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Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Thiopurine Dosing Based on TPMT and NUDT15
Maud Maillard1,2, Matthias Schwab3,4, Michelle Whirl-Carrillo5
1Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Clinical Pharmacology and Therapeutics
|January 31, 2026
Summary
Genetic testing for Thiopurine methyltransferase (TPMT) and Nudix hydrolase 15 (NUDT15) variants can guide thiopurine drug dosing. This helps prevent severe side effects like myelosuppression in patients receiving mercaptopurine, thioguanine, or azathioprine.
Area of Science:
- Pharmacogenomics
- Clinical Pharmacology
- Genetics
Background:
- Thiopurine drugs (mercaptopurine, thioguanine, azathioprine) are essential treatments for various conditions.
- Thiopurine S-methyltransferase (TPMT) and Nudix hydrolase 15 (NUDT15) enzymes are critical for metabolizing thiopurines.
- Genetic variations in TPMT and NUDT15 genes lead to reduced enzyme activity, increasing the risk of severe adverse drug reactions, particularly myelosuppression.
Purpose of the Study:
- To provide updated clinical practice guideline recommendations for thiopurine drug dosing based on pharmacogenetic testing.
- To incorporate genetic variants in both TPMT and NUDT15 genes for personalized dosing strategies.
- To offer guidance for adjusting starting doses of mercaptopurine, thioguanine, and azathioprine.
Main Methods:
- Review and synthesis of existing literature and clinical data on TPMT and NUDT15 genetic variants.
- Development of dosing algorithms that integrate TPMT and NUDT15 genotype information.
- Guideline formulation based on evidence for genotype-guided thiopurine therapy.
Main Results:
- Individuals with decreased or no-function TPMT and/or NUDT15 alleles require adjusted thiopurine starting doses.
- Genetic variants in TPMT and NUDT15 are found across all populations, with varying frequencies based on ancestry.
- Recommendations cover scenarios with variants in one or both genes, including compound heterozygotes.
Conclusions:
- Genotype-guided dosing of thiopurines based on TPMT and NUDT15 status is crucial for optimizing safety and efficacy.
- Personalized medicine approaches using pharmacogenetics can mitigate severe adverse events like myelosuppression.
- These updated guidelines aim to improve patient outcomes by tailoring thiopurine therapy to individual genetic profiles.
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