Fresenius Kabi Announces Availability of Fulvestrant Injection 250mg per 5mL prefilled syringe

LAKE ZURICH, Ill., October 7, 2019 – Fresenius Kabi announced today the immediate availability in the United States of Fulvestrant Injection 250mg per 5mL prefilled syringe, an expansion of the company’s broad portfolio of injectable oncology medicines.

Fresenius Kabi developed its Fulvestrant Injection prefilled syringe to be stable at room temperature, making it the only form of Fulvestrant Injection to require no refrigeration.  This can help pharmacists save on the limited refrigeration space available to them. Fresenius Kabi Fulvestrant Injection is bioequivalent to Faslodex®   and provides clinicians a treatment alternative.

Fresenius Kabi is a leading developer and supplier of generic injectable medicines used in the treatment of cancer, helping to make oncology therapies more affordable and accessible.

“Fresenius Kabi is pleased to continue the expansion of our oncology portfolio by offering Fulvestrant Injection,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are pleased to be the only company offering this product in a room temperature stable formulation to assist clinicians in managing their costs and workflow.” 

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.

About Fulvestrant Injection

Fulvestrant Injection is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy; HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine therapy or following disease progression on endocrine therapy; HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemacicilib in women with disease progression after endocrine therapy.

Important Safety Information
 

• Fulvestrant Injection is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema, have been reported in association with Fulvestrant Injection.
   
• Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. 
   
• Increased Exposure in Patients with Hepatic Impairment: Use a 250 mg dose for patients with moderate hepatic impairment.  
   
• Injection Site Reaction: Use caution while administering Fulvestrant Injection at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve.
   
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.  
   
• Immunoassay Measurement of Serum Estradiol: Fulvestrant Injection can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.
   
• The most common adverse reactions occurring in ≥5% of patients receiving Fulvestrant 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation.
   
• Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of Fulvestrant patients and were not dose-dependent. 
   
• Because of the potential for serious adverse reactions in breast-fed infants from Fulvestrant Injection, advise lactating women not to breastfeed during treatment with Fulvestrant Injection and for one year after the last dose.

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.

This Important Safety Information does not include all the information needed to use Fulvestrant Injection safely and effectively. Please see the full prescribing information for Fulvestrant Injection (https://tinyurl.com/yxgkbhy4). Full prescribing information is available at www.fresenius-kabi.com/us.
 

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 critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.  

 

¹ Internal Data on File. Fresenius Kabi USA, LLC.

Faslodex® is a registered trademark of AstraZeneca.