Tacrolimus (topical): Difference between revisions

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-15,19-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)<br>
 
-tetrone, monohydrate
 
| image = Tacrolimus-2D-skeletal.png
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| CAS_number = 104987-11-3
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| ATC_supplemental= {{ATC|D11|AX14}}
 
| PubChem = 656830
|indication=
| DrugBank = APRD00276
 
| C=44 | H=69 | N=1 | O=12
 
| molecular_weight = 804.018 g/mol
 
| smiles = C=CC[C@@H]1C=C(C)C[C@H](C)C[C@H](OC)[C@H]2O[C@](O)([C@H](C)C[C@@H]2OC)C(=O) C(=O)N2CCCC[C@H]2C(=O)O[C@H](\C(=C\[C@@H]2CC[C@@H](O)[C@H](OC)C2)/C)[C@H](C )[C@@H](O)CC1=O
|hasBlackBoxWarning=
| bioavailability = 20%, less after eating food rich in fat
 
| protein_bound =75-99%
Yes
| metabolism = Hepatic [[CYP3A4]]
 
| elimination_half-life = 11.3 hours (range 3.5-40.6 hours)
|adverseReactions=
| excretion = Mostly faecal
 
| pregnancy_category = A
 
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| routes_of_administration = Topical, oral, [[Intravenous|iv]]
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<!--How Supplied-->


'''Tacrolimus''' (also '''FK-506''' or '''Fujimycin''') is an [[immunosuppression|immunosuppressive]] [[medication|drug]] whose main use is after allogenic [[organ transplant]] to reduce the activity of the patient's [[immune system]] and so the risk of organ [[Transplant rejection|rejection]]. It is also used in a topical preparation in the treatment of severe [[atopic dermatitis]] ("[[eczema]]"), severe refractory [[uveitis]] after [[bone marrow]] transplants, and the skin condition [[vitiligo]].  It is a 23-membered [[macrolide]] [[lactone]] discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the [[bacteria]] ''[[Streptomyces tsukubaensis]]''.
|howSupplied=


==History==
*
Tacrolimus was discovered in 1987 by a Japanese team headed by T. Goto, T. Kino and H. Hatanaka; it was among the first [[macrolide]] immunosuppressants discovered, preceded by the discovery of [[rapamycin]] (sirolimus) on Rapa Nui (Easter Island) in 1975.<ref name="JAntibiot1987-Kino">{{cite journal | author=Kino T, Hatanaka H, Hashimoto M, Nishiyama M, Goto T, Okuhara M, Kohsaka M, Aoki H, Imanaka H | title=FK-506, a novel immunosuppressant isolated from a Streptomyces. I. Fermentation, isolation, and physico-chemical and biological characteristics. | journal=J Antibiot (Tokyo) | volume=40 | issue=9 | pages=1249-55 | year=1987 | id=PMID 2445721}}</ref> Like [[ciclosporin]], it was found in a soil fungus, although it is produced by a type of bacteria, ''Streptomyces tsukubaensis''.<ref name="DrugDiscovToday2005-Pritchard">{{cite journal | author=Pritchard D | title=Sourcing a chemical succession for cyclosporin from parasites and human pathogens. | journal=Drug Discov Today | volume=10 | issue=10 | pages=688-91 | year=2005 | id=PMID 15896681}} <small>Supports source organism, but not team information</small></ref> The name tacrolimus is reportedly derived from '[[Tsukuba, Ibaraki|'''T'''sukuba]] m'''acrol'''ide '''im'''m'''u'''no'''s'''uppressant'.


The drug is owned by [[Astellas Pharma|Astellas Pharma Inc.]], and is sold under the tradenames '''Prograf''', '''Advagraf''', and '''Protopic'''. It is sometimes referred to as FK-506, an early name relating to its action. It was first approved by the [[Food and Drug Administration]] (FDA) in 1994 for use in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, bone marrow, and limb transplants.
<!--Patient Counseling Information-->


==Pharmacology==
|fdaPatientInfo=
Tacrolimus is chemically known as a [[macrolides|macrolide]]. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex interacts with and inhibits [[calcineurin]] thus inhibiting both T-[[lymphocyte]] signal transduction and IL-2 transcription.<ref name="Cell1991-Liu">{{cite journal | author=Liu J, Farmer J, Lane W, Friedman J, Weissman I, Schreiber S | title=Calcineurin is a common target of cyclophilin-cyclosporin A and FKBP-FK506 complexes. | journal=Cell | volume=66 | issue=4 | pages=807-15 | year=1991 | id=PMID 1715244}}</ref> Although this activity is similar to [[cyclosporin]], studies have shown that the incidence of acute rejection is reduced by tacrolimus use over [[cyclosporin]].


==Indications==
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
===Immunosuppresion following transplantation===
It has similar immunosuppressive properties to cyclosporin, but is much more potent in equal volumes. Also like cyclosporin it has a wide range of adverse interactions, including that with [[grapefruit]] which increases plasma-tacrolimus concentration. Several of the newer class of antifungals, especially of the azole class (fluconazole, posaconazole) also increase drug levels by competing for degradative enzymes. Immunosuppression with tacrolimus was associated with a significantly lower rate of acute rejection compared with cyclosporin-based immunosuppression (30.7% vs 46.4%) in one study.<ref name="Medscape2004-McCauley">{{cite web | last=McCauley | first=Jerry |date=2004-05-19 | url = http://www.medscape.com/viewarticle/474429 | title=Long-Term Graft Survival In Kidney Transplant Recipients | work=Slide Set Series on Analyses of Immunosuppressive Therapies | publisher=[[Medscape]] | accessdate=2006-06-06}}</ref>


===Use in treating ulcerative colitis===
<!--Precautions with Alcohol-->
In recent years, Tacrolimus has been used to suppress the inflammation associated with [[ulcerative colitis]], a form of [[inflammatory bowel disease]]. Although almost exclusively used in trial cases only, Tacrolimus has shown to be significantly effective in the suppression of outbreaks of UC.


===Dermatological use===
|alcohol=
''See also: [[Eczema#Immunomodulators|Immunomodulators in the treatment of eczema]]''


As an [[ointment]] ('''Protopic'''), tacrolimus is a recent addition in the treatment of [[eczema]], particularly [[atopic dermatitis]]. It suppresses inflammation in a similar way to [[steroid]]s, and is equally as effective as a mid-potency steroid.  An important advantage of tacrolimus is that unlike steroids, it does not cause skin thinning ([[atrophy]]), or other steroid related side-effects. It may therefore be used continuously on the body (clinical trials of up to one year in length have occurred), and applied to the thinner skin over the face and eyelids. Recently it has also been used to treat segmental vitiligo in children,especially on the face.<ref>Nanette B. Silverberg, Peggy Lin, Lisa Travis, Jeanne Farley-Li, Anthony J. Mancini, Annette M. Wagner, Sarah L. Chamlin and Amy S. Paller(Nov.2004)."Tacrolimus ointment promotes repigmentation of vitiligo in children: A review of 57 cases". Journal of the American Academy of Dermatology, Volume 51, Issue 5,Pages 760-766.</ref>
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


The most common adverse events associated with the use of Protopic included the sensation of skin burning, itching, flu-like symptoms, and headache. The use of Protopic should be avoided on known or suspected malignant lesions. The use of Protopic on patients with Netherton's syndrome or similar skin diseases is not recommended. Patients should minimize or avoid natural or artificial sunlight exposure. Skin infections should be cleared prior to application, and there may be an increased risk of certain skin infections. Protopic should not be used with occlusive dressings ([http://www.protopic.com/ http://www.protopic.com/]).
<!--Brand Names-->


==Contraindications and Precautions==
|brandNames=
* [[breast-feeding]]
* [[hepatic]] disease
* immunosuppression
* [[infant]]s
* [[infection]]
* intravenous administration
* [[neoplastic]] disease
* occlusive dressing
* [[oliguria]]
* [[pregnancy]]
* QT prolongation
* [[skin cancer]]
* [[sunlight]] ([[UV]]) exposure
* grapefruit juice<ref name="DrugMetab-Fukatsu">{{cite journal | author=Fukatsu S, Fukudo M, Masuda S, Yano I, Katsura T, Ogura Y, Oike F, Takada Y, Inui K | title=Delayed effect of grapefruit juice on pharmacokinetics and pharmacodynamics of tacrolimus in a living-donor liver transplant recipient | journal=Drug Metab Pharmacokinet | volume=21| issue=2 | pages=122-5 | year=2006 | id=PMID 16702731}}</ref>


==Side effects==
* ®<ref>{{Cite web | title = | url = }}</ref>
===From oral and intravenous administration===
Side effects can be severe and include blurred vision, liver and [[kidney]] problems (it is nephrotoxic), [[seizure]]s, [[tremor]]s, [[hypertension]], hypomagnesemia, [[diabetes mellitus]], [[hyperkalemia]], [[itch]]ing, [[insomnia]], confusion, loss of appetite, [[hyperglycemia]], weakness, depression, cramps, and neuropathy, as well as potentially increasing the severity of existing fungal or infectious conditions such as [[varicella-zoster virus|herpes zoster]] or [[polyomavirus|polyoma]] viral infections.


===From topical use===
<!--Look-Alike Drug Names-->
A common side effect of tacrolimus ointment, if used over a wide area, is to cause a burning or itching sensation on the first one or two applications. Less common side effects include flu-like symptoms, headache, cough and burning eyes.<ref name="JAcadDerm-Hanifin">{{cite journal | author=Hanifin JM, Paller AS, Eichenfield L, Clark RA, Korman N, Weinstein G, Caro I, Jaracz E, Rico MJ; US Tacrolimus Ointment Study Group | title=Efficacy and safety of tacrolimus ointment treatment for up to 4 years in patients with atopic dermatitis | journal=J Am Acad Derm | volume=53| issue=2 suppl 2| pages=S186-94 | year=2005 | id=PMID 16021174 }}</ref>


===Cancer risks===
|lookAlike=
{{see|Eczema#Immunomodulators}}
Tacrolimus and a related drug for eczema ([[pimecrolimus]]) were suspected of carrying a cancer risk, though the matter is still a subject of controversy. The FDA issued a health warning in March 2005 for the drug, based on animal models and a small number of patients. Until further human studies yield more conclusive results, the FDA recommends that users be advised of the potential risks. Whereas current practice by [[United Kingdom|UK]]  dermatologists  is not to consider this a significant real concern and they are increasingly recommending the use of these new drugs.<ref name=BAD2002">{{cite web | author= N H Cox and Catherine H Smith | year = 2002 | month = December | url = http://www.bad.org.uk/healthcare/guidelines/Advice_re_topical_tacrolimus.doc | title =Advice to dermatologists re topical tacrolimus | format =DOC | work = Therapy Guidelines Committee | publisher = British Association of Dermatologists}}</ref>


Dermatologists agree that the drug should be used as a second-line remedy only after conventional methods of treatment have failed.
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


==References==
<!--Drug Shortage Status-->
{{reflist|2}}


==External links==
|drugShortage=
* [http://www.astellas.us/docs/prograf.pdf Prograf prescribing information at Fujisawa]
}}
* [http://www.fda.gov/cder/drug/infopage/protopic/default.htm Tacrolimus (Protopic Cream) FDA advisory page (for eczema treatment)]
* [http://www.fda.gov/cder/drug/infopage/elidel/default.htm Pimecrolimus (Elidel Cream) FDA adivisory page (for eczema treatment)]
* [http://www.protopiclawyers.com Offers more information on possible cancer risks of Protopic (Tacrolimus)]
*[http://www.fermentek.co.il/FK506.htm Tacrolimus (FK506) ]product page from [[Fermentek]]


{{Other dermatological preparations}}
<!--Pill Image-->
{{immunosuppressants}}


[[Category:Immunosuppressive agents]]
{{PillImage
[[Category:Macrolide antibiotics]]
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
[[Category:Cardiology]]
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<!--Label Display Image-->


{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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[[de:Tacrolimus]]
<!--Category-->
[[es:Tacrolimus]]
[[fr:Tacrolimus]]
[[it:Tacrolimus]]
[[he:טקרולימוס]]
[[nl:Tacrolimus]]
[[ja:タクロリムス]]
[[pl:Takrolimus]]
[[ru:Такролимус]]


{{WH}}
[[Category:Drug]]
{{WS}}

Revision as of 16:21, 25 November 2014

Tacrolimus (topical)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Tacrolimus (topical) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tacrolimus (topical) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tacrolimus (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Tacrolimus (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tacrolimus (topical) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tacrolimus (topical) in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tacrolimus (topical) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tacrolimus (topical) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tacrolimus (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tacrolimus (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tacrolimus (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tacrolimus (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tacrolimus (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tacrolimus (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tacrolimus (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tacrolimus (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tacrolimus (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tacrolimus (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tacrolimus (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Tacrolimus (topical) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Tacrolimus (topical) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tacrolimus (topical) in the drug label.

Pharmacology

There is limited information regarding Tacrolimus (topical) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Tacrolimus (topical)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tacrolimus (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tacrolimus (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tacrolimus (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tacrolimus (topical) in the drug label.

How Supplied

Storage

There is limited information regarding Tacrolimus (topical) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Tacrolimus (topical) |?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::Tacrolimus (topical) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tacrolimus (topical) in the drug label.

Precautions with Alcohol

  • Alcohol-Tacrolimus (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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