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tolvaptan
generic
Black Box Warnings .
Appropriate Use
available for autosomal dominated polycystic kidney disease use only through restricted distribution program (Tolvaptan for ADPKD Shared System REMS) due to serious liver injury risk; prescribers, pharmacies, and patients must enroll at 1-866-244-9446 or www.TolvaptanADPKDSharedREMS.com; when used for hyponatremia, should be initiated and re-initiated only in hospital with serum Na monitoring
Serious Liver Injury and Monitoring Parameters
when used for autosomal dominated polycystic kidney disease, can cause serious and potentially fatal liver injury including acute liver failure requiring liver transplantation; monitor ALT, AST, bilirubin at baseline, 2wk and 4wk after tx start, then qmo x18mo, then q3mo; prompt action to lab abnormalities or hepatic injury signs/symptoms can mitigate but not eliminate serious hepatotoxicity risk
Monitor Serum Sodium
when used for hyponatremia, osmotic demyelination may occur with rapid correction of hyponatremia (>12 mEq/L/24h), resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death; slower rates of correction advised in patients with severe malnutrition, alcoholism or advanced liver disease
Adult Dosing .
Dosage forms: TAB: 15 mg, 30 mg; TAB (ADPKD pack): 15 mg x56; TAB (ADPKD pack): 30 mg x28 and 15 mg x28; TAB (ADPKD pack): 45 mg x28 and 15 mg x28; TAB (ADPKD pack): 60 mg x28 and 30 mg x28; TAB (ADPKD pack): 90 mg x28 and 30 mg x28
Restricted Distribution in US
- [1-866-244-9446 or www.TolvaptanADPKDSharedREMS.com for more info]
- Info: available for autosomal dominated polycystic kidney disease (ADPKD) use only through Tolvaptan for ADPKD Shared System REMS, due to serious liver injury risk
autosomal dominant polycystic kidney disease
- [60-120 mg/day PO divided bid]
- Start: 45 mg PO qam and 15 mg PO qpm, may incr. to 60 mg PO qam and 30 mg PO qpm, then to 90 mg PO qam and 30 mg PO qpm; Info: for slowing kidney function decline; give 1st dose in am, 2nd dose 8h later; may incr. dose no more frequently than qwk; avoid fluid restriction during tx
hyponatremia
- [15-60 mg PO qd]
- Start: 15 mg PO qd, may incr. dose no more frequently than q24h to 30 mg PO qd, then to 60 mg PO qd; Max: 60 mg/day; 30 days; Info: for hypervolemic and euvolemic hyponatremia, including patients with heart failure and SIADH; avoid fluid restriction during first 24h of tx
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl 10-30: not defined, caution advised; CrCl <10: avoid use; anuria: contraindicated
- HD/PD: not defined
hepatic dosing
- [autosomal dominant polycystic kidney disease]
- hepatic disease: contraindicated; Info: may use if uncomplicated polycystic liver disease
- [hyponatremia]
- hepatic disease: avoid use; Info: may use if uncomplicated polycystic liver disease
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.