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.
'''Thyroid-stimulating hormone''' (also known as '''TSH''' or '''thyrotropin''') is a [[peptide hormone]] synthesized and secreted by [[thyrotrope]] cells in the [[anterior pituitary gland]] which regulates the endocrine function of the [[thyroid gland]].<ref name="Sacher">{{cite book |last= Sacher|first= Ronald|coauthors= Richard A. McPherson|title= Wildmann's Clinical Interpretation of Laboratory Tests, 11th ed.|year= 2000|publisher= F.A. Davis Company|isbn= 0-8036-0270-7}}</ref>
<!--Pharmacology-->
==Physiology==
<!--Drug box 2-->
===Controlling the rate of release===
|drugBox=<!--Mechanism of Action-->
TSH stimulates the thyroid gland to secrete the hormones [[thyroxine]] (T<sub>4</sub>) and [[triiodothyronine]] (T<sub>3</sub>).<ref>{{GeorgiaPhysiology|5/5ch5/s5ch5_4}}</ref> TSH production is controlled by a Thyrotrophin Releasing Hormone, ([[TRH]]), which is manufactured in the [[hypothalamus]] and transported to the [[anterior pituitary gland]] via the [[superior hypophyseal artery]], where it increases TSH production and release. [[Somatostatin]] is also produced by the hypothalamus, and has an opposite effect on the pituitary production of TSH, decreasing or inhibiting its release.
|mechAction=*
The level of thyroid hormones (T<sub>3</sub> and T<sub>4</sub>) in the blood have an additional effect on the pituitary release of TSH; When the levels of T<sub>3</sub> and T<sub>4</sub> are low, the production of TSH is increased, and conversely, when levels of T<sub>3</sub> and T<sub>4</sub> are high, then TSH production is decreased. This effect creates a regulatory negative [[feedback loop]].
<!--Structure-->
|structure=*
===Subunits of TSH===
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
TSH is a glycoprotein and consists of two subunits, the ''alpha'' and the ''beta'' subunit.
* The [[Alpha subunit of glycoprotein hormones|α (''alpha'') subunit]] (i.e., [[chorionic gonadotropin alpha]]) is identical to that of [[human chorionic gonadotropin]] (HCG), [[luteinizing hormone]] (LH), [[follicle-stimulating hormone]] (FSH).
* The β (''beta'') subunit is unique to TSH, and therefore determines its function.
===The TSH receptor===
<!--Pharmacodynamics-->
The [[TSH receptor]] is found mainly on thyroid [[follicular cells]]<ref>Parmentier M, Libert F, Maenhaut C, Lefort A, Gérard C, Perret J, Van Sande J, Dumont JE and Vassart G., Molecular cloning of the thyrotropin receptor, Science 246 (1989), 1620-1622</ref>. Stimulation of the receptor increases T<sub>3</sub> and T<sub>4</sub> production and secretion.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
Stimulating antibodies to this receptor mimic TSH action and are found in [[Graves-Basedow disease|Graves' disease]].
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
==Diagnostic use==
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
TSH levels are tested in the blood of patients suspected of suffering from excess ([[hyperthyroidism]]), or deficiency ([[hypothyroidism]]) of thyroid hormone. Generally, a normal range for TSH for adults is between 0.4 and 5.0 [[Micro-|u]][[international unit|IU]]/mL (equivalent to [[milli|m]]IU/L), but values vary slightly among labs. The optimal goal TSH level for patients on treatment ranges between 0.3 to 3.0 mIU/L.<ref>[http://www.aace.com/newsroom/press/2006/index.php?r=20060110 American Association of Clinical Endocrinologists<!-- Bot generated title -->]</ref>. The interpretation depends also on what the blood levels of thyroid hormones (T<sub>3</sub> and T<sub>4</sub>) are. The [[National Health Service]] in the UK considers a "normal" range to be more like 0.1 to 5.0 uIU/mL.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
TSH levels for children normally start out much higher. In [[2002]], the [[National Academy of Clinical Biochemistry]] (NACB) in the [[United States]] recommended age-related reference limits starting from about 1.3-19 uIU/mL for normal term infants at birth, dropping to 0.6-10 uIU/mL at 10 weeks old, 0.4-7.0 uIU/mL at 14 months and gradually dropping during childhood and puberty to adult levels, 0.4-4.0 uIU/mL.<ref>{{cite web| last =Demers| first =Laurence M.| authorlink =| coauthors =Carole A. Spencer| title = LMPG: Laboratory Support for the Diagnosis and Monitoring of Thyroid Disease| work =| publisher =[[National Academy of Clinical Biochemistry]] (USA)| date =2002| url =http://www.nacb.org/lmpg/thyroid_LMPG_PDF.stm |format =| doi =| accessdate =2007-04-13 }} - see ''Section 2. Pre-analytic factors''</ref>
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
The NACB also stated that it expected the normal (95%) range for adults to be reduced to 0.4-2.5 uIU/mL, because research had shown that adults with an initially measured TSH level of over 2.0 uIU/mL had "an increased odds ratio of developing [[hypothyroidism]] over the [following] 20 years, especially if thyroid antibodies were elevated".<ref>{{cite web| last =Demers| first =Laurence M.| authorlink =| coauthors =Carole A. Spencer| title = LMPG: Laboratory Support for the Diagnosis and Monitoring of Thyroid Disease| work =| publisher =[[National Academy of Clinical Biochemistry]] (USA)| date =2002| url =http://www.nacb.org/lmpg/thyroid_LMPG_PDF.stm |format =| doi =| accessdate =2007-04-13 }} - see ''Section 3.C.Thyrotropin/ Thyroid Stimulating Hormone (TSH) measurement</ref>
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Clearly, both TSH and T<sub>3</sub> and T<sub>4</sub> should be measured to ascertain where a specific thyroid dysfunction is caused by primary pituitary or by a primary thyroid disease. If both are up (or down) then the problem is probably in the pituitary. If the one component (TSH) is up, and the other (T<sub>3</sub> and T<sub>4</sub>) is down, then the disease is probably in the thyroid itself. The same holds for a low TSH, high T3 and T4 finding.
<!--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>
A TSH assay is now also the recommended screening tool for thyroid disease. Recent advances in increasing the sensitivity of the TSH assay make it a better screening tool than free T<sub>4</sub>.<ref name="Sacher">{{{{cite book |last= Sacher|first= Ronald|coauthors= Richard A. McPherson|title= Wildmann's Clinical Interpretation of Laboratory Tests, 11th ed.|year= 2000|publisher= F.A. Davis Company|isbn= 0-8036-0270-7}}</ref>
<!--Drug Shortage Status-->
|drugShortage=
}}
{{PillImage
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{{LabelImage
|fileName={{PAGENAME}}11.png
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{{LabelImage
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<!--Pill Image-->
==Therapeutic use==
A drug, recombinant human TSH (rhTSH), called Thyrogen, is manufactured by [[Genzyme|Genzyme Corp.]] in Cambridge, Massachusetts. The rhTSH is used in patients with thyroid cancer which is related to tumoral factors.
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Thyroid-stimulating hormone is a {{{drugClass}}} that is FDA approved for the treatment 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
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Condition4
Dosing Information
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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 Thyroid-stimulating hormone in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Thyroid-stimulating hormone 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 Thyroid-stimulating hormone 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 Thyroid-stimulating hormone in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Thyroid-stimulating hormone 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 Thyroid-stimulating hormone 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 Thyroid-stimulating hormone in the drug label.
There is limited information regarding Patient Counseling Information of Thyroid-stimulating hormone in the drug label.
Precautions with Alcohol
Alcohol-Thyroid-stimulating hormone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
