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SAMSCA is contraindicated in the following conditions: Use in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD): Samsca can cause serious and potentially fatal liver injury. SAMSCA should not be prescribed or used outside of the approved indications.
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 CYP3A inhibitors: Ketoconazole 200 mg administered with SAMSCA increased SAMSCA exposure by 5-fold. Larger doses would be expected to produce larger increases in SAMSCA exposure. There is no adequate experience to define the dose adjustment that would
be needed to allow safe use of SAMSCA 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 Postmarketing Experience under Adverse Reactions].
Hypernatremia patients.
