Nipent for Injection (Supergen) - America[美国药品]

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Nipent for Injection (Supergen)(五)

2013-10-08 11:24:23 来源: 作者: 【大中小】浏览:6305次评论:0条

19
Neurologic Disorder, CNS/CNS Toxicity	1	NR	11
Lung Disorder/ Disease	NR	1	12
Nausea	NR	NR	22
Genitourinary Disorder	NR	NR	15
NR = Not Reported
^aOccurring in more than 10% of patients, in any group, regardless of drug association
^bIncludes only nausea with vomiting
^cThese figures represent only unspecified infections. Refer to infection table.
^dElevated liver enzymes and liver disorder for SWOG

INDICATIONS AND USAGE
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.
CONTRAINDICATIONS
NIPENT is contraindicated in patients who have demonstrated hypersensitivity to NIPENT.
WARNINGS
See Boxed Warning .
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 eva luated 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. (See DOSAGE AND ADMINISTRATION .)
Rashes, occasionally severe, were commonly reported and may worsen with continued treatment. Withholding of treatment may be required (See DOSAGE AND ADMINISTRATION .)
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.
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/m 2 ) to pregnant rats on days 6 through 15 o