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Safe administration and pharmacokinetic monitoring of crushed venetoclax tablets with posaconazole and clarithromycin via percutaneous endoscopic gastrostomy tube in a patient with acute myeloid leukemia



Purpose:

Leukemic stem cells in acute myeloid leukemia (AML) express high B cell lymphoma 2 (BCL2) levels, which contribute to leukemic cell survival and resistance to therapy. Venetoclax-a BCL-2 inhibitor-is indicated for the treatment of AML, which may also target leukemic stem cells; however, it is only available as a tablet. There are no reports of venetoclax use in patients who cannot take oral drugs; therefore, the efficacy, safety, and pharmacokinetics (PK) of venetoclax administered through a gastrostomy tube is unknown.


Case presentation:

We report, for the first time, a case of relapsed Japanese AML patient treated with crushed venetoclax tablets through a percutaneous endoscopic gastrostomy (PEG) tube because of esophageal stricture due to complications of stem cell transplantation. The patient was also taking posaconazole and clarithromycin concomitantly. We evaluated the plasma concentrations of venetoclax administered through a PEG tube. Time to maximum concentration, maximum plasma concentration, and the area under the plasma concentration-time curve were similar to the previously reported PK parameters after oral administration of intact venetoclax tablets in Japanese patients with AML. The clinical course passed safely without the occurrence of unexpected adverse events during the administration of crushed venetoclax tablets in combination with azacitidine.


Conclusions:

The PK parameters of the crushed administered venetoclax via PEG tube was similar to the previously reported PK parameters of the orally administered venetoclax. Therefore, administration of crushed venetoclax tablets through a PEG tube could be an alternate route for patients who have difficulty with oral administration.


Keywords:

Acute myeloid leukemia; Crushed administration; Percutaneous endoscopic gastrostomy tube; Pharmacokinetics; Plasma concentration; Venetoclax.



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