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Jynarque Generic Name & Formulations
Legal Class
Rx
General Description
Tolvaptan 15mg, 30mg, 45mg, 60mg, 90mg; tabs.
Pharmacological Class
Selective vasopressin V2-receptor antagonist.
How Supplied
Tabs—14, 56
Manufacturer
Jynarque Indications
Indications
To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Jynarque Dosage and Administration
Adult
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.
Children
Not established.
Jynarque Contraindications
Contraindications
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.
Jynarque Boxed Warnings
Boxed Warning
Risk of serious liver injury.
Jynarque Warnings/Precautions
Warnings/Precautions
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.
REMS
Jynarque Pharmacokinetics
See Literature
Jynarque Interactions
Interactions
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).
Jynarque Adverse Reactions
Adverse Reactions
Thirst, polyuria, nocturia, pollakiuria, polydipsia; serious hepatic injury, hypernatremia, dehydration, hypovolemia.
Jynarque Clinical Trials
See Literature
Jynarque Note
Not Applicable
Jynarque Patient Counseling
See Literature
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