Tolvaptan (tol-VAP-tan)

Treats hyponatremia (low sodium levels in the blood) and slows kidney function decline in patients who are at risk of autosomal dominant polycystic kidney disease (ADPKD).

Brand Name(s):

Jynarque, Jynarque 15/15, Jynarque 30/15, Jynarque 45/15, Jynarque 60/30, Jynarque 90/30, Samsca

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You need to start or restart this medicine while you are in the hospital. A nurse or other healthcare provider will monitor the sodium levels in your blood. This will allow your doctor to check if this medicine is working well and monitor any unwanted problems that may occur.
• This medicine might make you urinate more than usual, so you need to drink water whenever you feel thirsty to stay hydrated.
• This medicine is not for long-term use. Most people should not take this medicine for more than 30 days.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Jynarque™: If you miss a dose of this medicine, skip the missed dose, and go back to your regular dosing schedule.
  • Samsca®: If you miss a dose of this medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also taking clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, or telithromycin.
• Do not use this medicine together with hypertonic saline, unless your doctor tells you otherwise.
• Some medicines can affect how tolvaptan works. Tell your doctor if you are using any of the following:
  • Aprepitant, bosentan, carbamazepine, cyclosporine, desmopressin, digoxin, diltiazem, erythromycin, fluconazole, furosemide, glyburide, methotrexate, nateglinide, phenobarbital, phenytoin, repaglinide, rifabutin, rifampin, rifapentine, rosuvastatin, St John's wort
  • Blood pressure medicine (including benazepril, enalapril, lisinopril, verapamil)
  • Diuretic (water pill)
• Ask your doctor first before you use any medicine or salt substitute that contains potassium.
• Do not drink alcohol while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including cirrhosis), dehydration, or high potassium levels in the blood. Tell your doctor if you have trouble eating enough or might be malnourished. Also tell your doctor if you drink alcohol regularly.
• Do not breastfeed during treatment with Jynarque™.
• This medicine may cause the following problems:
  • Brain or nerve problems
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Tell your doctor if you stop taking this medicine. You may need to limit how much water and other beverages you drink. You should never start taking this medicine again on your own. You must do that in a hospital where your sodium levels can be tested.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, weakness, trouble breathing, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting or dizziness
• Feeling like something is stuck in your throat
• Seizures
• Trouble controlling body movement, weakness in the arms or legs
• Trouble talking or swallowing
• Urinating less or less often than normal, diarrhea

If you notice these less serious side effects, talk with your doctor:

• Constipation, loss of appetite
• Dry mouth
• Mild weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088