PURINETHOL SUMMARY
PURINETHOL® (mercaptopurine) 50-mg Scored Tablets
PURINETHOL (mercaptopurine) was synthesized and developed by Hitchings, Elion, and associates at the Wellcome Research Laboratories. It is one of a large series of purine analogues which interfere with nucleic acid biosynthesis and has been found active against human leukemias.
PURINETHOL (mercaptopurine) is indicated for remission induction and maintenance therapy of acute lymphatic leukemia. The response to this agent depends upon the particular subclassification of acute lymphatic leukemia and the age of the patient (pediatric patient or adult).
Acute Lymphatic (Lymphocytic, Lymphoblastic) Leukemia: Given as a single agent for remission induction, PURINETHOL induces complete remission in approximately 25% of pediatric patients and 10% of adults. However, reliance upon PURINETHOL alone is not justified for initial remission induction of acute lymphatic leukemia since combination chemotherapy with vincristine, prednisone, and L-asparaginase results in more frequent complete remission induction than with PURINETHOL alone or in combination. The duration of complete remission induced in acute lymphatic leukemia is so brief without the use of maintenance therapy that some form of drug therapy is considered essential. PURINETHOL, as a single agent, is capable of significantly prolonging complete remission duration; however, combination therapy has produced remission duration longer than that achieved with PURINETHOL alone.
Acute Myelogenous (and Acute Myelomonocytic) Leukemia: As a single agent, PURINETHOL will induce complete remission in approximately 10% of pediatric patients and adults with acute myelogenous leukemia or its subclassifications. These results are inferior to those achieved with combination chemotherapy employing optimum treatment schedules.
Central Nervous System Leukemia: PURINETHOL is not effective for prophylaxis or treatment of central nervous system leukemia.
Other Neoplasms: PURINETHOL is not effective in chronic lymphatic leukemia, the lymphomas (including Hodgkins Disease), or solid tumors.
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NEWS HIGHLIGHTS
Published Studies Related to Purinethol (Mercaptopurine)
Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease. [2009.10.07]
CONCLUSIONS: Azathioprine and 6-mercaptopurine are effective therapy for inducing remission in active Crohn's disease. The OR of response increases after > 17 weeks of therapy, suggesting that there is a minimum length of time for a trial of azathioprine or 6-mercaptopurine therapy. Adverse events were more common among patients on active therapy.
Toxicity and efficacy of 6-thioguanine versus 6-mercaptopurine in childhood lymphoblastic leukaemia: a randomised trial. [2006.10.14]
BACKGROUND: 6-mercaptopurine has been a standard component of long-term continuing treatment for childhood lymphoblastic leukaemia, whereas 6-thioguanine has been mainly used for intensification courses. Since preliminary data have shown that 6-thioguanine is more effective than 6-mercaptopurine, we compared the efficacy and toxicity of the two drugs for childhood lymphoblastic leukaemia... INTERPRETATION: Compared with 6-mercaptopurine, 6-thioguanine causes excess toxicity without an overall benefit. 6-mercaptopurine should remain the thiopurine of choice for continuing therapy of childhood lymphoblastic leukaemia.
Intravenous 6-mercaptopurine decreases salvage after relapse in childhood acute lymphoblastic leukemia: a report from the Children's Cancer Group study CCG 1922. [2005.07]
PURPOSE: To compare outcomes of patients with NCI standard risk acute lymphoblastic leukemia (ALL) who relapsed after being randomized to receive either oral or intravenous 6-mercaptopurine (6MP) in the Children's Cancer Group study CCG 1922... CONCLUSION: Treatment with intravenous 6MP during a brief period of total therapy had a significant negative impact on the prognosis in childhood ALL even though oral 6MP was used during maintenance.
Value of intravenous 6-mercaptopurine during continuation treatment in childhood acute lymphoblastic leukemia and non-Hodgkin's lymphoma: final results of a randomized phase III trial (58881) of the EORTC CLG. [2005.05]
Between November 1990 and November 1996, EORTC Children Leukemia Group conducted a randomized trial in de novo acute lymphoblastic leukemia and lymphoblastic non-Hodgkin's lymphoma patients using a Berlin-Frankfurt-Munster protocol to evaluate the monthly addition of intravenous 6-mercaptopurine (i.v...
Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial. [2004.09]
BACKGROUND & AIMS: No therapy has been shown to reliably prevent the evolution of postoperative recurrence of Crohn's disease. The aim of the current trial was to compare 6-mercaptopurine (6-MP) and mesalamine with placebo for the prevention of clinical, endoscopic, and radiographic recurrence of Crohn's disease after resection and ileocolic anastomosis... CONCLUSIONS: 6-MP, 50 mg daily, was more effective than placebo at preventing postoperative recurrence of Crohn's disease and should be considered as a maintenance therapy after ileocolic resection.
Clinical Trials Related to Purinethol (Mercaptopurine)
Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine
50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg)
dose administered under fasting conditions.
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions [Completed]
The objective of this study was to assess the bioequivalence of a potential generic
6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol®
(mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the
fasted state.
Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients [Not yet recruiting]
The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC)
of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard
6MP (100 mg Purinethol) in 12 patients with Crohn's Disease.
The study is being undertaken to prove that the new test formulation is indeed
delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following
local absorption are lower than that seen following standard Purinethol dosing. This should
result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer
side effects.
Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease [Recruiting]
The study is being undertaken to evaluate whether delayed-release medications, designed to
begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more
effective than standard systemically delivered drugs to promote remission or response in CD
patients. It is hypothesized that the delayed-release medications will go right to the
injured tissue and heal the disease more quickly.
The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol
(at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body
weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in
the body that is derived from Vitamin D. There is much medical evidence that shows that lack
of Vitamin D can be a possible risk factor in developing autoimmune disorders, including
Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the
symptoms of Crohn's Disease.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy [Recruiting]
The purpose of this study is to increase the fraction of patients, who become MRD-negative
during consolidation for the non-HR ALL group through individualized intensification of the
6MP-dosage days 30-85.
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