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Initiate and re-initiate in a hospital and monitor serum sodium: SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely.
Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.
Not for use for autosomal dominant polycystic kidney disease (ADPKD): Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS [see Use in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outside of FDA-Approved REMS under Contraindications].
