Stimufend® (pegfilgrastim-fpgk) Now Available in the United States

Fresenius Kabi introduces its first biosimilar in the U.S.

Extensive experience in oncology and commitment to patients highlight company’s portfolio expansion

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today the immediate availability in the U.S. of Stimufend^® (pegfilgrastim-fpgk), the company’s biosimilar to Neulasta^® (pegfilgrastim), for use in patients at risk for febrile neutropenia, a common side effect of many anti-cancer medications. Stimufend is available in a single-dose, pre-filled syringe that delivers 6mg/0.6mL solution for subcutaneous injection.

“Fresenius Kabi is excited to launch Stimufend as it represents both our first biosimilar product in the U.S. and our long-term commitment to build a U.S. biosimilars business that supports patients, health care providers and payers,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. “With Fresenius Kabi’s heritage of quality manufacturing, supply reliability and extensive experience in oncology, I am confident the introduction of Stimufend will be the first of many examples of our commitment to biosimilars in the U.S.”

Fresenius Kabi is a leading producer of injectable medicines in the U.S. The company has more than 25 years of experience supplying oncology medications in the U.S. and one of the largest injectable portfolios in the industry with more than 30 products used in more than 460 different chemotherapy regimens. Additionally, more than 220 chemotherapy regimens can be supported entirely by administering Fresenius Kabi products.

“The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta. Health care providers and patients can be confident in Stimufend as a treatment option given its proven structural, functional and clinical similarity, including highly similar safety and tolerability profiles,” said Brandee Pappalardo, Ph.D., M.P.H., senior vice president and Chief Medical Officer for Fresenius Kabi USA. “Equally important to the clinical development of Stimufend is Fresenius Kabi’s dedication to providing patients with ongoing support.”

To learn more about how Fresenius Kabi provides comprehensive patient support for Stimufend^® please click here.

Stimufend^® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: Stimufend^® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

• Stimufend^® (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
• Reactions have included anaphylaxis

Splenic Rupture

• Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
• Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

• ARDS can occur in patients receiving pegfilgrastim products
• Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Stimufend
• Discontinue Stimufend in patients with ARDS

Serious Allergic Reactions

• Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
• The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial anti-allergic treatment
• Permanently discontinue Stimufend in patients with serious allergic reactions

Use in Patients with Sickle Cell Disorders

• In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products
• Discontinue Stimufend if sickle cell crisis occurs

Glomerulonephritis

• Has occurred in patients receiving pegfilgrastim products
• Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
• Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products
• If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of Stimufend

Leukocytosis

• Increased white blood cell counts of 100 x 109/L have been observed
• Monitoring of complete blood count (CBC) during Stimufend therapy is recommended

Thrombocytopenia

• Thrombocytopenia has been reported in patients receiving pegfilgrastim products. Monitor platelet counts

Capillary Leak Syndrome (CLS)

• CLS has been reported after G-CSF administration, including pegfilgrastim products
• Characterized by hypotension, hypoalbuminemia, edema and hemoconcentration
• Episodes vary in frequency, severity and may be life-threatening if treatment is delayed
• Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

• G-CSF receptor has been found on tumor cell lines
• The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

• MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis

• Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
• Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
• Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Stimufend if aortitis is suspected

Nuclear Imaging

• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

• Bone pain
• Pain in extremity

This Important Safety Information does not include all the information needed to use Stimufend^® (pegfilgrastim-fpgk) Injection safely and effectively. Please see Stimufend^® Full Prescribing Information here.

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.

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. To learn about U.S. career opportunities at Fresenius Kabi, visit us at http://www.fresenius-kabi.com/us/join-us and follow us on LinkedIn.

For more information about Fresenius Kabi biosimilars in the U.S., please visit https://biospecialized.com/.

Neulasta^® is a registered trademark of Amgen Inc.