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Purinethol

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Purinethol

Indications
Dosage
How Supplied

INDICATIONS

PURINETHOL (mercaptopurine) is indicated for maintenance therapy of acute lymphatic (lymphocytic, lymphoblastic) leukemia as part of a combination regimen. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric or adult).

PURINETHOL is not effective for prophylaxis or treatment of central nervous system leukemia.

PURINETHOL is not effective in acute myelogenous leukemia, chronic lymphatic leukemia, the lymphomas (including Hodgkins Disease), or solid tumors.

DOSAGE AND ADMINISTRATION

Maintenance Therapy

Once a complete hematologic remission is obtained, maintenance therapy is considered essential. Maintenance doses will vary from patient to patient. The usual daily maintenance dose of PURINETHOL is 1.5 to 2.5 mg/kg/day as a single dose. It is to be emphasized that in pediatric patients with acute lymphatic leukemia in remission, superior results have been obtained when PURINETHOL has been combined with other agents (most frequently with methotrexate) for remission maintenance. PURINETHOL should rarely be relied upon as a single agent for the maintenance of remissions induced in acute leukemia.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.J"8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Dosage with Concomitant Allopurinol

When allopurinol and mercaptopurine are administered concomitantly, the dose of mercaptopurine must be reduced to one third to one quarter of the usual dose to avoid severe toxicity.

Dosage in TPMT-deficient Patients

Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe PURINETHOL toxicity from conventional doses of mercaptopurine and generally require substantial dose reduction. The optimal starting dose for homozygous deficient patients has not been established. (See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections.)

Most patients with heterozygous TPMT deficiency tolerated recommended PURINETHOL doses, but some require dose reduction. Genotypic and phenotypic testing of TPMT status are available. (See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections.)

Dosage in Renal and Hepatic Impairment

It is probably advisable to start with lower dosages in patients with impaired renal function, due to slower elimination of the drug and metabolites and a greater cumulative effect. Consideration should be given to reducing the dosage in patients with impaired hepatic function.

HOW SUPPLIED

Pale yellow to buff, scored tablets containing 50 mg mercaptopurine, imprinted with "PURINETHOL" and "04A"; bottles of 60 (NDC 57844-522-06).

Store at 15° to 25°C (59° to 77°F) in a dry place.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society;1999:32-41.

2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety; Clinical Center Pharmacy Department and Cancer Nursing Services,
National Institutes of Health; 1992. US Dept of Health and Human Services. Public Health Service publication NIH 92-2621.

3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.

4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med JAustralia. 1983;l:426-428.

6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clinicians. 1983;33:258-263.

7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am JHosp Pharm. 1990;47:1033-1049.

8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am JHealth-Syst Pharm. 1996;53:1669-1685.

Manufactured for: Gate Pharmaceuticals, div. of Teva Pharmaceuticals USA Sellersville, PA 18960. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834. Rev. 4/2011

Last reviewed on RxList: 7/1/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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