Gonal-f RFF

Gonal-f RFF is used to help women who have trouble ovulating to become pregnant. Gonal-f RFF does not work for women with primary ovarian failure (when the ovaries cannot produce an egg).

Gonal-f RFF is also used in men to help produce sperm. This medicine does not work for men with primary testicular failure (when the testicles cannot produce sperm).

Gonal-f RFF is often used along with another medicine called human chorionic gonadotropin (hCG).

Gonal-f RFF may also be used for other reasons not mentioned in this medication guide.

You should not use Gonal-f RFF 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, testicle, hypothalamus, or pituitary gland.

Do not use this medicine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment.

Your doctor will do blood tests to ensure you do not have conditions that would make it unsafe for you to use Gonal-f RFF.

You should not use Gonal-f RFF if you are allergic to it, 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 evaluated by a doctor;
• an ovarian cyst;
• cancer of the breast, ovary, uterus, testicle, hypothalamus, or pituitary gland; or
• if you are allergic to benzyl alcohol, follitropin, sucrose, neomycin, sodium phosphate, or streptomycin.

Do not use this medicine if you are already pregnant. You may need to take a pregnancy test that shows a negative result before starting this treatment. Inform your doctor immediately if you become pregnant.

Tell your doctor if you have ever had:

• unusual vaginal bleeding;
• polycystic ovary disease;
• twisting (torsion) of your ovary;
• a stroke or blood clot;
• asthma; or
• stomach surgery.

Fertility treatment may increase your chances of having multiple births (twins, triplets, etc.). These pregnancies are considered high-risk for both the mother and the babies. Discuss any concerns about this risk with your doctor.

You should not breastfeed while using Gonal-f RFF.

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

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), which can be life-threatening. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using Gonal-f RFF:

• severe pain in your lower stomach, nausea, vomiting, diarrhea;
• bloating, rapid weight gain;
• little or no urination; or
• trouble breathing.

Also call your doctor immediately if you have:

• severe pelvic pain on one side;
• a cough with bloody mucus;
• fever, sore throat, swollen glands;
• a lump or swelling in your testicles;
• signs of acute respiratory distress syndrome--fever with shortness of breath or rapid breathing; or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects of Gonal-f RFF may include:

• redness, swelling, or bruising where an injection was given;
• an ovarian cyst;
• headache, tiredness;
• breast pain or swelling;
• stuffy nose, sneezing, sinus pain;
• acne; or
• nausea.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You must remain under the care of a doctor while using Gonal-f RFF.

Gonal-f RFF is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

You may need to mix Gonal-f RFF with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

To get pregnant, you may need to have sex daily for several days in a row. The timing of sex and medication dosing is important for Gonal-f RFF to work.

You will need frequent medical tests.

If you use this medicine to get pregnant, you may also need occasional ultrasound exams. Based on your blood work, you may need to stop having sex for a short time. Follow your doctor's instructions very carefully.

Storing this medicine unopened (not in use):

• Refrigerate (do not freeze) and use until expiration date; or
• Store at room temperature protected from light, and use within 3 months or until expiration date.

Storing this medicine opened (in use):

• Store in a refrigerator (do not freeze), or at room temperature protected from light.
• Use within 28 days.

Take the medicine out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not heat the medicine.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Call your doctor for instructions if you miss a dose.

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

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

Other drugs may affect Gonal-f RFF, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.