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Drugs & Medications

Gonal-F subcutaneous

FOLLITROPIN ALFA MULTIDOSE VIAL - INJECTION

GENERIC NAME(S): FOLLITROPIN ALFA, RECOMB

Uses

This medication is used in combination with another hormone (hCG) to treat certain fertility problems in women and men.

Follitropin alfa provides the hormone (FSH) that makes healthy ovaries produce eggs. It helps 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).

In males, hCG is used before and with this medication to stimulate sperm production. Follitropin alfa is not recommended for men that cannot make sperm (primary testicular failure).

How to use Gonal-F subcutaneous

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 in women and three times a week in men, or as directed by your doctor. Dosage and duration of therapy is based on your medical condition and response to therapy.

Wash hands with soap and water before using this medication. Follow all instructions for proper mixing of this medication with the mixing liquid provided. Do not shake the vial. If bubbles appear, wait a few seconds for the bubbles to disappear.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to measure the dose correctly. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site with each new injection to avoid discomfort or problem areas under the skin. Consult your doctor or pharmacist if you have any questions.

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 as scheduled. 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, diarrhea, redness/pain at the injection site, breast tenderness/pain, acne, 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 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, 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 (such as benzyl alcohol), 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 or testicular failure), thyroid or adrenal gland problems, cancer of the reproductive organs (e.g., breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), abnormal uterine/vaginal bleeding, 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.

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 a poison control center or emergency room immediately. 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.

Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol or testosterone levels, ultrasound) should be performed regularly to monitor your progress or check for side effect. 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 vial refrigerated or at room temperature between 36-77 degrees F (2-25 degrees C). After mixing, the vial may be stored refrigerated or at room temperature between 36-77 degrees F (2-25 degrees C) for up to 28 days. Discard unused solution after 28 days. 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 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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