Physical function and disability were assessed using the Health Assessment Questionnaire (HAQ-DI) and the general health-related quality of life questionnaire SF-36. Improvement in Psoriasis Area and Severity Index (PASI) in psoriatic arthritis patients with baseline body surface area (BSA) ≥ 3% (n = 87 placebo, n = 83 infliximab) was achieved at Week 14, regardless of concomitant methotrexate use, with 64% of infliximab-treated patients achieving at least 75% improvement from baseline vs. 2% of placebo-treated patients; improvement was observed in some patients as early as Week 2. In the 3 mg/kg infliximab group, 4 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Renflexis. partnered territories. The first one, Inflectra (infliximab-dyyb), was approved in April 2016. Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis. Renflexis is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. The reconstituted solution concentration is 10 mg/mL. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Concurrent use of folic acid, oral corticosteroids (≤0.2 mg/kg/day of prednisone or equivalent), NSAIDs, and/or disease modifying antirheumatic drugs (DMARDs) was permitted. and symptoms and inducing and maintaining clinical remission in Appropriate personnel and medication should be available to treat anaphylaxis if it occurs. intravenous infusion. Additional safety and pharmacokinetic data were collected in an open-label pediatric UC trial in 60 pediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; Endoscopic subscore ≥ 2) and an inadequate response to conventional therapies. RENFLEXIS is a biosimilar. Found insideMonitor pt; reserve for approved uses. IND & DOSE Tx of Crohn disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis. Adult, child: 5 mg/kg IV at 0, 2, 6 wk; maint, 5 mg/kg IV q 8 wk (q 6 wk for ... The solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab-abda is a protein. All patients were required to be on a stable dose of 6-MP, AZA, or MTX; 35% were also receiving corticosteroids at baseline. Manufactured by: Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea Agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In addition, your healthcare professional may decide to treat your symptoms. Corticosteroid taper was permitted after Week 6. Similar proportions of patients in Studies UC I and UC II were receiving corticosteroids (61% and 51%, respectively), 6-MP/AZA (49% and 43%) and aminosalicylates (70% and 75%) at baseline. This is the first time the FDA has approved two biosimilars for one original, “reference” medication. Similar ACR responses were observed in an earlier randomized, placebo-controlled study of 104 psoriatic arthritis patients, and the responses were maintained through 98 weeks in an open-label extension phase. Found inside – Page 413Renflexis was approved under the FDA category for biosimilars and demonstrated no clinically meaningful differences for use, dosing regimens, strengths, dosage forms, and routes of administration from the FDA-approved biological product ... The longer term (greater than 1 year) safety and effectiveness of infliximab products in pediatric Crohn's disease patients have not been established in clinical trials. Patients who achieved a response and subsequently lost response were eligible to receive infliximab on an episodic basis at a dose that was 5 mg/kg higher than the dose to which they were randomized. It is recommended that therapeutic infectious agents not be given concurrently with Renflexis [see Warnings and Precautions (5.15)]. Most of the patients were receiving concomitant immunosuppressants. The results of these studies are presented in Table 12. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on Renflexis. Prevention. Overall lesions were graded with consideration to the percent of body involvement as well as overall induration, scaling, and erythema. Of the enrolled patients, 114 (46%) received the Week 26 additional dose. Autoimmune hepatitis has been diagnosed in some of these cases. Study II (EXPRESS II) evaluated 835 patients who received placebo or infliximab at doses of 3 mg/kg or 5 mg/kg at Weeks 0, 2, and 6 (induction therapy). Among infliximab-treated patients, serious infections included pneumonia, cellulitis, abscess, skin ulceration, sepsis, and bacterial infection. Must infuse Generic name: infliximab Medically reviewed by Drugs.com. Treatment with infliximab products can be associated with the development of antibodies to infliximab products. Talk to your doctor about the best way to feed your baby while receiving Renflexis. Symptoms of infusion reactions may include: Children with Crohn's disease showed some differences in side effects of treatment compared with adults with Crohn's disease. Medications for the treatment of hypersensitivity reactions Additionally, 4% (1/25) of placebo patients and 48% (13/27) of patients receiving 5 mg/kg infliximab achieved clinical remission (CDAI < 150) at Week 4. regular follow-up visits with a physician. These reactions were associated with a marked increase in antibodies to infliximab products, loss of detectable serum concentrations of infliximab products and possible loss of drug efficacy. In Study RA II, after 54 weeks of treatment, both doses of infliximab + MTX resulted in statistically significantly greater response in signs and symptoms compared to MTX alone as measured by the proportion of patients achieving ACR 20, 50 and 70 responses (Table 7). Biosimilars like RENFLEXIS are approved under a law called the Biologics Price Competition and Innovation Act. At Week 30, a significantly greater proportion of these patients in the 5 mg/kg and 10 mg/kg maintenance groups achieved clinical remission compared to patients in the placebo maintenance group (Table 3). The most common serious adverse reactions observed in clinical trials of infliximab were infections [see Adverse Reactions (6.1)]. heart failure, unless your doctor has examined you and decided that you are able to receive Renflexis. A randomized study. Overall proportions of adverse reactions, including infusion reactions, were similar between the 6 to 11 and 12 to 17 year age groups (13%). For more than a century, Merck, a leading global biopharmaceutical An enzyme immunoassay (EIA) method was originally used to measure anti-infliximab antibodies in clinical studies of infliximab. Targeted tuberculin testing and treatment of latent tuberculosis infection. About the Merck and Samsung Bioepis collaboration. The FDA refers to the already approved biologic as the reference product. Each mL contains 10 mg infliximab-abda, dibasic sodium phosphate heptahydrate (0.12 mg), monobasic sodium phosphate monohydrate (0.63 mg), polysorbate 80 (0.05 mg), and sucrose (50 mg). What should I avoid while receiving Renflexis? Adverse Reactions, Pediatric Ulcerative Colitis (6.1). At 8 weeks after a maintenance dose of 3 to 10 mg/kg of infliximab, median infliximab serum concentrations ranged from approximately 0.5 to 6 mcg/mL; however, infliximab concentrations were not detectable (<0.1 mcg/mL) in patients who became positive for antibodies to infliximab. Because of the nature of the adverse reactions seen with these combinations with TNF-blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNFα-blocking agents. Each Renflexis vial contains 100 mg of the infliximab-abda antibody. Must reconstitute and dilute before Some of the dosage forms listed on this page may not apply to the brand name Renflexis.. For the Consumer Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Pharmacokinetic results for single doses of 3 mg/kg to 10 mg/kg in rheumatoid arthritis, 5 mg/kg in Crohn's disease, and 3 mg/kg to 5 mg/kg in plaque psoriasis indicate that the median terminal half-life of infliximab is 7.7 to 9.5 days. TNF-alpha is made by your body's immune system. Infliximab has not been studied in patients with mild heart failure (NYHA Class I/II) [see Contraindications (4) and Warnings and Precautions (5.5)]. The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Some cases were fatal. No clastogenic or mutagenic effects of infliximab were observed in the in vivo mouse micronucleus test or the Salmonella-Escherichia coli (Ames) assay, respectively. Carefully assess the risks and benefits of treatment with healing, and eliminating corticosteroid use in adult patients with In a subset of patients who began the study without erosions, infliximab + MTX maintained an erosion-free state at 1 year in a greater proportion of patients than MTX alone, 79% (77/98) vs. 58% (23/40), respectively (P<0.01). for the following indications. Patients treated with infliximab products are at increased risk for Some of these cases were fatal or necessitated liver transplantation. Use of TNF blockers, including infliximab products, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. infection. Corticosteroid taper was permitted after Week 8. Greater effects on each component of the ACR 20 were observed in all patients treated with infliximab + MTX compared to placebo + MTX (Table 8). In the psoriasis Study III, which also included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 20% of patients treated with 5 mg/kg induction (weeks 0, 2 and 6), and in 27% of patients treated with 3 mg/kg induction. with appropriate supportive treatment. Doses of 3 mg/kg infliximab or placebo were administered intravenously at Weeks 0, 2 and 6. available in the U.S. under a global biosimilars development and cases have occurred in patients with Crohn’s disease or ulcerative The safety and effectiveness of infliximab products for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients aged 6 years and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy are supported by evidence from adequate and well-controlled studies of infliximab in adults. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab products, the formation of CYP450 enzymes could be normalized. There was no change in the SF-36 mental component summary score in either the infliximab group or the placebo group. In Study I and Study III, another evaluated outcome included the proportion of patients who achieved a score of "cleared" or "minimal" by the sPGA. Remicade, Inflectra, Renflexis, and Avsola require prior authorization from HealthPartners Pharmacy Administration. Temporary Update to the Terms and Conditions – RENFLEXIS ® (infliximab-abda) for injection, for intravenous use 100 mg- (Medical Benefit): EFFECTIVE 06/15/2020 – 09/30/2021: Patient will not have a minimum co-pay per administration of Program Product for any date of administration of Program Product between 06/15/2020 and 09/30/2021 . Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Results of this study were similar to those seen in a multicenter double-blind, placebo-controlled study of 70 patients with ankylosing spondylitis. Each single dose vial contains 100 mg of lyophilized infliximab-abda for final reconstitution volume of 10 mL. The interval between vaccination and initiation of Renflexis therapy should be in accordance with current vaccination guidelines. Indications for RENFLEXIS (infliximab-abda) for Injection, 100 mg. RENFLEXIS is a tumor necrosis factor (TNF) blocker approved in the U.S. More patients treated with infliximab reached a major clinical response than placebo-treated patients (Table 7). More patients in the placebo group (12%) had readily apparent radiographic progression compared with the infliximab group (3%). Clinical Response, Clinical Remission, and Mucosal Healing. The use of tocilizumab in combination with biological DMARDs such as TNF antagonists, including Renflexis, should be avoided because of the possibility of increased immunosuppression and increased risk of infection. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. There were some differences in the adverse reactions observed in the pediatric patients receiving infliximab compared to those observed in adults with Crohn's disease. At Week 16, placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape). Cases of transient visual loss have been reported during or within 2 hours of infusion of infliximab product. It is also known as the originator or original biologic product. In psoriatic arthritis clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids. 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