Generic Name and Formulations:
Tolvaptan 15mg, 30mg, 45mg, 60mg, 90mg; tabs.
Otsuka America Pharmaceutical, Inc.
Indications for JYNARQUE:
To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Initially 60mg/day (45mg on waking + 15mg taken 8hrs later). Titrate to 60mg + 30mg, then to 90mg + 30mg per day if tolerated; separate titrations at least weekly. Concomitant moderate CYP3A inhibitors: reduce Jynarque dose (see full labeling); temporarily interrupt if recommended reduced doses are not available.
History, signs or symptoms of significant liver impairment or injury except uncomplicated polycystic liver disease. Concomitant strong CYP3A inhibitors. Uncorrected abnormal blood sodium concentrations or urinary outflow obstruction. Unable to sense or respond to thirst. Hypovolemia. Anuria.
Risk of serious liver injury.
Can cause serious and potentially fatal liver injury. Assess ALT/AST, bilirubin prior to treatment, at 2 and 4 weeks after initiation, then monthly for 18 months, and every 3 months thereafter. Discontinue immediately if signs/symptoms of hepatic injury occur, ALT/AST or bilirubin >2XULN; if resolves, may reinitiate (with more monitoring) if ALT/AST remains <3XULN. Do not restart if hepatic injury occurs or ALT/AST >3XULN. Ensure adequate hydration. Correct sodium concentration prior to initiation. Monitor for weight loss, tachycardia, hypotension. Suspend therapy until normalized if serum sodium increases above normal range, or hypovolemia or dehydration occurs and fluid intake cannot be increased. Elderly. Pregnancy. Nursing mothers: not recommended.
Selective vasopressin V2-receptor antagonist.
See Contraindications. Concomitant moderate CYP3A inhibitors: dose adjustment is needed (see Adult). Avoid concomitant grapefruit juice, strong CYP3A inducers, OATP1B1/3 and OAT3 substrates (eg, statins, bosentan, glyburide, nateglinide, repaglinide, methotrexate, furosemide), BCRP substrates (eg, rosuvastatin), and V2-receptor agonists (eg, desmopressin).
Thirst, polyuria, nocturia, pollakiuria, polydipsia; serious hepatic injury, hypernatremia, dehydration, hypovolemia.
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