In plaque psoriasis, treatment with infliximab products may reduce the epidermal thickness and infiltration of inflammatory cells. Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. To get answers to questions about insurance, co-pay assistance for eligible, privately-insured patients, and more, theres The Organon Access Program for RENFLEXIS. All patients received induction dosing of 5 mg/kg infliximab at Weeks 0, 2, and 6. Tell your baby's doctor about your RENFLEXIS use. Some of these reactions were severe. Brands mentioned are trademarks of their respective owners. The median time to onset of response and median duration of response in infliximab-treated patients was 2 and 12 weeks, respectively. Learn about options for co-pay assistance for eligible, privately-insured patients. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Serious infections have happened in patients receiving RENFLEXIS. Figure 1 Kaplan-Meier estimate of the proportion of patients who had not lost response through Week 54. Patients with Crohn's disease who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants [see Adverse Reactions (6.1)]. There was no change in the SF-36 mental component summary score in either the infliximab group or the placebo group. Fifty-five percent of patients previously received systemic therapy, and 64% received a phototherapy. RENFLEXIS was approved by the U.S. Food and Drug Administration (FDA) on April 21 for all eligible indications. RENFLEXIS (Infliximab-abda) a biosimilar to Remicade, is a drug used in the treatment of Inflammatory Bowel Disease, as well as other autoimmune diseases. Single doses up to 20 mg/kg of infliximab have been administered without any direct toxic effect. Some people treated with infliximab products, such as Renflexis, have developed certain kinds of skin cancer. At both Week 30 and Week 54, the proportion of patients in clinical remission was also greater in the every 8-week treatment group than in the every 12week treatment group (60% vs. 35% at Week 30, and 56% vs. 24% at Week 54), (Table 4). These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. have heart failure or other heart conditions. What Are Side Effects of Renflexis? Seventy-one percent of patients previously received systemic therapy, and 82% received phototherapy. Figure 4 Proportion of patients achieving 75% improvement in PASI from baseline through Week 50; patients randomized at Week 14. Patients with Crohn's disease, rheumatoid arthritis or plaque psoriasis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blocking therapy. 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). Adults and children taking RENFLEXIS should not receive live vaccines or treatment with a weakened bacteria (such as Bacille Calmette-Gurin [BCG] for bladder cancer) while taking RENFLEXIS. Your doctor will determine the right dose of Renflexis for you and how often you should receive it. The most common side effects of infliximab products include: Infusion reactions can happen up to 2 hours after your infusion of RENFLEXIS. Atypical Hemolytic Uremic Syndrome (aHUS) is a rar, Our team of medical professionals is thoroughly tr, March is National Nutrition Month! Do not dilute the reconstituted Renflexis solution with any other diluent. Cases of agranulocytosis in infants exposed in utero have also been reported [see Adverse Reactions (6.2)]. The proportion of patients with infections in the pediatric UC trial was similar to that in the pediatric Crohn's disease study (Study Peds Crohn's) but higher than the proportion in the adults' ulcerative colitis studies (Study UC I and Study UC II). At Week 54, 38% (33/87) of infliximab-treated patients had no draining fistulas compared with 22% (20/90) of placebo-treated patients (P=0.02). Inflectra was the first biosimilar to Remicade, manufactured by Pfizer and released in April 2016. Your congestive heart failure may get worse while you are receiving RENFLEXIS. Renflexis is administered by intravenous infusion over a period of not less than 2 hours. This site is intended only for residents of the United States, its territories, and Puerto Rico. In Crohn's disease, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis studies, there were insufficient numbers of patients aged 65 and over to determine whether they respond differently from patients aged 18 to 65. The rate of malignancies among infliximab-treated patients was similar to that expected in the general population whereas the rate in control patients was lower than expected. What should I tell my doctor before I take RENFLEXIS? Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohns disease who havent responded well to other therapies, Can reduce signs and symptoms and induce and maintain remission in children (ages 617) with moderately to severely active Crohns disease who havent responded well to other therapies, Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who havent responded well to other therapies, Can reduce signs and symptoms and induce and maintain remission in children (ages 617) with moderately to severely active ulcerative colitis who haven't responded well to other therapies, Can reduce signs and symptoms, help stop further joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate, Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in patients with psoriatic arthritis, Can reduce signs and symptoms in patients with active ankylosing spondylitis, Approved for the treatment of adult patients with chronic (doesnt go away) severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if RENFLEXIS is appropriate considering other available therapies. RENFLEXIS. The risks and benefits of treatment with Renflexis should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. 2022 Organon group of companies. Tell your doctor if you have ever had any type of cancer. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. All rights reserved. RENFLEXIS is a prescription medication used to treat: RENFLEXIS is a medicine that affects your immune system. Renflexis should be discontinued if a patient develops a serious infection or sepsis. Crohn's Disease - children 6 years and older and adults with Crohn's disease who have not responded well to other medicines. Adults and children taking RENFLEXIS should not receive live vaccines or treatment with a weakened bacteria (such as Bacille Calmette-Gurin [BCG] for bladder cancer) while taking RENFLEXIS. For children and adults taking TNF blockers, including RENFLEXIS, the chances of getting lymphoma or other cancers may increase. Do not take Renflexis together with medicines such as KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics that are used to treat the same conditions as Renflexis. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, cryptococcosis, or blastomycosis is common, ask your doctor. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. Patients received either placebo + MTX or one of 4 doses/schedules of infliximab + MTX: 3 mg/kg or 10 mg/kg of infliximab by IV infusion at Weeks 0, 2 and 6 followed by additional infusions every 4 or 8 weeks in combination with MTX. Renflexis can cause serious side effects, including: If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Renflexis. Dosing CALCULATOR For children and adults taking TNF blockers, including RENFLEXIS, the chances of getting lymphoma or other cancers may increase. Common side effects of Renflexis include the following: stomach pain. The higher incidence of antibodies to infliximab by the ECLIA method was due to the 60-fold higher sensitivity compared to the EIA method. Anti-TNF antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Results of this study were similar to those seen in a multicenter double-blind, placebo-controlled study of 70 patients with ankylosing spondylitis. Of these, the most common malignancies were breast, colorectal, and melanoma. Compared to placebo maintenance, patients on infliximab maintenance had a trend toward fewer hospitalizations. In Study RA II, both infliximab treatment groups showed greater improvement in HAQ-DI from baseline averaged over time through Week 54 compared to MTX alone; 0.7 for infliximab + MTX vs. 0.6 for MTX alone (P0.001). Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. More patients treated with infliximab reached a major clinical response than placebo-treated patients (Table 7). Of patients on corticosteroids at baseline, greater proportions of patients in the infliximab treatment groups were in clinical remission and able to discontinue corticosteroids at Week 30 compared with the patients in the placebo treatment groups (22% in infliximab treatment groups vs. 10% in placebo group in Study UC I; 23% in infliximab treatment groups vs. 3% in placebo group in Study UC II). In Study RA I, approximately 80% of patients had paired X-ray data at 54 weeks and approximately 70% at 102 weeks. Ask your doctor or pharmacist for more information. Your doctor will check you for TB with a skin test. Concurrent use of stable doses of corticosteroids, 5-aminosalicylates, antibiotics, MTX, 6-mercaptopurine (6-MP) and/or azathioprine (AZA) was permitted. Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. 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. Overall proportions of adverse reactions, including infusion reactions, were similar between the 6 to 11 and 12 to 17 year age groups (13%). If you received Renflexis while you were pregnant, your baby may be at higher risk for getting an infection. Organon does not review or control the content of any non-Organon site. 2022 Organon group of companies. The active ingredient is infliximab-abda. At both Week 30 and Week 54, the proportion of patients in clinical response was greater in the every 8-week treatment group than in the every 12-week treatment group (73% vs. 47% at Week 30, and 64% vs. 33% at Week 54). Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. 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. RENFLEXIS can make you more likely to get an infection or make any infection that you have worse. For other types of vaccines, talk with your doctor. Renflexis In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who received infliximab at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. It is uncertain whether the occurrence of HSTCL is related to TNF-blockers or TNF-blockers in combination with these other immunosuppressants. Patients should be tested for HBV infection before initiating TNF blocker therapy, including Renflexis. Tell your doctor if you have: Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Antibodies to infliximab developed in 38% (20/53) of patients who received 3 mg/kg infliximab compared with 12% (6/49) of patients who received 6 mg/kg. At randomization, all patients received MTX (optimized to 20 mg/wk by Week 8) and either placebo, 3 mg/kg or 6 mg/kg infliximab at Weeks 0, 2, and 6 and every 8 weeks thereafter. Renflexis, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. This Medication Guide has been approved by the U.S. Food and Drug Administration. Patients who had a negative TB skin test before receiving infliximab products have developed active TB. In controlled trials, more infliximab-treated patients developed malignancies than placebo-treated patients [see Warnings and Precautions (5.2)]. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. Patients with guttate, pustular, or erythrodermic psoriasis were excluded from these studies. This site is intended only for residents of the United States, its territories, and Puerto Rico. Infliximab pharmacokinetic characteristics (including peak and trough concentrations and terminal half-life) were similar in pediatric (aged 6 to 17 years) and adult patients with Crohn's disease or ulcerative colitis following the administration of 5 mg/kg infliximab. Renflexis should be discontinued for severe hypersensitivity reactions. Talk to your doctor about stopping Renflexis if you are pregnant or plan to become pregnant. What are the new drugs for the treatment of plaque psoriasis? In some cases, patients have died as a result of hepatitis B virus being reactivated. For children and adults receiving TNF-blocker medicines, including Renflexis, the chances of getting lymphoma or other cancers may increase. Across all treatment groups, the median baseline PASI score was 19, and the baseline sPGA score ranged from moderate (62% of patients) to marked (22%) to severe (3%). Antibody development was lower among rheumatoid arthritis and Crohn's disease patients receiving immunosuppressant therapies such as 6-MP/AZA or MTX. No preservatives are present. Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who haven't responded well to other therapies, Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies, Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies, Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active ulcerative colitis who haven't responded well to other therapies, Approved for the treatment of adult patients with chronic (doesn't go away) severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if RENFLEXIS is appropriate considering other available therapies. 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