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SAMSCA is contraindicated in the following conditions: Use in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outside of FDA-Approved REMS: Tolvaptan can cause serious and potentially fatal liver injury. Tolvaptan should not be prescribed or used outside of the FDA-approved Risk Evaluation and Mitigation Strategy (REMS) for ADPKD patients [see Liver Injury under Precautions].
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 Postmarketing Experience under Adverse Reactions].
