Follistim^® AQ Cartridge (follitropin beta injection)

Follistim^® AQ Cartridge (follitropin beta injection) was the first follicle-stimulating hormone (FSH) treatment available in the United States in a pre-filled, pre-mixed solution. Follistim^® AQ Cartridge (follitropin beta injection), an effective and widely used prescription fertility medication, contains the active ingredient follitropin beta made using recombinant DNA technology. This hormone is the same as follicle-stimulating hormone (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 Cartridge (follitropin beta injection) 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 multiple eggs when participating in an Assisted Reproductive Technology (ART) program, such as in vitro fertilization.

Follistim® AQ Cartridge (follitropin beta injection) and the Follistim Pen®

Follistim^® AQ Cartridge (follitropin beta injection) for use with the Follistim Pen^®, is administered by subcutaneous injection. The Follistim Pen^® is an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection.

Follistim® AQ Cartridge

Follistim^® AQ Cartridge (follitropin beta injection), for use with the Follistim Pen^®, provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. In addition, Follistim^® AQ Cartridge (follitropin beta injection) can be stored at room temperature.*

Additional Information For You

This section of the web site discusses Follistim^® AQ Cartridge (follitropin beta injection) in detail so you can feel more in control of your treatment. Here you can find information about how Follistim^® AQ Cartridge (follitropin beta injection) works, how it is administered and how it is prescribed. As with any treatment, it is important to speak to your doctor or a nurse about any concerns or questions you and your partner may have.

Patients should always follow their doctor’s instructions when administering Follistim^® AQ Cartridge (follitropin beta injection). Your doctor will individualize the dose to be administered based on medical history. Do not change your dose unless instructed by your doctor.

*The product may be stored by the patient at 2-8°C (36-46°F) until the expiration date, or at 25°C (77°F) for 3 months, or until the expiration date, whichever occurs first. Once the rubber inlay of the Follistim^® AQ Cartridge (follitropin beta injection) has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2-25°C (36-77°F). Protect from light. Do not freeze.

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.

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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.

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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.