Tolvaptan Oral Tablets (Hyponatremia)

What is this medication?

TOLVAPTAN (tol VAP tan) is a diuretic. It helps you make more urine and to lose excess water from your body. It treats low sodium levels in the blood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): JYNARQUE, Samsca

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 alcohol abuse or addiction
• kidney disease
• liver disease
• malnutrition
• prostate disease
• an unusual or allergic reaction to tolvaptan, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine 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 health care provider tells you to stop.

Do not take this medicine 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 health care provider about the use of this drug 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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• ceritinib
• certain antibiotics like chloramphenicol, clarithromycin, dalfopristin; quinupristin, telithromycin
• certain antiviral medicines for HIV or AIDS like atazanavir, cobicistat, darunavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir
• certain medicines for fungal infection like ketoconazole, itraconazole, posaconazole, voriconazole
• conivaptan
• idelalisib
• lonafarnib
• mifepristone
• nefazodone
• ribociclib
• tucatinib

This medicine may also interact with the following medications:

• aprepitant
• certain antibiotics like erythromycin, rifampin, and rifapentine
• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cyclosporine
• desmopressin
• digoxin
• diuretics
• fluconazole
• grapefruit juice
• hypertonic saline
• St. John's Wort

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

Check with your health care provider 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 drug.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• liver injury (dark yellow or brown urine, general ill feeling or flu-like symptoms, loss of appetite, right upper belly pain, unusually weak or tired, yellowing of the eyes or skin, light-colored stool)
• too rapid of rise in levels of sodium in blood (confusion, extreme tiredness, mood changes, muscle weakness, seizures, trouble speaking, trouble swallowing, uncontrollable body movements)
• trouble passing urine

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

• constipation
• dry mouth

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.

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 medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.