follicle stimulating hormone and ganirelix (injectable kit)

What is the most important information I should know about follicle stimulating hormone and ganirelix?

Treatment with follicle stimulating hormone and ganirelix increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Ovarian hyperstimulation syndrome (OHSS) is an uncommon complication of treatment with follicle stimulating hormone, 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 are follicle stimulating hormone and ganirelix?

Follicle stimulating hormone (FSH) is a naturally occurring hormone. FSH is important in the development of follicles (eggs) produced by the ovaries. FSH is also important in the development of sperm.

Ganirelix is a man-made protein that inhibits the actions of the naturally-occurring hormone gonadotropin-releasing hormone (GnRH).

Follicle stimulating hormone and ganirelix are used together in the treatment of infertility. Follicle stimulating hormone is used to stimulate a follicle (egg) to develop and mature. It is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone is also used to stimulate the development of multiple eggs for in vitro fertilization. Follicle stimulating hormone can be used by men to increase the production of sperm. Ganirelix is used to regulate hormone response during medication treatments for infertility in women.

Follicle stimulating hormone and ganirelix may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using follicle stimulating hormone and ganirelix?

Follicle stimulating hormone (Follistim) will not induce ovulation if the ovaries are not capable of producing an egg. Also, follicle stimulating hormone will not induce the production of sperm if the testes are not capable of producing sperm.

Do not use ganirelix (Antagon) without first talking to your doctor if you have ever had an allergic reaction to ganirelix or to another gonadotropin-releasing hormone (GnRH) product such as goserelin (Zoladex) or gonadorelin (Factrel).

Do not use ganirelix (Antagon) without first talking to your doctor if you have an allergy to latex or rubber. The packaging of this product contains natural rubber latex.

Before using these medications, tell your doctor if you

• might be pregnant;
• have a thyroid problem;
• have adrenal dysfunction;
• have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
• have undiagnosed abnormal vaginal bleeding; or
• have ovarian cysts or enlargement not due to polycystic ovary disease (PCOD).

You may not be able to use follicle stimulating hormone and ganirelix, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not use follicle stimulating hormone and ganirelix if you are pregnant. These medications are in the FDA pregnancy category X. This means that they are known to cause birth defects in an unborn baby (when used beyond the period of ovulation).

It is not known whether follicle stimulating hormone and ganirelix pass into breast milk. Do not use these medications without first talking to your doctor if you are breast-feeding a baby.

How should I use follicle stimulating hormone and ganirelix?

Use follicle stimulating hormone and ganirelix exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Follicle stimulating hormone and ganirelix should be prescribed by a doctor experienced in infertility treatment. Before starting treatment with these medications, it should be determined that you are not already pregnant. Follicle stimulating hormone and ganirelix may be harmful to an unborn baby.

Follicle stimulating hormone may be administered as a subcutaneous (under the skin) or intramuscular injection (injection into the muscle). Ganirelix is administered as a subcutaneous (under the skin) injection. If you are administering these medications at home, your doctor will give you detailed instructions on how to mix the solution and administer the injections. Do not inject these medications if you are not sure how.

After adding the diluent, do not shake the vial of follicle stimulating hormone, but gently swirl until the solution is clear. Do not inject any medication that is discolored or that has particles in it. After mixing the follicle stimulating hormone solution for injection, use it immediately.

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 follicle stimulating hormone and ganirelix to monitor progress and side effects.

Store unmixed follicle stimulating hormone at room temperature or in the refrigerator away from light, moisture, and heat.

Store ganirelix at room temperature protected from light.

What happens if I miss a dose?

Contact your doctor if you miss a dose of follicle stimulating hormone or ganirelix.

What happens if I overdose?

An overdose of follicle stimulating hormone or 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 follicle stimulating hormone or ganirelix overdose are not known.

What should I avoid while using follicle stimulating hormone and ganirelix?

There are no restrictions on food, beverages, or activity during therapy with follicle stimulating hormone and ganirelix unless otherwise directed by your doctor.

What are the possible side effects of follicle stimulating hormone and ganirelix?

Ovarian hyperstimulation syndrome (OHSS) is an uncommon complication of treatment with follicle stimulating hormone, 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.

Stop using follicle stimulating hormone and ganirelix and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
• confusion, severe dizziness, or severe headache (which may indicate a blood clot in the head); or
• difficulty breathing.

Other side effects may also occur. Notify your doctor if you experience

• abdominal or pelvic pain, tenderness, pressure, or swelling (potential symptoms of ovarian enlargement);
• nausea, vomiting, diarrhea, or flatulence (gas);
• fever or chills;
• headache;
• dizziness;
• rapid pulse or heart rate;
• muscle or joint weakness or aching;
• breast tenderness;
• spotting or menstrual changes;
• pain, swelling, or irritation at the injection site; or
• dry skin, a rash, or hair loss.

Treatment with follicle stimulating hormone and ganirelix increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

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 follicle stimulating hormone and ganirelix?

It is not known whether other medications will interact with follicle stimulating hormone or ganirelix. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

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

What does my medication look like?

Follicle stimulating hormone and ganirelix is available with a prescription as a kit under the brand names Follistim and 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.

Copyright 1996-2003 Cerner Multum, Inc. Version: 2.01. Revision date: 5/20/04.