Gonal-F 450U Powder Vial - 1ct

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 contains follicle-stimulating hormone (FSH) and is used to treat certain fertility problems in women. Follitropin alfa helps stimulate healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) to bring about 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).

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using follitropin alfa and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Learn all preparation and usage instructions from your health care professional and the product package. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If the medication is stored in the refrigerator, allow the medication to warm to room temperature before use. Inject this medication under the skin or into a muscle as directed by your doctor, usually once a day. Your doctor may direct you to use this medication in a treatment cycle (for example, only on certain days each month). Carefully follow your doctor\'s instructions. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Use only the pen needle provided with the pen. Also, use a new pen needle for each injection. The dosage is based on your medical condition, response to treatment, and lab tests. Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed. Learn how to store and discard needles and medical supplies safely.

SIDE EFFECTS: Headache, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: bleeding from the vagina/uterus, flu-like symptoms (such as fever, chills, muscle ache, tiredness), swelling of ankles/hands/feet. Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden severe headache, trouble speaking, weakness on one side of the body, sudden vision changes. This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (such as primary ovarian failure), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (such as breast, uterus, ovary), tumor in the brain (such as pituitary tumor), ovarian cysts or enlarged ovaries, blood clots, stroke, certain heart diseases (such as angina, heart attack), lung problems (such as asthma). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Multiple births may occur as a result 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 right away. It is unknown if this drug passes into breast milk. 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. A product that may interact with this drug is: gonadorelin.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Lab and/or medical tests (such as vaginal ultrasound, hormone levels, liver tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store the unused pen in the refrigerator. If necessary, the unused pen may also be stored at room temperature for up to 3 months. Once used, the pen may be stored in the refrigerator or at room temperature. Discard the used pen after 28 days. Protect from light. Do not freeze. Do not store in the bathroom. Keep all medications 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.

Information last revised January 2022. Copyright(c) 2023 First Databank, Inc.