  |  Frequently Asked Questions
What is Follistim® AQ Cartridge (follitropin beta injection)?Follistim® AQ Cartridge (follitropin beta injection) is a follicle stimulating hormone (FSH) treatment available in a pre-filled, pre-mixed solution, approved in the U.S., eliminating the need for patients to mix one or more vials of medication. Follistim® AQ Cartridge (follitropin beta injection) is designed to be used only with the Follistim Pen®, an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, an effective and widely used prescription fertility medication made using recombinant DNA technology. What is Follistim® AQ Cartridge (follitropin beta injection) used for?Doctors specializing in treating women who have problems getting pregnant use Follistim® AQ Cartridge (follitropin beta injection) for the patient who needs medical help to have a child because that patient:
Follistim® AQ Cartridge (follitropin beta injection) should be used only for women seeking to become pregnant. Follistim® AQ Cartridge (follitropin beta injection) 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 Cartridge (follitropin beta injection). Your doctor has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your doctor. How does Follistim® AQ Cartridge (follitropin beta injection) work?Follistim® AQ Cartridge (follitropin beta injection) acts like naturally produced follicle-stimulating hormone (FSH), the hormone that stimulates the ovaries. It binds to the surface of the immature follicle to trigger a series of events that lead to the growth of the follicle and the maturation of the egg. Follistim® AQ Cartridge (follitropin beta injection) (or other drugs containing FSH) will not induce ovulation. For ovulation to occur, a second hormone called human chorionic gonadotropin, available as Pregnyl® (chorionic gonadotropin for injection, USP), is administered. Human chorionic gonadotropin acts like luteinizing hormone (LH) to induce ovulation and release the mature egg from the follicle. How is Follistim® AQ Cartridge (follitropin beta injection) administered?Follistim® AQ Cartridge (follitropin beta injection) is administered as a subcutaneous injection (under the skin) using the Follistim Pen®. You load a pre-mixed, pre-filled Follistim® AQ Cartridge (follitropin beta injection) containing the medication into the Follistim Pen®, dial up your exact dose and give yourself an injection. Always follow your healthcare professional’s dosing instructions when administering Follistim® AQ Cartridge (follitropin beta injection). Your healthcare professional has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your healthcare professional. For additional information on how to use Follistim® AQ Cartridge (follitropin beta injection) and Follistim Pen® download the Instructional Quick Guide. How does my doctor know that Follistim® AQ Cartridge (follitropin beta injection) is working?Before beginning therapy, your doctor will explain the standard tests and monitoring procedures that he or she will use to track your progress. It is very important that you keep all your appointments during therapy since infertility treatments require precise timing of hormone injections and induction of ovulation. Delays may lead to cancellation of the treatment cycle or complications. Your doctor can monitor your progress in two ways: By measuring your blood levels of estrogen. As the follicles grow and respond to Follistim® AQ Cartridge (follitropin beta injection), they release estrogen. A rise in your serum estrogen levels indicates that the follicles are developing. By performing ultrasound scanning or ultrasonography. Ultrasound scanning allows your doctor to see the developing follicles and assess their stage of maturation. These monitoring techniques can minimize the risk of multiple births for patients undergoing ovulation induction and the chance of other complications. What can I expect from therapy with Follistim® AQ Cartridge (follitropin beta injection)?After the initial doses of the hormone, your doctor can monitor your progress through blood tests and ultrasound scanning. Based on his or her observations, the daily dose of Follistim® AQ Cartridge (follitropin beta injection) will be adjusted to minimize the risks of adverse events while maintaining adequate ovarian stimulation. When the follicles have reached the appropriate size (in approximately 6 to 12 days), you will receive an injection of human chorionic gonadotropin, available as Pregnyl® (chorionic gonadotropin for injection, USP), to induce ovulation. Note to patients undergoing ovulation induction: Note to patients undergoing ART procedures:
What are the possible side effects of Follistim® AQ Cartridge (follitropin beta injection)?Follistim® AQ Cartridge (follitropin beta injection) and other FSH products may cause serious side effects including:
Other side effects with Follistim® AQ Cartridge (follitropin beta injection) include: stomach pain, gas, pelvic pain, nausea, breast pain, injection site problems, enlarged abdomen, back pain, constipation, headache, ovarian pain, sinusitis, and upper respiratory tract infection. These are not all the side effects with Follistim® AQ Cartridge (follitropin beta injection). 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 (follitropin beta injection), including the complete list of side effects and important safety information, download the physician prescribing information. What treatment is available for ovarian hyperstimulation syndrome (OHSS)?In mild cases of OHSS, doctors advise patients to avoid intercourse and get a lot of bed rest. OHSS usually resolves itself spontaneously with the onset of menstruation. If more severe symptoms occur, hospitalization may be necessary. Your healthcare provider will advise you on the risks of OHSS. What are the chances of conceiving and giving birth to more than one child?Treatment with FSH products, such as Follistim® AQ Cartridge (follitropin beta injection), may result in multiple births. You and your partner should be advised by your physician of the potential risk of multiple births before starting treatment. How do you store Follistim® AQ Cartridge (follitropin beta injection)?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 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. Does Follistim® AQ Cartridge (follitropin beta injection) contain any latex?The packaging of this product does not contain natural rubber latex. Is Follistim® AQ Cartridge (follitropin beta injection) kosher?Please note that Follistim® contains polysorbate 20, which is from a non-kosher sorbitol source. How is Follistim® AQ Cartridge (follitropin beta injection) supplied?Follistim® AQ Cartridge (follitropin beta injection) is supplied in a box containing one disposable prefilled glass cartridge, with an aluminium crimp-cap and black rubber inlay and in the following presentations: Follistim® AQ Cartridge 350 IU/0.420 mL (delivering 300 IU) with silver crimp- caps and 5 BD Micro-Fine™ Pen Needles Follistim® AQ Cartridge 650 IU/0.780 mL (delivering 600 IU) with gold crimp-caps and 7 BD Micro-Fine™ Pen Needles Follistim® AQ Cartridge 975 IU/1.170 mL (Delivering 900 IU) with blue crimp-caps and 10 BD Micro-Fine™ Pen Needles Who should not take Follistim® AQ?Do not use Follistim® AQ Cartridge (follitropin beta injection) if you: Tell your healthcare provider if you are breast-feeding. It is not known if follitropin beta injection passes into your milk. 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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