First avail­able IV admin­istra­tion alter­na­tive to VELCADE® (Bortezomib for Injection)

Lake Zurich, IL (Press Release) – Fresenius Kabi announced today the avail­a­bil­ity in the United States of Bortezomib for Injection. Fresenius Kabi Bortezomib for Injection is avail­able as a single dose vial con­taining 3.5 mg of lyophilized powder.

Fresenius Kabi is a global health care com­pany that specializes in medicines and tech­nolo­gies for infusion, transfusion and clin­i­cal nutrition.

“Fresenius Kabi Bortezomib is a cost efficient prod­uct alter­na­tive for our customers and the patients they treat. We are proud to offer an expansive on­col­ogy portfolio and will con­tinue to develop these essential medicines,” said John Ducker, pres­i­dent and CEO of Fresenius Kabi USA.

Fresenius Kabi Bortezomib for Injection for in­tra­venous use is indicated for the treat­ment of patients with multiple myeloma and for the treat­ment of patients with mantle cell lym­phoma who have received at least 1 prior ther­apy.

Important Safety Information

Bortezomib for Injection is contraindicated in patients with hypersensitivity (not in­­clud­ing local reac­tions) to bor­tez­o­mib, boric acid or glycine, in­­clud­ing anaphylactic reac­tions; contraindicated for intrathecal admin­istra­tion – fatal events have occurred.

Peripheral neu­rop­athy: Manage periph­eral neu­rop­athy with dose modification or dis­con­tinu­a­tion. Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. Cardiac Toxicity: Worsening of and devel­op­ment of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease. Pulmonary Toxicity: Acute res­pira­tory syn­dromes have occurred. Monitor closely for new or worsening symp­toms. Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symp­toms; dis­con­tinue bor­tez­o­mib if sus­pected. Gastrointestinal Toxicity: Nausea, diarrhea, con­sti­pa­tion, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. Thrombocytopenia or Neutropenia: Monitor com­plete blood counts regularly throughout treat­ment. Tumor Lysis Syndrome: Closely monitor patients with high tumor burden. Hepatic Toxicity: Monitor hepatic enzymes during treat­ment. Embryo-Fetal Toxicity: Bortezomib can cause fetal harm. Advise females of reproductive poten­tial of the poten­tial risk to a fetus and to avoid pregnancy. Herpes Virus Infection: Consider using antiviral prophylaxis. After reconstitution, the dose of Bortezomib for Injection must be individualized to prevent overdose. Most commonly reported adverse reac­tions (incidence ≥20%) in clin­i­cal studies in­clude nausea, diarrhea, thrombo­cytopenia, neu­tro­penia, periph­eral neu­rop­athy, fatigue, neuralgia, anemia, leu­ko­penia, con­sti­pa­tion, vomiting, lymphopenia, rash, pyrexia, and anorexia.

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 Bortezomib for Injection safely and effectively. Please click on the fol­low­ing link https://tinyurl.com/yd7d2g7d for the full pre­scrib­ing in­­for­ma­tion for Bortezomib for Injection.

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.

VELCADE is a registered trademark of Millennium Pharma­ceu­ticals, Inc.

Source: Fresenius Kabi.