Ganirelix (injectable)

What is the most important information I should know about ganirelix?

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 is ganirelix?

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?

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?

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?

It is important not to miss a dose of ganirelix. Contact your doctor immediately if you miss a dose of this medication.

What happens if I overdose?

An overdose of ganirelix is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a ganirelix overdose are not known.

What should I avoid while taking ganirelix?

There are no restrictions on food, beverages, or activity during treatment with ganirelix, unless otherwise directed by your doctor.

What are the possible side effects of ganirelix?

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

• mild nausea;
• headache;
• vaginal bleeding; or
• pain, redness, or irritation at the injection site.

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.

What other drugs will affect ganirelix?

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.

Where can I get more information?

Your pharmacist has additional information about ganirelix written for health professionals that you may read.

What does my medication look like?

Ganirelix is available with a prescription under the brand name Antagon. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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