July 29, 2014
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Drug Factsheets

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Gonal-f

(follitropin alpha)

DIN (Drug Identification Number)

02248156 GONAL-F 450 UNITS/VIAL
02248154 GONAL-F 75 UNITS/VIAL
02248157 GONAL-F 1050 UNITS/VIAL

What side effects are possible with Gonal-f?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • bloating (not severe or continuing)
  • breast tenderness
  • fatigue
  • headache
  • nausea or diarrhea (not severe or continuing)
  • pain, rash, swelling, or irritation at the place of injection
  • rash

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of a blood clot in the blood vessels (e.g., difficulty breathing, chest pain, pain and swelling in one leg muscle)
  • signs of stroke (e.g., sudden trouble with vision, dizziness, sudden severe and unusual headache, weakness, difficulty speaking)
  • symptoms of a severe allergic reaction (shortness of breath, swelling of the face or throat, or hives)
  • symptoms of ovarian hyperstimulation syndrome (difficulty breathing, abdominal or pelvic pain or discomfort, bloating, nausea, vomiting, diarrhea, decreased amount of urine, rapid weight gain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Gonal-f?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. Talk to your doctor about the risks and benefits of using this medication.

Ectopic pregnancies: This medication may increase the risk of having an ectopic pregnancy (i.e., the baby develops in one of the fallopian tubes instead of in the uterus). It is important to have an early ultrasound to ensure that the baby is developing inside the uterus.

Instructions: It is extremely important to understand your treatment and to follow instructions closely. Be sure to ask your doctor any questions you might have.

Lung problems: Rarely, this medication can cause problems with the lungs. Get immediate medical attention if you experience wheezing or difficulty breathing.

Multiple births: This medication may increase the risk of multiple births (e.g., twins). Talk to your doctor about the risks of multiple births before beginning treatment.

Ovarian enlargement: Some women using this medication may experience ovarian enlargement associated with abdominal bloating or pain. In most cases, the bloating and pain stop without treatment within 2 or 3 weeks. If you experience these symptoms contact your doctor.

Ovarian hyperstimulation syndrome (OHSS): Treatment with this medication can cause a condition called ovarian hyperstimulation syndrome (OHSS). With OHSS, too many follicles grow and cause abdominal or pelvic discomfort or pain, nausea, vomiting, and weight gain. Some women may experience difficulty breathing, diarrhea, and decreased urination. OHSS can progress rapidly and may become serious. If you experience any of these symptoms while using this medication, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. This medication should not be used while breast-feeding.

Children: This medication is intended for use by women of child-bearing age and therefore, the safety and effectiveness of this medication have not been established for children.

Seniors: This medication is intended for use by women of child-bearing age and therefore, the safety and effectiveness of this medication have not been established for seniors.

What other drugs could interact with Gonal-f?

There may be an interaction between follitropin alpha and any of the following:

  • cetrorelix
  • clomiphene
  • follitropin beta
  • ganirelix
  • gonadorelin acetate
  • human chorionic gonadotropin (hCG)
  • menotropins
  • nafarelin
  • urofollitropin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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