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U.S. Department of Health and Human Services

Safety

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Samsca (tolvaptan) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

February 2014

Summary View

CONTRAINDICATIONS

4.6 Hypersensitivity…section added

ADVERSE REACTIONS

Postmarketing Experience
  • Immune System Disorders: Hypersensitivity reactions including anaphylactic shock and rash generalized [see Contraindications (4.6)].

MEDICATION GUIDE

Who should not take Samsca?, the following bullet was added:

  • you are allergic to tolvaptan or any of the ingredients in SAMSCA. See the end of this Medication Guide for a complete list of ingredients in SAMSCA.

 

May 2013

Summary View

MEDICATION GUIDE

'liver disease' term deleted from following text:

  • SAMSCA is a prescription medicine used to help increase low sodium levels in the blood, in adults with conditions such as heart failure and certain hormone imbalances. SAMSCA helps raise salt levels in your blood by removing extra body water as urine.It is not known if SAMSCA is safe or works in children.

 

 

April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Liver Injury - Samsca can cause serious and potentially fatal liver injury. In a placebo-controlled and open label extension study of chronically administered tolvaptan in patients with autosomal dominant polycystic kidney disease, cases of serious liver injury attributed to tolvaptan were observed…
 

ADVERSE REACTIONS

Clinical Trials Experience
  • Gastrointestinal bleeding in patients with cirrhosis - In patients with cirrhosis treated with Tolvaptan in the hyponatremia trials, gastrointestinal bleeding was reported in 6 out of 63 (10%) Tolvaptan-treated patients and 1 out of 57 (2%) placebo treated patients.
 

USE IN SPECIAL POPULATIONS

Use in Patients with Hepatic Impairment
  • Avoid use of tolvaptan in patients with underlying liver disease.
 

MEDICATION GUIDE

What is the most important information I should know about Samsca?
  • Samsca may cause liver problems, including life-threatening liver failure…

 

November 2012

Summary View

WARNINGS AND PRECAUTIONS

  • Osmotic demyelination syndrome has been reported in association with SAMSCA Therapy
Drug Interactions
  • As a V2 receptor antagonist, tolvaptan may interfere with the V2 agonist activity of desmopressin (dDAVP). In a male subject with mild Von Willebrand (vW) disease, intravenous infusion of dDAVP 2 hours after administration of oral tolvaptan did not produce the expected increases in vW Factor Antigen or Factor VIII activity. It is not recommended to administer SAMSCA with a V2 agonist.

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use of SAMSCA. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Neurologic: Osmotic demyelination syndrome
  • Investigations: Hypernatremia
  • Removal of excess free body water increases serum osmolality and serum sodium concentrations. All patients treated with tolvaptan, especially those whose serum sodium levels become normal, should continue to be monitored to ensure serum sodium remains within normal limits. If hypernatremia is observed, management may include dose decreases or interruption of tolvaptan treatment, combined with modification of freewater intake or infusion. During clinical trials of hyponatremic patients, hypernatremia was reported as an adverse event in 0.7% of patients receiving tolvaptan vs. 0.6% of patients receiving placebo; analysis of laboratory values demonstrated an incidence of hypernatremia of 1.7% in patients receiving tolvaptan vs. 0.8% in patients receiving placebo.

Medication Guide

What should I tell my healthcare provider before taking Samsca?

  • are taking desmopressin (dDAVP). 

 

 

 

February 2012 

Summary View

 

USE IN SPECIFIC POPULATIONS

  • No dose adjustment is necessary based on renal function. There are no clinical trial data in patients with CrCl < 10 mL/min, and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a CrCL <10 mL/min is not recommended. No benefit can be expected in patients who are anuric