Usual Adult Dose for Hyponatremia

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days
Comments:

• During initiation and titration, frequently monitor for changes in serum electrolytes and volume.
• Avoid fluid restriction during the first 24 hours of therapy.
• Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst.
• Tolvaptan may be dosed without regard to meals.

Uses: Hypervolemic and euvolemic hyponatremia [serum sodium less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH)

Usual Adult Dose for Hyponatremia, euvolemic

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days
Comments:

• During initiation and titration, frequently monitor for changes in serum electrolytes and volume.
• Avoid fluid restriction during the first 24 hours of therapy.
• Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst.
• Tolvaptan may be dosed without regard to meals.

Uses: Hypervolemic and euvolemic hyponatremia [serum sodium less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH)

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 10 to 79 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 10 mL/min): Not recommended for use.

Liver Dose Adjustments

Moderate and severe hepatic impairment do not affect exposure to tolvaptan to a clinically relevant extent. No dose adjustment of tolvaptan is necessary.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes a communication plan, elements to assure safe use, and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

CONTRAINDICATIONS:

• Hypersensitivity to this drug or to any of its components
• Anuria
• Hypovolemic hyponatremia
• Patients unable to perceive or respond to thirst
• Concomitant use of strong CYP450 3A inhibitors
• Autosomal Dominant Polycystic Kidney Disease (ADPKD) outside of FDA-approved REMS

US BOXED WARNINGS:

• INITIATING THERAPY AND MONITORING SODIUM: This drug should be initiated and reinitiated only in a hospital setting where serum sodium can be monitored closely. Rapid correction of hyponatremia (e.g., greater than 12 mEq/L/24 hrs) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death.
• AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD): Due to risk of hepatotoxicity, this drug should not be used for ADPKD outside of the FDA-approved REMS.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken without regard to meals.

Storage requirements:

• Store at 25C (77F)
• Keep out of the reach of children.

General:

• Grapefruit juice should be avoided during treatment with this drug.
• Following discontinuation, patients should be advised to resume fluid restriction and should be monitored for changes in serum sodium and volume status.

Patient advice:

• Female patients should inform their healthcare provider of a known or suspected pregnancy.

Frequently asked questions

• What is the difference between Jynarque (tolvaptan) and Samsca (tolvaptan)?