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Formulation : Prefilled Syringe Injection
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Indications

Orgalutran Injection (ganirelix acetate) is indicated for women undergoing certain fertility treatments, specifically controlled ovarian stimulation as part of Assisted Reproductive Technology (ART) such as in vitro fertilization (IVF).

The medication is typically used in combination with other hormones, such as follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hCG). It works by blocking the release of luteinizing hormone (LH), which helps prevent premature ovulation. By delaying ovulation, Orgalutran allows the eggs in the ovaries to grow properly.

Use and Dosage

Read the Patient Information Leaflet if available from your pharmacist before you start using ganirelix each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Learn all preparation and usage instructions from your healthcare professional and the product package.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin as directed by your doctor, usually once a day for several days. Carefully follow your doctor’s instructions on when to start and stop this medication.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed.

Learn how to store and discard medical supplies safely.

Side Effects

Redness or pain at the injection site, headache, mild nausea/stomach pain, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, such as unusual vaginal bleeding.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.

This is not a complete list of side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Cautions

  • Before using ganirelix, tell your doctor or pharmacist if you are allergic to it; or to other products containing gonadotropin-releasing hormone (GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
  • Before using this medication, tell your doctor or pharmacist your medical history.
  • Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).
  • Multiple births may occur as a result of this treatment. Consult your doctor for more details.
  • Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.
  • It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Forms and Strengths

Orgalutran Injection is available in the following forms and strengths:

  • Orgalutran Injection Prefilled Syringe Injection:
    • 0.25mg/0.5mL

FAQ

How does Orgalutran work?

The active substance in Orgalutran, ganirelix, blocks the receptors for a natural hormone called gonadotrophin-releasing hormone (GnRH). GnRH controls the secretion of another hormone called luteinizing hormone (LH), which causes ovulation (the release of eggs during the menstrual cycle).

How has Orgalutran been studied?

The ability of Orgalutran to prevent premature ovulation has been studied in three main studies involving 1,335 women.

Orgalutran was compared with buserelin, leuprorelin, and triptorelin (GnRH agonists: another group of medicines used to prevent premature ovulation, which works by stimulating the receptor for GnRH to such an extent that the body stops making LH). The main measures of effectiveness were the number of eggs that could be harvested and the number of women who became pregnant.

What benefit has Orgalutran shown during the studies?

After treatment with Orgalutran, the average number of eggs that could be harvested was between 7.9 and 11.6 per woman.

Between 20% and 31% of the women became pregnant. Overall, the values for the GnRH agonists were slightly higher.

What is the risk associated with Orgalutran?

In studies, the most common side effect of Orgalutran (seen in more than 1 patient in 10) was a skin reaction at the injection site, mainly redness with or without swelling. For the full list of all side effects reported with Orgalutran, see the package leaflet.

Resources:

  1. https://www.drugs.com/uk/orgalutran.html
  2. https://www.ivf.com.au/sites/ivfa/files/2022-12/IVFA59%20Single%20Sheets%20Drug%20Info-Orgalutran%2028.04.22-LR.pdf
  3. https://www.webmd.com/drugs/2/drug-75166/ganirelix-subcutaneous/details

Additional information

Quantities Available:

1

Formulation:

Prefilled Syringe Injection