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Follistim information


Forum: Trying to Conceive with Medical Assistance

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April 18th, 2006, 08:45 AM
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What is the most important information I should know about Follistim?
• Treatment with Follistim 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 is Follistim?
• 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.
• Follistim 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. Follistim is also used to stimulate the development of multiple eggs for in vitro fertilization. Follistim can be used by men to increase the production of sperm.
• Follistim may also be used for purposes other than those listed in this medication guide.




What should I discuss with my healthcare provider before using Follistim?
• Follistim will not induce ovulation if the ovaries are not capable of producing an egg. Also, Follistim 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
· 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 Follistim, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.
• Treatment with Follistim 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. Follistim is in the FDA pregnancy category X. This means that Follistim is known to cause birth defects in an unborn baby (when used beyond the period of ovulation).
• It is not known whether Follistim passes into breast milk. Do not use Follistim without first talking to your doctor if you are breast-feeding a baby.




How should I use Follistim?
• Use Follistim 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 Follistim 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?
• Contact your doctor if you miss a dose of Follistim.




What happens if I overdose?
• An overdose of Follistim 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 Follistim overdose are not known.




What should I avoid while using Follistim?
• There are no restrictions on food, beverages, or activity during treatment with Follistim unless otherwise directed by your doctor.




What are the possible side effects of Follistim?
• Stop using Follistim 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, severe headache; or
· difficulty breathing.
• Approximately 5% of patients treated with Follistim 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
· ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
· 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.
• 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 Follistim?
• It is not known whether other medications will interact with Follistim. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.




Where can I get more information?
• Your pharmacist has additional information about Follistim written for health professionals that you may read.
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