PURIXAN suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Mercaptopurine (UNII: E7WED276I5) (MERCAPTOPURINE ANHYDROUS - UNII:PKK6MUZ20G)

Доступна з:

Nova Laboratories, Ltd

ІПН (Міжнародна Ім'я):

Mercaptopurine

Склад:

Mercaptopurine 20 mg in 1 mL

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

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

Статус Авторизація:

New Drug Application

Характеристики продукта

PURIXAN - PURIXAN SUSPENSION
NOVA LABORATORIES, LTD
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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