A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ceenu Warnings, Precautions, Pregnancy, Nursing, Abuse - Lomustine
Ceenu Warnings, Precautions, Pregnancy, Nursing, Abuse - Lomustine
WARNINGS
WARNINGS
CeeNU® (lomustine) should be administered under the supervision of a
qualified physician experienced in the use of cancer chemotherapeutic
agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which
may contribute to bleeding and overwhelming infections in an already compromised
patient, is the most common and severe of the toxic effects of CeeNU (see
WARNINGSand ADVERSE REACTIONS).
Since the major toxicity is delayed bone marrow suppression, blood counts
should be monitored weekly for at least 6 weeks after a dose (see ADVERSE
REACTIONS). At the recommended dosage, courses of CeeNU should not
be given more frequently than every 6 weeks.
The bone marrow toxicity of CeeNU is cumulative and therefore dosage
adjustment must be considered on the basis of nadir blood counts from
prior dose (see Dosage Adjustment Table under DOSAGE AND ADMINISTRATION
).
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Since the major toxicity is delayed bone marrow suppression, blood counts should
be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS
). At the recommended dosage, courses of CeeNU should not be given more
frequently than every 6 weeks.
The bone marrow toxicity of CeeNU is cumulative and therefore dosage adjustment
must be considered on the basis of nadir blood counts from prior dose (see Dosage
Adjustment Table under DOSAGE AND ADMINISTRATION ).
Pulmonary toxicity from CeeNU appears to be dose related (see ADVERSE REACTIONS
).
Long-term use of nitrosoureas has been reported to be possibly associated with
the development of secondary malignancies.
Liver and renal function tests should be monitored periodically (see ADVERSE
REACTIONS).
Pregnancy: Pregnancy "Category D". CeeNU can cause fetal
harm when administered to a pregnant woman. CeeNU is embryotoxic and teratogenic
in rats and embryotoxic in rabbits at dose levels equivalent to the human dose.
There are no adequate and well controlled studies in pregnant women. If this
drug is used during pregnancy, or if the patient becomes pregnant while taking
(receiving) this drug, the patient should be apprised of the potential hazard
to the fetus. Women of childbearing potential should be advised to avoid becoming
pregnant.
PRECAUTIONS
General: In all instances where the use of CeeNU is considered
for chemotherapy, the physician must evaluate the need and usefulness of the
drug against the risks of toxic effects or adverse reactions. Most such adverse
reactions are reversible if detected early. When such effects or reactions do
occur, the drug should be reduced in dosage or discontinued and appropriate
corrective measures should be taken according to the clinical judgment of the
physician. Reinstitution of CeeNU therapy should be carried out with caution
and with adequate consideration of the further need for the drug and alertness
as to possible recurrence of toxicity.
Laboratory Tests: Due to delayed bone marrow suppression,
blood counts should be monitored weekly for at least 6 weeks after a dose.
Baseline pulmonary function studies should be conducted along with frequent
pulmonary function tests during treatment. Patients with a baseline below 70%
of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity
(DL co ) are particularly at risk.
Since CeeNU (lomustine) Capsules may cause liver dysfunction, it is recommended
that liver function tests be monitored periodically.
Renal function tests should also be monitored periodically.
Carcinogenesis, Mutagenesis, Impairment of Fertility: CeeNU
is carcinogenic in rats and mice, producing a marked increase in tumor incidence
in doses approximating those employed clinically. Nitrosourea therapy does have
carcinogenic potential in humans (see ADVERSE REACTIONS). CeeNU also
affects fertility in male rats at doses somewhat higher than the human dose.
Pregnancy: Pregnancy "Category D". (See WARNINGS
.)
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk and because of
the potential for serious adverse reactions in nursing infants from CeeNU, a
decision should be made whether to discontinue nursing or to discontinue the
drug, taking into account the importance of the drug to the mother.
Pediatric Use: See ADVERSE REACTIONS, Pulmonary
Toxicity, and DOSAGE AND ADMINISTRATION.
Information for the Patient: Patients receiving CeeNU should
be given the following information and instructions by the physician:
- Patients should be told that CeeNU is an anticancer drug and belongs to
the group of medicines known as alkylating agents.
- In order to provide the proper dose of CeeNU, patients should be aware that
there may be two or more different types and colors of capsules in the container
dispensed by the pharmacist.
- Patients should be told that CeeNU is given as a single oral dose and will
not be repeated for at least 6 weeks.
- Patients should be told that nausea and vomiting usually last less than
24 hours, although loss of appetite may last for several days.
- If any of the following reactions occur, notify the physician: fever, chills,
sore throat, unusual bleeding or bruising, shortness of breath, dry cough,
swelling of feet or lower legs, mental confusion, or yellowing of eyes and
skin.
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