Gonal-f RFF

Generic Name: follicle stimulating hormone (FOL ik al STIM ue lay ting HOR mone)
Brand Name: Follistim AQ, Follistim AQ Cartridge, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

What is Gonal-f RFF (follicle stimulating hormone)?

Follicle stimulating hormone is a man-made form of a hormone that occurs naturally in the body. This hormone regulates ovulation, the growth and development of eggs in a woman's ovaries.

Follicle stimulating hormone is used to treat infertility in women who cannot ovulate and do not have primary ovarian failure.

Follicle stimulating hormone is also used to stimulate sperm production in men.

Follicle stimulating hormone is often used together with another medication called human chorionic gonadotropin (hCG).

Follicle stimulating hormone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Gonal-f RFF (follicle stimulating hormone)?

Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone.

Follicle stimulating hormone is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use this medicine if you are allergic to follicle stimulating hormone, neomycin (Mycifradin, Neo-Fradin) or streptomycin, or if you have an untreated or uncontrolled endocrine disorder (thyroid, pituitary gland, or adrenal gland), heavy or abnormal vaginal bleeding that has not been checked by a doctor, an ovarian cyst, or cancer of the breast, ovary, uterus, or testicle.

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Before using follicle stimulating hormone, tell your doctor if you have polycystic ovary disease, asthma, or a history of stroke or blood clot.

You should not breast-feed while you are using follicle stimulating hormone.

Avoid having sex and call your doctor right away if you have any of the following symptoms of a fluid buildup in your stomach or chest area: severe pain in your lower stomach, nausea, vomiting, diarrhea, bloating, feeling short of breath, swelling or weight gain, or urinating less than usual.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

What should I discuss with my healthcare provider before using Gonal-f RFF (follicle stimulating hormone)?

This medication is not effective in women with primary ovarian failure (when the ovaries are unable to produce an egg).

This medication is not effective in men with primary testicular failure (when the testicles are unable to produce sperm).

You should not use follicle stimulating hormone if you are allergic to it, if you are already pregnant, or if you have:

  • an untreated or uncontrolled disorder of the thyroid, pituitary gland, or adrenal glands;

  • heavy or abnormal vaginal bleeding that has not been checked by a doctor;

  • an ovarian cyst;

  • cancer of the breast, ovary, uterus, testicle, hypothalamus, or pituitary gland; or

  • if you are allergic to neomycin (Mycifradin, Neo-Fradin) or streptomycin.

To make sure you can safely use follicle stimulating hormone, tell your doctor if you have:

  • polycystic ovary disease;

  • asthma; or

  • a history of stroke or blood clot.

FDA pregnancy category X. Follicle stimulating hormone can harm an unborn baby or cause birth defects. Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone. Tell your doctor right away if you become pregnant during treatment.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

It is not known whether follicle stimulating hormone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using follicle stimulating hormone.

How should I use Gonal-f RFF (follicle stimulating hormone)?

You must remain under the care of a doctor while using follicle stimulating hormone.

Follicle stimulating hormone is injected under the skin or into a muscle. You will be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

The cartridge and injection pen are used only for an injection under the skin. Follicle stimulating hormone in a vial (bottle) is for injection into a muscle using a syringe.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may occasionally change your dose to make sure you get the best results.

Prepare your syringe or injection pen only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you use follicle stimulating hormone to get pregnant, you may need to have sex daily for several days in a row. The timing of sex within your dosing schedule is important for this treatment to work.

To be sure this medication is helping your condition, your blood may need to be tested often. You may also need ultrasound exams. Visit your doctor regularly.

Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator or at room temperature. Do not freeze. Protect from light and use within 3 months.

Storing after your first use: Keep the vial, cartridge, or injection pen at room temperature or in the refrigerator and use within 28 days. Protect from light.

Take the injection pen out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

Throw away any unused vial, cartridge, or pen after the expiration date on the label has passed.

Do not share this medication with another person, even if they have the same symptoms you have.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of follicle stimulating hormone.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Gonal-f RFF (follicle stimulating hormone)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Gonal-f RFF (follicle stimulating hormone) side effects

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;

  • nausea, vomiting, diarrhea, bloating;

  • feeling short of breath;

  • swelling in your hands or legs;

  • weight gain;

  • urinating less than usual.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness (especially on one side of the body);

  • pain, swelling, warmth, or redness in your arms or legs; or

  • severe pelvic pain on one side.

Less serious side effects may include:

  • headache;

  • mild nausea or stomach pain;

  • mild numbness or tingly feeling;

  • mild pelvic pain, tenderness, or discomfort;

  • runny or stuffy nose, sore throat;

  • breast swelling or tenderness;

  • acne;

  • mild skin rash; or

  • pain, bruising, redness, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Gonal-f RFF (follicle stimulating hormone)?

There may be other drugs that can interact with follicle stimulating hormone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about follicle stimulating hormone.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2010-12-15, 5:01:39 PM.

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