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Table 3 Summary of product caracteristics (SmPC) for 6-thioguanine

From: Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0–45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol

Genric name

(abbreviation)

6-thioguanine

(6TG)

ATC-code

ATC-code L0JBB03

Name and formulation

Oral suspension, 5 mg/ml

Adverse Reactions

(frequency)

Very common

(> 1/10)

Bone marrow failure, sinusoidal obstruction syndrome (SOS), hyperbilirubinemia, hepatomegaly, weight increase due to fluid retention and ascites, portal hypertension, splenomegaly, esophageal varices and thrombocytopenia, increased hepatic enzymes, increased blood alkaline phosphatase and gamma glutamyl transferase, jaundice, portal fibrosis, nodular regenerative hyperplasia, peliosis hepatis

Common

(> 1/100 to < 1/10)

Stomatitis, gastrointestinal disorder, SOS in short-term cyclical therapy, hyperuricemia, hyperuricosuria and urate nephopathy

Uncommon

(≥1/1000 to < 1/100)

 

Rare

(≥1/10,000 to < 1/1000)

Necrotising colitis, hepatic necrosis

Very rare

(< 1/10,000)

 
 

Unknown

Photosensitivity

  1. SmPC accessed at medicines.org.uk