MERCAPTOPURINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals 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. 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. Women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. In a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. There are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with mercaptopurine tablets and for 1 week after the last dose. Mercaptopurine tablets can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)] . Verify the pregnancy status in females of reproductive potential prior to initiating mercaptopurine tablets [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 6 months after the last dose. Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 3 months after the last dose [see Nonclinical Toxicology (13.1)] . Based on findings from animal studies, mercaptopurine tablets can impair female and male fertility [see Nonclinical Toxicology (13.1)] . The long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied. Safety and effectiveness of mercaptopurine tablets have been established in pediatric patients. Use of mercaptopurine tablets in pediatrics is supported by evidence from the published literature and clinical experience. Symptomatic hypoglycemia has been reported in pediatric patients with ALL receiving mercaptopurine. Reported cases were in pediatrics less than 6 years of age or with a low body mass index. Clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy. Use the lowest recommended starting dosage for mercaptopurine tablets or increase the dosing interval to every 36-48 hours in patients with renal impairment (CLcr less than 50 mL/min). Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Dosage and Administration (2.3)] . Use the lowest recommended starting dosage for mercaptopurine tablets in patients with hepatic impairment. Adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for adverse reactions [see Dosage and Administration (2.3)] .

Product summary:

Mercaptopurine Tablets, USP are available containing 50 mg of mercaptopurine, USP. The 50 mg tablets are off-white to light yellow, round, scored tablets debossed with M above the score and 547 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3547-52 bottles of 25 tablets NDC 0378-3547-25 bottles of 250 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mercaptopurine tablets are a cytotoxic drug. Follow special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MERCAPTOPURINE- MERCAPTOPURINE TABLET
MYLAN PHARMACEUTICALS 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 are 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)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg (3)
CONTRAINDICATIONS
None.
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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
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 require a dose reduction. (2.2, 5.1)
Hepatotoxic