First available IV administration alternative to VELCADE®
(Bortezomib for Injection)
LAKE ZURICH, Ill.–(BUSINESS WIRE)–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
“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
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,
VELCADE is a registered trademark of Millennium Pharmaceuticals, Inc.