Fresenius Kabi USA LLC

Expands Access to Oncology Medicines Broadens Health Care’s Most Comprehensive Portfolio of Generic Injectable Medicines for Oncology LAKE ZURICH, Ill.--(BUSINESS WIRE)-- 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 . 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 . About Fresenius Kabi Fresenius Kabi ( ) 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 and follow us on LinkedIn. *Mozobil® is a registered trademark of Sanofi. *Neulasta® is a registered trademark of Amgen Inc. View source version on businesswire.com: Contacts Joanie Clougherty (614) 717-5741 joan.clougherty@fresenius-kabi.com Source: Fresenius Kabi View this news release online at:

FDA-approved generic for MRI procedures is fully substitutable for Gadavist® LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has launched Gadobutrol Injection, a generic substitute for the contrast agent Gadavist®, which is used in magnetic resonance imaging (MRI) procedures. Fresenius Kabi Gadobutrol Injection, a high-relaxivity macrocyclic agent, is available immediately in the United States. It is the second MRI offering in the company’s growing radiology portfolio, which also includes: Gadoterate Meglumine Injection, USP, a generic equivalent of Dotarem® Sincalide for Injection, an authorized generic of Kinevac®; and Iodixanol Injection, USP, a generic for Visipaque® "Fresenius Kabi is pleased to introduce Gadobutrol Injection as the newest addition to our U.S. radiology portfolio, expanding the range of cost-effective contrast agent options available to hospitals and clinics," said John Ducker, president and CEO of Fresenius Kabi USA. Gadobutrol Injection is a gadolinium-based contrast agent indicated for use with MRI.1 It is the fourth product offering in the Fresenius Kabi radiology portfolio, which first launched in July 2022 with the introduction of Iodixanol Injection, USP during a nationwide shortage. Gadobutrol Injection is available to order direct from the company and through wholesalers and distributors. It is currently available in 2 mL, 7.5 mL, 10 mL and 15 mL Single Dose Vials. Fresenius Kabi Gadobutrol Injection is preservative-free, and the container closure is not made with natural rubber latex. INDICATIONS AND USAGE Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates. To assess the presence and extent of malignant breast disease in adult patients. To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates. To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full prescribing information for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. IMPORTANT SAFETY INFORMATION Contraindications: History of severe hypersensitivity reaction to gadobutrol injection. Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase the risk. Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of gadobutrol injection. Gadolinium is retained for months or years in brain, bone, and other organs. Adverse Events: Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness. Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. 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 . This Important Safety Information does not include all the information needed to use Gadobutrol Injection safely and effectively. Please see full prescribing information, including BOXED WARNING, for Gadobutrol Injection at . About Fresenius Kabi Fresenius Kabi ( ) 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 and follow us on LinkedIn. References Gadobutrol Injection Package Insert, January 2023 *Gadavist® is a registered trademark of Bayer. *Dotarem® is a registered trademark of Guerbet. *Kinevac® is a registered trademark of Bracco Diagnostics Inc. *Visipaque® is a registered trademark of GE Healthcare.

Fresenius Kabi introduces its first immunology biosimilar in the U.S. CMS grants Fresenius Kabi permanent, product-specific Q-Code for IDACIO ® (adalimumab-aacf) Commitment to the development of biologic treatments across multiple therapeutic targets in immunology through an expanded pipeline LAKE ZURICH, IL, USA I July 03, 2023 I Fresenius Kabi announced today the immediate availability in the U.S. of its citrate-free adalimumab biosimilar IDACIO ® (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira ® (adalimumab). IDACIO ® is available in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector). “We are thrilled to launch IDACIO, our first immunology biosimilar in the U.S.,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases.” An IDACIO ® branded biosimilar is available in more than 35 countries.* IDACIO ® (adalimumab-aacf) is indicated for reducing signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis in adults and plaque psoriasis. The Centers for Medicare and Medicaid Services (CMS) issued a permanent product-specific Q-code for IDACIO ® (adalimumab-aacf) . Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code assigned to IDACIO ® is effective for patients administered IDACIO on and after July 1, 2023. The new code for IDACIO ® is Q 5131. To learn more about how Fresenius Kabi provides comprehensive patient support for IDACIO ® please click here . IDACIO ® (adalimumab-aacf) is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira ® (adalimumab). Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. Q-codes are permanent reimbursement codes granted to biosimilars and used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like IDACIO ® that are administered by a physician. Claims submission and documentation are simplified with a permanent Q-code, facilitating and streamlining the billing and reimbursement process. IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with IDACIO ® (adalimumab-aacf) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue IDACIO ® if a patient develops a serious infection or sepsis. Reported infections include: Carefully consider the risks and benefits of treatment with IDACIO ® prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with IDACIO ® , including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with IDACIO ® should not be initiated in patients with an active infection, including localized infections. Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue IDACIO ® if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with IDACIO ® , closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of adalimumab products with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of IDACIO ® and institute appropriate therapy. In clinical trials of adalimumab, hypersensitivity reactions (e.g., rash, anaphylactoid reaction, fixed drug reaction, non-specified drug reaction, urticaria) have been observed. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including IDACIO ® , may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. In patients who develop HBV reactivation, stop IDACIO ® and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of IDACIO ® therapy in this situation and monitor patients closely. NEUROLOGICAL REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of IDACIO ® in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of IDACIO ® should be considered if any of these disorders develop. HEMATOLOGICAL REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping IDACIO ® if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on IDACIO ® should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating IDACIO ® therapy. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. INDICATIONS Please see IDACIO full Prescribing Information , including the BOXED WARNING. About IDACIO ® , an adalimumab biosimilar IDACIO ® (adalimumab-aacf), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira ® (adalimumab). Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders. IDACIO ® has been developed by Fresenius Kabi SwissBioSim, using advanced analytical methods for use in the treatment of several chronic conditions including rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. 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/ . *Citrate formulation, manufactured by a different process. SOURCE: Fresenius Kabi