When was tolvaptan approved by the FDA?

When was tolvaptan approved by the FDA?

Samsca (tolvaptan) was approved in May 2009 for the treatment of clinically significant euvolemic and hypervolemic hyponatremia. Patients should be in a hospital for initiation and re-initiation of therapy to evaluate the therapeutic response before subsequently receiving Samsca in the outpatient setting.

Where is tolvaptan approved?

On April 24, 2018, the U.S. Food and Drug Administration (FDA) granted approval of tolvaptan to be the first treatment in the United States for adult patients with autosomal dominant polycystic kidney disease (ADPKD), the most common form of polycystic kidney disease (PKD).

Who makes tolvaptan?

Otsuka, maker of JYNARQUE (tolvaptan), is committed to helping patients access the medications they need. Otsuka is committed to helping adults at risk of rapidly progressing ADPKD and will work closely with these patients, providers and payers to ensure JYNARQUE is broadly accessible.

What is tolvaptan used for?

Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH).

Who needs tolvaptan?

Recommendation 1.1: We suggest that tolvaptan can be prescribed to adult ADPKD patients aged <50 years with CKD stages 1–3a (eGFR >45 mL/min/1.73 m²) who have demonstrated or who are likely to have rapidly progressing disease, but that CKD stage must be interpreted in conjunction with age.

What type of drug is tolvaptan?

Tolvaptan is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine. Removing fluid from the body helps to increase the level of sodium in the blood.

What is the cost of tolvaptan?

The cost for tolvaptan oral tablet 30 mg is around $4,651 for a supply of 10 tablets, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.