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SAMSCA (tolvaptan)

For clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction)

Treatment that can transition from hospital to home

It is imperative that patients discharged from the hospital with the prescription for SAMSCA have timely and reliable fulfillment

SAMSCA (tolvaptan) is selectively distributed through a Specialty Pharmacy Network with a goal of convenient, timely fulfillment

Otsuka America Pharmaceutical, Inc., the distributor of SAMSCA, uses a network of specialty pharmacies to fulfill and retain prescriptions of SAMSCA.

  • Otsuka is committed to ensuring that patients have access to the medications they need

SAMSCA is covered nationwide on many Medicaid, Medicare Part D, and commercial plans.*

*Not a guarantee of coverage and reimbursement

Resources for patients continuing SAMSCA® (tolvaptan) postdischarge

The ideal time to start the discharge planning process is when the clinical decision is made to prescribe SAMSCA for continued use postdischarge. Planning ahead for discharge may help avoid gaps in SAMSCA therapy.

Have Questions?
Your Otsuka sales representative is a great place to start. Your representative can also facilitate contact for you with an Otsuka reimbursement support manager. You may also want to contact your patient’s specialty pharmacy, once established, to help you with questions about prescription fulfillment.

For clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction)

Treatment that can transition from hospital to home

It is imperative that patients discharged from the hospital with the prescription for SAMSCA have timely and reliable fulfillment

SAMSCA (tolvaptan) is selectively distributed through a Specialty Pharmacy Network with a goal of convenient, timely fulfillment

Otsuka America Pharmaceutical, Inc., the distributor of SAMSCA, uses a network of specialty pharmacies to fulfill and retain prescriptions of SAMSCA.

  • Otsuka is committed to ensuring that patients have access to the medications they need

SAMSCA is covered nationwide on many Medicaid, Medicare Part D, and commercial plans.*

*Not a guarantee of coverage and reimbursement

Resources for patients continuing SAMSCA® (tolvaptan) postdischarge

The ideal time to start the discharge planning process is when the clinical decision is made to prescribe SAMSCA for continued use postdischarge. Planning ahead for discharge may help avoid gaps in SAMSCA therapy.

Prescribing information for SAMSCA

How can I find a pharmacy that dispenses SAMSCA?

SAMSCA is dispensed to patients through select specialty pharmacies. ASSURE Pathways can help you find a pharmacy and access coverage information. Prescriptions should be sent to a specialty pharmacy via ePrescribe, phone, or fax before the patient leaves the hospital to help ensure timely fulfillment.

How can I find a pharmacy that dispenses SAMSCA?

Prescribing information for SAMSCA

SAMSCA is dispensed to patients through select specialty pharmacies. ASSURE Pathways can help you find a pharmacy and access coverage information. Prescriptions should be sent to a specialty pharmacy via ePrescribe, phone, or fax before the patient leaves the hospital to help ensure timely fulfillment.

What tools might help me create a process for referring prescriptions for SAMSCA to a specialty pharmacy in the network?

This template is provided for informational purposes only and includes data commonly required by specialty pharmacies to dispense a prescription for SAMSCA.

What tools might help me create a process for referring prescriptions for SAMSCA to a specialty pharmacy in the network?

This template is provided for informational purposes only and includes data commonly required by specialty pharmacies to dispense a prescription for SAMSCA.

How can I manage insurance requirements?

The ASSURE Program™ can help you with insurance precertification requirements. 

How can I help my patient obtain SAMSCA?

For patients without adequate insurance coverage, there may be additional assistance available through the Otsuka Patient Assistance Foundation, Inc.

INDICATION and IMPORTANT SAFETY INFORMATION for SAMSCA® (tolvaptan)

INDICATION:

SAMSCA is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <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).

Important Limitations:

  • Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with SAMSCA
  • It has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients

IMPORTANT SAFETY INFORMATION:

WARNING: INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM

  • SAMSCA 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

WARNING: NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)

  • Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS.

SAMSCA is contraindicated in the following conditions:

  • — Use in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) outside of FDA-approved REMS
  • — Urgent need to raise serum sodium acutely
  • — Inability of the patient to sense or appropriately respond to thirst
  • — Hypovolemic hyponatremia
  • — Concomitant use of strong CYP 3A inhibitors
  • — Anuric patients
  • — Hypersensitivity (e.g. anaphylactic shock, rash generalized) to tolvaptan or its components
  • Too Rapid Correction of Serum Sodium Can Cause Serious Neurologic Sequelae: During initiation and after titration monitor patients to assess serum sodium concentrations and neurologic status. Subjects with SIADH or very low baseline serum sodium concentrations may be at greater risk for too-rapid correction of serum sodium. In patients receiving SAMSCA who develop too rapid a rise in serum sodium, discontinue or interrupt treatment with SAMSCA and consider administration of hypotonic fluid. Fluid restriction during the first 24 hours with SAMSCA may increase the likelihood of overly-rapid correction of serum sodium, and should generally be avoided. Co-administration of diuretics also increases the risk of too rapid correction of serum sodium and such patients should undergo close monitoring of serum sodium.
  • Liver Injury: Tolvaptan can cause serious and potentially fatal liver injury. In clinical trials, cases of serious liver injury have been attributed to chronically administered tolvaptan in patients with ADPKD. Liver failure requiring transplantation has been reported in postmarketing experience with tolvaptan in ADPKD. Limit duration of therapy with SAMSCA to 30 days. Avoid use in patients with underlying liver disease, including cirrhosis, because the ability to recover may be impaired.
  • Dehydration and Hypovolemia: In patients who develop medically significant signs or symptoms of hypovolemia, discontinuation is recommended. Dehydration and hypovolemia can occur, especially in potentially volume-depleted patients receiving diuretics or those who are fluid restricted
  • Co-administration with Hypertonic Saline: Not recommended
  • Other Drugs Affecting Exposure to SAMSCA:
  • CYP 3A Inhibitors: Do not use with strong inhibitors of CYP 3A; avoid concomitant use with moderate CYP 3A inhibitors
  • CYP 3A Inducers: Avoid concomitant use with CYP 3A inducers. If co-administered, the dose of SAMSCA may need to be increased
  • P-gp Inhibitors: The dose of SAMSCA may have to be reduced if co-administered with P-gp inhibitors
  • Hyperkalemia or Drugs that Increase Serum Potassium: Monitor serum potassium levels in patients with a serum potassium >5 mEq/L and in patients receiving drugs known to increase serum potassium levels

Adverse Reactions: The most common adverse reactions (SAMSCA incidence  ≥5% more than placebo, respectively): thirst (16% vs 5%), dry mouth (13% vs 4%), asthenia (9% vs 4%), constipation (7% vs 2%), pollakiuria or polyuria (11% vs 3%) and hyperglycemia (6% vs 1%)

Gastrointestinal Bleeding in Patients with Cirrhosis: In patients with cirrhosis in the hyponatremia trials, GI bleeding was reported in 10% of tolvaptan-treated patients vs 2% for placebo

Pregnancy and Nursing Mothers: SAMSCA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from SAMSCA, a decision should be made to discontinue nursing or SAMSCA, taking into consideration the importance of SAMSCA to the mother

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.