Tolvaptan — Membership Pricing

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About Tolvaptan

Tolvaptan is a medication with distinct applications, primarily known for its role in managing fluid balance and certain kidney conditions. It is specifically approved to treat clinically significant euvolemic and hypervolemic hyponatremia (low sodium levels in the blood) in adults, particularly those associated with conditions like heart failure, cirrhosis, or Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Beyond hyponatremia, tolvaptan also plays a crucial role in slowing the progression of cyst growth in Autosomal Dominant Polycystic Kidney Disease (ADPKD).

How Tolvaptan Works

Tolvaptan is classified as a selective vasopressin V2-receptor antagonist. In simpler terms, it works by blocking the action of vasopressin (also known as antidiuretic hormone) in the kidneys. This blockade prevents the kidneys from reabsorbing too much water, leading to an increase in water excretion without a significant loss of electrolytes like sodium. For patients with hyponatremia, this helps to raise serum sodium levels by removing excess water from the body. In ADPKD, by inhibiting the V2 receptors, tolvaptan is thought to reduce the proliferation of renal tubular epithelial cells and fluid secretion into cysts, thereby slowing the enlargement of kidney cysts and preserving kidney function.

Typical Costs of Tolvaptan

Tolvaptan is a high-cost medication, reflecting its specialized nature and the conditions it treats. Without insurance or significant discounts, the monthly cost for a typical prescription can range from several hundred to several thousand dollars, depending on the dosage, pharmacy, and specific formulation. This substantial expense can be a

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Tolvaptan is approved for (FDA label)

Tolvaptan tablet is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Tolvaptan tablet is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: August 26, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Tolvaptan (FDA label)

WARNING: RISK OF SERIOUS LIVER INJURY Tolvaptan tablets can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported [see Warnings and Precautions ( 5.1 )] . Measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter [see Warnings and Precautions ( 5.1 )] . Prompt action in response to laboratory abnormalities, signs, or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity. Because of the risks of serious liver injury, tolvaptan tablets are available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the tolvaptan tablets REMS Program [see Warnings and Precautions ( 5.2 )] . WARNING: RISK OF SERIOUS LIVER INJURY See full prescribing information for complete boxed warning . Tolvaptan tablets can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported ( 5.1 ) Measure transaminases and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then continuing monthly for the first 18 months and every 3 months thereafter ( 5.1 ) Tolvaptan tablets are available only through a restricted distribution program called the tolvaptan tablets REMS Program ( 5.2 )

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Tolvaptan (FDA label)

Tolvaptan tablets are supplied as Light blue to blue colored, mottled appearance, uncoated tablets, debossed with “TOL” on one side and the tablet strength (mg) on other side. Tolvaptan 15 mg tablets are round, 30 mg tablets are round, 45 mg tablets are square, 60 mg tablets are rectangular, and 90 mg tablets are pentagonal. Tablets: 15 mg, 30 mg, 45 mg, 60 mg and 90 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Tolvaptan (FDA label)

The following adverse reactions are discussed in more detail in other sections of the labeling: Serious Liver Injury [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hypernatremia, Dehydration and Hypovolemia [see Warnings and Precautions ( 5.3 )] Drug Interactions with Inhibitors of CYP 3A [see Warnings and Precautions ( 5.4 )] Most common observed adverse reactions with tolvaptan tablets (incidence greater than 10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Tolvaptan (FDA label)

Tolvaptan tablets are contraindicated in patients: With a history, signs or symptoms of significant liver impairment or injury.

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Tolvaptan (FDA label)

Hypernatremia, dehydration and hypovolemia: May require intervention ( 5.3 ) 5.1 Serious Liver Injury Tolvaptan tablets can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. In a 3-year placebo-controlled trial and its open-label extension (in which patients’ liver tests were monitored every 4 months), evidence of serious hepatocellular injury (elevations of hepatic transaminases of at least 3 times ULN combined with elevated bilirubin at least 2 times the ULN) occurred in 0.2% (3/1487) of tolvaptan treated patients compared to none of the placebo treated patients.

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Tolvaptan (FDA label)

Avoid concomitant use with: Strong CYP 3A Inducers ( 7.1 ) V 2 -Receptor Agonists ( 7.2 ) 7.1 CYP 3A Inhibitors and Inducers CYP 3A Inhibitors Tolvaptan’s AUC was 5.4 times as large and C max was 3.5 times as large after co-administration of tolvaptan and 200 mg ketoconazole [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )] . Larger doses of the strong CYP 3A inhibitor would be expected to produce larger increases in tolvaptan exposure. Concomitant use of tolvaptan with strong CYP 3A inhibitors is contraindicated [see Contraindications ( 4 )]. Dose reduction of tolvaptan tablets is recommended for patients while taking moderate CYP 3A inhibitors [see Dosage and Administration ( 2.4 )]. Patients should avoid grapefruit juice beverages while taking tolvaptan tablets.

Source: FDA prescribing information (DailyMed). Set ID: 82ef58ef-ce46-434e-bf99-89fce51094f1. SPL document ID: 2a51dd17-fedf-4168-be2a-337ab74667a8. Label effective date: August 26, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.