Pentostatin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
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WARNING
See full prescribing information for complete Boxed Warning.
* NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.
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Overview
Pentostatin is an antineoplastic agent that is FDA approved for the treatment of hairy cell leukemia, untreated or alpha-interferon-refractory. There is a Black Box Warning for this drug as shown here. Common adverse reactions include disorder of skin, pruritus,abdominal pain, diarrhea, nausea, vomiting, anemia,leukopenia, thrombocytopenia, myalgia, headache,fever,fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Dosage
- It is recommended that patients receive hydration with 500 to 1,000 mL of 5% Dextrose in 0.5 Normal Saline or equivalent before NIPENT administration. An additional 500 mL of 5% Dextrose or equivalent should be administered after NIPENT is given.
- The recommended dosage of NIPENT for the treatment of hairy cell leukemia is 4 mg/m2 every other week. NIPENT may be administered intravenously by bolus injection or diluted in a larger volume and given over 20 to 30 minutes. (See Preparation of Intravenous Solution.)
- Higher doses are not recommended.
- No extravasation injuries were reported in clinical studies.
- The optimal duration of treatment has not been determined. In the absence of major toxicity and with observed continuing improvement, the patient should be treated until a complete response has been achieved. Although not established as required, the administration of two additional doses has been recommended following the achievement of a complete response.
- All patients receiving NIPENT at 6 months should be assessed for response to treatment. If the patient has not achieved a complete or partial response, treatment with NIPENT should be discontinued.
- If the patient has achieved a partial response, NIPENT treatment should be continued in an effort to achieve a complete response. At any time thereafter that a complete response is achieved, two additional doses of NIPENT are recommended. NIPENT treatment should then be stopped. If the best response to treatment at the end of 12 months is a partial response, it is recommended that treatment with NIPENT be stopped.
- Withholding or discontinuation of individual doses may be needed when severe adverse reactions occur. Drug treatment should be withheld in patients with severe rash, and withheld or discontinued in patients showing evidence of nervous system toxicity.
- NIPENT treatment should be withheld in patients with active infection occurring during the treatment but may be resumed when the infection is controlled.
- Patients who have elevated serum creatinine should have their dose withheld and a creatinine clearance determined. There are insufficient data to recommend a starting or a subsequent dose for patients with impaired renal function (creatinine clearance <60 mL/min).
- Patients with impaired renal function should be treated only when the potential benefit justifies the potential risk. Two patients with impaired renal function (creatinine clearances 50 to 60 mL/min) achieved complete response without unusual adverse events when treated with 2 mg/m2.
- No dosage reduction is recommended at the start of therapy with NIPENT in patients with anemia, neutropenia, or thrombocytopenia. In addition, dosage reductions are not recommended during treatment in patients with anemia and thrombocytopenia if patients can be otherwise supported hematologically. NIPENT should be temporarily withheld if the absolute neutrophil count falls during treatment below 200 cells/mm3 in a patient who had an initial neutrophil count greater than 500 cells/mm3 and may be resumed when the count returns to predose levels.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pentostatin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pentostatin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Pentostatin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pentostatin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pentostatin in pediatric patients.
Contraindications
- NIPENT is contraindicated in patients who have demonstrated hypersensitivity to NIPENT.
Warnings
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WARNING
See full prescribing information for complete Boxed Warning.
* NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.
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- Patients with hairy cell leukemia may experience myelosuppression primarily during the first few courses of treatment. Patients with infections prior to NIPENT treatment have in some cases developed worsening of their condition leading to death, whereas others have achieved complete response. Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient. Efforts should be made to control the infection before treatment is initiated or resumed.
- In patients with progressive hairy cell leukemia, the initial courses of NIPENT treatment were associated with worsening of neutropenia. Therefore, frequent monitoring of complete blood counts during this time is necessary. If severe neutropenia continues beyond the initial cycles, patients should be evaluated for disease status, including a bone marrow examination.
- Elevations in liver function tests occurred during treatment with NIPENT and were generally reversible.
- Renal toxicity was observed at higher doses in early studies; however, in patients treated at the recommended dose, elevations in serum creatinine were usually minor and reversible. There were some patients who began treatment with normal renal function who had evidence of mild to moderate toxicity at a final assessment.
- Rashes, occasionally severe, were commonly reported and may worsen with continued treatment. Withholding of treatment may be required.
- Acute pulmonary edema and hypotension, leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of the ablative regimen for bone marrow transplant.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pentostatin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Pentostatin in the drug label.
Drug Interactions
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): Pregnancy Category D
- Pentostatin can cause fetal harm when administered to a pregnant woman. Pentostatin was administered intravenously at doses of 0, 0.01, 0.1, or 0.75 mg/kg/day (0, 0.06, 0.6, and 4.5 mg/m2) to pregnant rats on days 6 through 15 of gestation. Drug-related maternal toxicity occurred at doses of 0.1 and 0.75 mg/kg/day (0.6 and 4.5 mg/m2). Teratogenic effects were observed at 0.75 mg/kg/day (4.5 mg/m2) manifested by increased incidence of various skeletal malformations. In a dose range-finding study, pentostatin was administered intravenously to rats at doses of 0, 0.05, 0.1, 0.5, 0.75, or 1 mg/kg/day (0, 0.3, 0.6, 3, 4.5, 6 mg/m2), on days 6 through 15 of gestation. Fetal malformations that were observed were an omphalocele at 0.05 mg/kg (0.3 mg/m2), gastroschisis at 0.75 mg/kg and 1 mg/kg (4.5 and 6 mg/m2), and a flexure defect of the hindlimbs at 0.75 mg/kg (4.5 mg/m2). Pentostatin was also shown to be teratogenic in mice when administered as a single 2 mg/kg (6 mg/m2) intraperitoneal injection on day 7 of gestation. Pentostatin was not teratogenic in rabbits when administered intravenously on days 6 through 18 of gestation at doses of 0, 0.005, 0.01, or 0.02 mg/kg/day (0, 0.015, 0.03, or 0.06 mg/m2); however maternal toxicity, abortions, early deliveries, and deaths occurred in all drug-treated groups. There are no adequate and well-controlled studies in pregnant women. If NIPENT 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 receiving NIPENT should be advised to avoid becoming pregnant.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pentostatin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pentostatin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pentostatin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Pentostatin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Pentostatin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Pentostatin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pentostatin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pentostatin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pentostatin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pentostatin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pentostatin in patients who are immunocompromised.
Administration and Monitoring
Administration
- Intravenous
Monitoring
There is limited information regarding Monitoring of Pentostatin in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Pentostatin in the drug label.
Overdosage
There is limited information regarding Pentostatin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Pentostatin Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Pentostatin in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Pentostatin in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Pentostatin in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Pentostatin in the drug label.
How Supplied
Storage
There is limited information regarding Pentostatin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Pentostatin in the drug label.
Precautions with Alcohol
- Alcohol-Pentostatin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- NIPENT
Look-Alike Drug Names
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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