Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Samsca is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca has to be initiated in hospital.
Tolvaptan has to be initiated at a dose of 15 mg once daily. The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium.
For patients at risk of overly rapid correction of sodium e.g. patients with oncological conditions, very low baseline serum sodium, taking diuretics, or taking sodium supplementation a dose of 7.5 mg should be considered (see section 4.4).
During titration, patients must be monitored for serum sodium and volume status (see section 4.4). In case of inadequate improvement in serum sodium levels, other treatment options have to be considered, either in place of or in addition to tolvaptan. Use of tolvaptan in combination with other options may increase the risk of overly rapid correction of serum sodium (see sections 4.4 and 4.5). For patients with an appropriate increase in serum sodium, the underlying disease and serum sodium levels must be monitored at regular intervals to evaluate further need of tolvaptan treatment. In the setting of hyponatremia, the treatment duration is determined by the underlying disease and its treatment. Tolvaptan treatment is expected to last until the underlying disease is adequately treated or until such time that hyponatremia is no longer a clinical issue.
Samsca must not be taken with grapefruit juice (see section 4.5).
Tolvaptan is contraindicated in anuric patients (see section 4.3).
Tolvaptan has not been studied in patients with severe renal failure. The efficacy and safety in this population is not well established.
Based on the data available, no dose adjustment is required in those with mild to moderate renal impairment.
No information is available in patients with severe hepatic impairment (Child-Pugh class C). In these patients dosing has to be managed cautiously and electrolytes and volume status must be monitored (see section 4.4). No dose adjustment is needed in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B).
No dose adjustment is needed in elderly patients.
The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established. Samsca is not recommended in the paediatric age group.
Oral use.
Administration preferably in the morning, without regard to meals. Tablets must be swallowed without chewing with a glass of water.
Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers. There is no specific antidote for tolvaptan intoxication. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia (profuse and prolonged aquaresis).
In patients with suspected tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended. Appropriate replacement of water and/or electrolytes must continue until aquaresis abates. Dialysis may not be effective in removing tolvaptan because of its high binding affinity for human plasma protein (>98%).
Samsca 7.5 mg tablets: 5 years.
Samsca 15 mg tablets and Samsca 30 mg tablets: 4 years.
Store in the original package in order to protect from light and moisture.
Samsca 7.5 mg tablets:
10 tablets in PP/Alu blisters
30 tablets in PP/Alu blisters
10 × 1 tablet in PVC/Alu perforated unit dose blisters
30 × 1 tablet in PVC/Alu perforated unit dose blisters
Samsca 15 mg and Samsca 30 mg tablets:
10 × 1 tablet in PVC/Alu perforated unit dose blisters
30 × 1 tablet in PVC/Alu perforated unit dose blisters
Not all pack sizes may be marketed.
No special requirements.
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