Possible side effects

Follistim® AQ Vial (follitropin beta injection) and other FSH products may cause serious side effects including:

• Ovarian hyperstimulation syndrome (OHSS) is a serious medical condition that can happen when the ovaries have been over-stimulated. In the early stages of the condition, ovaries become suddenly enlarged with a collection of fluid in the abdomen.

Early warning signs of OHSS to be aware of include: pelvic pain, nausea, vomiting, weight gain, and reduced urine production. In more severe cases, fluid may collect in the lungs, causing breathing difficulties. If an ovary ruptures, blood can also collect in the abdominal area. Other complications that may occur include severe fluid imbalances, which can also cause blood-clotting problems such as inflammation of veins, stroke, and lung clots. In rare cases, complications from OHSS, including blood clotting and/or breathing difficulties, may be life threatening. Some women, such as those with polycystic ovarian syndrome (PCOS), run a higher risk of hyperstimulation.

Most often, OHSS will occur after treatment with FSH-containing drugs. It can develop rapidly and become most pronounced 7 to 10 days following FSH treatment. Because of this, your doctor will continue to monitor and examine you for at least 2 weeks after the administration of Pregnyl® (chorionic gonadotropin for injection, USP).

Multiple births

Follistim® AQ Cartridge and other FSH products can cause multiple births. Your healthcare provider will discuss your chances of multiple births.

Side effects reported in clinical studies with Follistim® AQ Cartridge include: abdominal pain, flatulence, nausea, breast pain, injection site reaction, enlarged abdomen, back pain, constipation, headache, ovarian pain, ovarian hyperstimulation syndrome (OHSS), sinusitis, and upper respiratory tract infection.

Contact your doctor without delay if you are experiencing any of these symptoms, including significant abdominal pain, or if symptoms develop some days after the last injection has been given. For additional information on Follistim® AQ Cartridge, including the complete list of side effects and safety information, download the physician prescribing information.