JYNARQUE contains the active ingredient tolvaptan, which is a selective vasopressin V2-receptor antagonist. It is available in immediate release tablets for oral administration in 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg strengths. Key inactive ingredients include corn starch, lactose monohydrate, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Confusion or trouble speaking, unusual weakness or fatigue, pain or trouble swallowing, loss of balance or coordination, seizures
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High potassium level—muscle weakness, fast or irregular heartbeat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dry mouth
• Increase in amount of urine
• Increased thirst

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cannot feel if you are thirsty
• Dehydration
• History of substance use disorder
• Kidney disease
• Liver disease
• Malnutrition
• Prostate disease
• An unusual or allergic reaction to tolvaptan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Adagrasib
• Ceritinib
• Certain antibiotics, such as chloramphenicol, clarithromycin, dalfopristin; quinupristin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infection, such as ketoconazole, itraconazole, posaconazole, voriconazole
• Idelalisib
• Levoketoconazole
• Lonafarnib
• Mifepristone
• Nefazodone
• Ribociclib
• Tucatinib

This medication may also interact with the following:

• Certain medications for blood pressure, heart disease, irregular heartbeat
• Desmopressin
• Digoxin
• Diuretics
• Fluconazole
• Grapefruit juice
• Hypertonic saline
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

You may need blood work done while you are taking this medication.

What are the most serious risks of this medication?

This medicine increases sodium levels in your blood. If sodium rises too fast it can cause serious nerve damage. The nerve damage can lead to coma or death.

Treatment with this medicine should be started, or re-started, in a hospital.