 |  Frequently asked questions
What is Follistim® AQ Cartridge?Follistim® AQ Cartridge was the first 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 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, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology. Who is prescribed Follistim® AQ Cartridge?Follistim® AQ Cartridge is for 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. How does Follistim® AQ Cartridge work?Follistim® AQ Cartridge 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 (or other drugs containing FSH) will not induce ovulation. For ovulation to occur, a second hormone called Pregnyl® (chorionic gonadotropin for injection, USP) is administered. Pregnyl® acts like luteinizing hormone (LH) to induce ovulation and release the mature egg from the follicle. How is Follistim® AQ Cartridge administered?Follistim® AQ Cartridge is administered as a subcutaneous injection (under the skin) using the Follistim Pen®. You load a pre-mixed, pre-filled Follistim® AQ Cartridge 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. 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 and Follistim Pen® download a PDF of step-by-step instructions. How is Follistim® AQ Cartridge different from the Follistim® freeze-dried powder?Although both Follistim® and Follistim® AQ Cartridge contain the same active ingredient, rFSH, Follistim® AQ Cartridge (follitropin beta injection) is NOT the same formulation as Follistim® in the freeze-dried powder presentation, which is administered with a conventional syringe and needle. Consult with your doctor or other healthcare provider if you have any questions about the difference between these two products. Why might my dose be different with Follistim® AQ Cartridge for use only with Follistim Pen®?If you have previously used gonadotropins, your dose may be different with Follistim® AQ Cartridge. Follistim® AQ Cartridge is delivered by the Follistim Pen® which accurately delivers the dose to which it is set. It was shown that on average an 18% higher amount of Follistim® AQ in the Follistim® AQ Cartridge was delivered with the Follistim Pen® as compared to the amount of Follistim® delivered with the standard syringe after diluting a freeze-dried powder preparation. Always follow your doctor’s dosing instructions when administering Follistim® AQ Cartridge. 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 my doctor know that Follistim® AQ Cartridge 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: What can I expect from therapy with Follistim® AQ Cartridge?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 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 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?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. What is ovarian hyperstimulation syndrome (OHSS)?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). 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, may result in multiple births. Your healthcare provider will advise you on the risk of multiple births. How do you store Follistim® AQ Cartridge?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 has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2-25 oC(36-77 oF). Protect from light. Do not freeze. Does Follistim® AQ Cartridge contain any latex?The packaging of this product does not contain natural rubber latex. Is Follistim® AQ Cartridge kosher?Please note that Follistim® contains polysorbate 20, which is from a non-kosher sorbitol source. How is Follistim® AQ Cartridge supplied?Follistim® AQ Cartridge (follitropin beta injection) is supplied in a box containing one disposable, blister packed, prefilled, colorless glass cartridge, with grey rubber piston and an aluminium crimp-cap with black rubber inlay and in the following presentations: • Follistim® AQ Cartridge 437.5 IU/0.525 mL (delivering 300 IU) with silver crimp- caps and 5 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. |
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