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USP DI Vol. II - GANIRELIX (Systemic)

GANIRELIX (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Antagon

? Not commercially available in Canada.


Category

  • Gonadotropin-releasing hormoneantagonist

Description

Ganirelix (ga-ni-REL-iks)isused 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 followingdosage form:

    Parenteral
  • For injection (U.S)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to ganirelix or other related medicines. Also tell yourhealth 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 discussedthis with your doctor.

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

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

Other medical problems?The presence of other medicalproblems may affect the use of ganirelix. Make sure you tell your doctor ifyou have any other medical problems.


Proper Use of This Medicine

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

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

  • Understand and use the proper method of safely preparing the medicineif you are going to prepare your own medicine.
  • Wash your hands with soap and water and use a clean work area toprepare your injection.
  • Make sure you clearly understand and carefully follow your doctor'sinstructions on how to give yourself an injection, including using the properneedle 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 preventskin problems from developing.
  • Throw away needles, syringes, bottles, and unused medicine afterthe injection in a safe manner.
  • Tell your doctor when you use your last dose of ganirelix. Your doctorwill 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 fordifferent patients.If you are receiving ganirelix at home,follow your doctor's orders or the directions on the label. If youhave 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 yourdoctor 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 yourmenstrual cycle, 250 micrograms (mcg) of ganirelix is injected under the skinonce a day during the early to midfollicular phase (about Day 7 or Day 8 ofyour menstrual cycle).

Missed dose?If you miss a dose of this medicine, do not injectthe missed dose at all and do not double the next one. Check with your doctorfor 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 otherdamp places.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Itis very important that your doctor check your progressoften at regular visits to make sure that the medicine is working properlyand to check for unwanted effects. Your doctor will probably want to followthe developing eggs inside the ovaries by doing an ultrasound examinationand 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 othermethod, your doctor will help you decide when you are most fertile and whenovulation occurs. It is important that sexual intercourse take place aroundthe time when you are most fertile to give you the best chance of becomingpregnant. 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. Donot receive the injection of human chorionic gonadotropin (hCG) and avoidsexual intercourse.


Side Effects of This Medicine

    Side Effects of This Medicine

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

        Stop taking this medicineand get emergency help immediately if any of the following side effectsoccur:

          Less common

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

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

          Less common

              Nausea; vaginal bleeding

    Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor ifany of the following side effects continue to occur or are bothersome:

    Less common

      Headache; redness, pain or swellingat injection site

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.


Developed: 12/07/1999