Table 1.

Tolvaptan treatment for ADPKD patients according to the drug label

Indication

To slow progression of cyst development and renal failure in adult ADPKD patients with CKD stages 1 – 3 with fast disease progression

Contraindications

Elevated liver enzymes or other signs of liver impairment; hypersensitivity; volume depletion; hypernatremia; patients who cannot feel or respond to thirst; pregnancy or breast-feeding; incompliance to monthly liver enzyme control

Special warnings

Idiosyncratic hepatotoxicity; urine outflow obstruction; access to water or dehydration; fluid and electrolyte disturbances; anaphylaxis, lactose, or galactose intolerance; diabetes mellitus; increased uric acid; interactions with drugs metabolized by CYP3A inhibitors, CYP2A inducers, and CYP3A substrates; digoxin or other drugs which may increase sodium concentration; vasopressin analogs; skin inspections at regular intervals (neoplasia); measurements of the intraocular pressure at regular intervals (glaucoma)

ADPKD = Autosomal dominant polycystic kidney disease.