Gonadorelin acetate (Fertagyl) is used for ovulation induction in female patients with amenorrhea and infertility caused by disorders of the hypothalamus and anterior pituitary gland.

Gonadorelin acetate Uses:

• It is indicated for ovulation induction in females with amenorrhea due to a hypothalamic cause.

Gonadorelin acetate dose in Adults

Gonadorelin acetate dose in the treatment of Primary hypothalamic amenorrhea:

• Females:

  • Initial dose: 5 mcg subcutaneously or intravenously every 90 minutes via a pulsatile pump.
  • The dose may be adjusted every 21 days if required.
  • If no response to treatment is observed after 3 treatment intervals, the dose may be increased (up to 20 mcg).
  • To keep the corpus luteum healthy, the medication should be continued for two weeks after ovulation.

Note: Select the appropriate vials. A typical dose of 5 mcg is delivered with the use of a 0.8 mg vial.

Dose in Children:

Not indicated.

Pregnancy Risk Category: B

• Infants born to moms who had been exposed while pregnant were not reported to experience any negative side effects from the medication.
• It appears that there is very little risk to fetal harm. The risk of fetal abnormalities was not present when the drug was administered to mothers in the first trimester.
• To protect the corpus luteum, the medication should be continued for two weeks after ovulation.
• Once a pregnancy is confirmed, no further treatment is required.

Gonadorelin acetate use during breastfeeding:

• It has not been tested in lactating mothers. It is not recommended for use during breastfeeding.

Dose in Kidney disease:

Dosage adjustments have not been provided in the manufacturer's labelling. It has not been studied in patients with kidney disease.

Dose in Liver disease:

It has not been studied in patients with liver disease. Use it with caution.

Side effects of Gonadorelin acetate (Fertagyl):

• Cardiovascular:

  • Superficial thrombophlebitis

• Local:

  • Injection site irritation

Contraindications to Gonadorelin acetate:

• Allergy reactions to gonadorelin and any component of the formulation
• Pregnancy can exacerbate medical conditions such as pituitary probinoma.
• Patients suffering from ovarian cysts
• Reproductive hormones can worsen medical conditions like hormone-dependent tumors.

Warnings and precautions

• Hypersensitivity and anaphylactic reactions

  • Rarely have anaphylactic and allergic reactions been reported.

• Ovarian cancer: [Canadian Boxed Warn]

  • Although it is not possible to prove a causal link, some infertile women who received fertility drugs have been found to develop ovarian carcinoma.
  • For patients who have used these drugs in the past, it is important to monitor for any unusual signs or symptoms.

• Ovarian hyperstimulation Syndrome: [Canadian-Bound Warning]

  • Ovarian hyperstimulation syndrome is a serious side effect of hormone stimulation. This is a heightened response to ovulation-induction therapy.
  • This condition can develop within 24 hours of treatment but may worsen after seven to ten consecutive days.
  • Mild to moderate OHSS symptoms include:
    • Abdominal discomfort or distension
    • diarrhea,
    • Nausea and/or vomiting
    • vomiting.
  • Symptoms of severe OHSS could include:
    • Extreme abdominal pain
    • Anuria or Oliguria
    • ascites,
    • severe dyspnea,
    • Hypotension, or
    • Intractable vomiting and nausea
  • Laboratory abnormalities in OHSS include:
    • Reduce creatinine clearance,
    • hemoconcentration,
    • hypoproteinemia,
    • Elevated liver enzymes
    • electrolyte imbalances.
  • Symptomatic treatment of OHSS should be discontinued. 
  • Stop taking gonadotropin medication. 
  • Symptomatic therapy is the treatment of pain and fluid abnormalities. It also prevents thromboembolic complications.

Monitoring parameters:

• Monitor LH, FSH, estradiol, progesterone in the mid-luteal phase, and body temperature.
• Perform a baseline ovarian ultrasound and then at weekly intervals until ovulation has been confirmed.
• Perform a pelvic check, and keep an eye out for any hypersensitive reactions at the injection site.
• At least two weeks after receiving HCG, patients should be checked for the clinical signs of ovarian hyperstimulation syndrome.

Monitoring parameters of OHSS that should be checked daily include:

• Daily monitoring:
  • abdominal circumference,
  • albumin,
  • cardiorespiratory status,
  • electrolytes,
  • fluid balance,
  • hematocrit,
  • hemoglobin,
  • serum creatinine,
  • urine output,
  • urine specific gravity,
  • vital signs,
  • weight
• Weekly monitoring:
  • Liver enzymes should be checked weekly.

How to administer Gonadorelin acetate?

Lutrepulse vials for IV or SubQ use:

• The constituents of the medicine are first reconstituted and then administered as intravenous or a subcutaneous injection via a pulsatile pump.
• The infusion pump is set to deliver 25 or 50 mcL of the solution, depending on the required dose and the strength of the formulation used.
• When using the 0.8 mg vial, the pump can be set to deliver a dose of 2.5 mcg equivalent to 25 mcL per pulse or 5 mcg equivalent to 50 mcL per pulse.
• When using the 3.2 mg vial, the pump can be set to deliver a dose of 10 mcg equivalent to 25 mcL per pulse or 20 mcg equivalent to 50 mcL per pulse.
• The pump should deliver the dose over a pulse period of one minute and a pulse frequency of 90 minutes.

Mechanism of action of Gonadorelin acetate:

• It stimulates the anterior pituitary to release LH (luteinizinghormone), which results in induction of ovulation.

The onset of action:

• Treatment response is usually observed within 14 to 21 days.

Metabolism:

• It is metabolized primarily via the kidneys.

Half-life elimination:

• Terminal half-life elimination is about 10-40 minutes that is increased in patients with kidney disease.

Excretion:

• It is excreted in urine as inactive metabolites.

International Brand Names of Gonadorelin acetate:

• Lutrepulse
• Relisorm
• Cryptocur
• Gonavet
• HRF
• Kryptocur
• LH-RH Tanabe
• Luforan
• Lutamin
• Lutrelef
• Relefact
• Relefact LH-RH
• Relisorm L
• Wyeth-Ayerst HRF
• Zyklomat

Gonadorelin acetate Brand Names in Pakistan:

No Brands Available in Pakistan.