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title Fertility Fact Sheet Infertility is not uncommon. Recent estimates indicate infertility affects one in eight couples, or 7.3 million men and women in the US. Infertility is defined as the inability to achieve pregnancy after one year of regular, unprotected intercourse (six months if the woman is over 35). While infertility can be an emotionally uncertain and frustrating journey, it may be successfully treated. Many patients who complete treatment for infertility ultimately succeed in having a child. EMD Serono is the only company to offer a FSH portfolio of multiple presentations including multi-dose vial, single-dose vial and pen options. For more information, please visit Fertility LifeLines™ at www.fertilitylifelines.com or call 1-866-LETS-TRY (1-866-538-7879). These products should only be prescribed by physicians specializing in fertility or reproductive health. Patients prescribed the above products should be monitored carefully by a trained fertility specialist. Marketed Products Gonal-f® (follitropin alfa for injection) Gonal-f® is a recombinant human follicle stimulating hormone (r-hFSH) prescribed to supplement or replace naturally occurring FSH, one of the primary hormones used in the treatment of infertility. Gonal-F® (follitropin alfa for injection) Indication: Women: Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa for injection), and Gonal-f® RFF Pen (follitropin alfa injection) are indicated for (1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and (2) for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Men: Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. The Gonal-f® RFF* Pen (follitropin alfa injection), is the only prefilled and ready-to-use multidose FSH in the US. It was designed specifically for the treatment of infertility to allow patients to accurately deliver a precise daily dose of medication. Important Safety Information These products should be prescribed only by physicians specializing in fertility or reproductive health. Use of Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Pen by women can result in multiple births. EMD Serono offers recombinant versions of two hormones used in the treatment of infertility: Gonal-f® (follitropin alfa for injection) and Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection). Rounding out EMD Serono’s portfolio of fertility treatments is Cetrotide® (cetrorelix acetate for injection). Contact Kristen LaVerghetta 781-681-2065 [email protected] EMD Serono, Inc. is a subsidiary of Merck KGaA, Darmstadt, Germany. www.emdserono.com www.facebook.com/myemdserono Prescribers and patients should familiarize themselves with product and risk information before using. For more information on EMD Serono’s products, patient support services, and full prescribing information, visit emdserono.com. * Revised Formulation Female Last updated April 2013 | page 1 120525-103538 As a leader in fertility health, EMD Serono, Inc. is dedicated to providing therapies and devices that help treat infertility. Fact Sheet fertility Lindsay EMD Serono, Fertility Patient Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa for injection), and Gonal-f® RFF Pen (follitropin alfa injection) are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone–dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor. Additionally, Gonal-f®, Gonal-f® RFF, or Gonal-f® Pen should not be given to women with abnormal uterine bleeding, presence or enlargement of an ovarian cyst of undetermined origin or to women who are pregnant or nursing. The most common side effects reported in women using Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Pen include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections. Men using Gonal-f® have commonly reported acne, breast pain and growth, 2 and fatigue. Injection site reactions have been reported. This information is not intended to replace discussions with your doctor. For additional information about the risks of Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa for injection), and Gonal-f® RFF Pen (follitropin alfa injection), see the Prescribing Information. Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) Ovidrel® PreFilled Syringe is a ready-to-inject liquid infertility treatment and the only available recombinant version of human chorionic gonadotropin (hCG). Human chorionic gonadotropin is one of the gonadotropins used in the treatment of infertility. Ovidrel® PreFilled Syringe is the first and only recombinant hCG in the world. Essentially equivalent in structure to naturally occurring hCG, Ovidrel® PreFilled Syringe is used in infertility treatment cycles to help follicles mature and to trigger the actual release of mature eggs from a woman’s ovaries following treatment with products containing human follicle stimulating hormone such as Gonal-f®. Fact Sheet fertility Ovidrel® prefilled syringe (choriogonadotropin alfa injection) Indication: Ovidrel® PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an ART program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Important Safety Information Ovidrel® Prefilled Syringe should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® Prefilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel® Prefilled Syringe (choriogonadotropin alfa injection). The most common side effects in women using Ovidrel® Prefilled Syringe include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel® Prefilled Syringe treatment. For additional information about Ovidrel® Prefilled Syringe, see the Prescribing Information. Cetrotide® (cetrorelix acetate for injection) Cetrotide® is a gonadotropin-releasing hormone (GnRH) antagonist used to control hormone responses, which impact the development of eggs. Specifically, Cetrotide® helps delay a hormonal event known as the LH (luteinizing hormone) surge, which can result in premature ovulation. Cetrotide® works by directly blocking the trigger effect of GnRH, which controls the secretion of LH. This blocking action is designed to stop a possible LH surge before it begins, allowing eggs to reach the level of development needed for fertilization. Cetrotide® (cetrorelix acetate for injection) Indication Cetrotide® is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Important Safety Information Cetrotide® should only be prescribed by doctors specializing in infertility or reproductive health. Cetrotide® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Cetrotide® should not be used in women who, are allergic to cetrorelix acetate, mannitol or exogenous peptide hormones (medicines similar to Cetrotide®), who have kidney disease, are pregnant or think they are pregnant, or are breast-feeding. Mild and short-lasting injection reactions like reddening, itching and swelling at the injection sites have occurred in women using Cetrotide®. Nausea and headache have also been reported. For additional information about Cetrotide®, see the Prescribing Information. 3 Fact Sheet fertility Fertility LifeLines™ Fertility LifeLines™ is a free and confidential educational service offering customized information and support to patients at every stage of their journey. It is available via the Web at www.FertilityLifeLines.com or by calling tollfree 1-866-LETS-TRY (1-866-538-7879). Fertility LifeLines provides general infertility information, insurance/benefits assistance, local Fertility Specialist referral, EMD Serono product support, and support through compassionate listening to help put the patient journey into perspective, and to provide information about additional support and resources. For more information, please visit www.fertilitylifelines.com. 4