  |  Ovulatory DisordersThe most common causes of infertility include the inability to ovulate (anovulation) and irregular ovulatory cycles (oligoovulation). The causes of these types of ovulatory disorders are quite diverse, and may include problems with the central nervous system or pituitary gland, as well as complications with the developing follicles, ovary, or both. Common ovulatory disorders include: Hypothalamic-pituitary problemsSome women do not ovulate because there is little or no stimulation from their pituitary glands. This can affect the functioning of the hypothalamus (the part of the central nervous system which communicates with the pituitary gland). This is a common problem for women who exercise vigorously, are under significant stress, or who have eating disorders such as anorexia. These women do not produce sufficient follicle-stimulating hormone (FSH) and luteinizing hormone (LH) to stimulate the follicles in the ovaries to mature. Treatment involves either stimulating the pituitary to release LH and FSH or simply replacing the missing LH and FSH by administering it directly. Premature ovarian failureSome women do not ovulate because they have few or no eggs in their ovaries. When this happens prior to the age of 40, it is termed premature ovarian failure (POF) or premature menopause. This could be the result of prior chemotherapy or radiation therapy, prior removal of the ovaries, or various genetic abnormalities. However, often the explanation is not obvious and these women may have simply exhausted their supply of eggs at a very young age. Since these women do not have viable eggs they are not candidates for ovulation induction. Polycystic ovarian disease, chronic anovulation, and related syndromesA vast majority of women who do not ovulate regularly have a pituitary gland that is functional and have plenty of eggs containing follicles in their ovaries. The problem stems from the relationship between the stimulatory effects of the LH and FSH
released from the pituitary and how the follicles respond. While the source of this problem varies and is not known for many patients, the symptoms resemble those associated with polycystic ovarian disease (PCO). They include multiple small follicles
within the ovary and abnormal levels of LH and FSH in the blood stream. Although the cause of these disorders and the symptoms vary from patient to patient, a common finding is that these women lack sufficient FSH stimulation to keep their follicles developing to maturity. In many cases treatment focuses on raising FSH
levels to the point where follicular growth and development resumes, resulting in the release of a healthy mature egg (ovulation). 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:
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:
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. |
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