Follistim® AQ Vial

This section is for patients using Follistim^® AQ packaged in a single use vial, which should not be confused with Follistim^® AQ Cartridge (follitropin beta injection) for use with Follistim Pen^®.

If your physician prescribed Follistim^® AQ Cartridge, please see the Patient information for Follistim^® AQ Cartridge and read the Follistim^® AQ Cartridge section of this site before continuing.

Follistim^® AQ packaged as a single use vial is given by injection under the skin (subcutaneous injection) or into a muscle (intramuscular injection). Your healthcare provider will teach you how to inject yourself. See Giving yourself the injection for more information. Do not inject Follistim^® AQ at home until your healthcare provider has taught you the right way.

General information about Follistim® AQ

Follistim^® AQ is a recombinant follicle stimulating hormone (recombinant FSH) available in a pre-mixed aqueous solution. The active ingredient in Follistim^® AQ Vial/Cartridge is follitropin beta, an effective and widely used prescription fertility medication made using recombinant DNA technology. This hormone is identical to the FSH produced by the pituitary gland and belongs to the group of gonadotropins, which play an important role in human fertility and reproduction.

FSH is needed in women for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. FSH stimulates the ovaries to produce mature eggs. Follistim^® AQ is used for the development of eggs in women who have problems with ovulation and who are undergoing Ovulation Induction treatment. Some women will also be using this medicine for the development of more eggs when participating in an Assisted Reproductive Technology (ART) program, such as in vitro fertilization. Follistim^® AQ Vial is available in single, small volume (0.5 mL) 75 and 150 IU vials.

Ingredients in Follistim^® AQ

Follistim^® AQ contains the active ingredient follitropin beta. Inactive ingredients include sucrose, sodium citrate, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide.

Storing Follistim^® AQ

Store refrigerated at 2-8°C (36-46°F) until dispensed. Upon dispensing, the product may be stored by the patient at 2-8°C (36-46°F) until the expiration date, or at or below 25°C (77°F) for 3 months or until expiration date, whichever occurs first. Protect from light, keep container in carton. Do not freeze

If you would like more information, talk with your healthcare provider. Be sure to discuss any questions you may have before beginning treatment. For more detail on information contained in this site call 1-866-836-5633.

Follistim^® AQ (follitropin beta injection) is approved to help women who have problems with ovulation. Follistim® AQ will not help women whose ovaries do not work at all (primary ovarian failure). Follistim^® AQ is also for women that are in an assisted reproductive technology (ART) program, such as in vitro fertilization.

Important Safety Information:

Always follow your health care professional’s dosing instructions when administering Follistim^® AQ Cartridge. Your health care professional has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your health care professional.

Do not use Follistim^® AQ if you are allergic to recombinant human FSH products; have primary ovarian failure (your ovaries do not work at all); are pregnant or think you might be pregnant; have uncontrolled thyroid or adrenal gland problems; have tumors in your ovaries, breasts, uterus, hypothalamus, or pituitary gland; have heavy or irregular vaginal bleeding and the cause is not known; have ovarian cysts or enlarged ovaries not due to polycystic ovary syndrome (PCOS); or are allergic to streptomycin or neomycin. Follistim^® AQ may contain traces of these antibiotics and may cause allergic reactions.

Follistim^® AQ may cause ovarian hyperstimulation syndrome (OHSS), which 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. OHSS may occur after treatment with Follistim^® AQ. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Follistim^® AQ and other FSH products may cause serious lung problems including fluid in the lungs, trouble breathing, and worsening of asthma. Follistim^® AQ 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).

Follistim^® AQ and other FSH products can cause multiple births. Your health care professional will discuss your chances of multiple births.

Follistim^® AQ should only be prescribed by physicians experienced in infertility treatments.

Other side effects with Follistim^® AQ 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 health care professional. These are not all the side effects of Follistim^® AQ. Contact your doctor or other health care professional without delay if you are experiencing symptoms including significant abdominal pain or if symptoms develop some days after the last injection has been given.

Please click here for important Product Information on Follistim^® AQ Cartridge.

Please click here for important Product Information on Follistim^® AQ Vial.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Pregnyl^® (chorionic gonadotropin for injection, USP) is approved to induce ovulation and pregnancy in women who have problems with ovulation and who have been appropriately pretreated with human menopausal gonadotropins (medications containing follicle-stimulating hormone [FSH] and luteinizing hormone [LH]). Pregnyl^® will not help women whose ovaries do not work at all (primary ovarian failure).

Important Safety Information:
Do not use Pregnyl^® if you are allergic to human chorionic gonadotropin.

Pregnyl^® should be used in conjunction with human menopausal gonadotropins. Pregnyl^® should only be prescribed by physicians experienced in infertility treatments.

Pregnyl^® may cause ovarian hyperstimulation syndrome (OHSS), which 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. OHSS may occur after treatment with Pregnyl^®. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Pregnyl^® may also cause rupture of ovarian cysts resulting in internal bleeding (hemoperitoneum), multiple births, and artery blockage by a blood clot (arterial thromboembolism).

Other side effects with Pregnyl^® include headache, irritability, restlessness, depression, fatigue, edema, and pain at the site of injection. If you get any side effects that concern you, call your health care professional.

Please click here for important Product Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Ganirelix Acetate Injection is approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Important Safety Information:
Do not use Ganirelix Acetate Injection if you are allergic to ganirelix acetate or any of its components, gonadotropin releasing hormone (GnRH) or any other GnRH analog (including GnRH agonists and antagonists), or if you are pregnant or think you might be pregnant.

Ganirelix Acetate Injection should only be prescribed by physicians experienced in infertility treatments. Before starting treatment with Ganirelix, pregnancy must be excluded.

Hypersensitivity (allergic) reactions, some severe, have been reported after the first dose of Ganirelix Acetate Injection. Call your health care professional right away if you get any of the following symptoms: hives, difficulty breathing, chest tightness, high or low blood pressure, vomiting, or diarrhea. The packaging of this product contains natural rubber latex which may cause allergic reactions.

Ganirelix Acetate Injection may cause ovarian hyperstimulation syndrome (OHSS), which 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. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Other side effects with Ganirelix Acetate Injection include abdominal pain, death of unborn child, headache, vaginal bleeding, injection site reaction, and nausea. If you get any side effects that concern you, call your health care professional.

Please click here for important Product Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.