MITOXANTRONE injection, solution, concentrate

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MITOXANTRONE HYDROCHLORIDE (UNII: U6USW86RD0) (MITOXANTRONE - UNII:BZ114NVM5P)

Verfügbar ab:

Hospira, Inc.

INN (Internationale Bezeichnung):

MITOXANTRONE HYDROCHLORIDE

Zusammensetzung:

MITOXANTRONE 2 mg in 1 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Mitoxantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not indicated in the treatment of patients with primary progressive multiple sclerosis. The clinical patterns of multiple sclerosis in the studies were characterized as follows: secondary progressive and progressive relapsing disease were characterized by gradual increasing disability with or without superimposed clinical relapses, and worsening relapsing-remitting disease was characterized by clinical relapses resulting in a step-wise worsening of disability. Mitoxantrone in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. Mitoxantrone in combination with other approved

Produktbesonderheiten:

Mitoxantrone Injection, USP (concentrate) is a sterile aqueous solution containing mitoxantrone hydrochloride at a concentration equivalent to 2 mg mitoxantrone free base per mL supplied in vials for multiple-dose use as follows: Mitoxantrone Injection, USP (concentrate) should be stored between 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. DO NOT FREEZE. Store Upright.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

MITOXANTRONE- mitoxantrone injection, solution, concentrate
Hospira, Inc.
----------
MEDICATION GUIDE MitoXANTRONE
(mito-xan-trone) Injection, USP
(concentrate)
CONTAINS SODIUM METABISULFITE, A SULFITE THAT MAY CAUSE ALLERGIC-TYPE
REACTIONS INCLUDING ANAPHYLACTIC SYMPTOMS AND LIFE-THREATENING OR LESS
SEVERE ASTHMATIC EPISODES IN CERTAIN SUSCEPTIBLE PEOPLE. THE OVERALL
PREVALENCE OF SULFITE SENSITIVITY IN THE GENERAL POPULATION IS UNKNOWN
AND
PROBABLY LOW. SULFITE SENSITIVITY IS SEEN MORE FREQUENTLY IN ASTHMATIC
THAN
IN NONASTHMATIC PEOPLE.
Read this Medication Guide before you start receiving MitoXANTRONE and
each time you receive
MitoXANTRONE. There may be new information. This information does not
take the place of talking to
your doctor about your medical condition or your treatment.
What is the most important information I should know about
MitoXANTRONE?
MitoXANTRONE can cause serious side effects, including:
•
decrease in the ability of your bone marrow to make blood cells
(myelosuppression). Your doctor
may do blood tests during treatment with MitoXANTRONE to check your
blood cell counts. The
symptoms of myelosuppression can include:
•
feeling tired
•
increased infections
•
bruising and bleeding easily
•
heart problems (congestive heart failure) that may lead to death even
in people who have never had
heart problems before. Heart failure can happen while you receive
MitoXANTRONE, or months to
years after you stop receiving MitoXANTRONE. Your risk of heart
failure increases the more
MitoXANTRONE you receive.
Call your doctor or get medical help right away if you have any of
these problems during or after
treatment with MitoXANTRONE:
•
shortness of breath
•
swelling of your ankles or feet
•
sudden weight gain
•
fast heartbeat or pounding in your chest
Before receiving MitoXANTRONE for the first time, you should have the
following tests done:
•
physical examination
•
a test to check your heart's electrical activity (electrocardiogram)
•
a test to check your heart's ability to pump blood

Fachinformation

MITOXANTRONE- MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
----------
MITOXANTRONE INJECTION, USP
(CONCENTRATE)
Rx only
WARNING
Mitoxantrone Injection, USP (concentrate) should be administered under
the
supervision of a physician experienced in the use of cytotoxic
chemotherapy
agents.
Mitoxantrone Injection, USP (concentrate) should be given slowly into
a freely
flowing intravenous infusion. It must _NEVER_ be given subcutaneously,
intramuscularly, or intra-arterially. Severe local tissue damage may
occur if there is
extravasation during administration. (See ADVERSE REACTIONS, GENERAL,
CUTANEOUS and DOSAGE AND ADMINISTRATION, PREPARATION AND
ADMINISTRATION PRECAUTIONS).
NOT FOR INTRATHECAL USE. Severe injury with permanent sequelae can
result
from intrathecal administration. (See WARNINGS, GENERAL)
Except for the treatment of acute nonlymphocytic leukemia,
mitoxantrone therapy
generally should not be given to patients with baseline neutrophil
counts of less
than 1,500 cells/mm . In order to monitor the occurrence of bone
marrow
suppression, primarily neutropenia, which may be severe and result in
infection, it
is recommended that frequent peripheral blood cell counts be performed
on all
patients receiving mitoxantrone.
CARDIOTOXICITY
Congestive heart failure (CHF), potentially fatal, may occur either
during therapy
with mitoxantrone or months to years after termination of therapy.
Cardiotoxicity
risk increases with cumulative mitoxantrone dose and may occur whether
or not
cardiac risk factors are present. Presence or history of
cardiovascular disease,
radiotherapy to the mediastinal/pericardial area, previous therapy
with other
anthracyclines or anthracenediones, or use of other cardiotoxic drugs
may
increase this risk. In cancer patients, the risk of symptomatic CHF
was estimated to
be 2.6% for patients receiving up to a cumulative dose of 140 mg/m .
To mitigate
the cardiotoxicity risk with mitoxantrone, prescribers should consider
the following:
ALL PATIENTS
-
-
MULTIPLE SCLEROSIS PATIENTS
-
-
-