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Pronunciation:

(goe nad oh RELL in)

U.S. Brand Names:

Factrel®

Synonyms:

GnRH; Gonadorelin Acetate; Gonadorelin Hydrochloride; Gonadotropin Releasing Hormone; LHRH; LRH; Luteinizing Hormone Releasing Hormone

Generic Available:

Canadian Brand Names:

Lutrepulse™

Use:

Evaluation of functional capacity and response of gonadotrophic hormones; evaluate abnormal gonadotropin regulation as in precocious puberty and delayed puberty.

Orphan drug: Lutrepulse®: Induction of ovulation in females with hypothalamic amenorrhea

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown

Contraindications:

Hypersensitivity to gonadorelin or any component of the formulation; women with any condition that could be exacerbated by pregnancy; patients who have ovarian cysts or causes of anovulation other than those of hypothalamic origin; any condition that may worsened by reproductive hormones

Warnings/Precautions:

Hypersensitivity and anaphylactic reactions have occurred following multiple-dose administration; multiple pregnancy is a possibility; use with caution in women in whom pregnancy could worsen pre-existing conditions (eg, pituitary prolactinemia).

Adverse Reactions:

1% to 10%: Local: Pain at injection site

<1%: Flushing, lightheadedness, headache, rash, nausea, abdominal discomfort

Overdosage/Toxicology:

Symptoms of overdose include abdominal discomfort, nausea, headache, and flushing. Treatment is symptomatic.

Drug Interactions:

Decreased levels/effect: Oral contraceptives, digoxin, phenothiazines, dopamine antagonists

Increased levels/effect: Androgens, estrogens, progestins, glucocorticoids, spironolactone, levodopa

Stability:

Factrel®: Prepare immediately prior to use; after reconstitution, store at room temperature and use within 1 day; discard unused portion

Lutrepulse®: Store at room temperature; reconstitute with diluent immediately prior to use and transfer to plastic reservoir. The solution will supply 90 minute pulsatile doses for 7 consecutive days (Lutrepulse® pump).

Mechanism of Action:

Stimulates the release of luteinizing hormone (LH) from the anterior pituitary gland

Pharmacodynamics/Kinetics:

Onset of action: Peak effect: Maximal LH release: ~20 minutes

Duration: 3-5 hours

Half-life elimination: 4 minutes

Dosage:

Diagnostic test: Children >12 years and Female Adults: I.V., SubQ hydrochloride salt: 100 mcg administered in women during early phase of menstrual cycle (day 1-7)

Primary hypothalamic amenorrhea: Female Adults: Acetate: I.V.: 5 mcg every 90 minutes via Lutrepulse® pump kit at treatment intervals of 21 days (pump will pulsate every 90 minutes for 7 days)

Administration:

Factrel®: Dilute in 3 mL of normal saline; administer I.V. push over 30 seconds

Lutrepulse®: A presterilized reservoir bag with the infusion catheter set supplied with the kit should be filled with the reconstituted solution and administered I.V. using the Lutrepulse® pump. Set the pump to deliver 25-50 mL of solution, based upon the dose, over a pulse period of 1 minute and at a pulse frequency of 90 minutes.

Monitoring Parameters:

LH, FSH

Patient Education:

If receiving this drug via pulsating pump, check all procedures with prescriber, and use exactly as prescribed. Report any rash, pain, or inflammation at injection site, and any change in respiratory status. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

Antipsychotics may decrease the effects of gonadorelin

Dosage Forms:

Injection, powder for reconstitution, as hydrochloride (Factrel®): 100 mcg [diluent contains benzyl alcohol]

International Brand Names:

Cryptocur® (HK, NL); HRF® (BE, GB, LU, NL, NZ); Kryptocur® (AT, BE, CH, DE, IT, LU, TR); LHRH Ferring® (DE); LH-RH® (HU, TR); Luforan® (ES); Lutrelef® (BE, CH, DE, FR, IL, IT, NL, SE); Lutrepulse™ (CA); Relefact® (AT, DE, IE, IL); Relisorm L® (BR, HK, HU, MX, PL); Stimu-LH® (FR); Wyeth-Ayerst HRF® (AU); Zyklomat pulse set® (PL)

References

Pescovitz OH, Comite F, Hench K, et al, "The NIH Experience With Precocious Puberty: Diagnostic Subgroups and Response to Short-Term Luteinizing Hormone-Releasing Hormone Analogue Therapy,"J Pediatr, 1986, 108(1):47-54.

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