Tolvaptan Dosage

Medically reviewed by Drugs.com. Last updated on Feb 27, 2023.

Applies to the following strengths: 15 mg; 30 mg; 45 mg-15 mg; 60 mg-30 mg; 90 mg-30 mg

Usual Adult Dose for:

Hyponatremia
Hyponatremia, euvolemic

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

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

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.

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: