In the U.S.—

• Gonadotropin–releasing hormone antagonist

Ganirelix (ga-ni-REL-iks) is used as a fertility medicine to prevent premature luteinizing hormone (LH) surges in women undergoing the fertility procedure of controlled ovarian hyperstimulation. LH is involved in ovulation, which is the development of eggs in the ovaries. Ganirelix may help reduce the need for follicle-stimulating hormone (FSH) , which is also involved in ovulation.

Ganirelix is available only with your doctor's prescription in the following dosage form:

Parenteral
• For injection (U.S)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ganirelix, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ganirelix or other related medicines. Also tell your health care professional if you have any allergies to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ganirelix is not recommended during pregnancy. It has been shown to cause problems in animals. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known whether ganirelix passes into breast milk. It is recommended that you avoid ganirelix if you are breast-feeding.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

To make using ganirelix as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of ganirelix. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes ganirelix can be given by injection at home. If you are using this medicine at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.
• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.
• Do not inject more or less of the medicine than your doctor ordered.
• Remember to move the site of injection to different areas to prevent skin problems from developing.
• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.
• Tell your doctor when you use your last dose of ganirelix. Your doctor will give you another medicine called human chorionic gonadotrophin (hCG) or arrange for you to get this medicine at the right time.

Dosing—

The dose of ganirelix will be different for different patients.If you are receiving ganirelix at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of ganirelix, ask your doctor.

The following information includes only the average doses of ganirelix. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For treatment of female infertility:
    • Adults—After receiving FSH treatment on Day 2 or 3 of your menstrual cycle, 250 micrograms (mcg) of ganirelix is injected under the skin once a day during the early to midfollicular phase (about Day 7 or Day 8 of your menstrual cycle).

Missed dose—

If you miss a dose of this medicine, do not inject the missed dose at all and do not double the next one. Check with your doctor for further instructions.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.

If severe abdominal pain occurs with use of ganirelix, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following side effects occur:

• Less common

• Abdominal pain (severe) ;  nausea and vomiting;  weight gain (rapid) 

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Nausea;  vaginal bleeding  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue to occur or are bothersome:

• Less common
  • Headache;  redness, pain or swelling at injection site 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.