Gonal-F

Gonal-F is used in women as part of certain fertility treatments, in addition to other medications, and also in men to promote viable sperm production. 

Gonal-F belongs to a group of medications called gonadotropins. These work to promote ovulation and pregnancy by effectively mimicking naturally-occuring hormones in the body that are critical to the development of the follicle and embryo implantation. Gonal-F works to promote production of viable sperm in men by mimicking the effects of the primary hormone involved in sperm production. 

This medication is available as an injection 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.

Common side effects of Gonal-F include headache, stomach pain, and nausea. 

Gonal-F can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Gonal-F affects you.

Gonal-F is used in women as part of certain fertility treatments in addition to other medications to promote ovulation and pregnancy and in men to promote production of viable sperm. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• EMD Serono, Inc.

Serious side effects have been reported with Gonal-F. See the “Gonal-F Precautions” section.

Common side effects of Gonal-F include the following:

• headache
• ovarian cysts
• vaginal bleeding
• injection site reactions
• upper respiratory tract infections
• stomach pain
• nausea

This is not a complete list of Gonal-F side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

• ganirelix
• follicle stimulating hormone 
• clomiphene
• gonadorelin

This is not a complete list of Gonal-F drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Gonal-F including the following:

• Ovarian Hyperstimulation Syndrome. Discontinue use of Gonal-F and get medical attention immediately if you experience the following combination of symptoms:
  • severe pelvic pain
  • nausea
  • vomiting
  • weight gain
• Serious pulmonary complications. Asthma exacerbations and acute respiratory distress syndrome have been reported with use of Gonal-F. Consult with your physician if you have asthma or lung problems before taking Gonal-F.
• Blood clots. Consult with your physician if you have a history of heart disease and/or blood clots. Get medical attention immediately if you experience sudden difficulty breathing, persistent leg or other extremity pain and/or sudden severe headaches.

Gonal-F can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Gonal-F affects you.

Do not take Gonal-F if you:

• are allergic to Gonal-F or to any of its ingredients
• have thyroid and/or adrenal gland disease
• have active cancer
• have abnormal vaginal bleeding
• have ovarian cysts
• are pregnant 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gonal-F , there are no specific foods that you must exclude from your diet when receiving this medication.

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 pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Gonal-F falls into category X. It has been shown that women taking Gonal-F during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

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.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age
• your gender

The recommended dose range of Gonal-F when used as part of fertility treatments in women is 75 international units (IU) to 300 IU injected subcutaneously once per day.

The recommended dose range of Gonal-F when used to promote production of viable sperm in men is 150 IU to 300 IU injected subcutaneously three times per week.

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.