  |  Follistim Pen®"Fertility treatment can create anxiety for patients, in large part because they have to mix, measure and inject the medicine themselves," said Samuel Pang, MD, Medical Director, Reproductive Science Center of Boston, and an investigator in the Follistim® AQ Cartridge (follitropin beta injection)/Follistim Pen®, clinical trials. Follistim® AQ Cartridge (follitropin beta injection), for use with the Follistim Pen®, provides women with a discreet, convenient method to self-administer FSH with ease and confidence. The pre-filled, pre-mixed solution in the Follistim® AQ Cartridge (follitropin beta injection) eliminates the need to mix one or more vials of medication and inject with a conventional syringe. Background of the Follistim Pen®This pen injector offers a safe, accurate and discreet method of self-injection. This innovative method of delivering FSH makes the process go smoothly, because the medicine is already mixed and the patient just has to dial the correct dose and give themselves an injection. Also, the microneedle (29 gauge) and small volume of medication (0.09 ml = 75 IU) may contribute to patient tolerability of the injection. Benefits of the Follistim Pen®Easy to learn, easy to use — three-stage process of administration. Unique fingertip "dial-a-dose" feature – it is easy to dial and inject the accurate dose every time. Easy to correctly self-administer the prescribed dose. Completely portable – fits discreetly into purse. BD Micro-Fine™ Pen Needle provides an injection. Using the Follistim Pen®The Follistim Pen® is an accurate injection device. In two clinical trials, one for women undergoing ovulation induction and the other for IVF, patients found the Follistim® AQ Cartridge (follitropin beta injection) and the Follistim Pen® to be easy to use and convenient.1,2 The special features allow you to inject Follistim® AQ Cartridge (follitropin beta injection) safely, easily and effectively. With the Follistim Pen® you follow a 3-stage process: • Ready: Insert premixed Follistim® AQ Cartridge (follitropin beta injection) into the Follistim Pen® and attach the BD Micro-Fine™ Pen Needle. • Set: Dial your prescribed dose. • Inject: Push injection button to administer medication. The first steps section explains in more detail how to load the Follistim Pen® with Follistim® AQ Cartridge (follitropin beta injection), how to dial the prescribed dose, and how to give yourself an injection using the Follistim Pen®. 1 Pang, S. et al. “Administration of recombinant human FSH (solution in cartridge) with a pen device in women undergoing ovarian stimulation.” RBM online 7(3): 319-326, 2003. 2 Kettel LM. et al. “Evaluation of a pen device for self-administration of recombinant human FSH in clomiphene citrate-resistant anovulatory women undergoing ovulation induction.” RBM online 9(4): 373-380, 20034. 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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