n intravenously by bolus injection or diluted in a larger volume (25 to 50 mL) with 5% Dextrose Injection USP or 0.9% Sodium Chloride Injection USP. Dilution of the entire contents of a reconstituted vial with 25 mL or 50 mL provides a pentostatin concentration of 0.33 mg/mL or 0.18 mg/mL, respectively, for the diluted solutions.
NIPENT solution when diluted for infusion with 5% Dextrose Injection USP or 0.9% Sodium Chloride Injection USP does not interact with PVC infusion containers or administration sets at concentrations of 0.18 mg/mL to 0.33 mg/mL.
Stability
NIPENT vials are stable at refrigerated storage temperature 2° to 8° C (36° to 46°F) for the period stated on the package. Vials reconstituted or reconstituted and further diluted as directed may be stored at room temperature and ambient light but should be used within 8 hours because NIPENT contains no preservatives.
HOW SUPPLIED
NIPENT (pentostatin for injection) is supplied as a sterile lyophilized white to off-white powder in single-dose vials containing 10 mg of pentostatin. The vials are packed in individual cartons. NDC 0409-0801-01.
Storage: Store NIPENT vials under refrigerated storage conditions 2° to 8° C (36° to 46°F).
REFERENCES
Malspeis L, et al. Clinical pharmacokinetics of 2’-Deoxycoformycin. Cancer Treatment Symposia 2:7-15, 1984
Recommendations for the safe handling of parenteral antineoplastic drugs. NIH Publication 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
AMA council Report. Guidelines for handling parenteral antineoplastics. JAMA 253:1590-2, 1985.
National Study Commission on Cytotoxic Exposure—Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426-8, 1983.
Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA: A Cancer Journal for Clinicians 33:258-63, 1983.
American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 47:1033-49, 1990.
Hospira, Inc.
Lake Forest, IL 60045
Product of Australia
Revised: April 2009
431508
431511
NIPENT
pentostatin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-0801
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTOSTATIN(Pentostatin) PENTOSTATIN 2mg in1mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0409-0801-01 1VIALIn1CARTON contains a VIAL, SINGLE-DOSE
1 5mLIn1VIAL, SINGLE-DOSE This package is con
