Once-Daily Samsca Increases Serum Sodium Levels
Through Increase in Free Water Clearance.
 

Your privacy on Samsca.com

This web site is administered by Otsuka America Pharmaceutical, Inc. (OAPI), the distributor and marketer of Samsca. We want you to feel secure when visiting our site and are committed to maintaining your privacy when doing so.

The following provides an overview of how we protect your privacy during your visit.

What information do we gather?

Information on Samsca.com is gathered in two ways: (1) indirectly (for example, through our site's technology); and (2) directly (for example, when you provide information on various pages of Samsca.com). One example of information we collect indirectly is through our Internet access logs. When you access Samsca.com, your Internet address is automatically collected and is placed in our Internet access logs.

We collect information directly from you in a number of ways, some of which we describe in this Privacy Statement. One way is through the use of cookies. Cookies are small files of information which save and retrieve information about your visit to Samsca.com—for example, how you entered our site, how you navigated through the site, and what information was of interest to you. The cookies we use identify you merely as a number. (If you are uncomfortable regarding cookies use, please keep in mind you can disable cookies on your computer by changing the settings in preferences or options menu in your browser.) We also collect information when you voluntarily submit it to us. Our site may provide opportunities to contact us to ask questions or provide comments, ideas and/or suggestions. When you communicate with us and request a response, we may ask for your name and contact information. If we collect this type of information, we will notify you as to why we are asking for it and how this information will be used. It is completely up to you whether or not you want to provide it.

How do we use this information?

We analyze the information to determine what is most effective about our site, to help us identify ways to improve it, and eventually, to determine how we can tailor Samsca.com to make it more effective. We may also use data for other purposes, which we would describe to you at the point we collect the information.

Will we share this with outside parties?

As a global organization, data we collect may be transferred internationally throughout our worldwide organization. We will not sell individual information and will share it only with our affiliates and consultants as needed. There may be other times when we need to share information; however, before you submit any information, we will notify you as to why we are asking for it and it is completely up to you whether or not you want to provide it.

What about sensitive personal data?

We do not generally seek to collect sensitive personal data through this site. If we do seek to collect such data, we will ask you to consent to our proposed uses of the data. We may also collect some sensitive personal data incidentally. By providing us with unsolicited sensitive personal data, you consent to our using the data subject to applicable law as described in this Privacy Statement. The references to "sensitive personal data" are to the various categories of personal data identified by U.S., European and other data privacy laws as requiring special treatment, including in some circumstances the need to obtain explicit consent. These categories comprise personal identity numbers; personal data about personality and private life; racial or ethnic origin; nationality; political opinions; membership in political parties or movements; religious, philosophical or other similar beliefs; membership in a trade union or profession or trade association; physical or mental health; genetic code; addictions; sexual life; property matters; or criminal record (including information about suspected criminal activities).

What about data security?

We take appropriate steps to maintain the security of your data on Samsca.com. You should understand that the open nature of the Internet is such that data may flow over networks without security measures and may be accessed and used by people other than those for whom the data is intended. For questions about Otsuka America Pharmaceutical, Inc. or our privacy policy, send us an e-mail.



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, cirrhosis, 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

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.

SAMSCA is contraindicated in the following conditions:

  • – 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
  • 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
  • Gastrointestinal Bleeding in Patients with Cirrhosis – Use in cirrhotic patients only when need to treat outweighs this risk
  • 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

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.

Commonly observed 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%).

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, and Medication Guide.