This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda

tion receiving etoposide have exhibited reduced total body clearance, increased AUC and alower volume of distribution at steady state. (See PRECAUTIONS section.) Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also
result in a decrease of etoposide total body clearance in children.
Although some minor differences in pharmacokinetic parameters between age and gender
have been observed, these differences were not considered clinically significant.

F.P.O.

Rx only

VePesid®

(etoposide)

For Injection and Capsules
WARNINGSVePesid (etoposide) should be administered under the supervision of a qualified
physician experienced in the use of cancer chemotherapeutic agents. Severe
myelosuppression with resulting infection or bleeding may occur.
DESCRIPTIONVePesid® (etoposide) (also commonly known as VP-16) is a semisynthetic derivative of
podophyllotoxin used in the treatment of certain neoplastic diseases. It is4'-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very
soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble inwater and ether. It is made more miscible with water by means of organic solvents. It has amolecular weight of 588.58 and a molecular formula of C29H32O13.
VePesid may be administered either intravenously or orally. VePesid For Injection is available
in 100 mg (5 mL), 150 mg (7.5 mL), 500 mg (25 mL), or 1 gram (50 mL) sterile, multiple dosevials. The pH of the clear, nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg
etoposide, 2 mg citric acid, 30 mg benzyl alcohol, 80 mg modified polysorbate 80/tween 80,
650 mg polyethylene glycol 300, and 30.5 percent (v/v) alcohol. Vial headspace contains nitrogen.
VePesid is also available as 50 mg pink capsules. Each liquid filled, soft gelatin capsulecontains 50 mg of etoposide in a vehicle consisting of citric acid, glycerin, purified water,
and polyethylene glycol 400. The soft gelatin capsules contain gelatin, glycerin, sorbitol,
purified water, and parabens (ethyl and propyl) with the following dye system: iron oxide(red) and titanium dioxide; the capsules are printed with edible ink.
The structural formula is:

Item 2 Vol 1
Page 018

CLINICAL PHARMACOLOGY
VePesid has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Two different dosedependent responses are seen. At high concentrations (10 µg/mL or more), lysis of cells
entering mitosis is observed. At low concentrations (0.3 to 10 µg/mL), cells are inhibitedfrom entering prophase. It does not interfere with microtubular assembly. The predominant
macromolecular effect of etoposide appears to be the induction of DNA strand breaks by aninteraction with DNA topoisomerase II or the formation of free radicals.
Pharmacokinetics
On intravenous administration, the disposition of etoposide is best described as a biphasic
process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to
36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over arange 100-600 mg/m2. Over the same dose range, the areas under the plasma concentration
vs time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearlywith dose. Etoposide does not accumulate in the plasma following daily administration of
100 mg/m2 for 4 to 5 days.
The mean volumes of distribution at steady state fall in the range of 18 to
29 liters or 7 to 17 L/m2. Etoposide enters the CSF poorly. Although it is detectable in CSF
and intracerebral tumors, the concentrations are lower than in extracerebral tumors and inplasma. Etoposide concentrations are higher in normal lung than in lung metastases andare similar in primary tumors and normal tissues of the myometrium. In vitro, etoposide ishighly protein bound (97%) to human plasma proteins. An inverse relationship between
plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeledetoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin
displaced protein-bound etoposide at concentrations achieved in vivo.
Etoposide binding ratio correlates directly with serum albumin in patients with cancer
and in normal volunteers. The unbound fraction of etoposide significantly correlated withbilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide. (See PRECAUTIONS section.)
After intravenous administration of 14C-etoposide (100-124 mg/m2 ), mean recovery ofradioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as
etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours.
In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours.
The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total bodyclearance over a dose range of 80 to 600 mg/m2. Etoposide, therefore, is cleared by both
renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known.
Biliary excretion of unchanged drug and/or metabolites is an important route of etoposideelimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxyacid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-β-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It
is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate
conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous
dose is excreted in the urine as radiolabeled metabolites of 14C-etoposide. In addition,
O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme
pathway to produce the corresponding catechol.
After either intravenous infusion or oral capsule administration, the Cmax and AUC values
exhibit marked intra- and inter-subject variability. This results in variability in the estimatesof the absolute oral bioavailability of etoposide oral capsules.
Cmax and AUC values for orally administered etoposide capsules consistently fall in thesame range as the Cmax and AUC values for an intravenous dose of one-half the size of theoral dose. The overall mean value of oral capsule bioavailability is approximately 50%(range 25–75%). The bioavailability of etoposide capsules appears to be linear up to a doseof at least 250 mg/m2.
There is no evidence of a first-pass effect for etoposide. For example, no correlation
exists between the absolute oral bioavailability of etoposide capsules and nonrenal clearance. No evidence exists for any other differences in etoposide metabolism and excretion
after administration of oral capsules as compared to intravenous infusion.
In adults, the total body clearance of etoposide is correlated with creatinine clearance,
serum albumin concentration, and nonrenal clearance. Patients with impaired renal func-

INDICATION AND USAGE
VePesid (etoposide) is indicated in the management of the following neoplasms:
Refractory Testicular Tumors—VePesid For Injection in combination therapy with otherapproved chemotherapeutic agents in patients with refractory testicular tumors who havealready received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Adequate data on the use of VePesid Capsules in the treatment of testicular cancer are notavailable.
Small Cell Lung Cancer—VePesid For Injection and/or Capsules in combination withother approved chemotherapeutic agents as first line treatment in patients with small celllung cancer.
CONTRAINDICATIONSVePesid is contraindicated in patients who have demonstrated a previous hypersensitivity toetoposide or any component of the formulation.
WARNINGS
Patients being treated with VePesid must be frequently observed for myelosuppression bothduring and after therapy. Myelosuppression resulting in death has been reported. Doselimiting bone marrow suppression is the most significant toxicity associated with VePesid
therapy. Therefore, the following studies should be obtained at the start of therapy and prior
to each subsequent cycle of VePesid: platelet count, hemoglobin, white blood cell count, anddifferential. The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil
count below 500/mm3 is an indication to withhold further therapy until the blood counts
have sufficiently recovered.
Physicians should be aware of the possible occurrence of an anaphylactic
reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension.
Higher rates of anaphylactic-like reactions have been reported in children who received
infusions at concentrations higher than those recommended. The role that concentration of
infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is
uncertain. (See ADVERSE REACTIONS section.) Treatment is symptomatic. The infusion
should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
For parenteral administration, VePesid should be given only by slow intravenous infusion(usually over a 30- to 60-minute period) since hypotension has been reported as a possible
side effect of rapid intravenous injection.
Pregnancy
VePesid can cause fetal harm when administered to a pregnant woman. Etoposide has beenshown to be teratogenic in mice and rats.
In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human doseon a mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher
doses of 1.2 and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on a mg/m2 basis)
resulted in 90 and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th ofhuman dose on a mg/m2 basis) dose of etoposide administered intraperitoneally on days 6,
7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m2 basis) on
day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight.
Women of childbearing potential should be advised to avoid becoming pregnant. If thisdrug is used during pregnancy, or if the patient becomes pregnant while receiving this drug,
the patient should be warned of the potential hazard to the fetus.
VePesid should be considered a potential carcinogen in humans. The occurrence of acuteleukemia with or without a preleukemic phase has been reported in rare instances in patientstreated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with VePesid
have not been conducted in laboratory animals.
PRECAUTIONSGeneral
In all instances where the use of VePesid is considered for chemotherapy, the physician mustevaluate the need and usefulness of the drug against the risk of adverse reactions. Most suchadverse reactions are reversible if detected early. If severe reactions 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 VePesid 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.
Patients with low serum albumin may be at an increased risk for etoposide associatedtoxicities.
Drug Interactions
High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered withoral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease intotal body clearance of etoposide compared to etoposide alone.
Laboratory Tests
Periodic complete blood counts should be done during the course of VePesid treatment.
They should be performed prior to each cycle of therapy and at appropriate intervals during
and after therapy. At least one determination should be done prior to each dose of VePesid.
Renal Impairment
In patients with impaired renal function, the following initial dose modification should beconsidered based on measured creatinine clearance:

Measured Creatinine Clearance
etoposide>50 mL/min

15-50 mL/min

100% of dose

75% of dose

Subsequent VePesid dosing should be based on patient tolerance and clinical effect.
Data are not available in patients with creatinine clearances <15 mL/min and further
dose reduction should be considered in these patients.
Carcinogenesis (see WARNINGS section), Mutagenesis, Impairment of Fertility
Etoposide has been shown to be mutagenic in Ames assay.
Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of VePesid on day 7 of gestation
increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected.
Irreversible testicular atrophy was present in rats treated with etoposide intravenously for
30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis).
Pregnancy
Pregnancy “Category D.” (See WARNINGS section.)
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 VePesid, a decision should be made whether to discontinue nursing or to discontinue thedrug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
VePesid (etoposide) For Injection contains polysorbate 80. In premature infants, a lifethreatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing
polysorbate 80. Anaphylactic reactions have been reported in pediatric patients. (SeeWARNINGS section.)
Geriatric Use
Clinical studies of VePesid (etoposide) for the treatment of refractory testicular tumors did
not include sufficient numbers of patients aged 65 years and over to determine whether
they respond differently from younger patients. Of more than 600 patients in four clinicalstudies in the NDA databases who received VePesid or etoposide phosphate in combination
with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC),
about one third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatmentgroups were performed for the elderly subset. In the one study (etoposide in combination

with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or
cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen
compared with the control regimens. No differences in myelosuppression were seen between
elderly and younger patients in these studies except for an increased frequency of WHO Grade III
or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients.
In five single-agent studies of etoposide phosphate in patients with a variety of tumor types,
34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients.
Postmarketing experience also suggests that elderly patients may be more sensitive to someof the known adverse effects of etoposide, including myelosuppression, gastrointestinal
effects, infectious complications, and alopecia.
Although some minor differences in pharmacokinetic parameters between elderly andnonelderly patients have been observed, these differences were not considered clinically significant.
Etoposide and its metabolites are known to be substantially excreted by the kidney, and therisk of adverse reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should betaken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS:
Renal Impairment for recommended dosing adjustments in patients with renal impairment).
ADVERSE REACTIONS
The following data on adverse reactions are based on both oral and intravenous administration of VePesid (etoposide) as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.
Hematologic Toxicity
Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to
14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has
been reported. Fever and infection have also been reported in patients with neutropenia. Deathassociated with myelosuppression has been reported.
The occurrence of acute leukemia with or without a preleukemic phase has been reported
rarely in patients treated with VePesid in association with other antineoplastic agents. (SeeWARNINGS section.)
Gastrointestinal Toxicity
Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea andvomiting is generally mild to moderate with treatment discontinuation required in 1% of
patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy.
Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more
frequent after oral administration than after intravenous infusion.
Hypotension
Transient hypotension following rapid intravenous administration has been reported in 1% to
2% of patients. It has not been associated with cardiac toxicity or electrocardiographic
changes. No delayed hypotension has been noted. To prevent this rare occurrence, it is recommended that VePesid be administered by slow intravenous infusion over a 30- to 60-minuteperiod. If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. When restarting the infusion, a slower
administration rate should be used.
Allergic Reactions
Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving
intravenous VePesid and in less than 1% of the patients treated with the oral capsules. These
reactions have usually responded promptly to the cessation of the infusion and administrationof pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Bloodpressure usually normalizes within a few hours after cessation of the infusion. Anaphylacticlike reactions have occurred during the initial infusion of VePesid.
Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm,
back pain, and/or loss of consciousness have sometimes occurred in association with the above
reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At
investigational doses, a generalized pruritic erythematous maculopapular rash, consistent
with perivasculitis, has been reported.
Alopecia
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66%
of patients.
Other Toxicities
The following adverse reactions have been infrequently reported: abdominal pain, aftertaste,
constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness,
optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.
Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with VePesid. Metabolic acidosis has also been reported inpatients receiving higher doses.
Reports of extravasation with swelling have been received postmarketing. Rarely extravasation has been associated with necrosis and venous induration.
The incidences of adverse reactions in the table that follows are derived from multiple databases from studies in 2,081 patients when VePesid was used either orally or by injection as asingle agent.

VePesid Capsules
In small cell lung cancer, the recommended dose of VePesid Capsules is two times the IVdose rounded to the nearest 50 mg.
The dosage, by either route, should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or
chemotherapy which may have compromised bone marrow reserve.
Administration Precautions
As with other potentially toxic compounds, caution should be exercised in handling andpreparing the solution of VePesid. Skin reactions associated with accidental exposure to
VePesid may occur. The use of gloves is recommended. If VePesid solution contacts the skinor mucosa, immediately and thoroughly wash the skin with soap and water and flush themucosa with water.
Preparation for Intravenous Administration
VePesid For Injection must be diluted prior to use with either 5% Dextrose Injection, USP, or
0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If
solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur.
Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the VePesid solution be administered over a 30- to 60-minute period. A
longer duration of administration may be used if the volume of fluid to be infused is a concern. VePesid should not be given by rapid intravenous injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration(see DESCRIPTION section) prior to administration whenever solution and container permit.
Stability
Unopened vials of VePesid For Injection are stable for 24 months at room temperature (25° C).
Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and24 hours, respectively, at room temperature (25° C) under normal room fluorescent light inboth glass and plastic containers.
VePesid Capsules must be stored under refrigeration 2°–8° C (36°–46° F). The capsules
are stable for 24 months under such refrigeration conditions.
Procedures for proper handling and disposal of anticancer drugs should be considered.
Several guidelines on this subject have been published.1–8 There is no general agreement that
all of the procedures recommended in the guidelines are necessary or appropriate.
HOW SUPPLIED
VePesid ® (etoposide) For Injection
NDC 0015-3095-20—100 mg/5 mL Sterile, Multiple Dose Vial, 10’s
NDC 0015-3084-20—150 mg/7.5 mL Sterile, Multiple Dose Vial
NDC 0015-3061-20—500 mg/25 mL Sterile, Multiple Dose Vial
NDC 0015-3062-20—1 gram/50 mL Sterile, Multiple Dose Vial
VePesid ® (etoposide) Capsules
NDC 0015-3091-45—50 mg pink capsules with “BRISTOL 3091” printed in black in blisterpacks of 20 individually labeled blisters, each containing one capsule.
Capsules are to be stored under refrigeration 2°–8° C (36°–46° F).
DO NOT FREEZE.
Dispense in child-resistant containers.
For information on package sizes available, refer to the current price schedule.
References
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington,
DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human
Services, Public Health Service publication NIH 83-2621.
3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics.
JAMA. 1985;253:1590-1591.
4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission
on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences,
179 Longwood Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe
handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from theMount Sinai Medical Center. CA–A Cancer J for Clin. 1983;33:258-263.
7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice
Guidelines.). Am J Health-SystPharm. 1996;53:1669-1685.
Capsules:Manufactured by:
R.P. Scherer GmbH
Eberback/Baden, Germany

Injection:

Bristol-Myers Squibb Co.
Princeton, New Jersey 08543 USA

Distributed by:Bristol-Myers Squibb Co.
Princeton, New Jersey 08543 USA

PERCENT RANGE OF
ADVERSE DRUG EFFECTREPORTED INCIDENCE
Hematologic toxicity
3–17
Leukopenia (less than 1,000 WBC/mm3)
60–91
Leukopenia (less than 4,000 WBC/mm3)
1–20
Thrombocytopenia (less than 50,000 platelets/mm3)
22–41
Thrombocytopenia (less than 100,000 platelets/mm3)
Anemia0–33
Gastrointestinal toxicity
Nausea and vomiting
31–43
Abdominal pain
0–20
Anorexia
10–13
Diarrhea
1–13
Stomatitis
1–60
Hepatic
0–30
Alopecia
8–66
Peripheral neurotoxicity
1–20
Hypotension
1–20
Allergic reaction
1–20
OVERDOSAGENo proven antidotes have been established for VePesid overdosage.
DOSAGE AND ADMINISTRATION
Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used with undiluted
VePesid For Injection.
VePesid For Injection
The usual dose of VePesid For Injection in testicular cancer in combination with other approved
chemotherapeutic agents ranges from 50 to 100 mg/m2/day on days 1 through 5 to 100 mg/m2/day
on days 1, 3, and 5.
In small cell lung cancer, the VePesid For Injection dose in combination with other approved
chemotherapeutic drugs ranges from 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days.
For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section.
Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery fromany toxicity.

51-001106-05

Revised November 2004

OMNI
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Printed Code No.: 51-001106-05
6/27/05
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