Patients with active JRA between the ages of 4 and 17 years who had been treated with MTX for at least 3 months were enrolled. During the controlled portions of infliximab trials for labeled indications, 14 patients were diagnosed with malignancies (excluding lymphoma and NMSC) among 4,019 infliximab-treated patients vs. 1 among 1,597 control patients (at a rate of 0.52/100 patient-years among infliximab-treated patients vs. a rate of 0.11/100 patient-years among control patients), with median duration of follow-up 0.5 years for infliximab-treated patients and 0.4 years for control patients. No evidence of accumulation of infliximab has been observed after repeated dosing 3 mg/kg or 10 mg/kg IV at 4 or 8-week intervals. An embryofetal development study was conducted in pregnant mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF. Gastroenterology. Prescribers should exercise caution when considering the use of infliximab in patients with pre-existing or recent onset neurological disease or seizure disorder. Patients also had plaque psoriasis with a qualifying target lesion 2 cm in diameter. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Physical function and disability were assessed using the Health Assessment Questionnaire (HAQ-DI) and the general health-related quality of life questionnaire SF-36. Must reconstitute and dilute beforeintravenous infusion. 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. Each of these effects was maintained through the end of each trial (Week 54 in Study UC I, and Week 30 in Study UC II). Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis, cryptococcosis, or blastomycosis are common. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration. [27994] [60724] [61891] [62698] Intravenous Infusion AdministrationPrior to IV infusion, premedication may be administered at the prescriber's discretion. Among patients who were not in response at Week 2, 59% (92/157) of infliximab maintenance patients responded by Week 14 compared to 51% (39/77) of placebo maintenance patients. 1. Reconstitute each RENFLEXIS vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smaller needle as follows: Remove the flip-top from the vial and wipe the top with an alcohol swab. Gently mix. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products [see Adverse Reactions (6.2)]. The recommended dose of RENFLEXIS is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at Weeks 0, 2, 6, 14, and 22 (100 patients in each group). Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of infliximab; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases. At Week 54, the proportion of patients able to discontinue corticosteroids while in remission was 46% for the every 8-week maintenance group and 17% for the every 12-week maintenance group. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis and tuberculosis have been reported with TNF-blockers. Of these infliximab-treated patients, 9 developed a malignancy, including 1 lymphoma, for a rate of 7.67 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 3.51 -14.56). Links to other websites are provided as a convenience to the visitor. Overlapping biological activity may further increase the patients' susceptibility to infectious pathogens. Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of Crohn's disease including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates. The American College of Gastroenterology strongly recommends the use of infliximab to treat Crohn's disease that is resistant to treatment with corticosteroids. In clinical trials, the use of concomitant immunosuppressant agents appeared to reduce the frequency of antibodies to infliximab and appeared to reduce infusion reactions. In accordance with the product label, each vial of SB2 was reconstituted aseptically with 10 mL of water for injection delivered by a 21-gauge or smaller needle and a 10 mL Kovax syringe (Korea Vaccine Co., Ltd).2 The contents of one reconstituted vial were then transferred by sterile needle and . 888-727-0015. The RENFLEXIS infusion should begin within 4 hours of reconstitution and dilution. It is recommended that all pediatric and adult patients be brought up to date with all vaccinations prior to initiating infliximab therapy. Discontinue riluzole if clinical signs of liver dysfunction are present. Your doctor will test you for HBV. Anifrolumab: (Major) Coadministration is not recommended. Program Contact Information. Infliximab products cross the placenta and infants exposed in utero should not be administered live vaccines for at least 6 months after birth [see Clinical Considerations]. Malignancies, some fatal, have been reported among children, adolescents and young adults who received treatment with TNF-blocking agents (initiation of therapy 18 years of age), including infliximab products. 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. Parenteral drug products should be inspected visually before and after reconstitution for particulate matter and discoloration prior to administration, whenever solution and container permit. Remicade, Inflectra, Avsola, Cosentyx, Enbrel, Entyvio, Humira, Ilumya, Otezla, Stelara. The safety and efficacy of infliximab were assessed in 2 randomized, double-blind, placebo-controlled studies in patients with fistulizing Crohn's disease with fistula(s) that were of at least 3 months duration. 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). Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Tell your doctor about all the medicines you take. 2022 Organon group of companies. Skin Cancerany changes in or growths on your skin. Some patients receiving infliximab products have developed serious liver problems. At Weeks 30 and 54, significant improvement from baseline was seen among the 5 mg/kg and 10 mg/kg infliximab-treated groups compared to the placebo group in the disease-specific inflammatory bowel disease questionnaire (IBDQ), particularly the bowel and systemic components, and in the physical component summary score of the general health-related quality of life questionnaire SF-36. Upon initiation or discontinuation of RENFLEXIS in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. Clinically relevant drug interactions may occur with CYP450 substrates that have a narrow therapeutic index such as theophylline. Structural damage in both hands and feet was assessed radiographically at Week 54 by the change from baseline in the van der Heijde-modified Sharp (vdH-S) score, a composite score of structural damage that measures the number and size of joint erosions and the degree of joint space narrowing in hands/wrists and feet.3. The majority of the malignancies developed in the lung or head and neck. Dexamethasone: (Moderate) Many serious infections during infliximab therapy have occurred in patients who received concurrent immunosuppressives that, in addition to their underlying Crohn's disease or rheumatoid arthritis, predisposed patients to infections. The types of infections, including serious infections, reported in patients with ulcerative colitis were similar to those reported in other clinical studies. No worsening in the SF-36 mental component summary score was observed. If infliximab is initiated or discontinued in a patient taking warfarin, check the INR; warfarin dose adjustment may be needed. Cells expressing transmembrane bound TNFalpha bound by infliximab can be lysed in vitro by complement or effector cells. have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. It is recommended that therapeutic infectious agents not be given concurrently with RENFLEXIS [see Warnings and Precautions (5.15)]. The REMICADE infusion should begin within 3 hours of preparation. The data described herein reflect exposure to infliximab in 4779 adult patients (1304 patients with rheumatoid arthritis, 1106 patients with Crohn's disease, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 484 with ulcerative colitis, 1373 with plaque psoriasis, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. Periodic screening should continue in women treated with RENFLEXIS [see Adverse Reactions (6.2)]. Infliximab has not been studied in patients with mild heart failure (NYHA Class I/II) [see Contraindications (4) and Warnings and Precautions (5.5)]. - Uses, Side Effects, and More. A separate, drug-tolerant electrochemiluminescence immunoassay (ECLIA) method for detecting antibodies to infliximab was subsequently developed and validated. In the combined clinical trial population for rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis, 5 lymphomas were observed for a rate of 0.10 cases per 100 patient-years of follow-up, which is approximately 4-fold higher than expected in the general population. 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. You can ask your doctor or pharmacist for information about RENFLEXIS that is written for health professionals. Do not use if opaque particles, discoloration, or other foreign particles are present. RENFLEXIS can be used with or without methotrexate. (. Patients who undergo surgery while taking a biologic therapy, such as infliximab, may be at greater risk for postoperative infections. Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving infliximab. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. These are not all of the side effects with RENFLEXIS. Eight percent also had rectovaginal fistulas. Copay Range. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Psoriatic Arthritis and Plaque Psoriasis: For injection: 100 mg of lyophilized infliximab-abda in a 20 mL vial for intravenous infusion. Cerebrovascular accidents, myocardial ischemia/infarction (some fatal), and arrhythmia occurring within 24 hours of initiation of infusion have also been reported [see Warnings and Precautions (5.8)]. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. Infliximab is administered intravenously. This site is intended for health care professionals in the United States, its territories, and Puerto Rico. At 6 months, the PASI 75 and PASI 90 responses were achieved by 60% and 39%, respectively, of patients receiving infliximab compared to 1% and 0%, respectively, of patients receiving placebo. A potential exists for an increased risk for serious infection or an impact on the development of malignancies from increased activity toward TNF. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Each RENFLEXIS vial contains 100 mg of the infliximab-abda antibody. 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter. Specific guidelines for dosage adjustments in renal impairment are not available. Concomitant MTX use may decrease the incidence of anti-drug antibody production and increase infliximab product concentrations. (, treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. [See also Clinical Studies (14.8)]. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. Dosing continued for all patients through Week 46. Reports of lupus and lupus-like syndromes, however, remain uncommon. Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab product infusion. More patients in Study UC II than UC I were taking solely aminosalicylates for UC (26% vs. 11%, respectively). The concomitant use of RENFLEXIS with these biologics is not recommended because of the possibility of an increased risk of infection [see Drug Interactions (7.3)]. Tuberculosis should be strongly considered in patients who develop a new infection during RENFLEXIS treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis. In plaque psoriasis, treatment with infliximab products may reduce the epidermal thickness and infiltration of inflammatory cells. For patients that do not tolerate the infusion following these interventions, RENFLEXIS should be discontinued. In the controlled portions of clinical trials of all the TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared with control patients. RENFLEXIS is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. In clinical trials, the use of concomitant immunosuppressant agents appeared to reduce the frequency of antibodies to infliximab and appeared to reduce infusion reactions. Cyclosporine: (Moderate) The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNF-alpha) during chronic inflammation. Almost all patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Reconstitution of SB2. In Study Peds Crohn's, infections were reported more frequently for patients who received every 8-week as opposed to every 12-week infusions (74% and 38%, respectively), while serious infections were reported for 3 patients in the every 8-week and 4 patients in the every 12-week maintenance treatment group. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. RENFLEXIS can block the damage caused by too much TNF-alpha. Study II also evaluated the proportion of patients who achieved a score of "clear" or "excellent" by the relative Physician's Global Assessment (rPGA). In Study Peds Crohn's, in which all patients received stable doses of 6-MP, AZA, or MTX, excluding inconclusive samples, 3 of 24 patients had antibodies to infliximab. 5 mg/kg IV infusion at 0, 2, and 6 weeks for induction. If a decision is made to administer RENFLEXIS to patients with heart failure, they should be closely monitored during therapy, and RENFLEXIS should be discontinued if new or worsening symptoms of heart failure appear [see Contraindications (4) and Adverse Reactions (6.1)]. RENFLEXIS is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5mg/kg. infliximab-treated patients also demonstrated greater improvement in the SF-36 physical and mental component summary scores than placebo-treated patients. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Study III (SPIRIT) evaluated 249 patients who had previously received either psoralen plus ultraviolet A treatment (PUVA) or other systemic therapy for their psoriasis. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi, or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Infliximab has been associated with optic neuritis, seizures, central nervous system (CNS) manifestations of systemic vasculitis, and new onset or exacerbation of clinical symptoms and/or radiographic evidence of CNS demyelinating disorders including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders including Guillain-Barre syndrome. The improvement with infliximab was consistent across all Mayo subscores through Week 54 (Study UC I shown in Table 6; Study UC II through Week 30 was similar). The total dose of the reconstituted product must be further diluted to 250 mL with 0.9% Sodium Chloride Injection, USP. The most common side effects of infliximab products include: infliximab injection, powder, lyophilized, for solution, All Drug The results of Study I through Week 50 in the 5 mg/kg every 8 weeks maintenance dose group were similar to the results from Study II. It is recommended that live vaccines not be given concurrently with RENFLEXIS. Avoid concurrent use in patients with increased serum transaminases, total bilirubin, or direct bilirubin (more than ULN) or active liver or biliary tract disease. These differences are discussed in the following paragraphs. Infliximab neutralizes the biological activity of the cytokine tumor necrosis factor-alpha (TNFalpha). If jaundice and/or marked liver enzyme elevations [e.g., 5 times of more the upper limit of normal (ULN)] develop, infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken. If you get an infection while receiving treatment with RENFLEXIS your doctor will treat your infection and may need to stop your RENFLEXIS treatment. Among all infliximab infusions, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions. DO NOT SHAKE. This is especially true for people with very active disease. If needed, unopened RENFLEXIS vials may be stored at room temperatures up to a maximum of 30C (86F) for a single period of up to 6 months but not exceeding the original expiration date. Concomitant use may increase the risk for hepatotoxicity. Discontinue RENFLEXIS if a patient develops a serious infection or sepsis. There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab. 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