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When fluid restriction is not enough 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)

Sta r t

SAMSCA®
( tolvaptan )

Removing excess water with SAMSCA helps you
manage hyponatremia while you are treating
your patient’s primary condition.
• Too rapid correction of serum sodium can cause serious neurologic sequelae
• Avoid fluid restriction during the first 24 hours of therapy

INDICATION and Important Limitations:
• 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)
• 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

Contraindications: 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, and
hypersensitivity (e.g. anaphylactic shock, rash
generalized) to tolvaptan or its components
Warnings and Precautions:
• 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
or develop neurologic sequelae, discontinue or interrupt
treatment with SAMSCA and consider administration
of hypotonic fluid. Fluid restriction should generally be
avoided during the first 24 hours
• SAMSCA can cause serious and potentially fatal liver
injury. Avoid use in patients with underlying liver
disease, including cirrhosis, because the ability to
recover may be impaired. Limit duration of therapy with
SAMSCA to 30 days. SAMSCA is not approved for use
in ADPKD
• Dehydration and hypovolemia can occur, especially in
potentially volume-depleted patients receiving diuretics

or those who are fluid restricted. In patients who
develop medically significant signs or symptoms of
hypovolemia, discontinuation is recommended
• Co-administration with hypertonic saline is not recommended
• Avoid concomitant use with: CYP 3A inhibitors and
CYP 3A inducers. The dose of SAMSCA may have to be
reduced if co-administered with P-gp inhibitors
• 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
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 Brief Summary of FULL PRESCRIBING INFORMATION, including Boxed WARNING, on following pages.
Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850.
SAMSCA is a registered trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.

©2015 Otsuka America Pharmaceutical, Inc.

June 2015

Learn more at SAMSCA.com

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