Goserelin: Difference between revisions

Jump to navigation Jump to search
m (Robot: Automated text replacement (-{{SIB}} + & -{{EH}} + & -{{EJ}} + & -{{Editor Help}} + & -{{Editor Join}} +))
No edit summary
Line 1: Line 1:
{{CMG}}
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|aOrAn=a
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content


<!--Adult Indications and Dosage-->


'''''For patient information, click [[Goserelin (patient information)|here.]]'''
<!--FDA-Labeled Indications and Dosage (Adult)-->
''
|fdaLIADAdult======Condition1=====
<br>
 
{{drugbox |
* Dosing Information
| IUPAC_name = <nowiki>N-[1-[[1-[[1-[[1-[[1-[[1-[[1-[2-</nowiki><br>[(carbamoylamino)carbamoyl]pyrrolidin-1-yl]-<br>5-(diaminomethylideneamino)-1-oxo<br>-pentan-2-yl]carbamoyl]-3-methyl-<br>butyl]carbamoyl]-2-tert-butoxy-<br>ethyl]carbamoyl]-2-(4-hydroxyphenyl)<br>ethyl]carbamoyl]-2-hydroxy-ethyl]<br>carbamoyl]-2-(1H-indol-3-yl)ethyl]<br>carbamoyl]-2-(3H-imidazol-4-yl)ethyl]-<br>5-oxo-pyrrolidine-2-carboxamide
 
| image = Goserelin.svg
:* Dosage
| CAS_number = 65807-02-5
 
| ATC_prefix = L02
=====Condition2=====
| ATC_suffix =AE03
 
| PubChem = 47725
* Dosing Information
| DrugBank = BTD00113
 
| C=59 | H=84| N=18| O=14|
:* Dosage
| molecular_weight = 1269.410 g/mol
 
| protein_bound=27.3%
=====Condition3=====
| synonyms = D-Ser(But)<sup>6</sup>Azgly<sup>10</sup>LHRH
 
| elimination_half-life=4-5 hours
* Dosing Information
| excretion = renal
 
| pregnancy_category = D (3.6mg) / X (10.8mg) ([[United States|USA]])
:* Dosage
| legal_status = Rx-only
 
| routes_of_administration = [[Implant (medicine)|implant]]
=====Condition4=====
| Excipients = Lactide/glycolide copolymer
 
}}
* Dosing Information
{{SI}}
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Overview==
<!--Precautions with Alcohol-->
'''Goserelin''' Acetate is an injectable [[gonadotropin releasing hormone]] super-agonist ([[GnRH agonist]]). It stops the production of sex hormones ([[testosterone]] and [[Estrogen|oestrogen]]).
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


Goserelin Acetate is marketed by [[AstraZeneca]] with the brand name '''Zoladex'''.<ref>[http://www.zoladex.net/ AstraZeneca official Zoladex site]</ref> It was first launched in 1987 and is currently the second-largest selling GnRH analogue in the world. It is currently available in more than one hundred markets.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>


Zoladex 3.6 mg subcutaneous monthly biodegradable implant was first approved by the FDA on November 3, 1989<ref>[http://www.fda.gov/medwatch/safety/1999/nov99.htm#zolade FDA Approval for Zoladex 3.6 mg]</ref> for treatment of prostate cancer, a 10.8 mg subcutaneous 3-month biodegradable implant and other indications were subsequently approved.
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


==Pharmacokinetics==
<!--Drug Shortage Status-->
Goserelin is a synthetic analogue of a naturally occurring luteinising-hormone releasing hormone ([[LHRH]]). Bioavailability is almost complete. Gosereline is poorly protein bound and has a serum elimination half-life of two to four hours in patients with normal renal function. The half-life increases with patients with impaired renal function. There is no significant change in pharmacokinetics in subjects with hepatic failure. After administration, peak serum concentrations are reached in about two hours. It rapidly binds to the LHRH receptor cells in the [[pituitary gland]] thus leading to an initial increase in production of [[luteinizing hormone]] and thus leading to an initial increase in the production of corresponding sex hormones. This initial Flare may be treated by co-prescribing/co-administering [[Casodex]] (Bicalutamide) or similar medication. Eventually, after a period of about 14-21 days, production of LH is greatly reduced due to receptor [[downregulation]], and sex hormones are generally reduced to castrate levels.<ref>{{cite journal | last = Kotake | first = Toshihiko | coauthors = Michiyuki Usami, Hideyuki Akaza et al. | title = Goserelin Acetate with or without Antiandrogen or Estrogen in the Treatment of Patients with Advanced Prostate Cancer: a Multicenter, Randomized, Controlled Trial in Japan | journal = Japanese Journal of Clin. Oncol. | volume = 29 | issue = 11 | pages = 562-570 | date = August 1999 | url = http://jjco.oxfordjournals.org/cgi/content/full/29/11/562 | id = {{ISSN|1465-3621}} | accessdate = 2007-02-26 }}</ref>
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->


==Indications==
Goserelin Acetate is used to treat hormone-sensitive cancers of the [[prostate cancer|prostate]] and [[breast cancer|breast]] (in pre-/perimenopausal women) and some benign gynaecological disorders ([[endometriosis]], [[uterine fibroid]]s and endometrial thinning). In addition, goserelin is used in [[assisted reproduction]] and in the treatment of [[precocious puberty]]. The syringe applicator comes with a protective sleeve, called the SafeSystem, to reduce and prevent needlestick injuries to administering healthcare professionals.


It is available as a 1-month depot and a long-acting 3-month depot. Both depots are used for the treatment of prostate cancer, endometriosis and uterine fibroids but only the 1-month depot is approved for breast cancer, endometrial thinning and assisted reproduction.


NOTE: The above license is probably from the USA. It should be noted that licensed indications may vary from country to country. For example, in the UK the 1-month depot is licensed for prostate cancer, endometriosis, uterine fibroids, breast cancer, endometrial thinning and assisted reproduction, and not as above. You are advised to consult a Healthcare Professional or your local regulatory authorities if you need more information on your local license for this product.
<!--Label Display Image-->
{{-}}
==Side effects==


Goserelin Acetate may cause a temporary increase in bone pain and symptoms of prostatic cancer during the first few weeks of treatment. As the body adjusts to the medication, the symptoms will disappear. Goserelin may cause hot flushes, headache, stomach upset, difficulty urinating (isolated cases), weight gain, swelling and tenderness of breasts (infrequent), decreased erections, reduced sexual desire. Bone pain can be managed symptomatically, and decreased libido can be treated by [[Levitra]] (Vardenifil) or other similar oral therapies.


==Interactions==
No known interaction with other medicinal products.


==Effects on ability to drive and operate machinery==
There is no evidence that Goserelin Acetate results in impairment of these activities.


==References==
{{Reflist}}


==External links==
<!--Category-->
* [http://news.bbc.co.uk/1/hi/health/6320397.stm One man's experience of prostate cancer treatment using goserelin] - [[BBC News]]


{{Sex hormones}}
[[Category:Drug]]
[[Category:AstraZeneca]]
[[Category:GnRH agonists]]
{{WikiDoc Help Menu}}
{{WikiDoc Sources}}

Revision as of 14:27, 22 January 2015

Goserelin
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];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

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

Overview

Goserelin is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. 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 Goserelin in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Goserelin 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 Goserelin 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 Goserelin in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Goserelin in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
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 Goserelin 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 Goserelin 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 Goserelin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Goserelin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Goserelin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Goserelin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Goserelin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Goserelin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Goserelin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Goserelin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Goserelin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Goserelin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Goserelin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Goserelin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Goserelin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Goserelin in the drug label.

Pharmacology

There is limited information regarding Goserelin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Goserelin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Goserelin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Goserelin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Goserelin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Goserelin in the drug label.

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Goserelin in the drug label.

Precautions with Alcohol

  • Alcohol-Goserelin 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)

{{#subobject:

 |Page Name=Goserelin
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Goserelin
 |Label Name=Goserelin11.png

}}

{{#subobject:

 |Label Page=Goserelin
 |Label Name=Goserelin11.png

}}