What is Tolvaptan?

QUICK LINKS

• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH).

Sodium is a chemical that the body needs to be able to function well. If you have a low sodium blood level, your body will not function normally and you may not feel well. Tolvaptan works in the kidneys to help maintain the right amount of sodium for the body.

This medicine is available only with your doctor's prescription.

Proper UseTOP

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is important that you should take your first dose or restart your treatment with this medicine in a hospital. This will allow your doctor to check your response to this medicine and monitor any unwanted problems that may occur.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

This medicine is not for long-term use. You should not take this medicine for more than 30 days to lessen your risk of having liver injury.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For hyponatremia:
    • Adults—At first, 15 milligrams (mg) once a day. Your doctor will adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use & StorageTOP

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of tolvaptan in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tolvaptan in the elderly.

PregnancyTOP

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Delavirdine
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amobarbital
• Amprenavir
• Aprepitant
• Atazanavir
• Butabarbital
• Carbamazepine
• Ceritinib
• Crizotinib
• Digoxin
• Diltiazem
• Dronedarone
• Efavirenz
• Eliglustat
• Erythromycin
• Fluconazole
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Imatinib
• Letermovir
• Lumacaftor
• Modafinil
• Nevirapine
• Oxcarbazepine
• Pentobarbital
• Phenobarbital
• Phenytoin
• Pioglitazone
• Rifabutin
• Rifampin
• Rifapentine
• Secobarbital
• Simeprevir
• St John's Wort
• Verapamil
• Vincristine
• Vincristine Sulfate Liposome

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcoholism, chronic or
• Cirrhosis (a liver disease) or
• Liver disease, severe or
• Malnutrition (poor nutrition or undernourished condition)—May increase risk for more serious side effects.

• Anuria (not able to pass urine) or
• Hypovolemic hyponatremia (low blood sodium with low blood fluid) or
• Kidney disease, severe or
• Not able to sense or respond to thirst or
• Patients with sodium blood levels must be increased right away—Should not be used in patients with these conditions.

• Dehydration or
• Hyperkalemia (high potassium in the blood) or
• Hypovolemia (low blood volume) or
• Stomach or bowel bleeding—Use with caution. May make these conditions worse.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

You should not use tolvaptan together with clarithromycin (Biaxin®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone (Serzone®), nelfinavir (Viracept®), ritonavir (Norvir®), saquinavir (Fortovase®, Invirase®), or telithromycin (Ketek®). Using these medicines together may increase risk for more serious side effects.

Check with your doctor right away if you have drowsiness, confusion, mood changes, muscle weakness in the arms or legs, seizures (convulsions), or trouble with speaking, swallowing, or controlling body movements. These may be symptoms of a serious and rare condition called osmotic demyelination syndrome (ODS). This may occur if the sodium blood level rises too fast.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Certain medicines or illnesses, such as vomiting or diarrhea, may cause you to lose too much body water (dehydration). If you think you are dehydrated, tell your doctor right away. Always have water available to drink if you are thirsty, unless your doctor tells you otherwise.

Ask your doctor first before you use any medicine or salt substitutes that contain potassium.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit or grapefruit juice may increase the effects of tolvaptan in your body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.