EMD Serono Receives FDA Approval for Redesigned Fertility Pen *Gonal-f^® RFF* Redi-ject™ (follitropin alfa injection) incorporates updates and new features developed from patient and provider feedback Business Wire ROCKLAND, Mass. -- October 17, 2013 EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) approved Gonal-f^® RFF* Redi-ject™ (follitropin alfa injection), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f^® RFF. “EMD Serono is excited and proud to bring the Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) to the market. This device was designed with key features based on feedback we received from Healthcare Professionals (HCPs), patients, and significant others,” said Craig Millian, Senior Vice President, Head of the US Fertility Franchise at EMD Serono. “Bringing the Gonal-f^® RFF Redi-ject™ to market aligns directly to our mission, which is to create, innovate, and advocate for people who want to have a child. EMD Serono has a long heritage of fertility expertise, and we will continue to invest in emerging science, patient-centric programs, and our existing product portfolio to achieve our goal of reducing barriers to treatment.” The Gonal-f^® RFF Redi-ject™ will be available in December 2013 in three pen sizes: 300 IU, 450 IU and 900 IU. For more information about the Gonal-f^® RFF Redi-ject™, please call Fertility Lifelines at 1-866- 538-7879. For information about Gonal-f^® RFF Redi-ject™, please click here to visit emdserono.com for the Prescribing Information. Patients should consult their health care provider for additional information. *Revised Formulation Female About Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) is indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure, development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Prior to initiation of treatment with Gonal-f^® RFF Redi-ject™: Women should have a complete gynecologic and endocrinologic evaluation and diagnose the cause of infertility. Primary ovarian failure and potential pregnancy should be excluded. Tubal patency should be demonstrated. Gonal-f^® RFF Redi-ject™ is contraindicated in women who exhibit: Hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled non-gonadal endocrinopathies, sex hormone dependent tumors of the reproductive tract and accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome. This product should only be prescribed by physicians specializing in fertility or reproductive health and only when appropriate monitoring facilities are available. The lowest effective dose should be used. Gonal-f^® RFF Redi-ject™ is a potent gonadotropin capable of causing Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complication and multiple births. Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience with Gonal-f^® and Gonal-f^® RFF. Symptoms have included dyspnea, facial edema, pruritis, and urticaria. If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures if cardiovascular instability and/or respiratory compromise occur, and discontinue further use. In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with Gonal-f^® RFF Redi-ject™ therapy, treatment should be individualized and the lowest effective dose should be used. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation. If the ovaries are abnormally enlarged on the last day of Gonal-f^® RFF Redi-ject™ therapy, hCG should not be administered in order to reduce the chance of developing Ovarian Hyperstimulation Syndrome (OHSS). Intercourse should be prohibited in women with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from rupture of ovarian cysts. OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about 7 to 10 days following treatment. Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized and treated by a physician experienced in the management of this syndrome or in the management of fluid and electrolyte imbalances. During clinical trials with Gonal-f^® RFF, OHSS occurred in 7.2% of 83 women and 4.6% of 237 women treated with Gonal-f^® RFF for ovulation induction and during Assisted Reproductive Technology, respectively. Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. In addition, thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins. Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulation induction and assisted reproductive technology need to be weighed against the risks. It should be noted that pregnancy also carries an increased risk of thrombosis. Ovarian torsion has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion. Multi-fetal gestation and births have been reported with all gonadotropin therapy including therapy with Gonal-f^® RFF. During clinical trials with Gonal-f^® RFF, multiple births occurred in 20% of live births in women receiving therapy for ovulation induction and 35.1 % of live births in women undergoing ART. The woman and her partner should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy with Gonal-f^® RFF Redi-ject™. The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations. Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased. Early confirmation of intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound. The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility. There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation, however, a causal relationship has not been established. The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the OHSS and multiple gestation. The most common adverse reactions (≥5%) in ovulation induction include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). Advise patients to follow the Instructions for Use and not share the device or reuse needles. Before prescribing Gonal-f^® RFF Redi-ject™, please read the accompanying Prescribing Information. About EMD Serono, Inc. EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, endocrinology and in reproductive health. In addition, EMD Serono is growing its expertise and presence in the area of oncology, with more than 15 projects currently in development. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono’s US footprint continues to grow, with approximately 1,000 employees around the country and fully integrated commercial, clinical and research operations in the company’s home state of Massachusetts. For more information, please visit www.emdserono.com. About Merck KGaA Merck is a leading pharmaceutical, chemical and life science company with total revenues of € 11.2 billion in 2012, a history that began in 1668, and a future shaped by approx. 38,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since. For more information, please visit www.merckserono.com or www.merckgroup.com. About EMD Serono Fertility EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people’s lives. The company’s US footprint continues to grow, with more than 850 employees around the country and fully integrated commercial, clinical, and research operations in the company’s home state of Massachusetts. With a focus on specialized therapeutic areas, including reproductive health, neurology and metabolic endocrinology, the company is committed to growing existing therapeutic areas and entering into new ones by developing both biotherapeutic proteins and small molecules. Contact: For EMD Serono, Inc. Kristen LaVerghetta, 781-681-2065
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EMD Serono Receives FDA Approval for Redesigned Fertility Pen
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