA). The reconstituted solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab is a protein. Lexington, MA: Baxalta US Inc; 2017. Irvine, CA: Talon Therapeutics Inc; 2016. Refer to the Preparation and Administration Instructions and important information on what to do in the event your patient experiences an infusion reaction. I've been told this is to prevent molecules that are too large from entering the blood stream, since it is a biologic medication. Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE infusion. In the primary study phase, patients received REMICADE 5 mg/kg or placebo infusions at Weeks 0, 2, 6, 14, and 22; patients also received AZA capsules at a dose of 2.5 mg/kg/day or placebo capsules daily through Week 30. Common side . Horsham, PA: Janssen Biotech Inc; 2018. only. Atryn [package insert]. Antihemophilic factor VIII/von Willebrand Factor Complex (Alphanate, Humate P, Wilate). In clinical trials of some TNF blockers, including either REMICADE or Infliximab, more cases of other malignancies were observed compared with controls. The high incidence of anergy in patients with Crohn's disease who take immunosuppressants 14,15 makes tuberculin skin testing . Bolus injection: Filter prior to administration using a sterile, nonpyrogenic, low proteinbinding syringe filter. Patients randomized to REMICADE continued to receive REMICADE 5 mg/kg IV every 8 weeks through Week 46. Rockford, IL: Mylan Institutional LLC; 2018. as an induction regimen, 5 mg/kg IV given every 8 weeks thereafter Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE at or prior to diagnosis. REMICADE or Infliximab, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). The Complicated Colon: Remicade and Filters - Blogger Administer with a protein-sparing filter. Flolan [package insert]. PES = polyethersulfone; IV = intravenous; PVDF = polyvinylidene fluoride; PVC = poly(vinyl chloride). Nexterone [package insert]. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Defitelio [package insert]. Flexbumin [package insert]. The primary endpoint was the proportion of patients achieving 75% improvement in PASI from baseline to Week 10. Important Safety Information. Antihemophilic factor VIII (eg, Advate, Adynovate, Afstyla, Eloctate, Esperoct, Hemofil M, Jivi, Koate, Kogenate FS, Kovaltry, Monoclate-P, Novoeight, Nuwiq, Obizur, Recombinate, Xyntha). However, drugs with manufacturer-supplied, filter-containing vial adapters and/or vial transfer devices (eg, needleless vial transfer devices with built-in filters such as the Mix2Vial or Baxject reconstitution system) are only included in the chart if the product labeling states that a similar, commercially available device can be used instead of the manufacturer-supplied filter vial transfer device. Moderately to SeverelyActive Crohns Disease*. Lexington, MA: Baxalta US Inc; 2018. 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. Research Triangle Park, NC: GlaxoSmithKline; 2018. The majority of reported REMICADE cases have occurred in patients with Crohns disease or ulcerative colitis and most were in adolescent and young adult males. Vectibix [package insert]. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella. Deerfield, IL: Baxter Healthcare Corporation; 2016. I've been on Remicade for nearly 3 years now, and it's worked great at keeping my Ulcerative Colitis in remission. Provide the Medication Guide to your patients and encourage discussion. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of either REMICADE or Infliximab. Moderately to Severely Active Crohns Disease. The recommended dosage of REMICADE is 3 mg/kg IV given as an intravenous induction regimen at 0, 2, and 6 weeks, followed by a maintenance regimen of 3 mg/kg IV every 8 weeks thereafter for the treatment of moderately to severely active RA. Background: Infliximab is an anti-tumour necrosis factor- (Anti-TNF) antibody. Afstyla [package insert]. Uses Before taking Warnings Side effects Overdose Dosage FAQ Warning Very bad and sometimes deadly infections have happened in patients who take infliximab injection. Prior to initiating either REMICADE or Infliximab, update vaccinations in accordance with current vaccination guidelines. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2014. Patients were randomized to receive a single infusion of placebo (n=25) or REMICADE 5 mg/kg IV (n=27), 10 mg/kg IV (n=28), or 20 mg/kg IV (n=28). 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). Patients were receiving MTX for 3 months before randomization and at a stable dose (25 mg/week) for 4 weeks before randomization. Abelcet [package insert]. Raleigh, NC: Xellia Pharmaceuticals USA, LLC; 2017. Infliximab is also used to treat ulcerative colitis or Crohn's disease in adults and children at least 6 years old. 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. Patients were randomly assigned to 1 of 3 treatment groups through Week 30. It's available only as the brand-name drugs . Infliximab - Crohn's and Colitis UK Lexington, MA: Shire ViroPharma Incorporated; 2018. Mylotarg [package insert]. It's given as an infusion into your vein. 2000;161:S221-S247. Zemaira: Use the filter vial transfer device provided by the manufacturer during preparation. Princeton, NJ: Dr. Reddys Laboratories Inc; 2018. INFLECTRA Dosage and Administration (infliximab-dyyb) These patients had 10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of 12, and were candidates for systemic therapy or phototherapy. Alpha-1 proteinase inhibitor (eg, Aralast, Glassia, Prolastin-C, Zemaira). Administer with a PES in-line filter; manufacturer recommends attaching the filter while preparing (priming) the infusion set. However, patients with Crohns disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. Use the 19 gauge 1.5 in filter needle provided by manufacturer during preparation; use a nonfilter needle for the intravitreal injection. This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Mannitol [package insert]. In clinical trials of some TNF blockers, including REMICADE, more cases of other malignancies were observed compared with controls. Infliximab [Prescribing Information]. 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. 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. Dilution Remicade - Infliximab - GlobalRPH Lymphoma, or any other cancers in adults and children. Results from SONIC, a multicenter, randomized, double-blind, controlled, phase IIIb trial of 508 patients with moderately to severely active CD (baseline CDAI 220 and 450). Foaming of the solution on reconstitution is not unusual, Allow the reconstituted solution to stand for 5 minutes. Then hit Enter, and the appropriate dosage amount and number of single vials will populate. Fort Lee, NJ: Kedrion Biopharma, Inc; 2014. Medications for the treatment of hypersensitivity reactions should be available. 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. Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse). Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. Inflectra [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018. *Total dosage in mg = dose x kg. The primary endpoint was proportion of patients achieving PASI 75 at Week 10. Hemofil M [package insert]. Glassia: 5 m (preparation and administration). Dosing & Administration | HCP | Infliximab Berinert [package insert]. to Official Consumer Website for REMICADE (infliximab) | REMICADE Drugs are sorted and grouped in the chart by generic name. Thiotepa [package insert]. Use a sterile venting filter needle or other suitable device during preparation as recommended by the manufacturer; do not use an in-line filter for administration. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection. Rockford, IL: Mylan Institutional LLC; 2017. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2018. Remicade (infliximab) is a biologic medication that treats inflammation caused by several autoimmune disorders. material Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse). The resulting infusion concentration should range between 0.4 mg/mL (minimum recommended concentration) and 4 mg/mL (maximum recommended concentration) of infliximab. Use the filter needle (Hemofil M and Monoclate P) or vented filter spike (Monoclate P) provided by the manufacturer during preparation. Brineura [package insert]. Horsham, PA: Janssen Biotech, Inc; 2018. RENFLEXIS treatment Amphotericin B desoxycholate [package insert]. Preparation and Administration Instructions, Remove the flip-top from the vial and wipe the top with an alcohol swab, Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2016. The infusion process has become routine for me, but at one of my recent infusions I noticed that something was a little different. For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing. Use the filter needle provided by the manufacturer during preparation; do not use an in-line filter during administration. Privigen [package insert]. 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. Sylvant [package insert]. Infusions every 6 weeks after 3 induction doses. Durham, NC: BPL Inc; 2018. In patients treated with the monoclonal antibody infliximab (Remicade) -which binds to and blocks tumor necrosis factor alpha (TNF-alpha) - an infusomat filter is routinely used to prevent the very same early adverse events observed in individuals receiving intravenous immunoglobulins (IVIG). Bethlehem, PA: B. Braun Medical Inc; 2016. Provide the Medication Guide to your patients and encourage discussion. FOIA BabyBIG [package insert]. Live vaccines or therapeutic infectious agents should not be given with REMICADE due to the possibility of clinical infections, including disseminated infections. Kankakee, IL: CSL Behring LLC; 2017. Active tuberculosis (TB), including reactivation of latent TB. 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. 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). In clinical trials, other serious infections observed in patients treated with REMICADE included pneumonia, cellulitis, abscess, and skin ulceration. The Week-50 analysis included patients who did not enter the study extension. Use the filter vial transfer device provided by the manufacturer. Use a sterile syringe filter during preparation prior to dilution. Infliximab is administered by intravenous (IV) infusion over a period of not less than 2 hours. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Cases of transient visual loss have been reported during or within 2 hours of infusion of Infliximab. Phenytoin sodium [package insert]. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. 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). Administer with a low proteinbinding in-line filter. Obizur [package insert]. Branchburg, NJ: ImClone LLC; 2018. REMICADE [Prescribing Information]. 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. Please see full Prescribing Information, including BOXED WARNINGS for SIMPONI. Carimune NF [package insert]. The REMICADE infusion should begin within 3 hours of reconstitution and dilution. For more information, please see the full Prescribing Information and Medication Guide for REMICADE. Nutrilipid [package insert]. Vincristine sulfate liposome injection (Marqibo kit). For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Nearly 50% of patients had advanced disease. Cinryze [package insert]. 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. Discontinue the infusion if severe hypersensitivity reactions occur during the infusion. Aralast [package insert]. The primary endpoint was the proportion of patients with a 20% improvement response according to the criteria of the ASAS International Working Group. 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). Am J Respir Crit Care Med. Mannitol [package insert]. Beleodaq [package insert]. San Dimas, CA: Gilead Sciences Inc; 2018. The coprimary endpoints were reduction of signs and symptoms, inhibition of structural damage, and improvement in physical function from baseline to Week 54.
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