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ARMOUR
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H32I1GA-
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149
Rh
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CANCER
EDUCATIONAL
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some protecten against Rh isoimmunizaten but this protection is
Rtt,(Dl Immune Globulin (Human) Gamubn’ Rh should be used
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Calcium Injection
Whenever
a folic acid antagonist
is administered, Leucovorin
Calcium
should
be readily
available
to help offset
Exclusively
Leucovorin
effective
possible
from Lederle
Calcium
Laboratories,
is considered
in counteracting
effects
of possible
antagonist.
toxicity.
to be highly
the life-threatening
overdosage
of a folic
acid
LEUCOVORIN
CALCIUM
INJECTION
DESCRIPTION
Each 1 ml ampul of Leucovorin
Calcium
Leder/e
contains
Leucovorin
3 mg as the calcium
salt which is the form
preferred
for intramuscular
injection. Preservative:
benzyl alcohol
0.9% w/v. The inactive ingredients
are sodium chloride 0.56% w/
v, Water for Injection
qs 100% and sodium hydroxide
or hydrochloric acid is used to adjust the pH to approximately
7.7.
Each 50mg vial of Leucovorin
Calcium cryodesiccated
powder when reconstituted
with 5 ml of sterile diluent
contains
Leucovorin
10 mg per ml as the calcium
salt which is the form preferred
for intramuscular
injection.
Contains
no preservative.
Dilute only
with Bacteriostatic
Water for injection USP which
contains
benzyl
alcohol.
The inactive
ingredients
are sodium
chloride
40mg/vial,
and
sodium hydroxide
or hydrochloric
acid qs to pH
approximately
8.1. When reconstituted
as
directed,
the resulting
solution
must be used
within 7 days. If the product
is reconstituted
with Water for Injection USP. use immediately.
ACTIONS
Leucovorin
(folinic acid) is the formyl derivative
and active form of folic acid.
Leucovorin
Calcium
is useful clinically
in circumventing
the action of folate reductase.
There is no evidence
that intramuscular
doses
of greater than 1 mg have greater efficacy than
those of 1 mg.
INDICATIONS
Indicated
(a) to diminish
the
toxicity and counteract
the effect of inadvertently administered
overdosages
of folic acid
antagonists.
(See Warnings).
(b) In the treatment of the megaloblastic
anemias
due to
sprue, nutritional
deficiency,
pregnancy,
and
infancy when oral therapy is not feasible.
CONTRAINDICAT1ONS
Not to be administered
for the treatment of pernicious
anemia or other megaloblastic
anemias
where Vitamin B12 is deficient.
WARNINGS
Leucovorin
is improper
therapy
for pernicious
anemia and other megaloblastic
anemias secondary
to lack of
vitamin 12 A hematologic
remission
may occur while neurologic manifestations
remain progressive.
In the treatment
of overdosage
of folic acid antagonists,
Leucovorin
must be administered
within 1 hour, if possible,
And for the sake of convenience,
LeuCovorin
ent forms:
Ampuls
liquid.
Calcium
is available
in two differ-
of 3 mg, preservative-protected
Vials of 50 mg cryodesiccated
powder for
multiple
dose use. Remains
stable for 7
days after reconstitution
with diluent contaming benzyl alcohol.
For more information,
contact
your
Representative
or Call the Lederle
sional Medical Services
Department
Lederle
Profesat (914)
735-5000.
and is usua))y
ineffective
If
administered
after a delay of 4
hours.
PRECAUTIONS
In the presence of pernicious
anemia
a
hematologic
remission
may
occur while neuro)ogic
manifestations
remain progressive.
ADVERSE
REACTIONS
Allergic sensitization
has been
reported
following
both oral
and parentera)
administration
of folic acid.
DOSAGE
Megaloblastic
anemia: No more than or up to 1 mg
daIly. There is no evidence
that
intramuscular
doses greater
than 1 mg daily have greater
efficacy
than those of 1 mg:
additionally,
loss of folate in the
urine
becomes
roughly
logarithmic
as the amount
admInistered
exceeds
1 mg.
For the treatment
of
overdosage
of folio acid antagonlsts To be given in amounts
equal
to the weight
of the
antagonIst
given
HOW SUPPLIED
6-1 ml AmpulsProduct Number 4004
50 mg Vial of Cryodesiccated
powder-Product
Number
5330
REV 11/80
LEDERLE LABORATORIES
A Division
of American cyanamid
company
wayne. New Jersey 07470
C 1982 Lederie
Laboratones
001-2
THE
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M.D.,
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C. Marsh,
OF
CERUBIDINE#{174}
(DAUNORUBICIN
HCI) for injection
for remission
induction
in acute
nonlymphocytic
leukemia
WARNINGS
1 . cerubidine must be given into a rapidly flowing intravenous
infusion. It must never be given by the intramuscular
or subcutaneous
route. Severe local tissue necrosis will occur if there is extravasation
during administration.
2. Myocardialtoxicity
manifested
in its most severe form by potentiallyfatal congestive heart failure may be encountered
when total
cumulative
dosage
exceeds
550 mg/m2. This may occur either during therapy or several months after termination
oftherapy.
Treatment
with digitalis, diuretics, sodium restriction and bed-rest is indicated.
3. Severe myelosuppression
occurs when used in therapeutic
doses.
4. It is recommended
that cerubidine
be administered
only by physiclans who are experienced
in leukemia chemotherapy
and in facilities with laboratory and supportive resources
adequate to monitor
drug tolerance and protect and maintain a patient compromised
by
drug toxicity. The physician
and institution must be capable of respending
rapidly
and completelyto
severe hemorrhagic
conditions,
and/or overwhelming
infection.
5. Dosage
should
be reduced
in patients with impaired hepatic or
renal function.
(myelogenous,
Therapy
not be started
in patients
with pre-existing
drug-induced
bone marrow suppression
unless the benefit warrants the
risk. Pre-existing heart disease and previous therapy with doxorubicin
increase the nsk ofcerubidine-induced
cardiac toxicity: the benefit to
nsk ratio should be weighed before starting cewbidine
in such patients.
Bone Marrow-Cerubidine
is a potent bone marrow suppressant.
Suppression
will occur in all patients
given atherapeutic
dose of
this drug.
Cardiac Effects-Attotal
cumulative doses less than 550 mg/m2, acute
congestive
heart failure is seldom encountered,
but rare instances
of
pericarditis-myocarditis,
not dose-related,
have been reported; at cumulative doses exceeding 550 mg/rn2, the incidence
of drug-induced
congestive heartfailure
increases. This limit appears lower, 400 mg/m2,
in patients who received radiation therapy that encompassed
the heart:
the total dose administered
should also take into account any previous
or concomitant
therapy with other potentially cardiotoxic agents or related compounds
such as doxorubicin. Although there is no reliable
method for predicting acute congestive heart failure, certain changes in
the electrocardiogram
and a decrease
in the systolic ejection fraction
from pretreatment
baseline
may help to recognize those patients at
greatest risk; a decrease equalto or greater than 30% in limb lead QRS
voltage has been associated
with a significant risk ofdrug-induced
car-
diomyopathy.
An electrocardiogram
and/or determination
restriction,
and bed rest.
hepatic or
doses of
with con-
impairment
Pregnancy-cewbidine
can cause fetal harm when administered
to a
pregnant
woman; patients using this drug during pregnancy,
or who become pregnant
while taking this drug, should be apprised
of the poten-
to the fetus.
tial hazard
atlnjectkjn
Site-Extravasation
of cerubidine atthe Site
administration
can cause severe local tissue necrosis.
Extravasa&,n
of intravenous
Therapy with cerubidine
requires close observation of
extensive
chemical
and laboratory
monitoring.
1-lyperurito rapid lysis of leukemic cells may be induced; blood
should be monitored
and appropriate
therapy initiated if
develops.
Appropriate
measures
must be taken to control
any systemic infection before beginning therapy with cerubidine.
Therapy with Cerubidine
may transiently
impart a red coloration
to the urine
after administration,
and patients should be advised
to expect this.
PrecautIons:
the patient and
cemia secondary
uric acid levels
hyperuricemia
Carcinogenesls,
mutagenesls,
atthe
injection
Impairment
into mice, causes
site. When
peritoneally,
no carcinogenic
Pregnancy
Category
administered
of fertilIty:
Cerubidine,
fibrosarcomas
to
to mice orally or intra-
effect was noted after 22 months
of
observation.
In male dogs at a daily dose of0.25 mg/kg administered
intravenously,
testicular
atrophy was noted at autopsy. Histologic examination
revealed
total aplasia ofthe spermatocyte
series in the seminiferous
tubules with
complete
aspermatogenesis.
D: See Warnings
Section.
Adverse
Reactions:
Dose-limiting toxicity includes myelosuppression
and cardiotoxicity (see Warnings).
Other reactions include: Cutaneous-Reversible
alopecia
in most patients.
Gastrrintestinal-Acute
nausea
and vomiting, usually mild, and antiemetic therapy may be of
some help; mucositis,
three to seven days after administration;
diarrhea.
Local-if
extravasation
occurs during administration,
tissue necrosis
can result atthe site. Acute Reactions-Fever,
chills, skin rash.
circular
before prescribing.
Consult
direction
IVES
LABORATORIES
of systolic
ejection fraction should be performed
before each course of Cerubidine;
ifone ofthese
predictive parameters
occurs, the benefit of continued
therapy must be weighed againstthe
risk of producing cardiac damage.
Early clinical diagnosis of drug-induced
congestive heart failure appears
to be essential
for successful
treatment
with digitalis, diuretics, sodium
inadults
OiHepatk
arid Renal Functkn-Since
significant
can enhance
the toxicity ofthe recommended
Cerubidine,
hepatic and renal functions should be evaluated
ventional clinical laboratory tests priorto administration.
renal
when injected subcutaneously
should
erythroid)
Evaluation
develop
Warnings:
monocytic,
685
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editk,n ofa dassic in itsfidd!A
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A new,
LEUKEMIA
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4th Edition
Edited
Formerly
W. GUNZ,
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Memorial
Institute,
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EDWARD
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Roswell
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All previous
editions
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published
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as “authoritative”
theJournal
ofthcAmerican
hematology”
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that tradition
upon
multi-authored,
experts
from
C. Moloney
in Blood.
ofexcellence.
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This
This
prognosis.
specialists
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and pathology.
new
practicing
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new
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For the first time,
edition,
edition
the work
on all aspects
of human
aspects,
etiology,
incidence,
sourcebook
in hematology,
ETIOLOGY
Frederick
W Gunz,
Edward
S. Hende,on,
Leukemia
in the Past
Definition
and
Classification
W Gunz,
NATURE
Paul C. Vincent,
Epidemiology
Granulocytic
F Smyth, Biochemistry
of
Lcukcmic
Cells
J. Breton-Gorius,
Ultrastructure
of
Lcukcmic
Cells
0. Margaret
Gacon, Cytogenetics
of
Lcukemic
Cells
EdwardS.
Hendecon,
Pathology
of the
John
Tissue
C. Vincent, Special
Laboratory
Manifestations
1983,
1024 pp., 204 illus.
ISBN:
0-8089-1513-4,
353004
Retroviruscs
and
in
C. Gallo,
W Gunz,
and Human
Ionizing
Leukemia
Myelocytic
Chronic
Leukemia
Mayer and George P Candllos,
Preleukemic
Syndromes
and Other
Myeloproliferative
Disorders
Daniel
Catovsky, Prolymphocytic
and
Hairy Cell Leukemias
CONDITIONS
LEUKEMIA
Edward
view
COMPLICATING
S. Henderson,
Steven C. Schimpif
Leukemia
Patient:
and Prevention
DonaldJ.
w. Archie
System
DIAGNOSIS
OF LEUKEMIA
Edward S. Henderson,
Clinical
Diagnosis
John
Edward
Leukemia
Morphol-
w
ogy and Cytochemistry
GENERAL
Infection
Diagnosis,
Over-
in the
Therapy,
of
Hqby, Transfusion
Therapy
Bleyer, Central Nervous
EPILOGUE
Frederick W Gunz,
M. Bennett,
A Selective
HarveyR.
Gralnick,
Control
Hemorrhagic
Diseases
Radiation
andHans
H. Gnnwald,
and Leukemia
FredRosner
Chemicals
Prognosis
S. Henderson
Gunz,
Recent
and Frederick
Findings
CONSIDERATIONS
OF TREATMENT
Edward
S. Hende,con,
Terminology
and
Perspectives
1.
Rustum,
Drug
including
30 in color,
Order Code: 791769
Factors
andRobert
Leukemia
and
Frederick
Patrick
Clinical
Genetic
Flossie Wong-Staal
and
Cells
Paul
OF LEUKEMIA
W Gunz,
Leukemia
Human
Related Disorders
Paul C. Vincent, Kinetics of Leukemia
and Control
of Cell Division
and
Replication
Jun Minowada,
Immunology
of
Leukemic
Acute
D. Spiers,
AlexanderS.
pediatrics,
Edward S. Hendenon,
Etiology
of Leukemia: A Persisting
Puzzle
Henry S. Kaplan,
Animal
Models
of
Leukemia
and Lymphoma
Frederick
OF LEUKEMIA
Pathophysiology
Phil:LtJ.
Fialkow,
Clonal
Development
and Stem Cell Origin ofLeukemias
Lcukemic
Preisler,
Leukemia
CONTENTS:
THE
Edward S. Henderson,
Acute
Lymphocytic
Leukemia
RobertJ.
INTRODUCTION
Frederith
in
OF SPECIFIC
OF LEUKEMIA
FORMS
Harve’vD.
for all
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E. Donnall
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MANAGEMENT
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Histo-
p 39
hemopoietic
Hemic
1969,
sub-groups
Globulins,
Cells
Wiley,
of the
is part
A
vol
4.
meeting:
T Jr: Genetic studies of
in Killander
Third
of unpublished
A: A morphologic
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Division,
lines:
Nobel
J (ed):
Symposium.
1967
of book that
Polliak
cell
In Vitro,
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vitamin
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First
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197 1 , p
Abstract:
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Curnutte
JT,
Karnovsky
ML,
Babior
BM:
Manganese-
dependent
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guinea pig granulocytes:
An alternative
interpretation.
Clin Res
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-
__trftco
ADVANCES
------
IN HEMATOLOGY
FROM
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measurement
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