SAMSCA® (tolvaptan) tablets for oral use
Brief Summary of Prescribing Information. Please see Full Prescribing Information for complete product 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.
INDICATIONS AND USAGE: 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.
CONTRAINDICATIONS: SAMSCA is contraindicated in the following conditions:
Urgent need to raise serum sodium acutely: SAMSCA has not been studied in a setting of urgent need to raise serum sodium
acutely.
Inability of the patient to sense or appropriately respond to thirst: Patients who are unable to auto-regulate fluid balance are at
substantially increased risk of incurring an overly rapid correction of serum sodium, hypernatremia and hypovolemia.
Hypovolemic hyponatremia: Risks associated with worsening hypovolemia, including complications such as hypotension and
renal failure, outweigh possible benefits.
Concomitant use of strong CYP 3A inhibitors: Ketoconazole 200 mg administered with tolvaptan increased tolvaptan exposure
by 5-fold. Larger doses would be expected to produce larger increases in tolvaptan exposure. There is not adequate experience to
define the dose adjustment that would be needed to allow safe use of tolvaptan with strong CYP 3A inhibitors such as clarithromycin,
ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin.
Anuric patients: In patients unable to make urine, no clinical benefit can be expected.
Hypersensitivity: SAMSCA is contraindicated in patients with hypersensitivity (e.g. anaphylactic shock, rash generalized) to
tolvaptan or any component of the product [see Adverse Reactions (6.2)].
WARNINGS AND PRECAUTIONS:
Too Rapid Correction of Serum Sodium Can