mitoXANTRONE Injection USP (concentrate)

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Teva Parenteral Medicines, Inc.

INN (Tarptautinis Pavadinimas):

MITOXANTRONE HYDROCHLORIDE

Sudėtis:

MITOXANTRONE 2 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Mitoxantrone injection USP (concentrate) 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 injection USP (concentrate) 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 injection USP (concentrate) in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain related to advanced

Produkto santrauka:

Mitoxantrone injection USP (concentrate) is a sterile aqueous solution containing mitoxantrone hydrochloride USP at a concentration equivalent to 2 mg mitoxantrone free base per mL supplied in vials for multidose use as follows: NDC 0703-4685 -01 10 mL/multidose vial (20 mg) NDC 0703-4680 -01 12.5 mL/multidose vial (25 mg) NDC 0703-4686 -01 15 mL/multidose vial (30 mg) Mitoxantrone injection USP (concentrate) should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT FREEZE. Rev. C 5/2012 Teva Parenteral Medicines, Inc. Irvine, CA 92618

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Teva Parenteral Medicines, Inc.
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MEDICATION GUIDE
mitoXANTRONE
(mito-xan-trone)
Injection USP (concentrate)
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
If you receive mitoXANTRONE to treat Multiple Sclerosis (MS), your
doctor should also do the tests above:
•
before you receive each mitoXANTRONE dose
•
yearly after you stop receiving mitoXANTRONE treatment
•
acute myeloid leukemia (AML). Receiving mitoXANTRONE increases your
risk of AML. AML is a
cancer of the blood-forming cells of your bone marrow. Symptoms of AML
can include:
•
feeling unusually tired and we

Prekės savybės

MITOXANTRONE- MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE
TEVA PARENTERAL MEDICINES, INC.
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MITOXANTRONE INJECTION USP (CONCENTRATE)
RX ONLY
4680
4685
4686
WARNING
Mitoxantrone injection (concentrate) should be administered under the
supervision
of a physician experienced in the use of cytotoxic chemotherapy
agents.
Mitoxantrone injection (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 injection
(concentrate) 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 injection
(concentrate).
Cardiotoxicity
Congestive heart failure (CHF), potentially fatal, may occur either
during therapy
with mitoxantrone injection (concentrate) or months to years after
termination of
therapy. Cardiotoxicity risk increases with cumulative mitoxantrone
injection
(concentrate) 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
cardiotoxicit