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Tolvaptan

Generic name: tolvaptan [ tol-VAP-tan ]
Brand names: Jynarque, Samsca, Jynarque 45 mg + 15 mg, Jynarque 60 mg + 30 mg, Jynarque 90 mg + 30 mg
Dosage form: oral tablet (15 mg; 30 mg; 45 mg-15 mg; 60 mg-30 mg; 90 mg-30 mg)
Drug class: Vasopressin antagonists

Medically reviewed by Drugs.com on Dec 12, 2023. Written by Cerner Multum.

What is tolvaptan?

Jynarque is used to slow the decline in kidney function in adults who have autosomal dominant polycystic kidney disease.

Jynarque is available only under a special program. You must be registered in the program and understand the risks and benefits of tolvaptan.

Samsca is used to treat adults with hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances.

Tolvaptan may also be used for purposes not listed in this medication guide.

Tolvaptan side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tolvaptan may cause serious side effects. Call your doctor at once if you have:

Samsca is given to treat low levels of sodium in your blood, but can be dangerous if your sodium level rises too fast. Tell your doctor or caregivers at once if you have any of these signs that your hyponatremia is being reversed too quickly:

Common side effects of tolvaptan may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Samsca is given to treat low levels of sodium in your blood, but can be dangerous if this condition is reversed too quickly. Tell your caregivers at once if you have problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, confusion, or seizure.

Tolvaptan can cause serious or fatal liver problems. Call your doctor right away if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not take tolvaptan if you are allergic to it, or if:

Samsca is not for use in people with autosomal dominant polycystic kidney disease (unless you receive Samsca through a special program that includes frequent liver function tests).

You should not take Samsca if your sodium level needs to be increased quickly.

You should not take Jynarque if you have been told that your sodium blood level is too high or too low, or if you have liver problems, excluding polycystic liver disease.

Some drugs should not be used with Samsca. Your treatment plan may change if you also use:

Tell your doctor if you have or have ever had:

It is not known if tolvaptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

How should I take tolvaptan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Drink plenty of fluids while taking tolvaptan, but do not drink grapefruit juice or alcoholic drinks.

You may take tolvaptan with or without food.

Samsca is usually taken once per day and Jynarque is taken twice per day. You should not use Samsca for longer than 30 days. Follow your doctor's dosing instructions very carefully.

You will need to be under observation in a hospital any time you start or restart treatment with Samsca, to quickly treat any serious side effects. If you stop taking Samsca for any length of time, do not start taking it again at home.

You can easily become dehydrated while taking tolvaptan, which can lead to serious side effects. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Tolvaptan dosing information

Usual Adult Dose for Hyponatremia:

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days
Comments:
-During initiation and titration, frequently monitor for changes in serum electrolytes and volume.
-Avoid fluid restriction during the first 24 hours of therapy.
-Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst.
-Tolvaptan may be dosed without regard to meals.

Uses: Hypervolemic and euvolemic hyponatremia [serum sodium less than 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)

Usual Adult Dose for Hyponatremia, euvolemic:

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days
Comments:
-During initiation and titration, frequently monitor for changes in serum electrolytes and volume.
-Avoid fluid restriction during the first 24 hours of therapy.
-Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst.
-Tolvaptan may be dosed without regard to meals.

Uses: Hypervolemic and euvolemic hyponatremia [serum sodium less than 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)

What happens if I miss a dose?

Samsca: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

Jynarque: Skip the missed dose and use your next dose at the regular time.

Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tolvaptan?

Avoid drinking alcohol.

Grapefruit may interact with tolvaptan and cause side effects. Avoid consuming grapefruit products.

What other drugs will affect tolvaptan?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect tolvaptan, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Frequently asked questions

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.