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{{WikiDoc Cardiology News}}
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'''Associate Editor-In-Chief:''' {{CZ}}


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|overdose====Acute Overdose===


==Overview==
====Signs and Symptoms====


'''Infliximab''' (brand name '''Remicade''') is a drug used to treat [[autoimmune]] [[List of autoimmune diseases|disorders]].  Infliximab is known as a "chimeric [[monoclonal antibody]]" (the term "chimeric" refers to the use of both mouse ([[murine]]) and human components of the drug i.e. murine binding VK and VH domains and human constant Fc domains).  The drug blocks the action of  [[TNFα]] (tumour necrosis factor alpha) by binding to it and preventing it from signaling the [[receptor (biochemistry)|receptors]] for TNFα on the surface of [[cell (biology)|cells]]. TNFα is one of the key [[cytokines]] that triggers and sustains the [[inflammation]] response. Remicade was developed by Junming Le and [[Jan Vilcek]] at [[New York University School of Medicine]] and developed by [[Centocor]], a biotechnology company later purchased by [[Johnson & Johnson]].<ref>Knight DM, Trinh H, Le J, Siegel S, Shealy D, McDonough M, Scallon B, Moore MA, Vilcek J, Daddona P, et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. ''Mol Immunol'' 1993;30:1443-53. PMID 8232330.</ref>
(Description)


Infliximab has been approved by the U.S. [[Food and Drug Administration]] for the treatment of [[psoriasis]],[[Crohn's disease]], [[ankylosing spondylitis]], [[psoriatic arthritis]], [[rheumatoid arthritis]], and [[ulcerative colitis]].  According to the manufacturer's websites, there are more patients world-wide who have been treated with Remicade (the first commercially available TNF antagonist) than [[Enbrel]] and [[Humira]] combined.
====Management====


Remicade is administered by [[intravenous therapy|intravenous infusion]], typically at 6-8 week intervals, and at a clinic or hospital.  It cannot be administered [[route of administration|orally]], because the [[digestive system]] would destroy the drug.
(Description)


== Pharmacology ==
===Chronic Overdose===
According to product labeling, Infliximab neutralizes the biological activity of [[TNF alpha|TNFα]] by binding with high [[affinity]] to the soluble (free floating in the blood) and transmembrane (located on the outer membranes of [[T cells]] and similar immune cells) forms of TNFα and inhibits or prevents the effective binding of TNFα with its receptors. Remicade and [[Humira]] (another TNF antagonist) are in the subclass of "anti-TNF antibodies" (they are in the form of naturally occurring antibodies), and are capable of neutralizing all forms (extracellular, [[transmembrane]], and [[Receptor (immunology)|receptor]]-bound) of TNF alpha.<ref> Choy EH et al. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907-916</ref> [[Enbrel]], a third TNF antagonist, is in a different subclass (receptor-construct fusion protein), and, because of its modified form, cannot neutralize receptor-bound TNFa.<ref>Etanercept product labeling</ref> Additionally, the anti-TNF antibodies Humira and Remicade have the capability of [[lysing]] cells involved in the inflammatory process, whereas the receptor fusion protein apparently lacks this capability.<ref>Etanercept, Adalimumab and Infliximab product labeling</ref> Although the clinical significance of these differences have not been absolutely proven, they may account for the differential actions of these drugs in both efficacy and side effects.


Infliximab has high [[Specificity (tests)|specificity]] for TNFα, and does not neutralize TNF beta (TNFβ, also called [[lymphotoxin]] α), a related but less inflammatory cytokine that utilizes the same receptors as TNFα. Biological activities that are attributed to TNFα include: induction of [[proinflammatory]] [[cytokine]]s such as [[interleukin]] (IL) 1 and IL 6, enhancement of [[leukocyte]] movement or migration from the blood vessels into the tissues by increasing the permeability of [[endothelial]] layer of blood vessels; and increasing the release of [[adhesion molecule]]s. Infliximab prevents disease in [[transgenic]] mice (a special type of mice that are biologically engineered to produce a human form of TNFα and which are used to test the results of these drugs that might be expected in humans).  These experimental mice develop arthritis as a
====Signs and Symptoms====
result of their production of human TNFα, and when administered after disease onset, infliximab allows eroded joints to heal.


==Infliximab in Crohn's disease==
(Description)
There are three [[phenotype]]s, or categories of disease presentation in [[Crohn's disease]]: '''stricturing''' disease (which causes narrowing of the bowel), '''penetrating''' disease (which causes [[fistula]]e or abnormal connections of the bowel), and '''inflammatory''' disease (which causes primarily [[inflammation]]).<!--
--><ref name=phenotypes>{{cite journal | author = Dubinsky MC, Fleshner PP. | title = Treatment of Crohn's Disease of Inflammatory, Stenotic, and Fistulizing Phenotypes. | journal = Curr Treat Options Gastroenterol | volume = 6 | issue = 3 | pages = 183-200 | year = 2003 | pmid = 12744819 | doi = 10.1007/s11938-003-0001-1}}</ref>
===Fistulizing disease===
Infliximab was first used for closure of fistulae in [[Crohn's disease]] in [[1999]].  In a 94 patient phase II clinical trial by ''Present et al'', the researchers showed that Infliximab was effective in closing fistulae between the [[skin]] and [[bowel]] in 56-68% of patients.<!--
--><ref name=Present>{{cite journal | author = Present D, Rutgeerts P, Targan S, Hanauer S, Mayer L, van Hogezand R, Podolsky D, Sands B, Braakman T, DeWoody K, Schaible T, van Deventer S | title = Infliximab for the treatment of fistulas in patients with Crohn's disease. | journal = N Engl J Med | volume = 340 | issue = 18 | pages = 1398-405 | year = 1999 | pmid = 10228190 | doi = 10.1056/NEJM199905063401804}}</ref>  <!--
-->A large 296 patient Phase III clinical trial conducted by [[Bruce Sands]] et al, called the ACCENT 2 trial, showed that infliximab was additionally beneficial in maintaining closure of fistulae, with almost two-thirds of all patients treated with the 3 initial doses REMICADE having a fistula response after 14 weeks, and 36% of patients maintaining closure of fistulae after a year, compared to 19% who received [[placebo]] therapy.  This final trial resulted in the FDA approval of the drug to treat fistulizing disease.<!--
--><ref name=ACCENT2>{{cite journal | author = Sands B, Anderson F, Bernstein C, Chey W, Feagan B, Fedorak R, Kamm M, Korzenik J, Lashner B, Onken J, Rachmilewitz D, Rutgeerts P, Wild G, Wolf D, Marsters P, Travers S, Blank M, van Deventer S | title = Infliximab maintenance therapy for fistulizing Crohn's disease. | journal = N Engl J Med | volume = 350 | issue = 9 | pages = 876-85 | year = 2004 | pmid = 14985485 | doi = 10.1056/NEJMoa030815}}</ref>, <ref>[http://www.remicade.com www.Remicade.com]</ref>


===Inflammatory disease===
====Management====
[[Image:CD colitis.jpg|right|thumb|150px|Inflammatory [[Crohn's disease]], seen here as [[ulcer]]s on [[colonoscopy]] can be treated with infliximab]]
Infliximab has also been used in order to induce and maintain remission in inflammatory [[Crohn's disease]].  The ACCENT 1 trial was a large multicentre trial that showed that 39 to 45% patients treated with infliximab who had an initial response to it, maintained remission after 30 weeks, compared to 21% who received placebo treatment.  It also showed a mean maintenance of remission from 38 to 54 weeks compared to 21 weeks for patients who received placebo treatment.<ref name=ACCENT1> {{cite journal | author = Hanauer S, Feagan B, Lichtenstein G, Mayer L, Schreiber S, Colombel J, Rachmilewitz D, Wolf D, Olson A, Bao W, Rutgeerts P | title = Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. | journal = Lancet | volume = 359 | issue = 9317 | pages = 1541-9 | year = 2002 | pmid = 12047962 | doi = 10.1016/S0140-6736(02)08512-4}} </ref> 


Crohn's patients have flares of their disease between periods of disease quiescence.  Severe flares are usually treated with [[Prednisone|steroid]] medications to obtain remission, but steroids have many undesirable side effects, and therefore some gastroenterologists are now advocating for the use of infliximab as the first drug to try to get patients into [[remission]].  This has been called the ''top-down'' approach to treatment.<!--
(Description)
--><ref name=topdown>{{cite journal | author = Hanauer S | title = Crohn's disease: step up or top down therapy. | journal = Best Pract Res Clin Gastroenterol | volume = 17 | issue = 1 | pages = 131-7 | year = 2003 | pmid = 12617888 | doi = 10.1053/bega.2003.0361}}</ref>
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==Infliximab in ulcerative colitis==
<!--Clinical data-->
As infliximab targets [[tumour necrosis factor|TNF]], thought to be more related to Th1 cytokines, it was initially thought to be of limited utility in ulcerative colitis, which was thought to be a Th2 disease.  However, patients with ulcerative colitis have begun to be treated with infliximab on the basis of two large clinical trials conducted in [[2005]] by Paul Rutgeerts and William Sandborn.  The ACT 1 and ACT 2 (Acute ulcerative Colitis Treatment) trials evaluated the utility of infliximab in ulcerative colitis and showed that 44-45% of patients treated with infliximab for a year maintained a response to the medication, compared to 21% of patients who were treated with placebo medication.  At 2 months, the response was 61-69% for patients treated with infliximab, and 31% for those who were treated with placebo.<ref name=ACT> {{cite journal | author = Rutgeerts P, Sandborn W, Feagan B, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer S, Lichtenstein G, de Villiers W, Present D, Sands B, Colombel J | title = Infliximab for induction and maintenance therapy for ulcerative colitis. | journal = N Engl J Med | volume = 353 | issue = 23 | pages = 2462-76 | year = 2005 | pmid = 16339095 | doi = 10.1056/NEJMoa050516}}</ref>
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== Safety ==
<!--Pharmacokinetic data-->
According to the product labeling of Infliximab, Etanercept, and Adalimumab, these drugs are in the class of immunosuppressants.  After a number of studies and reports of adverse reactions in patients receiving anti-TNFα therapy (including serious and sometimes fatal blood disorders, [[infection]]s, rare reports of lymphoma and solid tissue cancers, rare reports of serious liver injury, rare reports of drug induced lupus and rare reports of [[demyelinating]] [[central nervous system]] disorders), the FDA issued a warning to doctors appearing in the respective product labeling of these drugs instructing them to screen and monitor potential patients more carefully [http://www.fda.gov/medwatch/safety/2006/May_PIs/Remicade_PI.pdf].
| bioavailability =  
Maintenance therapy with the drug (versus intermittent or sporadic therapy) lessens the likelihood of developing antibodies to infliximab which could reduce the efficacy of the drug.  Combination treatment with [[methotrexate]] (an anti-folate drug which suppresses the immune system) has been shown to reduce the formation of these antibodies in patients with rheumatoid arthritis <ref>[http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=10622295 ATTRACT RA Trial]</ref>  and combination therapy with other immunosuppressants has been shown to reduce the liklihood of these antibodies being formed in Crohn's disease.<ref name="ACCENT1"/>  The use of immunosuppressants may not be necessary in all diseases for which infliximab is indicated, and indiscriminant use of these other immunosuppressants carry their own risks. Infliximab was studied in monotherapy (without concommitant immunosuppressants such as methotrexate or azathioprine) in psoriasis, psoriatic arthritis, and ankylosing spondylitis, and only its use in rheumatoid arthritis requires the concomitant use of methotrexate by FDA product labeling.  There are case reports of remicade infusions being associated with [[myocarditis]].
| metabolism =  
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== Other uses ==
<!--Identifiers-->
Case studies have been done into other uses of infliximab, such as to treat skin diseases. Remicade (infliximab) has been approved for treating [[ankylosing spondylitis]], [[Crohn's disease]], fistulizing Crohn's disease, [[pediatric]] Crohn's disease, [[psoriatic arthritis]], [[psoriasis]], [[rheumatoid arthritis]], and [[ulcerative colitis]].  Infliximab is also prescribed (out of indication) for the treatment of Behcet's disease.<ref>Sfikakis PP. Behcet's disease: a new target for anti-tumour necrosis factor treatment. ''Ann Rheum Dis'' 2002;61 Suppl 2:ii51-3. PMID 12379622.</ref> and infusions of infliximab have been used successfully in the treatment of sciatica due to slipped discs.<ref>Korhonen T et al. Efficacy fo infliximab for disc herniation-induced sciatica: a one-year follow-up. Spine 2004;29:2115-9.</ref>
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There have been numerous case reports of the efficacy of infliximab in various inflammatory skin conditions diseases; psoriasis, in which increased TNFα has been demonstrated, is the most recent indication.<ref>Gupta AK, Skinner AR. A review of the use of infliximab to manage cutaneous dermatoses. ''J Cutan Med Surg'' 2004;8:77-89. PMID 15685387.</ref>
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|clinicalStudies======Condition 1=====


Psoriatic arthritis (PsA), a chronic systemic inflammatory disorder characterized by the association of arthritis and psoriasis, follows a heterogeneous and variable clinical course.  Inhibitors of TNF, such as infliximab, substantially improve the signs and symptoms of psoriasis (level 1b, grade A). Several therapies with modest efficacy have been studied in nail psoriasis. Among available agents, higher quality data are available to support the efficacy of cyclosporine and infliximab, a TNF antagonist. Based on studies in AS, the results suggest that infliximab, etanercept, and adalimumab have the potential to reduce the signs and symptoms of moderate to severely active axial involvement in PsA in patients who have had an inadequate response to NSAID (level 1a, grade A).The anti-TNF agents (infliximab and etanercept; level 1b, grade A) are more effective for the treatment of enthesitis than traditional agents.Results suggest that infliximab is effective for the treatment of dactylitis in PsA (level 1b, grade B). KAVANAUGH et al., Systematic Review of Treatments for Psoriatic Arthritis: An Evidence Based Approach and Basis for Treatment Guidelines. 2006; J Rheumatol 2006;33:1417–21)
(Description)


== Availability/Affordability ==
=====Condition 2=====
Like all of the TNF inhibitors, Remicade is an expensive medication, costing about $1000 for a 100mg dose, and is covered by almost every medical insurance plan. It is administered every 6-8 weeks, with an initial startup requiring smaller time frames between infusions. According to the labeling, the current [[posology]] is:
* [[Ankylosing Spondylitis]]: 5mg per kg
* [[Crohn's disease]]: 5mg per kg
* [[Psoriatic Arthritis]]: 5mg per kg
* [[Rheumatoid Arthritis]]: 3mg per kg
* [[Psoriasis]]: 5mg per kg


== See also ==
(Description)
* [[Adalimumab]]
* [[Biological therapy for inflammatory bowel disease]]
* [[Etanercept]]
* [[Monoclonal antibody]]
* [[Tumor necrosis factors]]


==External links==
=====Condition 3=====
*[http://www.remicade.com Remicade information]
*[http://healthcarebase.com/remicade-for-crohns-disease.php Remicade for Crohn's disease]
*[http://www.druglib.com/druginfo/remicade/ Remicade Drug Label]


==References==
(Description)
{{Reflist|2}}
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* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|drugShortage=Drug Shortage
}}


{{Immunosuppressants}}
{{Immunosuppressants}}

Revision as of 15:06, 30 July 2014

Infliximab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
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Use in Specific Populations
Administration & Monitoring
Overdosage
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Infliximab is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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Pediatric Indications and Dosage

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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Contraindications

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Warnings

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Adverse Reactions

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Condition 2
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Cardiovascular
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Gastrointestinal
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Use in Specific Populations

Pregnancy

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Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Infliximab
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Infliximab Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Infliximab |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Infliximab |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Infliximab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Infliximab Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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