TOLVAPTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, 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 is contraindicated in the following conditions: - Patients with autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS [see Warnings and Precautions (5.2)] - Unable to sense or respond to thirst - Hypovolemic hyponatremia - Taking strong CYP3A inhibitors [see Warnings and Precautions (5.5)] - Anuria - Hypersensitivity (e.g., anaphylactic shock

Product summary:

How Supplied Tolvaptan tablets are available in the following strengths and packages. Tolvaptan tablets 15 mg are non-scored, light blue to blue coloured, round shaped, uncoated tablets, debossed with "TOL" on one side and “15" on other side, may have mottled appearance. Bottles of 10                                               NDC 67877-635-02 Bottles of 100                                             NDC 67877-635-01 Carton of 10 (1 X 10 Unit-dose Tablets)     NDC 67877-635-33 Tolvaptan tablets 30 mg are non-scored, light blue to blue coloured, round shaped, uncoated tablets, debossed with "TOL" on one side and “30" on other side, may have mottled appearance. Bottles of 10                                              NDC 67877-636-02 Bottles of 100                                            NDC 67877-636-01 Carton of 10 (1 X 10 Unit-dose Tablets)    NDC 67877-636-33 Tolvaptan tablets 60 mg are non-scored, light blue to blue coloured, round shaped, uncoated tablets, debossed with "TOL" on one side and “60" on other side, may have mottled appearance. Bottles of 10                                              NDC 67877-637-02 Bottles of 100                                            NDC 67877-637-01 Carton of 10 (1 X 10 Unit-dose Tablets)    NDC 67877-637-33 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 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
Ascend Laboratories, LLC
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MEDICATION GUIDE
Tolvaptan Tablets (tol vap' tan)
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 thir

Summary of Product characteristics

TOLVAPTAN - TOLVAPTAN TABLET
ASCEND LABORATORIES, 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 TABLETS 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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5, 5.7) 04/2021
INDICATIONS AND USAGE
Tolvaptan tablets is a selective vasopressin V2-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 patie