MERCAPTOPURINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quinn Pharmaceuticals

INN (International Name):

MERCAPTOPURINE

Composition:

MERCAPTOPURINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mercaptopurine Tablets is indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Mercaptopurine Tablets is 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 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. Animal Data Mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. Risk Summary 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)]. Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating Mercaptopurine Tablets [see Use in Specific Populations (8.1)]. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with Mercaptopurine Tablets and for 6 months after the last dose. Males 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)]. Infertility Females and Males 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 has 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 are supplied as biconvex, round, pale yellow to buff, scored tablets containing 50 mg mercaptopurine, imprinted with “9|3” available in: • bottles of 25 NDC 69076-913-02 • bottles of 250 NDC 69076-913-25 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a dry place. Dispense in tight container as defined in the USP. Mercaptopurine Tablets is a cytotoxic drug. Follow special handling and disposal procedures. 1

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MERCAPTOPURINE- MERCAPTOPURINE TABLET
QUINN PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
MERCAPTOPURINE TABLETS 50 MG
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
RECENT MAJOR CHANGES
Warnings and Precautions, Treatment Related Malignancies (5.4) 4/2020
Warnings and Precautions, Macrophage Activation Syndrome (5.5) 4/2020
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
• The recommended starting dose of Mercaptopurine Tablets is 1.5 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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg (3) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
• 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) (5)
• Hepatotoxicity: Monitor transaminases, alkaline phosphatase and
bilirubin. Withhold Mercaptopurine
Tablets at onset of hepatotoxicity. (5.2)
• Immunosuppression: Response to all vaccines may be diminished and