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Pronunciation
(goe nad oh RELL in)
Index Terms
Brand Names: Canada
Pharmacologic Category
Use: Labeled Indications
Induction of ovulation in females with hypothalamic amenorrhea
Pregnancy Considerations
The risk of fetal harm appears remote if gonadorelin is used during pregnancy. Clinical studies of pregnant women have not demonstrated an increased risk of fetal abnormalities during the first trimester. Follow-up reports of infants born to exposed mothers revealed no adverse effects or complications attributed to gonadorelin therapy. Based on its indicated use, gonadorelin treatment is continued for 2 weeks following ovulation to maintain the corpus luteum; initiation of treatment is not appropriate if pregnancy has been established.
Breast-Feeding Considerations
Not indicated for use in nursing women.
Contraindications
Hypersensitivity to gonadorelin or any component of the formulation; women with any condition (eg, pituitary prolactinoma) that could be exacerbated by pregnancy; patients who have ovarian cysts; any condition (eg, hormone-dependent tumor) that may be worsened by reproductive hormones
Warnings/Precautions
Boxed warnings:
• Ovarian cancer: See “Concerns related to adverse effects below”.
• Ovarian hyperstimulation syndrome: See “Concerns related to adverse effects below”.
Concerns related to adverse effects:
• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported rarely.
• Ovarian cancer: [Canadian Boxed Warning]: Ovarian cancer has been reported in a very small number of infertile women treated with fertility drugs. A causal relationship has not been established.
• Ovarian hyperstimulation syndrome (OHSS): [Canadian Boxed Warning]: OHSS is a risk of ovulation induction therapy although it is rare with pulsatile gonadotropin releasing hormone (GnRH) therapy. Discontinue therapy if OHSS occurs; spontaneous resolution may be expected. Clinicians should be alert for evidence of ascites, pleural effusion, fluid/electrolyte imbalance, hemoconcentration, cyst rupture, sepsis.
Other warnings/precautions:
• Experienced physician: Therapy should only be conducted by clinicians familiar with infertility problems and their management.
• Multiple births: May result from the use of these medications; advise patients of the potential risk of multiple births before starting treatment.
Adverse Reactions
Local: Injection site irritation, superficial thrombophlebitis
<1%, postmarketing, and/or case reports: Abdominal pain, anaphylactic reaction, anaphylactic shock, antibody formation (with long-term therapy resulting in therapy failure), fever, headache, injection site reddening, injection site thrombophlebitis (mild and severe), menstrual bleeding increased, nausea, ovarian hyperstimulation (moderate)
Metabolism/Transport Effects
None known.
Drug Interactions
There are no known significant interactions.
Storage
Store gonadorelin acetate and diluent (0.9% sodium chloride) at 15°C to 30°C (59°F to 86°F).
Reconstitution
Reconstitute gonadorelin vial with 8 mL of diluent immediately prior to use. Shake vial until solution is clear and particulate-free. Transfer to a polypropylene plastic reservoir. Following dilution of the 0.8 mg vial with 8mL of diluent, the pump can be set to deliver a dose/pulse of 2.5 mcg or 5 mcg. Following dilution of the 3.2 mg vial with 8 mL of diluent, the pump can be set to deliver a dose/pulse of 10 mcg or 20 mcg.
Mechanism of Action
Stimulates the release of luteinizing hormone (LH) from the anterior pituitary gland
Pharmacodynamics/Kinetics
Onset of action: Response to therapy usually observed within 2-3 weeks
Distribution: Vd: ~10-15 L
Metabolism: Primarily renal
Half-life elimination: Terminal: ~10-40 minutes; increased in patients with renal impairment
Excretion: Urine (as inactive metabolites)
Dosage
Primary hypothalamic amenorrhea: Adults (females): I.V., SubQ.: Initial dose: 5 mcg every 90 minutes via suitable pulsatile pump. Dosage adjustments may be made every 21 days if necessary. An increase in dosage may be necessary if no response after 3 treatment intervals. In clinical trials, doses of 1-20 mcg were successfully administered. Treatment should be continued for 2 weeks after ovulation to maintain the corpus luteum.
Note: Appropriate vial should be selected for individualized treatment. Typical dose (5 mcg) is delivered with use of 0.8 mg vial.
Administration: I.V.
Administer I.V. using a suitable pulsatile pump. Set the pump to deliver 25-50 mcL of solution, based upon the dose, over a pulse period of 1 minute and a pulse frequency of 90 minutes.
Administration: Other
Administer SubQ using a suitable pulsatile pump. Set the pump to deliver 25-50 mcL of solution, based upon the dose, over a pulse period of 1 minute and a pulse frequency of 90 minutes.
Monitoring Parameters
Ovarian ultrasound at baseline and at least weekly while on therapy or until ovulation is confirmed; LH, FSH, estradiol, progesterone (midluteal phase); basal body temperature; injection site
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
Nursing: Physical Assessment/Monitoring
Assess other medications patient may be taking for effectiveness and interactions. When used for induction of ovulation, assess results of laboratory tests and therapeutic effectiveness. Assess knowledge/teach patient appropriate use (use of pulsating pump if applicable), interventions to reduce side effects, and adverse symptoms to report.
References
Kesrouani A, Abdallah MA, Attieh E, et al, “Gonadotropin-Releasing Hormone for Infertility in Women with Primary Hypothalamic Amenorrhea. Toward a More-Interventional Approach,” J Reprod Med, 2001, 46(1):23-8.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2012
Content last modified January 2012
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