MERCAPTOPURINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

MERCAPTOPURINE

Composition:

MERCAPTOPURINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mercaptopurine Tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. None. Risk Summary Mercaptopurine Tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation i

Product summary:

Mercaptopurine Tablets, USP 50 mg supplied as pale yellow, biconvex tablets, with product identification “54 420” on one side and a score on the other side. NDC 0054-4581-11: Bottle of 25 Tablets NDC 0054-4581-27: Bottle of 250 Tablets Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Dispense in a tight, child-resistant container as defined in the USP/NF. Mercaptopurine Tablets is a cytotoxic drug. Follow special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MERCAPTOPURINE- MERCAPTOPURINE TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MERCAPTOPURINE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MERCAPTOPURINE
TABLETS.
MERCAPTOPURINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Mercaptopurine Tablets is a nucleoside metabolic inhibitor indicated
for treatment of adult and pediatric
patients with acute lymphoblastic leukemia (ALL) as part of a
combination chemotherapy maintenance
regimen. (1.1) (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg (3) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction (>20%) is myelosuppression, including
anemia, leukopenia and
thrombocytopenia. Adverse reactions occurring in 5% to 20% of patients
include anorexia, nausea,
vomiting, diarrhea, malaise and rash. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
The recommended starting dose of Mercaptopurine Tablets is 1.5 mg/kg
to 2.5 mg/kg 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)
Myelosuppression: Monitor complete blood count (CBC) and adjust the
dose of Mercaptopurine
Tablets 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 or
homozygous TPMT or NUDT15
deficiency may