Tolvaptan (kidney disease)

WHY is this medicine prescribed?

Tolvaptan (Jynarque) is used to slow the worsening of kidney function in certain patients with autosomal dominant polycystic kidney disease (ADPKD; a certain type of inherited kidney disease). Tolvaptan (Jynarque) is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine and decreases the growth of cysts in the kidneys. Removing fluid from the body and slowing the growth of cysts helps to slow the worsening of kidney function.

Tolvaptan is also available as a tablet (Samsca) to treat low blood levels of sodium in people who have heart failure or certain other conditions. This monograph only gives information about tolvaptan tablets (Jynarque) to slow the worsening of kidney function in patients with ADPKD. If you are using this medication to treat low levels of sodium in the blood, read the monograph entitled tolvaptan (low blood sodium).

HOW should this medicine be used?

Tolvaptan (Jynarque) comes as a tablet to take by mouth. It is usually taken twice a day, one tablet in the morning and one tablet 8 hours later, with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tolvaptan (Jynarque) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of tolvaptan (Jynarque) and gradually increase your dose.

Your doctor may need to decrease your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking tolvaptan (Jynarque),

• tell your doctor and pharmacist if you are allergic to tolvaptan (Jynarque, Samsca), any other medications, or any of the ingredients in tolvaptan tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with tolvaptan. Other medications may cause dosing changes or extra monitoring when taken with tolvaptan. Make sure you have discussed any medications you are currently taking or plan to take before starting tolvaptan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking tolvaptan, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with tolvaptan: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking tolvaptan. Do not start this medication while taking tolvaptan without discussing with your healthcare provider.
• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, if you have or have ever had a high level of sodium in your blood, if you have difficulty urinating or are unable to urinate, if you have had severe vomiting or diarrhea or think you may be dehydrated, or if you are unable to notice that you are thirsty. Your doctor may tell you not to take tolvaptan (Jynarque).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tolvaptan (Jynarque), call your doctor. You should not breastfeed while you are taking tolvaptan (Jynarque).

What SPECIAL DIETARY instructions should I follow?

You will need to drink enough water while you are taking tolvaptan (Jynarque) so you do not become thirsty or dehydrated.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Tolvaptan (Jynarque) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• thirst
• dry mouth
• frequent, excessive urination
• heartburn
• decreased appetite

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• diarrhea
• inability to drink normally
• dizziness
• faintness
• decreased urination
• weakness
• drowsiness
• confusion
• weight loss
• rapid or pounding heartbeats
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• hives

Tolvaptan (Jynarque) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• excessive urination
• excessive thirst
• dizziness
• faintness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tolvaptan (Jynarque).

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2020.