Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Mercaptopurine (UNII: E7WED276I5) (MERCAPTOPURINE ANHYDROUS - UNII:PKK6MUZ20G)
Nova Laboratories, Ltd
Mercaptopurine
Mercaptopurine 20 mg in 1 mL
ORAL
PRESCRIPTION DRUG
PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Read these Instructions for Use before you start taking PURIXAN, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important information about measuring PURIXAN oral suspension • Always use the oral dispensing syringe provided with your PURIXAN oral suspension to make sure you measure the right amount. • You will be provided: - 1 bottle of PURIXAN oral suspension - 1 bottle adapter - 2 oral dispensing syringes (one 1 mL and one 5 mL) If you did not receive an oral dispensing syringe with your PURIXAN oral suspension, ask your pharmacist to give you one. You will need disposable gloves. - Do not forcefully push on the plunger. - Do not squirt the medicine to the back of your mouth or throat. This may cause you to ch
PURIXAN (mercaptopurine) oral suspension is supply as 2000 mg/100 mL (20 mg/mL) is a pink to brown viscous liquid in amber glass multiple-dose bottles. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided. Each carton NDC 62484-0020-2 contains 1 bottle of PURIXAN NDC 62484-0020-1. PURIXAN is a cytotoxic drug. Follow special handling and disposal procedures.1
New Drug Application
PURIXAN - PURIXAN SUSPENSION NOVA LABORATORIES, LTD ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PURIXAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PURIXAN. PURIXAN (MERCAPTOPURINE) ORAL SUSPENSION INITIAL U.S. APPROVAL: 1953 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.(1.1) DOSAGE AND ADMINISTRATION The recommended starting dosage of PURIXAN is 1.5 to 2.5 mg/kg (50 to 75 mg/m ) orally once daily as part of a combination chemotherapy maintenance regimen. Adjust dose to maintain desirable absolute neutrophil count and for excessive myelosuppression.(2.1) Renal Impairment: Use the lowest recommended starting dose or increase the dosing interval. (2.3,8.6) Hepatic Impairment: Use the lowest recommended starting dose. (2.3,8.7) DOSAGE FORMS AND STRENGTHS Oral suspension: 2000 mg/100 mL (20 mg/mL). (3) CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Myelosuppression: Monitor complete blood count (CBC) and adjust the dose of PURIXAN for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction. (2.2,5.1) Hepatotoxicity: Monitor transaminases, alkaline phosphatase and bilirubin. Withhold PURIXAN at onset of hepatotoxicity. (5.2) Immunosuppression:Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics. (5.3) Treatment Related Malignancies: Aggressive and fatal cases of hepatosplenic T-cell lymphoma have occurred. (5.4) Macrophage Activation Syndrome: Monitor for and treat promptly; discontinue PURIXAN. (5.5) Embryo-Fetal Прочетете целия документ