LAKE ZURICH, Ill., June 1, 2017 – Fresenius Kabi announced today the immediate availability in the United States of Azacitidine for Injection. Fresenius Kabi Azacitidine for Injection is available as 100 mg lyophilized powder in a 30 mL single dose vial.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
“Fresenius Kabi is pleased to introduce Azacitidine for Injection, our second generic cancer medicine launch this year,” said John Ducker, president and CEO of Fresenius Kabi USA. “The addition of Azacitidine for Injection to the Fresenius Kabi oncology portfolio is an example of our continued pursuit of providing value to our oncology customers and the patients they serve."
About Azacitidine for Injection
Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Important Safety Information
Azacitidine is contraindicated in patients with advanced malignant hepatic tumors or a known hypersensitivity to Azacitidine or mannitol.
Azacitidine causes anemia, neutropenia and thrombocytopenia: monitor complete blood counts frequently. Patients with severe preexisting hepatic impairment are at a higher risk for toxicity.
Monitor patients with renal impairment for toxicity since Azacitidine and its metabolites are primarily excreted by the kidneys. Azacitidine may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate. Azacitidine can cause fetal harm. Advise females with reproductive potential of the potential risk to a fetus and to avoid pregnancy.
Most common adverse reactions (> 30%) by SC route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by IV route also included petechiae, rigors, weakness and hypokalemia.
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 Azacitidine for Injection safely and effectively. Please see the full prescribing information available at www.fresenius-kabi.us or US-PH-Azacitidine_for_Inj_FK-451537_Dec_2016-PI.pdf.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.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.