What is ganirelix (injectable)?
Ganirelix is a man-made protein that inhibits the actions of the naturally-occurring hormone
gonadotropin-releasing hormone (GnRH).
Ganirelix is used along with other medications to regulate hormone response in the treatment of
infertility in women.
Ganirelix may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking ganirelix (injectable)?
Do not use ganirelix without first talking to your doctor if you have ever had an allergic
reaction to this medication or to another gonadotropin-releasing hormone (GnRH) product such as
goserelin (Zoladex) or gonadorelin (Factrel).
Before using ganirelix, tell your doctor if you have any other medical conditions or take any
other medications. You may require a dosage adjustment or special monitoring during treatment.
Do not
take ganirelix if you are pregnant. Ganirelix is in the FDA
pregnancy category X. This means that ganirelix is known to be harmful to an unborn baby. Before
starting treatment with ganirelix, it should be determined that you are not already pregnant.
It is not known whether ganirelix passes into breast milk.
Do not
take
ganirelix without first talking to your doctor if you are breast-feeding a baby.
How should I take ganirelix (injectable)?
Use ganirelix exactly as directed by your doctor. If you do not understand these directions, ask
your pharmacist, nurse, or doctor to explain them to you.
Ganirelix should be prescribed by a doctor experienced in infertility treatment. Before starting
treatment with ganirelix, it should be determined that you are not already pregnant. Ganirelix may be
harmful to an unborn baby.
Ganirelix is administered as a subcutaneous (under the skin) injection once daily on specific
days of the menstrual cycle between the use of other infertility medications.
Ganirelix may be administered by your healthcare provider or your doctor may want you to
administer this medication at home. If you are administering the medication at home, your doctor will
give you detailed instructions on how and where to administer the injection. In general, the injection
should be administered as follows:
-
Wash your hands thoroughly with soap and water.
-
Use an alcohol wipe to clean an area about two inches
around the intended injection site (usually an area around the bellybutton or on the upper thigh).
Allow the skin to dry for at least one minute.
-
Remove the needle cover.
-
Pinch up an area of skin between the finger and thumb.
Insert the needle at a 45 to 90 degree angle to the skin at the base of the pinched-up skin.
-
Pull back slightly on the plunger of the syringe. When the
needle is correctly positioned under the skin, it should be difficult to pull back on the plunger. If
any blood is drawn into the syringe, the needle tip has entered a vein or artery. If this happens,
withdraw the needle slightly and reposition the needle without removing it from the skin.
Alternatively, remove the needle and use a new, sterile, prefilled syringe.
-
Once the needle is correctly positioned, depress the plunger
slowly and steadily so the solution is correctly administered and the skin is not damaged.
-
Pull the needle out quickly and apply pressure to the
injection site with an alcohol swab.
Rotate injection sites as directed by your healthcare provider.
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture
resistant disposal container.
Your healthcare provider may want to perform blood tests or other forms of monitoring during
treatment with ganirelix to evaluate progress and side effects.
Store ganirelix at room temperature protected from light.
What happens if I miss a dose of ganirelix (injectable)?
It is important not to miss a dose of ganirelix. Contact your doctor immediately if you miss a
dose of this medication.
Where can I get more information about ganirelix (injectable)?
Your pharmacist has information about ganirelix (injectable) written for health professionals that you may read.
What are the possible side effects of ganirelix (injectable)?
Ovarian hyperstimulation syndrome (OHSS) is an uncommon complication of treatment with
ganirelix and other fertility medications. Symptoms of OHSS include severe pelvic pain, swelling of the
hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea,
severe nausea, and vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency
medical attention if you develop any of these symptoms.
Seek emergency medical attention if you experience a rare but serious allergic reaction
(difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to ganirelix.
Other side effects may also occur. Notify your doctor if you experience
Side effects other than those listed here may also occur. Talk to your doctor
about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about ganirelix (injectable)?
Ganirelix should be prescribed by a doctor experienced in infertility treatment. Before starting
treatment with ganirelix, it should be determined that you are not already pregnant. Ganirelix may be
harmful to an unborn baby.
Ovarian hyperstimulation syndrome (OHSS) is an uncommon complication of treatment with
ganirelix and other fertility medications. Symptoms of OHSS include severe pelvic pain, swelling of the
hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea,
severe nausea, and vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency
medical attention if you develop any of these symptoms.
What should I avoid while taking ganirelix (injectable)?
There are no restrictions on food, beverages, or activity during treatment with ganirelix, unless
otherwise directed by your doctor.
What other drugs will affect ganirelix (injectable)?
It is not known whether other medications will interact with ganirelix. Talk to your doctor and
pharmacist before taking any prescription or over-the-counter medicines, including herbal products
during treatment with ganirelix.
What happens if I have an overdose of ganirelix (injectable)?
