What is follicle stimulating hormone and ganirelix (injectable kit)?
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 taking follicle stimulating hormone and ganirelix (injectable kit)?
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
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might be pregnant;
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have a thyroid problem;
-
have adrenal dysfunction;
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have cancer or a tumor of the breast, ovary, uterus,
hypothalamus, or pituitary gland;
-
have undiagnosed abnormal vaginal bleeding; or
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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 take follicle stimulating hormone and ganirelix (injectable kit)?
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 of follicle stimulating hormone and ganirelix (injectable kit)?
Contact your doctor if you miss a dose of follicle stimulating hormone or ganirelix.
Where can I get more information about follicle stimulating hormone and ganirelix (injectable kit)?
Your pharmacist has information about follicle stimulating hormone and ganirelix (injectable kit) written for health professionals that you may read.
What are the possible side effects of follicle stimulating hormone and ganirelix (injectable kit)?
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:
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an allergic reaction (difficulty breathing; closing of the throat;
swelling of the lips, tongue, or face; or hives);
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pain, warmth, redness, numbness, or tingling in an arm or
leg (which may indicate a blood clot);
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confusion, severe dizziness, or severe headache (which may
indicate a blood clot in the head); or
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difficulty breathing.
Other side effects may also occur. Notify your doctor if you experience
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abdominal or pelvic pain, tenderness, pressure, or swelling
(potential symptoms of ovarian enlargement);
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nausea, vomiting, diarrhea, or flatulence (gas);
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fever or chills;
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headache;
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dizziness;
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rapid pulse or heart rate;
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muscle or joint weakness or aching;
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breast tenderness;
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spotting or menstrual changes;
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pain, swelling, or irritation at the injection site; or
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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 is the most important information I should know about follicle stimulating hormone and ganirelix (injectable kit)?
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 should I avoid while taking follicle stimulating hormone and ganirelix (injectable kit)?
There are no restrictions on food, beverages, or activity during therapy with follicle stimulating
hormone and ganirelix unless otherwise directed by your doctor.
What other drugs will affect follicle stimulating hormone and ganirelix (injectable kit)?
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.
What happens if I have an overdose of follicle stimulating hormone and ganirelix (injectable kit)?
