SIDE EFFECTS
Information on adverse reactions associated with the
use of CYTOXAN is arranged according to body system affected
or type of reaction. The adverse reactions are listed
in order of decreasing incidence. The most serious adverse
reactions are described in the WARNINGS section.
Reproductive System
See WARNINGS section for information on impairment of
fertility.
Digestive System
Nausea and vomiting commonly occur with cyclophosphamide
therapy. Anorexia and, less frequently, abdominal discomfort
or pain and diarrhea may occur. There are isolated reports
of hemorrhagic colitis, oral mucosal ulceration and jaundice
occurring during therapy. These adverse drug effects generally
remit when cyclophosphamide treatment is stopped.
Skin and Its Structures
Alopecia occurs commonly in patients treated with cyclophosphamide.
The hair can be expected to grow back after treatment
with the drug or even during continued drug treatment,
though it may be different in texture or color. Skin rash
occurs occasionally in patients receiving the drug. Pigmentation
of the skin and changes in nails can occur.
Hematopoietic System
Leukopenia occurs in patients treated with cyclophosphamide,
is related to the dose of drug, and can be used as a dosage
guide. Leukopenia of less than 2000 cells/mm3 develops
commonly in patients treated with an initial loading dose
of the drug, and less frequently in patients maintained
on smaller doses. The degree of neutropenia is particularly
important because it correlates with a reduction in resistance
to infections. Fever without documented infection has
been reported in neutropenic patients.
Thrombocytopenia or anemia develop occasionally in patients
treated with CYTOXAN. These hematologic effects usually
can be reversed by reducing the drug dose or by interrupting
treatment. Recovery from leukopenia usually begins in
7 to 10 days after cessation of therapy.
Urinary System
See WARNINGS section for information on cystitis and
urinary bladder fibrosis.
Hemorrhagic ureteritis and renal tubular necrosis have
been reported to occur in patients treated with cyclophosphamide.
Such lesions usually resolve following cessation of therapy.
Infections
See WARNINGS section for information on reduced host
resistance to infections.
Carcinogenesis
See WARNINGS section for information on carcinogenesis.
Respiratory System
Interstitial pneumonitis has been reported as party of
the postmarketing experience. Interstitial pulmonary fibrosis
has been reported in patients receiving high doses of
cyclophosphamide over a prolonged period.
Other
Anaphylactic reactions have been reported; death has
also been reported in association with this event. Possible
cross-sensitivity with other alkylating agents has been
reported. SIADH (syndrome of inappropriate ADH secretion)
has been reported with the use of cyclophosphamide. Malaise
and asthenia have been reported as party of the postmarketing
experience.
DRUG INTERACTIONS
The rate of metabolism and the leukopenic activity of
cyclophosphamide reportedly are increased by chronic administration
of high doses of phenobarbital.
The physician should be alert for possible combined drug
actions, desirable or undesirable, involving cyclophosphamide
even though cyclophosphamide has been used successfully
concurrently with other drugs, including other cytotoxic
drugs.
Cyclophosphamide treatment, which causes a marked and
persistent inhibition of cholinesterase activity, potentiates
the effect of succinylcholine chloride.
If a patient has been treated with cyclophosphamide within
10 days of general anesthesia, the anesthesiologist should
be alerted.
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