Fresenius Kabi Expands Women’s Health Portfolio with New Generic Option for Reproductive Health

Cetrorelix Acetate for Injection Kit Now Available

Fresenius Kabi announced today it has launched Cetrorelix Acetate for Injection kit, an FDA-approved, cost-effective, generic option for women’s reproductive health. Cetrorelix Acetate for Injection is available immediately from Fresenius Kabi in a kit that contains one single-dose vial (0.25 mg cetrorelix), one pre-filled syringe with 1 mL sterile water for injection, one 20-gauge needle, and one 27-gauge needle.

Fresenius Kabi’s Cetrorelix Acetate for Injection is a therapeutic equivalent to EMD Serono’s Cetrotide® (0.25 mg).

Cetrorelix Acetate for Injection is a prescription medicine used to block the effects of a natural hormone, called gonadotropin releasing hormone (GnRH). During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation.¹

“Our newest launch of Cetrorelix Acetate for Injection further demonstrates Fresenius Kabi’s strength in broadening access to cost-effective injectable medicines and our commitment to women’s health,” said Arun Verma, president of Fresenius Kabi USA.

According to the American Society for Reproductive Medicine, the number of babies born from IVF increased from 89,208 in 2021 to 91,771 in 2022, reflecting a steady increase in demand for fertility services. The latest national data means that 2.5% of all births in the US are a result of successful Assisted Reproductive Technology (ART) cycles.²

Cetrorelix Acetate for Injection is the fourth product in Fresenius Kabi’s growing portfolio of Women’s Health products. This addition underscores Fresenius Kabi’s commitment to providing a comprehensive range of FDA-approved, cost-effective treatment options.

Fresenius Kabi’s other Women’s Health products include Chorionic Gonadotropin for Injection, USP (hCG); Progesterone Injection, USP; and Ganirelix Acetate Injection. Fresenius Kabi plans to expand its Women’s Health portfolio, helping to meet the growing demand for reproductive health options in the U.S.

Please see Important Safety Information below.

IMPORTANT SAFETY INFORMATION

Cetrorelix acetate for injection is contraindicated under the following conditions:

1. Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.
2. Known hypersensitivity to GnRH or any other GnRH analogs.
3. Known or suspected pregnancy, and lactation.
4. Severe renal impairment

Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported.

Treatment with cetrorelix acetate for injection is not advised in women with severe allergic conditions.

The systemic adverse events reported at an incidence ≥ 1% in cetrorelix acetate for injection were ovarian hyperstimulation syndrome (3.5%), nausea (1.3%), and headache (1.1%).

Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration.

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.

Before starting treatment with cetrorelix acetate for injection, pregnancy must be excluded.

It is not known whether cetrorelix acetate for injection is excreted in human milk. Cetrorelix acetate for injection should not be used by nursing mothers.

INDICATIONS AND USAGE

Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

This Important Safety Information does not include all the information needed to use Cetrorelix Acetate for Injection safely and effectively. Please see the full prescribing information for Cetrorelix Acetate for Injection.

References

1. Fresenius Kabi. (2024). Cetrorelix Acetate for Injection – Full Prescribing Information [PDF]. Retrieved from http://editor.fresenius-kabi.us/admin/assets/PIs/US-PH-Cetrorelix_Acetate_Inj-FK-451801_April_2024-PI.pdf.

2. "ASRM News." American Society for Reproductive Medicine, April 2024, https://www.asrm.org/news-and-events/asrm-news/press-releasesbulletins/ivf-assisted-pregnancies-constitute/?_t_tags=siteid:01216f06-3dc9-4ac9-96da-555740dd020c,language:en&_t_hit.id=ASRM_Models_Pages_ContentPage/_e7377751-1dac-4142-abba-fe2fc0fa1a88_en&_t_hit.pos=1&_gl=1*4ntd5a*_gcl_au*MTAyNDM0NzgxMS4xNzIwMDMwOTUw*_ga*MTc4NTA0Njg5Ny4xNzIwMDMwOTUw*_ga_T403PGFCFZ*MTcyMDAzMDk1MC4xLjAuMTcyMDAzMDk1Mi41OC4wLjA.&_ga=2.35266081.1631880714.1720030950-1785046897.1720030950.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us), an operating company of Fresenius, specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition worldwide. The company’s products and services are used for the therapy and care of 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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“Our newest launch of Cetrorelix Acetate for Injection further demonstrates Fresenius Kabi’s strength in broadening access to cost-effective injectable medicines and our commitment to women’s health,” said Arun Verma, president of Fresenius Kabi USA.