What is follicle stimulating hormone (injectable)?
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.
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.
Follicle stimulating hormone 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 (injectable)?
Follicle stimulating hormone 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.
Before using this medication, tell your doctor if you
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might be pregnant;
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have a thyroid problem;
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have adrenal dysfunction;
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have cancer or a tumor of the breast, ovary, uterus,
hypothalamus, or pituitary gland;
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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, or you may require
a dosage adjustment or special monitoring if you have any of the conditions listed above.
Treatment with follicle stimulating hormone 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.
Tell your doctor if you are allergic to neomycin or streptomycin. The Follistim AQ Cartridge
may contain traces of these antibiotics and may cause allergic reactions.
Do not
use this medication if you are pregnant. Follicle stimulating
hormone is in the FDA pregnancy category X. This means that follicle stimulating hormone is known to
cause birth defects in an unborn baby (when used beyond the period of ovulation).
It is not known whether follicle stimulating hormone passes into breast milk. Do not use
follicle stimulating hormone without first talking to your doctor if you are breast-feeding a baby.
How should I take follicle stimulating hormone (injectable)?
Use follicle stimulating hormone exactly as directed by your doctor. If you do not understand
these directions, ask your doctor, nurse, or pharmacist to explain them to you.
Gonal-F and Follistim AQ should only be administered subcutaneously. Follistim may be
administered as a subcutaneous injection (injection under the skin) or intramuscular injection (injection
into the muscle). If you are administering this medication at home, your doctor will give you detailed
instructions on how to mix the solution and give the injection. Do not inject this medication if you are not
sure how.
Do not shake the vial, but gently swirl until the solution is clear. Do not inject any
medication that is discolored or that has particles in it.
Gonal F ampules and Follistim should be used immediately after mixing.
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate,
puncture-resistant disposal container.
Follistim AQ should only be used with the Follistim Pen.
Store unmixed vials of follicle stimulating hormone at room temperature or in the refrigerator
away from light, moisture, and heat.
Store the Follistim AQ cartridges in the refrigerator until the expiration date printed on the
cartridge. Alternatively, the cartridges can be stored at room temperature for up to 3 months or until the
expiration date, whichever comes first. Once the rubber stopper on the cartridge has been pierced by a
needle, the product must be used within 28 days.
Store mixed multi-dose vials of Gonal-F in the refrigerator between 36 and 46 degrees
Fahrenheit (2 and 8 degrees Celsius), protected from light. Throw away any unused medication 28
days after mixing.
What happens if I miss a dose of follicle stimulating hormone (injectable)?
Contact your doctor if you miss a dose of follicle stimulating hormone.
Where can I get more information about follicle stimulating hormone (injectable)?
Your pharmacist has information about follicle stimulating hormone (injectable) written for health professionals that you may read.
What are the possible side effects of follicle stimulating hormone (injectable)?
Stop using follicle stimulating hormone 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, severe headache; or
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difficulty breathing.
Approximately 5% of patients treated with follicle stimulating hormone
develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy.
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, and nausea or vomiting. OHSS
can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of
these symptoms.
Other side effects may also occur. Notify your doctor if you experience
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ovarian enlargement presenting as abdominal or pelvic pain,
tenderness, pressure, or swelling;
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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.
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 follicle stimulating hormone (injectable)?
Treatment with follicle stimulating hormone 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.
What should I avoid while taking follicle stimulating hormone (injectable)?
There are no restrictions on food, beverages, or activity during treatment with follicle stimulating
hormone unless otherwise directed by your doctor.
What other drugs will affect follicle stimulating hormone (injectable)?
It is not known whether other medications will interact with follicle stimulating hormone. Talk to
your doctor and pharmacist before taking any prescription or over-the-counter medicines, including
vitamins, minerals, and herbal products.
What happens if I have an overdose of follicle stimulating hormone (injectable)?