WARNINGS
RISK OF INFECTIONS
Patients treated with REMICADE are at increased risk for infections, including progression to serious infections leading to hospitalization or death (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections. Patients should be educated about the symptoms of infection, closely monitored for signs and symptoms of infection during and after treatment with REMICADE, and should have access to appropriate medical care. Patients who develop an infection should be evaluated for appropriate antimicrobial therapy and for serious infections REMICADE should be discontinued.
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving REMICADE. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection 1, 2 prior to initiating REMICADE and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with REMICADE. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving REMICADE. Some patients who tested negative for latent tuberculosis prior to receiving REMICADE have developed active tuberculosis. Physicians should monitor patients receiving REMICADE for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
HEPATOSPLENIC T-CELL LYMPHOMAS
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn's disease treated with REMICADE. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. All of these hepatosplenic T-cell lymphomas with REMICADE have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.
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REMICADE SUMMARY
REMICADE® is a chimeric IgG1(kappa) monoclonal antibody.
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 who have had an inadequate response to methotrexate.
REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in 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 patients with fistulizing Crohn's disease.
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NEWS HIGHLIGHTSMedia Articles Related to Remicade (Infliximab)
Reactions to Remicade Are Rare (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.07.16]
(MedPage Today) -- Canadian real-world study confirms infliximab safety
Remicade Phase 3 data show long-term psoriasis response
Source: The Doctors Lounge - Dermatology
Findings from two Phase 3 studies show high-level, sustained response with maintenance therapy.
Published Studies Related to Remicade (Infliximab)
Remission induction comparing infliximab and high-dose intravenous steroid,
followed by treat-to-target: a double-blind, randomised, controlled trial in
new-onset, treatment-naive, rheumatoid arthritis (the IDEA study). [2014]
infliximab (IFX) with MTX and intravenous corticosteroid for remission induction... CONCLUSIONS: In DMARD-naive early RA patients, initial therapy with MTX+high-dose
A clinical trial and extension study of infliximab in Korean patients with active
rheumatoid arthritis despite methotrexate treatment. [2013]
Currently, infliximab is given for disease control for active rheumatoid
arthritis (RA) patients despite methotrexate treatment. However, the efficacy and
safety of infliximab in Korean patients has not been assessed appropriately...
Hand bone loss in patients with psoriatic arthritis: posthoc analysis of IMPACT
II data comparing infliximab and placebo. [2013]
or infliximab (IFX)... CONCLUSION: This pilot study indicates that hand bone loss in PsA patients
Cost-efficacy of adalimumab, etanercept, infliximab and ustekinumab for moderate-to-severe plaque psoriasis. [2011.11.30]
Background Different biological agents are used for the treatment of psoriasis. Previous data have shown adalimumab to be the most efficient drug in terms of cost-efficacy... The robustness of this finding was confirmed by sensitivity analysis.
Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1). [2011.11]
BACKGROUND: Infliximab is indicated for treatment of moderate-to-severe plaque psoriasis in adults whose disease cannot be controlled with other systemic therapies, including methotrexate (MTX). To date, no studies have directly compared the efficacy and safety of infliximab and MTX. OBJECTIVES: To compare the efficacy and safety of infliximab vs. MTX in adults with moderate-to-severe plaque psoriasis... CONCLUSIONS: Infliximab was well tolerated and more efficacious than MTX in patients with moderate-to-severe plaque psoriasis. Infliximab also was efficacious in patients who failed MTX and switched to infliximab. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.
Clinical Trials Related to Remicade (Infliximab)
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis [Completed]
The purpose of this study is to evaluate the effectiveness and safety of infliximab
(Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
Effects of Infliximab (Remicade) on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia [Completed]
The purpose of this study is to determine whether infliximab is effective on fat-free mass in
the treatment of patients with moderate to severe COPD suffering from cachexia.
Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies [Completed]
Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role
in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking
monoclonal antibody efficacious and safe as treatment of adult-onset SpA.
In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients
with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and
that it will be well tolerated. At the end of this phase, patients will go into a 52-week
open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We
will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy
will be assessed by counting the number of actively inflamed joints and a number of other
parameters.
Observation Study of Remicade (Infliximab) Injection (Study P05725) [Recruiting]
The purpose of this study is to observe the safety and effectiveness of Remicade Injection
(infliximab) under actual conditions of use in patients, and to learn more about its side
effects. Patients with ankylosing spondylitis will have 6 Remicade injections and be
observed for 24-30 weeks. Patients with rheumatoid arthritis will have 6 Remicade
injections and be observed for 30 weeks. Patients will be observed for side effects and
disease activity.
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis [Completed]
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)
in patients with plaque-type psoriasis.
Reports of Suspected Remicade (Infliximab) Side Effects
Infusion Related Reaction (1121),
Crohn's Disease (639),
Dyspnoea (576),
Drug Ineffective (445),
Skin Cancer (440),
Arthralgia (391),
Pneumonia (375),
Pain (356),
Herpes Zoster (344),
Nausea (341), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 12 ratings/reviews, Remicade has an overall score of 6.50. The effectiveness score is 8.67 and the side effect score is 5.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Remicade review by 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | psoriatic arthritis |
| Dosage & duration: | | 400 mg taken every 8 weeks for the period of still taking it |
| Other conditions: | | osteo arthritis |
| Other drugs taken: | | Lexapro, Immuran | | |
Reported Results |
| Benefits: | | This drug has helped the pain and swelling in my hands and back from psoriatic arthritis. My fingers were also starting to twist, and this has helped to slow that down. The psoriasis on my skin has almost gone completely away. About a week or two before time for the next dose, a little comes back, but nothing like it used to be. |
| Side effects: | | I don't notice any side effects. |
| Comments: | | I go in to the office for an inter venous infusion every 8 weeks for two hours at a time. |
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| | Remicade review by 46 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Colitis |
| Dosage & duration: | | Not sure (dosage frequency: 8 weeks) for the period of Still taking |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Stopped bleeding and relieved some abdominal cramps. |
| Side effects: | | After only 3 treatments I have developed common side effects, as in dizzines which keeps me from being too active. I am always tired even though I am finally sleeping most of the night, I have developed the bumps on the forhead that everyone talks about, and I have the need to constantly unrinate. I have been reading reviews online now for a week and am getting concerned because most comments show that people find the side effects worse than the condition and I have just started. I believe that I am also suffering from depression, but because I am a single parent I try to keep myself busy with family issues which allows me to put aside the bad feelings temporarily. |
| Comments: | | Have done 3 infusions, starting with 2 weeks after first and then 4 weeks. Now I am awaiting my 4th which will be 8 weeks. The staff have been great, from the nurse who does the procedure to the councillor at Bio-Advance, but the one draw back is that I have been telling both the nurse and the councillor about my side effects and they acted so surprised. So why did I find out by going online myself that these side effects are common? |
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| | Remicade review by 51 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Stills Disase |
| Dosage & duration: | | According to my weight (dosage frequency: every 3 months) for the period of year |
| Other conditions: | | Major Headaches and High blood pressure, nasty skins sores |
| Other drugs taken: | | Ultram | | |
Reported Results |
| Benefits: | | To relieve muscle aches and joint pain |
| Side effects: | | Started getting severe headaches from the medication.It cause high blood pressure that lasted 12 to 14 weeks after my last infusion. Also sores on my scalp,arms, laegs and buttocks that hurt so bad and our so sore.They clear up and come right back at the same exact spot.
I ended up in the hospital. When I was at work a collapse to the floor and I didnt know what was going on until they found my blood pressure sky high and I had severe chest pains. They gave me nitro pill for my chest pain and medication to drop my blood pressure but it took almost 14 weeks before those side effects to go away. I stopped taking it back in 2004.
However the sores have nevr gone away and I keep getting these major flare ups with the sores all over my body.
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| Comments: | | The treatment is was fine how ever the side effects where much worest than the treatment.
Johnson and Johnson sent me a certified letter pertaining to my problems with the side effects and I answered their questions but they never did get back to me at all about my condition. |
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Page last updated: 2015-07-16
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