Uses of Tolvaptan:

• It is used to slow the progress of kidney problems in some people.

What do I need to tell my doctor BEFORE I take Tolvaptan?

• If you have an allergy to tolvaptan or any other part of tolvaptan (jynarque/jinarc).
• If you are allergic to tolvaptan (jynarque/jinarc); any part of tolvaptan (jynarque/jinarc); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you cannot tell when you are thirsty or you are not able to drink normally.
• If you are dehydrated, talk with your doctor.
• If you have ever had liver problems.
• If you have trouble passing urine.
• If you are not able to pass urine.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with tolvaptan (jynarque/jinarc), like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with tolvaptan (jynarque/jinarc). Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with tolvaptan (jynarque/jinarc).
• If you have a high or low sodium level.
• If you have other types of kidney problems.
• If you are breast-feeding. Do not breast-feed while you take tolvaptan (jynarque/jinarc).

This is not a list of all drugs or health problems that interact with tolvaptan (jynarque/jinarc).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tolvaptan (jynarque/jinarc) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tolvaptan?

• Tell all of your health care providers that you take tolvaptan (jynarque/jinarc). This includes your doctors, nurses, pharmacists, and dentists.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Avoid grapefruit and grapefruit juice.
• If diarrhea happens or you are throwing up, call your doctor. You will need to drink more fluids to keep from losing too much fluid.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tolvaptan (jynarque/jinarc) while you are pregnant.

How is this medicine (Tolvaptan) best taken?

Use tolvaptan (jynarque/jinarc) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking tolvaptan (jynarque/jinarc) as you have been told by your doctor or other health care provider, even if you feel well.
• You will need to avoid getting dehydrated while taking tolvaptan (jynarque/jinarc). Drink lots of water to avoid getting thirsty. This includes drinking if you feel thirsty, drinking during the day, and drinking at night if you are awake unless your doctor says otherwise. If you are not sure how to avoid getting dehydrated, talk with your doctor.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Dizziness.
• Weight loss.
• Trouble walking.
• Fever.

What are some other side effects of Tolvaptan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• More thirst.
• Feeling tired or weak.
• Dry mouth.
• Passing urine more often.
• Upset stomach.
• Diarrhea.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tolvaptan?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time tolvaptan (jynarque/jinarc) is refilled. If you have any questions about tolvaptan (jynarque/jinarc), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What is the difference between Jynarque (tolvaptan) and Samsca (tolvaptan)?