LUPIN-TOLVAPTAN is indicated to slow the progression of kidney enlargement and kidney function decline in patients with ADPKD. In ADPKD, kidney enlargement reflects renal cyst burden.
The manufacturer of LUPIN-TOLVAPTAN has implemented a safety monitoring initiative with regard to the use and access to LUPIN-TOLVAPTAN. This initiative is called the Controlled Distribution Program (CDP). All prescribers and patients must take part in the CDP in order to prescribe/receive LUPIN-TOLVAPTAN in Canada.
Please consult the LUPIN-TOLVAPTAN Product Monograph or click here for important information about:
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Contraindications: patients who have been asked to permanently discontinue Tolvaptan, patients with known or suspected hypersensitivity to Tolvaptan, benzazepine or benzazepine derivatives (e.g., mirtazapine) or any of the excipients, patients with hypovolemia, hypernatremia or anuria, patients who do not have access to fluids or who cannot respond to the physiologic sensation of thirst, patients with a history, signs or symptoms of significant liver impairment or injury, excluding uncomplicated polycystic liver disease, patients using strong CYP3A inhibitors, pregnancy, nursing women, patients with one of the following rare hereditary diseases: Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
- The most serious warning and precaution regarding idiosyncratic hepatic toxicity
- Other relevant warnings regarding dehydration, drug-drug interactions, hepatotoxicity, anaphylaxis, hypernatremia, hypokalemia, hyperuricemia, hypotension, serum sodium abnormalities, vasopressin analogues, and driving vehicles or operating machinery
- Conditions of clinical use, adverse reactions, dosing and monitoring
The Product Monograph is also available by calling
1-866-488-6017.
