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Ganirelix

Pronunciation

(ga ni REL ix)

Index Terms

  • Antagon
  • Ganirelix Acetate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous, as acetate:

Generic: 250 mcg/0.5 mL (0.5 mL)

Pharmacologic Category

  • Gonadotropin Releasing Hormone Antagonist

Pharmacology

Competitively blocks the gonadotropin-release hormone receptors on the pituitary gonadotroph and transduction pathway. This suppresses gonadotropin secretion and luteinizing hormone secretion preventing ovulation until the follicles are of adequate size.

Absorption

SubQ: Rapid

Distribution

Mean Vd: Single dose: 43.7 L; Multiple dosing: 76.5 L

Metabolism

Hepatic to two primary metabolites (1-4 and 1-6 peptide)

Excretion

Feces (75%) within 288 hours; urine (22%) within 24 hours

Time to Peak

1.1 hours

Duration of Action

<48 hours

Half-Life Elimination

Single dose: 12.8 hours; Multiple dosing: 16.2 hours

Protein Binding

81.9%

Use: Labeled Indications

Adjunct to controlled ovarian hyperstimulation: Inhibits premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Contraindications

Hypersensitivity to ganirelix or any component of the formulation; hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analog; known or suspected pregnancy

Dosing: Adult

Adjunct to controlled ovarian hyperstimulation: SubQ: 250 mcg once daily during the mid-to-late phase after initiating follicle-stimulating hormone on day 2 or 3 of cycle. Treatment should be continued daily until the day of chorionic gonadotropin administration.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Administer SubQ in abdomen (around navel) or upper thigh; rotate injection site.

Storage

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light.

Drug Interactions

Indium 111 Capromab Pendetide: Antigonadotropic Agents may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Adverse Reactions

1% to 10%:

Central nervous system: Headache (3%)

Endocrine & metabolic: Ovarian hyperstimulation syndrome (2%)

Gastrointestinal: Abdominal pain (1%), nausea (1%)

Genitourinary: Pelvic pain (5%), vaginal hemorrhage (2%)

Local: Injection site reaction (1%)

<1% (Limited to important or life-threatening): Anaphylactoid reaction, hypersensitivity reaction

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions, including anaphylactoid reactions, have been reported; may occur with the first dose; use is not recommended in women with severe allergic conditions. Use with caution in women with signs and symptoms of other allergic conditions.

Special populations:

• Pregnancy: Exclude pregnancy before beginning treatment.

Dosage form specific issues:

• Latex: The packaging may contain natural rubber latex.

Other warnings/precautions:

• Experienced specialists: Should only be prescribed by fertility specialists.

Monitoring Parameters

Ultrasound to assess follicle size

Pregnancy Considerations

Studies in animals have shown evidence of fetal abnormalities, including fetal resorption, and use is contraindicated in women who are pregnant. Fetal resorption is a result of hormonal alterations and could result in fetal loss in humans. Ganirelix is used to treat infertility; pregnancy should be ruled out prior to therapy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site irritation. Have patient report immediately to prescriber severe vaginal bleeding or signs of ovarian hyperstimulation syndrome (severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in how much urine is passed) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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