Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment

LAKE ZURICH, Ill., July 10, 2023 – Fresenius Kabi announced today it has launched Ganirelix Acetate Injection, a generic fertility drug, as part of the company’s expansion in women’s health. Ganirelix Acetate Injection is available immediately from Fresenius Kabi in 250 mcg/0.5 mL prefilled syringes.

Ganirelix Acetate Injection is indicated for the inhibition of premature surges in luteinizing hormone, or LH, a chemical in the body that triggers reproductive processes such as ovulation. Ganirelix is used to treat women who are undergoing controlled ovarian hyperstimulation, a fertility therapy.¹

“We're pleased to expand our Women’s Health portfolio with the introduction of Ganirelix Acetate Injection, which was developed to provide hopeful parents with more choice when navigating in vitro fertilization and other fertility treatments,” said John Ducker, president and CEO of Fresenius Kabi USA.

Ganirelix Acetate Injection is the third product offering in Fresenius Kabi’s Women’s Health portfolio, which includes Chorionic Gonadotropin for Injection, USP (hCG) and Progesterone Injection, USP. Fresenius Kabi plans to continue to expand its Women’s Health portfolio, helping to meet the growing demand for reproductive health options in the U.S.

Over the last six years, the total number of Assisted Reproductive Technology (ART) cycles has increased by 44 percent according to the latest national data released by the Society for Assisted Reproductive Technology (SART), possibly due to the resumption of post-COVID services and increased demand. Currently, more than two percent of all births in the U.S. are a result of successful ART cycles.²

Fresenius Kabi Ganirelix Acetate Injection is not made with preservatives or latex. It is a generic medication that is the therapeutic equivalent to Organon's Ganirelix Acetate injection, 250 mcg/0.5 mL.

Please see Important Safety Information below for Ganirelix Acetate Injection.

INDICATIONS AND USAGE

Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

IMPORTANT SAFETY INFORMATION

Ganirelix Acetate Injection is contraindicated under the following conditions:

• Known hypersensitivity to Ganirelix Acetate or to any of its components.
• Known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analog.
• Known or suspected pregnancy.

Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded. Safe use of Ganirelix Acetate during pregnancy has not been established.

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions including anaphylactoid reactions, have been reported, as early as with the first dose, during post-marketing surveillance. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.

Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and monitoring procedures that will be required. The risk of possible adverse reactions should be discussed.

The most common adverse events occurring in ≥1% of patients treated with Ganirelix Acetate Injection in clinical studies (N=794) include: abdominal pain (gynecological) (4.8%), death fetal (3.7%), headache (3.0%), ovarian hyperstimulation syndrome (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), nausea (1.1%), and abdominal pain (gastrointestinal) (1.0%).

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com.

Ganirelix Acetate Injection should not be used by lactating women.

This Important Safety Information does not include all the information needed to use Ganirelix Acetate Injection safely and effectively. Please see accompanying full prescribing information for Ganirelix Acetate Injection.  Full prescribing information is also available at www.fresenius-kabi.com/us.

References

1. Fresenius Kabi. (2023). Ganirelix Acetate Injection - Full Prescribing Information [PDF]. Retrieved from http://editor.fresenius-kabi.us/admin/assets/PIs/US-PH-Ganirelix_Acetate_Inj-FK-451721_Jan_2023-PI.pdf

2. "ASRM News." American Society for Reproductive Medicine, July 2023, https://www.asrm.org/news-and-events/asrm-news/press-releasesbulletins/egg-freezing-cycles-jumped-31-in-2021/. 

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

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