Tolvaptan

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

Index to FDA Drug Safety Information

Approved Risk Evaluation and Mitigation Strategies (REMS)

JYNARQUE (Tolvaptan) Oral

Patient Counseling Information

JYNARQUE

SAMSCA

Medication Guides

Patient Medication Guide - SAMSCA

Patient Medication Guide - JYNARQUE

Package Inserts

Tolvaptan