Follistim AQ

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

What is Follistim AQ?

Follistim AQ (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.

Follistim AQ is used to treat infertility in women who cannot ovulate and do not have primary ovarian failure. Follistim AQ is also used to stimulate sperm production in men.

Follistim AQ is often used together with another medication called human chorionic gonadotropin (hCG).

Follistim AQ may also be used for purposes not listed in this medication guide.

Important information

Do not use Follistim AQ if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive Follistim AQ.

Follistim AQ is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use Follistim AQ 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 Follistim AQ, 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 Follistim AQ. 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.

Before using Follistim AQ

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

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

You should not use Follistim AQ if you are allergic to follicle stimulating hormone, 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 Follistim AQ, tell your doctor if you have:

  • polycystic ovary disease;

  • asthma; or

  • a history of stroke or blood clot.

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

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Follistim AQ.

How should I use Follistim AQ?

You must remain under the care of a doctor while using Follistim AQ.

Follistim AQ 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. Follistim AQ in a vial (bottle) is for injection into a muscle using a syringe.

Follistim AQ 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 Follistim AQ 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 Follistim AQ 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 Follistim AQ 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 Follistim AQ.

What happens if I overdose?

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

What should I avoid?

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

Follistim AQ side effects

Some women using Follistim AQ 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 to Follistim AQ: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Follistim AQ 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 Follistim AQ 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 Follistim AQ?

There may be other drugs that can interact with Follistim AQ. 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 Follistim AQ.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Follistim AQ only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 5.01. Revision Date: 11/14/2010 9:08:35 AM.

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