TOLVAPTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOLVAPTAN (UNII: 21G72T1950) (TOLVAPTAN - UNII:21G72T1950)

Available from:

Novadoz Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use  Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.  It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. Tolvaptan tablets are contraindicated in the following conditions:   •  Patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS [seeWarnings and Precautions (5.2)]   •  Unable to sense or respond to thirst   •  Hypovolemic hyponatremia   •  Taking strong CYP3A inhibitors [seeWarnings and Precautions (5.5)]   •  Anuri

Product summary:

How Supplied Tolvaptan tablets are available in the following strengths and packages. Tolvaptan tablets 15 mg are light blue to blue colored, triangle, biconvex, uncoated tablets, debossed with “MT” on one side and “7” on other side, free from physical defects. Carton of 10 tablets (1 x 10 unit-dose)               NDC 72205-130-11 Tolvaptan tablets 30 mg are light blue to blue colored, round, biconvex, uncoated tablets, debossed with “MT” on one side and “8” on other side, free from physical defects. Carton of 10 tablets (1 x 10 unit-dose)               NDC 72205-131-11 Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOLVAPTAN - TOLVAPTAN TABLET
Novadoz Pharmaceuticals LLC
----------
MEDICATION GUIDE
Tolvaptan
(tol VAP tan)
Tablets
Read the Medication Guide that comes with tolvaptan tablets before you
take it and each time you get a
new prescription. There may be new information. This Medication Guide
does not take the place of
talking to your healthcare provider about your medical condition or
your treatment. Share this important
information with members of your household.
What is the most important information I should know about tolvaptan
tablets?
1) Tolvaptan tablets may make the salt (sodium) level in your blood
rise too fast. This can increase your
risk of a serious condition called osmotic demyelination syndrome
(ODS). ODS can lead to coma or
death. ODS can also cause new symptoms such as:
•
trouble speaking
•
swallowing trouble or feeling like food or liquid gets stuck while
swallowing
•
drowsiness
•
confusion
•
mood changes
•
trouble controlling body movement (involuntary movement) and weakness
in muscles of the arms
and legs
•
seizures
You or a family member should tell your healthcare provider right away
if you have any of these
symptoms even if they begin later in treatment. Also tell your
healthcare provider about any other new
symptoms while taking tolvaptan tablets.
You may be more at risk for ODS if you have:
•
liver disease
•
not eaten enough for a long period of time (malnourished)
•
very low sodium level in your blood
•
been drinking large amounts of alcohol for a long period of time
(chronic alcoholism)
To lessen your risk of ODS while taking tolvaptan tablets:
•
Treatment with tolvaptan tablets should be started and re-started only
in a hospital, where the
sodium levels in your blood can be checked closely.
•
Do not take tolvaptan tablets if you cannot tell if you are thirsty.
•
To prevent losing too much body water (dehydration), have water
available to drink at all times
while taking tolvaptan tablets. Unless your healthcare provider tells
you otherwise, drink when
you are th

Summary of Product characteristics

TOLVAPTAN - TOLVAPTAN TABLET
NOVADOZ PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOLVAPTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOLVAPTAN
TABLETS.
TOLVAPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM
SODIUM
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
(ADPKD)
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
(A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM
• TOLVAPTAN SHOULD BE INITIATED AND RE-INITIATED IN PATIENTS ONLY IN
A HOSPITAL WHERE
SERUM SODIUM CAN BE MONITORED CLOSELY.
• TOO RAPID CORRECTION OF HYPONATREMIA (E.G., >12 MEQ/L/24 HOURS)
CAN CAUSE OSMOTIC
DEMYELINATION RESULTING IN DYSARTHRIA, MUTISM, DYSPHAGIA, LETHARGY,
AFFECTIVE CHANGES,
SPASTIC QUADRIPARESIS, SEIZURES, COMA AND DEATH. IN SUSCEPTIBLE
PATIENTS, INCLUDING
THOSE WITH SEVERE MALNUTRITION, ALCOHOLISM OR ADVANCED LIVER DISEASE,
SLOWER RATES OF
CORRECTION MAY BE ADVISABLE.
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
(ADPKD)
• BECAUSE OF THE RISK OF HEPATOTOXICITY, TOLVAPTAN SHOULD NOT BE
USED FOR ADPKD
OUTSIDE OF THE FDA-APPROVED REMS (4)
INDICATIONS AND USAGE
Tolvaptan tablets are a selective vasopressin V -receptor antagonist
indicated for the treatment of
clinically significant hypervolemic and euvolemic hyponatremia [serum
sodium <125 mEq/L or less
marked hyponatremia that is symptomatic and has resisted correction
with fluid restriction], including
patients with heart failure and Syndrome of Inappropriate Antidiuretic
Hormone (SIADH) (1)
_Limitations of Use:_
Patients requiring intervention to raise serum sodium urgently to
prevent or to treat serious
neurological symptoms should not be treated with tolvaptan tablets (1)
It has not been established that tolvaptan tablets provides a
symptomatic benefit to patients (1)
DOSAGE AND ADMINISTRATION
Tolvaptan tablets should