Initiate and Re-Initiate in a Hospital and Monitor Serum Sodium
- Tolvaptan 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 risk of hepatoxicity, tolvptan should not be used for ADPKD outside of the FDA-approved REMS.
FDA and Industry Communications
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information