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All about: Gonal-f RFF Pen injectable

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Generic Name: follicle stimulating hormone (injectable) (PAH lich cull STIM u lay ting HORE moan)
Brand Names: Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

What is follicle stimulating hormone?

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

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 discuss with my healthcare provider before using follicle stimulating hormone?

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

  • 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, 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 use follicle stimulating hormone?

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?

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

What happens if I overdose?

An overdose of follicle stimulating hormone 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 overdose are not known.

What should I avoid while using follicle stimulating hormone?

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

Follicle stimulating hormone side effects

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:
  • 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 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

  • 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 follicle stimulating hormone?

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.

Where can I get more information?

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

What does my medication look like?

Follicle stimulating hormone is available with a prescription under the brand names Follistim, Follistim AQ Cartridge and Gonal-F. 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.

  • Follistim 75 IU powder for injection

  • Gonal-F 75 IU powder for injection

  • Gonal-F 150 IU powder for injection

  • Follistim AQ Cartridge 437.5IU/0.525 ml

  • Follistim AQ Cartridge 737.5IU/0.885 ml

  • 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 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision Date: 8/11/04 2:43:13 PM.

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