Fresenius Kabi Melphalan Hydrochloride for Injection Now Available

Generic equivalent to ALKERAN® is latest addition to large
oncology portfolio

LAKE ZURICH, Ill.–(BUSINESS WIRE)–Fresenius Kabi announced today the immediate availability in the United
States of Melphalan Hydrochloride for Injection. Fresenius Kabi
Melphalan Hydrochloride for Injection is available as a two-vial kit
containing one single dose vial of Melphalan Hydrochloride equivalent to
50 mg Melphalan and one vial of sterile diluent.


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

About Melphalan Hydrochloride for Injection

Melphalan Hydrochloride for Injection is indicated for the palliative
treatment of patients with multiple myeloma for whom oral therapy is not
appropriate.

IMPORTANT SAFETY INFORMATION

 

WARNING

Melphalan should be administered under the supervision of a
qualified physician experienced in the use of cancer
chemotherapeutic agents. Severe bone marrow suppression with
resulting infection or bleeding may occur. Controlled trials
comparing intravenous (IV) to oral melphalan have shown more
myelosuppression with the IV formulation. Hypersensitivity
reactions, including anaphylaxis, have occurred in approximately
2% of patients who received the IV formulation. Melphalan is
leukemogenic in humans. Melphalan produces chromosomal aberrations in
vitro
and in vivo and, therefore, should be considered
potentially mutagenic in humans.

Melphalan Hydrochloride for Injection should not be used in patients
whose disease has demonstrated prior resistance to this agent. Patients
who have demonstrated hypersensitivity to melphalan should not be given
the drug.

Melphalan Hydrochloride for Injection may cause local tissue damage
should extravasation occur, and consequently it should not be
administered by direct injection into a peripheral vein. It is
recommended that Melphalan Hydrochloride be administered by injecting
slowly into a fast-running IV infusion via an injection port, or via a
central venous line.

In all instances where the use of Melphalan Hydrochloride for Injection
is considered for chemotherapy, the physician must evaluate the need and
usefulness of the drug against the risk of adverse events. Melphalan
Hydrochloride for Injection should be used with extreme caution in
patients whose bone marrow reserve may have been compromised by prior
irradiation or chemotherapy or whose marrow function is recovering from
previous cytotoxic therapy.

Administration of live vaccines to immuno-compromised patients should be
avoided.

The following information on adverse reactions is based on data from
both oral and IV administration of Melphalan Hydrochloride as a single
agent, using several different dose schedules for treatment of a wide
variety of malignancies.

The most common side effect is bone marrow suppression leading to
leukopenia, thrombocytopenia, and anemia. White blood cell count and
platelet count nadirs usually occur 2 to 3 weeks after treatment, with
recovery in 4 to 5 weeks after treatment. Irreversible bone marrow
failure has been reported. Gastrointestinal disturbances such as nausea
and vomiting, diarrhea, and oral ulceration occur infrequently. Hepatic
disorders ranging from abnormal liver function tests to clinical
manifestations such as hepatitis and jaundice have been reported.
Hepatic veno-occlusive disease has been reported.

Other reported adverse reactions include skin hypersensitivity, skin
ulceration at injection site, skin necrosis rarely requiring skin
grafting, maculopapular rashes, vasculitis, alopecia, hemolytic anemia,
allergic reaction, pulmonary fibrosis (including fatal outcomes), and
interstitial pneumonitis. Temporary significant elevation of the blood
urea has been seen in the early stages of therapy in patients with renal
damage. Subjective and transient sensation of warmth and/or tingling.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA 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 MELPHALAN HYDROCHLORIDE FOR INJECTION safely
and effectively. Please click on
https://tinyurl.com/yd4wms5r
for the full prescribing information for MELPHALAN HYDROCHLORIDE FOR
INJECTION, including BOXED WARNING, or visit
www.fresenius-kabi.com/us.

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.

ALKERAN is a registered trademark of Apotex, Inc.

Contacts

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