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 BETA - INJECTION
COMMON BRAND NAME(S): Follistim
USES: This medication contains the hormone (FSH) and is used to treat certain fertility problems in women and men. In women, it 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). In men, it helps stimulate healthy testes to produce sperm. It is also used in combination with hCG.
This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure) or for men whose testes no longer make sperm properly (primary testicular failure).
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. Learn all the preparation and usage instructions in the product package. 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.
There are different follitropin products available, but they are not interchangeable, and the doses may be different. Do not switch to a different brand or type without your doctor's approval.
Inject this medication under the skin or into a muscle as directed by your doctor. Dosage is based on your medical condition and response to therapy.
Wash your 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 each time to avoid discomfort and problem areas under the skin.
If the medication is stored in the refrigerator, allow the medication to warm to room temperature before use.
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. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.
Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more information.
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 serious side effects occur: flu-like symptoms (e.g., fever, chills, muscle aches, tiredness), swelling of ankles/hands/feet, bleeding from the vagina.
Seek immediate medical attention if any of these unlikely but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, rapid breathing.
This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during therapy or 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 a 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.
Read the Follistim AQ Cartridge (follitropin beta injection) Side Effects Center for a complete guide to possible side effects
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 to streptomycin, or neomycin; 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: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary ovarian failure).
Multiple births may occur because of this treatment.
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.
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: Laboratory tests and/or medical tests (e.g., vaginal ultrasound, hormone levels, semen test) will be performed to monitor your progress.
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.
Do not share this medication with others.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store unopened vials in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Discard any unused portion of the vial.
Brief storage at 77 degrees F (25 degrees C) is permitted for up to three months. 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.