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{{Drugbox|
{{DrugProjectFormSinglePage
|IUPAC_name = <nowiki>[R-[[R*,R*-(E)]]-cyclic(L-alanyl-D-alanyl- N-methyl-L-leucyl-N-methyl-L-leucyl- N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl -L-α-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl- N-methyl-L-leucyl)</nowiki>
|authorTag=
| image=Ciclosporin2.jpg
 
| width=150px
 
| CAS_number=59865-13-3
<!--Overview-->
| ATC_prefix=L04
 
| ATC_suffix=AA01
|genericName=
| ATC_supvhmcgj,chg.,cg.guj.
 
plemental=
 
| PubChem=2909
 
| DrugBank=BTD00003
|aOrAn=
| C = 62| H = 111 | N = 11 | O = 12
 
| molecular_weight = 1202.61
a
| bioavailability= variable
 
| metabolism = [[liver|hepatic]]
|drugClass=
| elimination_half-life=variable (about 24 hours)
 
| excretion = biliary
 
| pregnancy_category = C <small>([[United States|U.S.]])</small>, C <small>([[Australia|Au]])</small>
 
| legal_status = S4 <small>(Au)</small>, POM <small>([[United Kingdom|UK]])</small>
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'''Associate Editor-In-Chief:''' {{CZ}}
 
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* Dosing Information
 
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=====Endocrine=====
 
 
 
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* Intravenous
 
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There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
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===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
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There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
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<!--How Supplied-->


|howSupplied=


For patient information, click [[Cyclosporine (patient information)|here]]
*


==Overview==
<!--Patient Counseling Information-->


'''Ciclosporin''' ([[International Nonproprietary Name|INN]]) ([[International Phonetic Alphabet|IPA]]: {{IPA|[ˈsaɪkləˌspɔrən]}}) , '''cyclosporine''' ([[United States Adopted Name|USAN]]) or '''cyclosporin''' (former [[British Approved Name|BAN]]), is an [[immunosuppressant]] [[medication|drug]] widely used [[Allograft|post-allogeneic]] [[organ transplant]] to reduce the activity of the patient's [[immune system]] and so the risk of organ [[Transplant rejection|rejection]]. It has been studied in transplants of skin, heart, kidney, lung, pancreas, bone marrow and small intestine. '''Ciclosporin A''', the main form of the drug, is a [[Cyclic compound|cyclic]] [[nonribosomal peptide]] of 11 [[amino acid]]s (an undecapeptide) produced by the [[fungus]] ''[[Tolypocladium inflatum Gams]]'', initially isolated from a Norwegian soil sample.<!--
|fdaPatientInfo=
  --><ref>Borel, Jean F. (one of the original researchers), "History of the discovery of cyclosporin and of its early pharmacological development," [http://www.springer.at/periodicals/article_pdf/xxxxxxxxxx55xxxxxx271109_1.pdf Wien Klin Wochenschr (2002) 114/12: 433–437.] Some sources list the fungus under an alternative species name [[Hypocladium inflatum gams]] such as Pritchard, DI. 2005. "Sourcing a chemical succession for cyclosporin from parasites and human pathogens". ''Drug Discovery Today'' '''10''' [10]: 688-691 and Walter Sneader 2005. "Ciclosporin" in: "Drug Discovery - A History", John Wiley & Sons, pages: 298-299 (refs. page 315).  However, the name, ''Tolypocladium inflatum Gams'', also appears in several other articles including in a 2001 online publication by Harriet Upton entitled "[http://www.world-of-fungi.org/Mostly_Medical/Harriet_Upton/Harriet_Upton.htm Origin of drugs in current use: the cyclosporin story]" (retrieved June 19, 2005). Mark Plotkin states in his book ''Medicine Quest'', Penguin Books 2001, pages 46-47, that in 1996 [[mycology]] researcher Kathie Hodge [http://www.angelfire.com/wizard/kimbrough/Textbook/IndustProductOfDrugs_blue.htm found] that it is in fact a species of ''[[Cordyceps]]''.</ref>


==Indications==
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
The immuno-suppressive effect of cyclosporin was discovered on January 31, 1972, by employees of [[Sandoz]] (now [[Novartis]]) in Basel, Switzerland, in a screening test on immune-suppression designed and implemented by Dr.[[Hartmann F. Stähelin]], M.D.  The success of Ciclosporin A in preventing organ rejection was shown in liver transplants performed by Dr. [[Thomas Starzl]] at the University of Pittsburgh hospital.  The first patient, on March 9, 1980, was a 28-year-old woman.  <ref name=Starzl>{{cite journal | author = Starzl and others | title = Liver transplantation with use of cyclosporin a and prednisone. | journal = N Engl J Med | volume = 305 | issue = 5 | pages = 266-9 | year = 1981}}</ref> Ciclosporin was subsequently approved for use in 1983.


Apart from in transplant medicine, ciclosporin is also used in [[psoriasis]], severe [[atopic dermatitis]] and infrequently in [[rheumatoid arthritis]] and related diseases, although it is only used in severe cases. It has been investigated for use in many other [[autoimmune disorder]]s.    Ciclosporin has also been used to help treat patients with [[ulcerative colitis]] who do not respond to treatment with steroids. <!--
<!--Precautions with Alcohol-->
--><ref name=Lichtiger>{{cite journal | author = Lichtiger S, Present D, Kornbluth A, Gelernt I, Bauer J, Galler G, Michelassi F, Hanauer S | title = Cyclosporine in severe ulcerative colitis refractory to steroid therapy. | journal = N Engl J Med | volume = 330 | issue = 26 | pages = 1841-5 | year = 1994 | id = PMID 8196726}}</ref> This drug is also used as a treatment of posterior or intermediate [[uveitis]] with non-infective etiology.


Ciclosporin A has been investigated as a possible [[neuroprotective]] agent in conditions such as [[traumatic brain injury]], and has been shown in animal experiments to reduce [[brain damage]] associated with injury.<!--
|alcohol=
  --><ref>Sullivan PG, Thompson M, and Scheff SW. 2000. "Continuous Infusion of Cyclosporin A Postinjury Significantly Ameliorates Cortical Damage Following Traumatic Brain Injury".  ''Experimental Neurology''. '''161''' [2]: 631-637.</ref>
Ciclosporin A  blocks the formation of the [[mitochondrial permeability transition pore]], which has been found to cause much of the damage associated with [[head injury]] and [[neurodegenerative disease]]s.


== Mode of action ==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Ciclosporin is thought to bind to the cytosolic protein [[cyclophilin]] (immunophilin) of immunocompetent lymphocytes, especially [[T-lymphocytes]]. This complex of ciclosporin and cyclophylin inhibits [[calcineurin]], which under normal circumstances is responsible for activating the transcription of [[interleukin-2]]. It also inhibits [[lymphokine]] production and [[interleukin]] release and therefore leads to a reduced function of effector T-cells. It does not affect cytostatic activity.
It has also an effect on [[mitochondria]]. Ciclosporin A prevents the mitochondrial PT pore from opening, thus inhibiting [[cytochrome c]] release, a potent [[apoptotic]] stimulation factor. However, this is not the primary mode of action for clinical use but rather an important effect for research on [[apoptosis]].


== Adverse effects and interactions ==
<!--Brand Names-->
Treatment may be associated with a number of potentially serious [[adverse drug reaction]]s (ADRs) and adverse drug interactions. Ciclosporin interacts with a wide variety of other drugs and other substances including grapefruit juice, although there have been studies into the use of grapefruit juice to increase the blood level of ciclosporin.


ADRs can include gum [[hyperplasia]], [[seizure|convulsion]]s, [[peptic ulcer]]s, [[pancreatitis]], [[fever]], [[vomit]]ing, [[diarrhea]], [[confusion]], breathing difficulties, [[numbness]] and [[tingling]], [[pruritus]], [[high blood pressure]], potassium retention and possibly [[hyperkalemia]], kidney and liver dysfunction ([[nephrotoxicity]] & [[hepatotoxicity]]), and obviously an increased vulnerability to opportunistic fungal and viral [[infection]]s.
|brandNames=


An alternate form of the drug, '''ciclosporin G''' (OG37-324), has been found to be much less nephrotoxic than the standard ciclosporin A<ref>Henry et al. 1995. "A clinical trial of cyclosporine G in cadaveric renal transplantation". ''Pediatric Nephrology'' ix:supplement 1.</ref>. Ciclosporin G ([[molecular mass|Mol. mass]] 1217) differs from ciclosporin A in the amino acid 2 position, where an L-nor-valine replaces the α-aminobutyric acid.<ref>Calne et al. 1985. "Cyclosporin G: Immunosuppressive Effect in Dogs with Renal Allografts". ''Lancet'' ii:1342.</ref>
* ®<ref>{{Cite web | title = | url = }}</ref>


===Cyclosporin Induced Hypertension===
<!--Look-Alike Drug Names-->
Hypertension occurs in 60% of patients on cyclosporine. The etiology is thought to be due to vasoconstriction. There is a loss of [[circadian rhythm]] in blood pressure.  [[Verapamil]], [[cardizem]] and [[nicardipine]] increase cyclosporine concentrations.


== Formulations ==
|lookAlike=
The drug is marketed by [[Novartis]] under the brand names '''Sandimmune''', the original formulation, and '''Neoral''' for the newer microemulsion formulation. Generic ciclosporin preparations have been marketed under various trade names including '''Cicloral''' ([[Sandoz|Sandoz/Hexal]]) and '''Gengraf''' ([[Abbott Laboratories|Abbott]]). Since 2002 a topical [[emulsion]] of ciclosporin for treating [[keratoconjunctivitis sicca]] has been marketed under the trade name '''Restasis'''. Annual sales of ciclosporin are around $1 billion.


The drug is also available in a dog preparation manufactured by Novartis called Atopica.  Atopica is indicated for the treatment of [[atopy|atopic dermatitis]] in dogs. Unlike the human form of the drug, the lower doses used in dogs mean the drug acts as an immuno-modulator and has fewer side effects than in man. The benefits of using this product include the reduced need for concurrent therapies to bring the condition under control.
* 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}}


== See also ==
|drugShortage=
}}


* [[Cremophor EL]]  ( Additive in Sandimmune )
<!--Pill Image-->
* [[Castor oil]]    ( Additive in Sandimmune )


==External links==
{{PillImage
* [http://www.pharma.us.novartis.com/product/pi/pdf/neoral.pdf Neoral U.S. Prescribing Information]
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
* [http://www.pharma.us.novartis.com/product/pi/pdf/sandimmune.pdf Sandimmune U.S. Prescribing Information]
|drugName=
* [http://www.atopica.com/ Atopica brand (for atopic dermatitis in dogs)]
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
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{{Immunosuppressants}}
<!--Label Display Image-->


[[Category:Immunosuppressive agents]]
{{LabelImage
[[Category:Novartis]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}
 
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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[[de:Ciclosporin]]
<!--Category-->
[[es:Ciclosporina]]
[[nl:Ciclosporine]]
[[ja:シクロスポリン]]
[[pl:Cyklosporyna]]
[[pt:Ciclosporina]]


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Revision as of 16:16, 24 October 2014

Cyclosporine (oral)
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

Cyclosporine (oral) 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 Cyclosporine (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cyclosporine (oral) 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 Cyclosporine (oral) 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 Cyclosporine (oral) 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 Cyclosporine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cyclosporine (oral) during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Cyclosporine (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Cyclosporine (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cyclosporine (oral) in the drug label.

Pharmacology

There is limited information regarding Cyclosporine (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

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

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cyclosporine (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cyclosporine (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cyclosporine (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cyclosporine (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Cyclosporine (oral) Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Cyclosporine (oral) 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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