tolvaptan (Jynarque)

Pronunciation: tol VAP tan (jin AR kew)

Brand: Jynarque

What is the most important information I should know about Jynarque?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

You should not use Jynarque if you have ever had liver problems (other than polycystic liver disease), or if you can't tell when you are thirsty, if you are dehydrated or unable to urinate, or if you have high or low levels of sodium in your blood.

Tolvaptan can cause serious or fatal liver problems. Call your doctor right away if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

You will need frequent medical tests before and during treatment with Jynarque.

What is Jynarque?

This medication guide provides information about the Jynarque brand of tolvaptan. Samsca is another brand of tolvaptan that is not covered in this medication guide.

Tolvaptan (Jynarque) is used to slow the decline in kidney function in adults who have autosomal dominant polycystic kidney disease.

Jynarque is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Jynarque may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Jynarque?

You should not use Jynarque if you are allergic to tolvaptan, or if:

  • you are unable to urinate;
  • you are unable to tell that you are thirsty;
  • you have high or low levels of sodium in your blood;
  • you are dehydrated; or
  • you have a history of liver problems (other than polycystic liver disease).

Some medicines can cause unwanted or dangerous effects when used with Jynarque. Your doctor may change your treatment plan if you also use:

  • nefazodone;
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole; or
  • antiviral medicine to treat HIV/AIDS --indinavir, nelfinavir, ritonavir, saquinavir.

Tell your doctor if you have ever had low sodium levels (hyponatremia).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breastfeed while using Jynarque.

How should I take Jynarque?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Jynarque is usually taken 2 times per day, once when you wake up and again 8 hours later. Follow your doctor's dosing instructions very carefully.

Drink plenty of fluids while taking Jynarque, but avoid grapefruit juice. Follow your doctor's instructions about the type and amount of liquids you should drink.

You will need frequent medical tests.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Jynarque, which can lead to serious side effects.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Jynarque?

Grapefruit may interact with tolvaptan and lead to unwanted side effects. Avoid the use of grapefruit products.

What are the possible side effects of Jynarque?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • weakness, confusion;
  • irregular heartbeats;
  • unexplained weight loss;
  • dehydration symptoms --feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
  • liver problems --right-sided upper stomach pain, vomiting, loss of appetite, fever, itching, yellowing of your skin or eyes, not feeling well.

Common side effects may include:

  • increased thirst; or
  • increased urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Jynarque?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Jynarque, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about tolvaptan (Jynarque).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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tolvaptan (Jynarque)