Version May 2024
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.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Abdominal pain (1%), nausea (1%)
Genitourinary: Ovarian hyperstimulation syndrome (2%), pelvic pain (5%), vaginal hemorrhage (2%)
Local: Injection-site reaction (1%)
Nervous system: Headache (3%)
Postmarketing:
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction
Local: Local hypersensitivity reaction
Hypersensitivity to ganirelix, dry natural rubber/latex, or any component of the formulation; hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analog; known or suspected pregnancy
Canadian labeling: Additional contraindications (not in US labeling): Moderate or severe renal impairment; moderate or severe hepatic impairment
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, anaphylactoid shock, angioedema, and urticaria, have been reported; may occur with the first dose. Discontinue treatment and institute appropriate therapy if hypersensitivity occurs. Use is not recommended in patients with severe allergic conditions; use with caution in patients with signs and symptoms of other allergic conditions.
Dosage form specific issues:
• Latex: The packaging may contain dry natural rubber/latex.
Other warnings/precautions:
• Experienced specialists: Should only be prescribed by fertility specialists.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous, as acetate:
Fyremadel: 250 mcg/0.5 mL (0.5 mL)
Generic: 250 mcg/0.5 mL (0.5 mL)
Solution Prefilled Syringe, Subcutaneous, as acetate [preservative free]:
Generic: 250 mcg/0.5 mL (0.5 mL)
Yes
Solution Prefilled Syringe (Fyremadel Subcutaneous)
250 mcg/0.5 mL (per 0.5 mL): $230.03
Solution Prefilled Syringe (Ganirelix Acetate Subcutaneous)
250 mcg/0.5 mL (per 0.5 mL): $220.80 - $259.79
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous, as acetate:
Orgalutran: 250 mcg/0.5 mL (0.5 mL)
SUBQ: Prefilled syringe may contain an air bubble; removal of the air bubble is not needed. Administer SUBQ in abdomen (around navel) or upper thigh; rotate injection site.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloves and a protective gown are required during administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
Adjunct to controlled ovarian hyperstimulation: To inhibit premature luteinizing hormone surges in patients undergoing controlled ovarian hyperstimulation.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
Antagon former US brand name for ganirelix, but also the brand name for ranitidine in Brazil
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Flotufolastat F18: Androgen Deprivation Therapy Agents may diminish the diagnostic effect of Flotufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of flotufolastat F18 in prostate cancer. The impact of ADT on the performance of flotufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Gallium Ga 68 PSMA-11: Androgen Deprivation Therapy Agents may diminish the therapeutic effect of Gallium Ga 68 PSMA-11. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of gallium Ga 68 PSMA-11 (gozetotide) in prostate cancer. The impact of ADT on the performance of gallium Ga 68 PSMA-11 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Indium 111 Capromab Pendetide: Antigonadotropic Agents may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Risk X: Avoid combination
Piflufolastat F18: Androgen Deprivation Therapy Agents may diminish the diagnostic effect of Piflufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of piflufolastat F18 in prostate cancer. The impact of ADT on the performance of piflufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Ganirelix is used to treat infertility; pregnancy should be excluded prior to treatment.
Ganirelix is used to treat infertility; use is contraindicated in patients who are already pregnant.
Studies in animals have shown evidence of fetal abnormalities, including fetal resorption. Fetal resorption is a result of hormonal alterations and could result in fetal loss in humans.
Pregnancies of patients enrolled in phase 2 and phase 3 studies were followed until 8 weeks postpartum; controlled ovarian stimulation protocols that included ganirelix or a gonadotropin releasing hormone agonist had similar pregnancy outcomes (Boerrigter 2002). A prospective study, which evaluated infants at 6 months postpartum, also found neonatal outcomes to be similar when either ganirelix or a gonadotropin releasing hormone agonist were used during controlled ovarian stimulation (Bonduelle 2010).
It is not known if ganirelix is present in breast milk.
Breastfeeding is not recommended by the manufacturer.
Ultrasound to assess follicle size. Exclude pregnancy prior to treatment.
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.
Duration: <48 hours
Absorption: SUBQ: Rapid
Distribution: Mean Vd: Single dose: 43.7 L; Multiple dosing: 76.5 L
Protein binding: 81.9%
Metabolism: Hepatic to two primary metabolites (1-4 and 1-6 peptide)
Bioavailability: SUBQ: 91.1%
Half-life elimination: Single dose: 12.8 hours; Multiple dosing: 16.2 hours
Time to peak: 1.1 hours
Excretion: Feces (75%) within 288 hours; urine (22%) within 24 hours
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