Generic Name and Formulations:
Mercaptopurine (6-MP) 20mg/mL; oral susp; contains fruit extract, aspartame.
Rare Disease Therapeutics, Inc.
Indications for PURIXAN:
Maintenance therapy of acute lymphoblastic leukemia as part of a combination regimen.
Adults and Children:
Shake bottle vigorously for at least 30 secs. Initially 1.5–2.5mg/kg (50–75mg/m2) per day as a single dose. Monitor subsequent doses to maintain desirable ANC level and adjust for excessive hematological toxicity. Thiopurine-S-methyltransferase (TPMT) and/or nucleotide diphosphatase (NUDT15)-deficient: if homozygous, may require ≤10% of standard dose; if heterozygous, some may require dose reduction based on toxicities. Renal or hepatic impairment: use lower starting doses; monitor for toxicity. See full labeling.
Myelosuppression; monitor CBCs and adjust dose for severe neutropenia and thrombocytopenia. Consider testing for TPMT and NUDT15 deficiency in patients who experience severe bone marrow toxicities or repeated myelosuppression. Monitor serum transaminase, alkaline phosphatase, and bilirubin levels at weekly intervals when starting therapy, then monthly thereafter; interrupt treatment if evidence of hepatotoxicity occurs. Concomitant other hepatotoxic drugs or with pre-existing liver disease; monitor LFTs more frequently. Immunosuppression. Increased risk of lymphoproliferative disorders and other malignancies (eg, skin cancers, sarcomas, uterine cervical cancer). Concomitant multiple immunosuppressants increase risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. Monitor and treat for EBV or cytomegalovirus; discontinue if macrophage activation syndrome occurs, or is suspected. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Pregnancy (esp. 1st trimester), nursing mothers: not recommended.
Avoid concomitant allopurinol. Increased risk of bone marrow suppression with allopurinol, aminosalicylate derivatives (eg, olsalazine, mesalamine, sulfasalazine), trimethoprim-sulfamethoxazole. Possibly decreased effectiveness with concomitant warfarin; monitor PT or INR; may need warfarin dose adjustments. Concomitant live virus vaccines: may get suboptimal response and risk of infection.
Myelosuppression, nausea, vomiting, anorexia, diarrhea, malaise, rash, urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, pancreatitis; hepatotoxicity.
Susp—100mL (w. oral syringes)