Gonal-F

Aside from possible ovarian hyperstimulation and multiple gestations (see WARNINGS), there is no information on the consequences of acute overdosage with Gonal-f® (follitropin alfa for injection).

Before taking Gonal-F, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Gonal-F or to any of its ingredients
• have heart disease
• have thyroid and/or adrenal gland disease
• have active cancer
• have asthma or lung diseases
• have abnormal vaginal bleeding
• have ovarian cysts
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Gonal-F crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Gonal-F.

Take Gonal-F exactly as prescribed.

Gonal-F comes in injection form to be given directly under the skin, typically on a daily basis when used as part of fertility treatments in women, and typically three times per week when used to promote production of viable sperm in men.

If your physician determines you may self-inject Gonal-F, follow their instructions exactly. You may use the following information to support the instructions provided by your provider.

Preparing the medication

1. Wash your hands with soap and water.
2. Using your thumb, flip off the plastic cap of the Gonal-f® Multi-Dose vial.

3. Wipe the top of the vial stopper with an alcohol swab.

4. Carefully twist the needle cap off the syringe labeled 'Bacteriostatic Water for Injection, USP'. Do not touch the needle or allow the needle to touch any surface.

5. Position the needle of the syringe of water in a straight, upright position over the marked center circle of the rubber stopper on the vial of Gonal-f powder. Keep the needle in a straight, upright position as you insert it through the center circle, or it may be difficult to depress the plunger. Slowly inject the water into the vial by depressing the syringe plunger. When all the water has been injected into the vial, withdraw the needle and safely dispose of it immediately in your needle container. Do not use this needle to inject your dose.

6. Do not shake the vial. If bubbles appear, wait a few moments for the bubbles to settle. The liquid drug should be clear.

7. Wipe the rubber stopper of the vial of Gonal-f liquid with an alcohol wipe.

8. Carefully pull the cap from the needle. Do not touch the needle or allow the needle to touch any surface. Firmly hold the vial of Gonal-f liquid on a flat surface, insert the needle through the marked center circle of the rubber stopper.
9. Keeping the needle in the vial, lift the vial and turn it upside down with the needle pointing toward the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the syringe fills to slightly more than the mark for your prescribed dose. Next, keeping the needle in the vial, slowly adjust the plunger to your prescribed dose – this will clear away any air bubbles.
10. Check that you have the plunger set at your prescribed dose.
11. Remove the syringe needle from the vial.

Administering your dose

• Inject the prescribed dose exactly as directed by your physician
• Usual injection sites include the skin on the stomach, upper arm, or upper leg
• Change the injection location each day to minimize discomfort
• Dispose of all used syringes and needles safely in a container

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Gonal-F at the same time.

If you take too much Gonal-F, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store away from light
• Store refrigerated or at room temperature between 36°- 77° F (2°- 25° C) 
• Keep this and all medicines out of the reach of children.

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.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal bleeding of genitals or uterus (unknown cause)—Use of follitropin alfa may make the diagnosis of this problem more difficult

• Adrenal gland or thyroid disease (not controlled) or
• Asthma or
• Tumor, brain or
• Tumor, sex hormone-dependent—Use of follitropin alfa may make these conditions worse

• Ovarian cyst or enlarged ovaries—Use of follitropin alfa may increase the size of a cyst on an ovary or increase the size of enlarged ovaries

• Primary testicular failure— Follitropin alfa will not work in patients who no longer are able to produce sperms

• Primary ovarian failure—Follitropin alfa will not work in patients whose ovaries no longer develop eggs

For all patients taking Gonal-f (follitropin alfa):

• Tell all of your health care providers that you take Gonal-f. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.

Women:

• You will need to have ultrasounds done while using this medicine. Talk with your doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• If your ovaries get too big, your doctor may tell you that you need to avoid sex. This may cause an ovarian cyst to burst. Talk with your doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• The rate of pregnancy loss (miscarriage) is higher in women using drugs like this one than in women who have a natural pregnancy. Talk with the doctor.
• If you have used drugs like this one more than 1 time to get pregnant, the chance of having tumors in your ovaries may be raised. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Gonal-f, call your doctor right away.