Azacitidine for Injection Now Available from Fresenius Kabi

Second oncology injectable introduced in last 30 days

LAKE ZURICH, Ill.–(BUSINESS WIRE)–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.com
or http://editor.fresenius-kabi.us/PIs/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.

Contacts

Matt Kuhn
Fresenius Kabi
847-550-5751
matt.kuhn@fresenius-kabi.com