Fresenius Kabi Launches Plerixafor Injection

LAKE ZURICH, Ill., August 9, 2023 – Fresenius Kabi announced today it has introduced Plerixafor Injection, a generic equivalent to Mozobil^®, available immediately in the United States in a 24 mg per 1.2 mL single dose vial. 

Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma and is the newest addition to the company’s generic injectable oncology medicine portfolio, the largest in U.S. health care.

“Fresenius Kabi is pleased to add Plerixafor Injection to our oncology portfolio, further demonstrating our commitment to expanding access to high-quality and cost-effective oncology medicines in the United States,” said John Ducker, president and CEO of Fresenius Kabi USA. “The introduction of this generic equivalent will provide patients and clinicians with access to more choices for their cancer care.”

Fresenius Kabi offers more than 30 different oncology drugs in the U.S. and introduced its first biosimilar in 2022 with the launch of Stimufend^® (pegfilgrastim-fpgk), a biosimilar of Neulasta^®. The company plans to bring more oncology and oncology supportive care products to U.S. patients to further support patient care and choice.

Indications and Usage for Plerixafor Injection

Plerixafor injection is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM).

Important Safety Information

• Plerixafor is contraindicated in patients with a history of hypersensitivity to Plerixafor.
• Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Plerixafor. Observe patients for signs and symptoms of hypersensitivity during and after Plerixafor administration for at least 30 minutes and until clinically stable. Only administer Plerixafor when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
• Plerixafor may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Plerixafor is not intended for HSC mobilization and harvest in patients with leukemia.
• Plerixafor in conjunction with G-CSF increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment.
• Thrombocytopenia has been observed in patients receiving Plerixafor. Platelet counts should be monitored in patients who receive Plerixafor and then undergo apheresis.
• In patients treated with Plerixafor in combination with G-CSF for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
• Post marketing cases of splenic enlargement and/or rupture have been reported following the administration of Plerixafor in conjunction with growth factor G-CSF. Individuals receiving Plerixafor in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
• Plerixafor can cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. Plerixafor administration to pregnant rats during organogenesis resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth at exposures approximately 10 times the exposure at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use an effective form of contraception during treatment with Plerixafor and for one week after the final dose.
• There are no data on the presence of plerixafor in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential serious adverse reactions in the breastfed child, advise females that breastfeeding is not recommended during treatment with Plerixafor and for one week after the final dose.
• The most common adverse reactions (≥10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%).

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 Plerixafor Injection safely and effectively. Please see accompanying full prescribing information for Plerixafor Injection. Full prescribing information is also available at www.fresenius-kabi.com/us.

*Mozobil^® is a registered trademark of Sanofi.
*Neulasta^® is a registered trademark of Amgen Inc.