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Gonal-f - 450unit Solution Vial
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Product ID: **GONALF
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Product Summary

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FOLLITROPIN ALFA PEN - INJECTION

(FOL-i-TROE-pin AL-fa)

COMMON BRAND NAME(S): Gonal-F RFF

USES: This medication is used to treat certain fertility problems in women. It provides the hormone (FSH) that helps stimulate healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) for the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat certain fertility problems in males.

HOW TO USE: Read the Patient Information Leaflet before starting this medication and each time you get a refill of this medication because new information may be available. You will be trained by a healthcare professional on how to properly use this medication. If any of the information is unclear, consult your healthcare professional. Inject under the skin (subcutaneously) usually once daily or as directed by your doctor. Dosage and duration of therapy is based on your medical condition and response to therapy. If the pen is stored in the refrigerator, allow the medication to warm to room temperature before use. Learn how to prepare the pen before you use it for the first time. Be sure you understand how to dial and set the prescribed dose correctly. Use only the pen needle provided and a new needle for each injection. Consult your doctor or pharmacist if you have any questions. Wash hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort or problem areas under the skin. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Use this medication exactly as directed by your doctor in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not change the dose unless instructed by your doctor or use this drug for a longer period than prescribed. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more information.

SIDE EFFECTS: Headache, stomach pain, bloating, redness/pain at the injection site, breast tenderness/pain, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal/uterine bleeding, flu-like symptoms (e.g., fever, chills, muscle ache, tiredness). Tell your doctor immediately if any of these rare but very serious side effects occur: sudden severe headache, pain/swelling of the calf muscles, swelling of ankles/hands/feet. Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, chest pain, shortness of breath. This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or change in the amount of urine. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid or adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome). Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, stroke, certain heart diseases (e.g., heart attacks), lung problems (e.g., asthma). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Multiple births may occur because of this treatment. Consult your doctor for more details. Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately. It is unknown if this drug passes into breast milk. Because of the possible harm to a nursing infant, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: gonadorelin.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol level, vaginal ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store the unused pen either in the refrigerator or at room temperature between 36-77 degrees F (2-25 degrees C). Refer to your pharmacist or the Patient Information Leaflet for details on how long you may store this medication. After the first injection, the pen may be stored refrigerated or at room temperature for up to 28 days. Discard unused solution in a used pen after 28 days or as directed in the Patient Information Leaflet. Protect from light. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

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