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Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with Remicade should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Remicade, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade [see Warnings and Precautions (5.2)].
Remicade 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. Remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
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 Crohn's disease who have had an inadequate response to conventional therapy.
Remicade 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. 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 ulcerative colitis who have had an inadequate response to conventional therapy. Remicade, 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. Remicade is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Remicade is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis. Prior to initiating Remicade and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see Warnings and Precautions (5.1)].
Adverse effects during administration of Remicade have included flu-like symptoms, headache, dyspnea, hypotension, transient fever, chills, gastrointestinal symptoms, and skin rashes.
During or following infusion, patients who have severe infusion-related hypersensitivity reactions should be discontinued from further Remicade treatment. Calculate the dose, total volume of reconstituted Remicade solution required and the number of Remicade vials needed. Reconstitute each Remicade 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. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents. Parenteral drug products should be inspected visually before and after reconstitution for particulate matter and discoloration prior to administration, whenever solution and container permit.
100 mg vial: 100 mg lyophilized infliximab in a 20 mL vial for injection, for intravenous use.
Remicade should not be re-administered to patients who have experienced a severe hypersensitivity reaction to Remicade.
Patients treated with Remicade are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF-blockers. Treatment with Remicade should not be initiated in patients with an active infection, including clinically important localized infections.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Remicade and periodically during therapy. Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Anti-tuberculosis therapy should also be considered prior to initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Tuberculosis should be strongly considered in patients who develop a new infection during Remicade 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.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Remicade, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. 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 Remicade. 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. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including Remicade [see Adverse Reactions (6.2)]. In the controlled portions of clinical trials of some TNF-blocking agents including Remicade, more malignancies (excluding lymphoma and nonmelanoma skin cancer [NMSC]) have been observed in patients receiving those TNF-blockers compared with control patients.
In a clinical trial exploring the use of Remicade in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, the majority of lung or head and neck origin, were reported in Remicade-treated patients compared with control patients. Psoriasis patients should be monitored for nonmelanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment. The potential role of TNF-blocking therapy in the development of malignancies is not known [see Adverse Reactions (6.1)]. Use of TNF blockers, including Remicade, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported rarely in postmarketing data in patients receiving Remicade.
Remicade has been associated with adverse outcomes in patients with heart failure, and should be used in patients with heart failure only after consideration of other treatment options. Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving Remicade.
Remicade has been associated with hypersensitivity reactions that vary in their time of onset and required hospitalization in some cases. In rheumatoid arthritis, Crohn's disease and psoriasis clinical trials, re-administration of Remicade after a period of no treatment resulted in a higher incidence of infusion reactions relative to regular maintenance treatment [see Adverse Reactions (6.1)].
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
In clinical studies, concurrent administration of TNF-blocking agents and abatacept have been associated with an increased risk of infections including serious infections compared with TNF-blocking agents alone, without increased clinical benefit. There is insufficient information regarding the concomitant use of Remicade with other biological therapeutics used to treat the same conditions as Remicade. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
Treatment with Remicade may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. It is recommended that all pediatric patients be brought up to date with all vaccinations prior to initiating Remicade therapy. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not predict the rates observed in broader patient populations in clinical practice.
The data described herein reflect exposure to Remicade 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. An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion.
Patients who became positive for antibodies to infliximab were more likely (approximately two- to three-fold) to have an infusion reaction than were those who were negative. In Remicade clinical studies, treated infections were reported in 36% of Remicade-treated patients (average of 51 weeks of follow-up) and in 25% of placebo-treated patients (average of 37 weeks of follow-up). In Remicade clinical studies in patients with ulcerative colitis, infections treated with antimicrobials were reported in 27% of Remicade-treated patients (average of 41 weeks of follow-up) and in 18% of placebo-treated patients (average 32 weeks of follow-up). The onset of serious infections may be preceded by constitutional symptoms such as fever, chills, weight loss, and fatigue. Approximately half of Remicade-treated patients in clinical trials who were antinuclear antibody (ANA) negative at baseline developed a positive ANA during the trial compared with approximately one-fifth of placebo-treated patients. In controlled trials, more Remicade-treated patients developed malignancies than placebo-treated patients [see Warnings and Precautions (5.2)]. In a randomized controlled clinical trial exploring the use of Remicade in patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease. Treatment with Remicade can be associated with the development of antibodies to infliximab.
The incidence of antibodies to infliximab was based on the original EIA method in all clinical studies of Remicade except for the Phase 3 study in pediatric patients with ulcerative colitis where the incidence of antibodies to infliximab was detected using both the EIA and ECLIA methods [see Adverse Reactions, Pediatric Ulcerative Colitis (6.1)]. The incidence of antibodies to infliximab in patients given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through 1 to 2 years of Remicade treatment. The data reflect the percentage of patients whose test results were positive for antibodies to infliximab in an immunoassay, and they are highly dependent on the sensitivity and specificity of the assay. Severe liver injury, including acute liver failure and autoimmune hepatitis, has been reported rarely in patients receiving Remicade [see Warnings and Precautions (5.4)]. In clinical trials in rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving Remicade than in controls (Table 1), both when Remicade was given as monotherapy and when it was used in combination with other immunosuppressive agents.


Placebo patients received methotrexate while Remicade patients received both Remicade and methotrexate.
ALT values are obtained in 2 Phase 3 psoriasis studies with median follow-up of 50 weeks for Remicade and 16 weeks for placebo. In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who received Remicade at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo. Safety data are available from 4779 Remicade-treated adult patients, including 1304 with rheumatoid arthritis, 1106 with Crohn's disease, 484 with ulcerative colitis, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 1373 with plaque psoriasis and 17 with other conditions. The most common serious adverse reactions observed in clinical trials were infections [see Adverse Reactions (6.1)]. There were some differences in the adverse reactions observed in the pediatric patients receiving Remicade compared to those observed in adults with Crohn's disease.
If Cheadle was to be in Epping to meet an eleven o'clock arrival, he would have to mark a brisk pace in order to be on time, and it would seem he would have to bring James with him. Dream Machine Marketing can add value to clients by using lead generation techniques on the internet to generate leads for businesses. We deliver our clients pointed market analysis and, thus, focus on the sectors most applicable to your needs. We work with you not only by personally developing and implementing those strategies, but also by managing your entire marketing program to ensure everything is done correctly to maximize your sales and profits. For a free no-obligation quote on how we will help you successfully market your product or service, both online and offline, contact us today by calling 0418 322 871A  or click here to email us. And it seems ironic that doctors try to IMPROVE the activity of the immune system in those with HIV in order to PREVENT these same illnesses, while diminishing the immune system so much in those with Crohn's Disease that they are actually CAUSING these diseases! And there ARE alternatives to traditional treatment for Crohn's Disease and other autoimmune diseases- but your doctor is NOT going to tell you about them!
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High quality probiotics such as Prescript Assist Probiotic have shown some success in improving symptoms of autoimmune problems. The goal at Journey With Crohns Disease is to help you find solutions for everyday Crohn's disease problems.
Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.
Remicade should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warnings, Warnings and Precautions (5)].
For patients that do not tolerate the infusion following these interventions, Remicade should be discontinued. The management of severe infusion reactions should be dictated by the signs and symptoms of the reaction. 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.
Remicade should not be infused concomitantly in the same intravenous line with other agents. If visibly opaque particles, discoloration or other foreign particulates are observed, the solution should not be used.
Additionally, Remicade should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins. Cases of active tuberculosis have also occurred in patients being treated with Remicade during treatment for latent tuberculosis. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Remicade, even for patients previously vaccinated with Bacille Calmette-Guérin (BCG). Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Tests for latent tuberculosis infection may also be falsely negative while on therapy with Remicade.
A patient who develops a new infection during treatment with Remicade should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.
Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. In the controlled and open-label portions of Remicade clinical trials, 5 patients developed lymphomas among 5707 patients treated with Remicade (median duration of follow-up 1.0 years) vs.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
During the controlled portions of Remicade trials in patients with moderately to severely active rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis, 14 patients were diagnosed with malignancies (excluding lymphoma and NMSC) among 4019 Remicade-treated patients vs. In the maintenance portion of clinical trials for Remicade, NMSCs were more common in patients with previous phototherapy [see Adverse Reactions (6.1)].
Rates in clinical trials for Remicade cannot be compared to rates in clinical trials of other TNF-blockers and may not predict rates observed in a broader patient population. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.
In general, the benefit-risk of re-administration of Remicade after a period of no-treatment, especially as a re-induction regimen given at weeks 0, 2 and 6, should be carefully considered. Prescribers should exercise caution in considering the use of Remicade in patients with these neurologic disorders and should consider discontinuation of Remicade if these disorders develop. Because of the nature of the adverse reactions seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents.
Therefore, the combination of Remicade and abatacept is not recommended [see Drug Interactions (7.1)]. The concomitant use of Remicade with these biologics is not recommended because of the possibility of an increased risk of infection [see Drug Interactions (7.3)]. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade, treatment should be discontinued [see Adverse Reactions (6.1)].
Infliximab is known to cross the placenta and has been detected up to 6 months following birth. It is recommended that therapeutic infectious agents not be given concurrently with Remicade. The interval between vaccination and initiation of Remicade therapy should be in accordance with current vaccination guidelines. In Phase 3 clinical studies, 18% of Remicade-treated patients experienced an infusion reaction compared to 5% of placebo-treated patients.
Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension.
The infections most frequently reported were respiratory tract infections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections. The types of infections, including serious infections, reported in patients with ulcerative colitis were similar to those reported in other clinical studies. The majority of serious infections, however, may also be preceded by signs or symptoms localized to the site of the infection. Anti-dsDNA antibodies were newly detected in approximately one-fifth of Remicade-treated patients compared with 0% of placebo-treated patients.
An enzyme immunoassay (EIA) method was originally used to measure anti-infliximab antibodies in clinical studies of Remicade.
A higher incidence of antibodies to infliximab was observed in Crohn's disease patients receiving Remicade after drug-free intervals >16 weeks.
Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medication, and underlying disease. Reactivation of hepatitis B virus has occurred in patients receiving TNF-blocking agents, including Remicade, who are chronic carriers of this virus [see Warnings and Precautions (5.3)].
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, or modification of concomitant medications. Patients who were randomized to the placebo maintenance group and then later crossed over to Remicade are included in the Remicade group in ALT analysis. Specifically, the median duration of follow-up was 30 weeks for placebo and 31 weeks for Remicade. Of these patients, 6 required hospitalization due to fever, severe myalgia, arthralgia, swollen joints, and immobility. We specialize in developing highly successful marketing programs for businesses of all sizes, including start-ups. Patients should be tested for latent tuberculosis before Remicade use and during therapy.1,2 Treatment for latent infection should be initiated prior to Remicade use.
Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Remicade in these patients.


Approximately 20% of Remicade-treated patients in all clinical trials experienced an infusion reaction compared with 10% of placebo-treated patients [see Adverse Reactions (6.1)]. Appropriate personnel and medication should be available to treat anaphylaxis if it occurs.
Slowly add the total volume of reconstituted Remicade solution to the 250 mL infusion bottle or bag. 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. Almost all patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Prescribers should exercise caution when considering the use of Remicade in patients with moderate to severe COPD. Caution should be exercised in considering Remicade treatment in patients with a history of malignancy or in continuing treatment in patients who develop malignancy while receiving Remicade. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of Remicade; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking Remicade. Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with Remicade who have ongoing or a history of significant hematologic abnormalities. These reactions were associated with a marked increase in antibodies to infliximab, loss of detectable serum concentrations of infliximab, and possible loss of drug efficacy. In the case where Remicade maintenance therapy for psoriasis is interrupted, Remicade should be reinitiated as a single dose followed by maintenance therapy. At least a six month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab. Of infliximab-treated patients who had an infusion reaction during the induction period, 27% experienced an infusion reaction during the maintenance period. In this study, the majority of serious infusion reactions occurred during the second infusion at Week 2. Among Remicade-treated patients, serious infections included pneumonia, cellulitis, abscess, skin ulceration, sepsis, and bacterial infection.
The EIA method is subject to interference by serum infliximab, possibly resulting in an underestimation of the rate of patient antibody formation.
For these reasons, comparison of the incidence of antibodies to infliximab with the incidence of antibodies to other products may be misleading. Adverse reactions reported in ≥5% of all patients with rheumatoid arthritis receiving 4 or more infusions are in Table 2. When you select us as your company’s marketing firm, we will develop an explosive marketing program for your business that crushes your competition and makes your company a dominant online leader in your industry.
She will never give up on the idea of me marrying James or trying to see it come to fruition, no matter to whom I am betrothed.abbott humira citizen petitionHe pulled her closer to him and left his arms around her, just go with it. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
The majority of reported Remicade cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males. Prior to infusion with Remicade, premedication may be administered at the physician's discretion. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy. The malignancies occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF blocker therapy. In rheumatoid arthritis patients, 2 lymphomas were observed for a rate of 0.08 cases per 100 patient-years of follow-up, which is approximately three-fold higher than expected in the general population. Patients should be tested for HBV infection before initiating TNF blocker therapy, including Remicade.
There have also been rare post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period. Remicade infusions beyond the initial infusion were not associated with a higher incidence of reactions. Symptoms included, but were not limited to, dyspnea, urticaria, facial edema, and hypotension. In clinical trials, 7 opportunistic infections were reported; 2 cases each of coccidioidomycosis (1 case was fatal) and histoplasmosis (1 case was fatal), and 1 case each of pneumocystosis, nocardiosis and cytomegalovirus.
A separate, drug-tolerant electrochemiluminescence immunoassay (ECLIA) method for detecting antibodies to infliximab was subsequently developed and validated. The clinical significance of apparent increased immunogenicity on efficacy and infusion reactions in psoriasis patients as compared to patients with other diseases treated with Remicade over the long term is not known. The types and frequencies of adverse reactions observed were similar in Remicade-treated rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and Crohn's disease patients except for abdominal pain, which occurred in 26% of Remicade-treated patients with Crohn's disease. 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 four-fold higher than expected in the general population. It is uncertain whether the occurrence of HSTCL is related to TNF-blockers or TNF-blockers in combination with these other immunosuppressants. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. Discontinuation of Remicade therapy should be considered in patients who develop significant hematologic abnormalities. The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis Study I.
Patients who were antibody-positive were more likely to have higher rates of clearance, reduced efficacy and to experience an infusion reaction [see Adverse Reactions (6.1)] than were patients who were antibody negative.
In the Crohn's disease studies, there were insufficient numbers and duration of follow-up for patients who never received Remicade to provide meaningful comparisons. Cost Per Click is where advertisers pay a fee for each click on the advertisement, whether it be a banner ad or a text ad. These cases were reported post-marketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.
The rate of malignancies among Remicade-treated patients was similar to that expected in the general population whereas the rate in control patients was lower than expected. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. If a decision is made to administer Remicade to patients with heart failure, they should be closely monitored during therapy, and Remicade should be discontinued if new or worsening symptoms of heart failure appear [see Contraindications (4) and Adverse Reactions (6.1)]. In psoriasis Study II, the rates were variable over time and somewhat higher following the final infusion than after the initial infusion.
Other cases of tuberculosis, including disseminated tuberculosis, also have been reported post-marketing. With the ECLIA method, all clinical samples can be classified as either positive or negative for antibodies to infliximab without the need for the inconclusive category.
Two active cases of tuberculosis were reported: 6 weeks and 34 weeks after starting Remicade. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Patients who are carriers of HBV and require treatment with TNF blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In clinical trials, mild or moderate elevations of ALT and AST have been observed in patients receiving Remicade without progression to severe hepatic injury [see Adverse Reactions (6.1)]. Most of these cases of tuberculosis occurred within the first 2 months after initiation of therapy with Remicade and may reflect recrudescence of latent disease [see Warnings and Precautions (5.1)]. The solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab is a protein.
Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.
In patients who develop HBV reactivation, TNF blockers should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. Do not use if the lyophilized cake has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present.
The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, prescribers should exercise caution when considering resumption of TNF blocker therapy in this situation and monitor patients closely. During the 54-week Crohn's II Study, 15% of patients with fistulizing Crohn's disease developed a new fistula-related abscess.



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