Follistim® AQ Vial (follitropin beta injection) is a medicine that contains the follicle-stimulating hormone (FSH). FSH helps (stimulate) healthy ovaries to make eggs.
Doctors specializing in treating women who have problems getting pregnant use Follistim® AQ Vial (follitropin beta injection) for the patient who needs medical help to have a child because that patient:
a. has problems with ovulation (producing and releasing eggs). Follistim® AQ Vial will not help women whose ovaries do not work at all (primary ovarian failure).
b. is participating in an Assisted Reproductive Technology (ART) program, such as in vitro fertilization, to help her ovaries make more eggs.
Follistim® AQ Vial should be used only for women seeking to become pregnant.
Follistim® AQ Vial may be one of several drugs prescribed to you as part of your treatment program. Always follow your doctor’s dosing instructions when administering Follistim® AQ Vial. Your doctor has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your doctor.
What are the possible side effects of Follistim® AQ Vial?
Follistim® AQ Vial (follitropin beta injection) and other FSH products may cause serious side effects including:
Ovarian Hyperstimulation Syndrome (OHSS). OHSS is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas.
Stop using Follistim® AQ Vial and call your healthcare provider right away if you get any of the following symptoms:
severe pelvic pain (lower stomach area)
nausea
vomiting
sudden weight gain
reduced urine output
Lung and blood vessel problems
Follistim® AQ Vial and other FSH products may cause serious lung problems including fluid in the lungs, trouble breathing and worsening of asthma. Follistim® AQ Vial and other FSH products may also cause blood clots in blood vessels. This can lead to blood vessel problems (thrombophlebitis), stroke, loss of limb, or a blood clot in the lung (pulmonary embolus).
Multiple births
Follistim® AQ Vial and other FSH products can cause multiple births. Your healthcare provider will discuss your chances of multiple births.
Other side effects with Follistim® AQ Vial include stomach pain, gas, pelvic pain, nausea, breast pain, injection site problems, enlarged stomach area, back pain, constipation, headache and ovarian pain. If you get any side effects that concern you, call your healthcare provider.
These are not all the side effects of Follistim® AQ Vial. Contact your doctor or other healthcare provider without delay if you are experiencing symptoms including significant abdominal pain, or if symptoms develop some days after the last injection has been given (see “Who should not take Follistim® AQ Vial?”).
Use Follistim® AQ Vial (follitropin beta injection) as prescribed for you. Your healthcare provider will decide on the dose of Follistim® AQ that is best for you. This dose may be increased or decreased as your treatment goes on. This will depend on your type of treatment. Do not change the dose of Follistim® AQ Vial unless your healthcare provider tells you to. It is very important that you follow your healthcare provider’s instructions exactly.
Follistim® AQ Vial is given by an injection under the skin (subcutaneous injection) or into a muscle (intramuscular injection).
Your healthcare provider will teach you how to inject yourself. Do not inject Follistim® AQ Vial at home until your healthcare provider has taught you the right way.
Close care by your healthcare provider is very important. Usually, ultrasound scans of the ovaries are regularly made. Blood or urine samples are regularly taken. The results of these tests allow your healthcare provider to choose the right dose of Follistim® AQ Vial for you each day. This is very important. Too high a dose of FSH may lead to rare, but serious problems as discussed above. Regular checking of your response to FSH treatment helps your healthcare provider lower your chances of ovarian overstimulation.
If you use too much Follistim® AQ Vial, call your healthcare provider right away.
Call your healthcare provider right away if you get strong abdominal pain. Also call your healthcare provider right away if this happens some days after the last injection has been given.
Do not use Follistim® AQ Vial for a condition for which it was not prescribed.
Do not give Follistim® AQ Vial to other people, even if they have the same symptoms that you have.
