EMD Serono's Redesigned Fertility Pen Available for Distribution in US

ROCKLAND, Mass., Dec. 16, 2013 /PRNewswire/ -- EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that Gonal-f^® RFF Redi-ject™, a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f^® RFF, is now available in the U.S. for distribution. Gonal-f^® RFF Redi-ject™ was approved by the U.S. Food and Drug Administration (FDA) on October 17, 2013.

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"EMD Serono is excited that Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) is now available to patients and customers. This device was designed with feedback from Healthcare Professionals (HCPs), patients and significant others," said Craig Millian, Senior Vice President, Head of US Fertility and Endocrinology at EMD Serono. "EMD Serono has a long heritage of fertility expertise, and is committed to strengthening that legacy. Adding this device to our product portfolio helps to further our mission, which is to create, innovate, and advocate for people who want to have a child – with the goal of reducing barriers to treatment."

The Gonal-f^® RFF Redi-ject™ is available in three pen sizes: 300 IU, 450 IU and 900 IU.

*Revised Formulation Female

Gonal-f^® RFF Redi-ject™ has been available in wholesaler channels since December 9. It is anticipated that pharmacies will be fully stocked by December 16.  To facilitate refills and supplementary orders for patients who have been trained on the Gonal-f^® RFF Pen (not Redi-ject™), EMD Serono will maintain a small inventory of the Gonal-f^® RFF Pen for a limited time.

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 visit fertilitylifelines.com. Patients should consult their health care provider for additional information.

About Gonal-f^® RFF Redi-ject™ (follitropin alfa injection)

Gonal-f^® RFF Redi-ject™ (follitropin alfa injection) is indicated for: The induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure. The development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Prior to treatment, complete an evaluation of female and male partners to determine infertility diagnosis. Primary ovarian failure should be excluded.

Gonal-f^® RFF Redi-ject™ is contraindicated in women who exhibit: Hypersensitivity to rhFSH preparations or excipients, high levels of FSH indicating primary gonadal failure, pregnancy (Pregnancy Category X), uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders), sex hormone dependent tumors of the reproductive tract and accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding, ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome.

For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available.

Gonal-f® RFF Redi-ject™ is a potent gonadotropin. The lowest effective dose should be used given risk of abnormal ovarian enlargement and Ovarian Hyperstimulation Syndrome (OHSS).  Ultrasound monitoring of ovarian response and/or measurement of estradiol levels are important to minimize risks.  If symptoms of OHSS (severe pelvic or abdominal pain and distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dsynea, oliguria) develop, all gondotropin treatment should be stopped, hCG should be withheld, and intercourse should be prohibited. OHSS can be severe and requires hospitalization and treatment of fluid and electroyle imbalances. OHSS may occur with or without pregnancy. Refer to full prescribing information for complete disclosure.

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.

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.

Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins.

Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience. 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.

The couple should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy.  During clinical trials, 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 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.

The incidence of spontaneous abortion and ectopic pregnancy may be increased.

Both benign and malignant ovarian neoplasms have been infrequently reported; causality has not been established.

Both ultrasound and serum estradiol measurement should be used to monitor 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 OI 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).

In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF Redi-ject™, not share the device or reuse needles, and to ask their HCP about questions.

HCP should refer to the full Prescribing Information for full disclosure.

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. 

SOURCE EMD Serono, Inc.