Jynarque

Jynarque is used to slow down the loss of kidney function in adults with autosomal dominant polycystic kidney disease.

Jynarque is available only through a special program. You need to be registered in the program and understand the risks and benefits of Jynarque.

Samsca is used to treat adults with hyponatremia (low sodium levels in your blood) in people with heart failure and certain hormonal imbalances.

Jynarque may also be used for reasons not mentioned in this medication guide.

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

Drink plenty of fluids while taking Jynarque, but do not drink grapefruit juice or alcoholic drinks.

You may take Jynarque with or without food.

Samsca is usually taken once per day and Jynarque is taken twice per day. You should not use Samsca for longer than 30 days. Follow your doctor's dosing instructions very carefully.

You will need to be under observation in a hospital any time you start or restart treatment with Samsca, to quickly treat any serious side effects. If you stop taking Samsca for any length of time, do not start taking it again at home.

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

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

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

Samsca is used to treat low sodium levels in your blood, but it can be dangerous if this condition is fixed too quickly. Inform your caregivers immediately if you experience problems with speech or muscle control, difficulty swallowing, trouble moving your arms and legs, confusion, or seizures.

Jynarque can lead to serious or life-threatening liver issues. Contact your doctor right away if you feel unwell and have pain in the upper right side of your stomach, vomiting, loss of appetite, or yellowing of your skin or eyes.

You should not take Jynarque if you are allergic to it, or if:

• you are unable to urinate;
• you cannot tell when you are thirsty; or
• you are severely dehydrated and feel like you might faint.

Samsca is not for use in people with autosomal dominant polycystic kidney disease (unless you receive Samsca through a special program that includes regular liver function tests).

You should not take Samsca if your sodium level needs to be raised quickly.

You should not take Jynarque if you have been told that your sodium blood level is too high or too low, or if you have liver problems, except for polycystic liver disease.

Some medications should not be used with Samsca. Your treatment plan may change if you also use:

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

Tell your doctor if you have or have ever had:

• any allergies;
• if you drink large amounts of alcohol;
• if you are malnourished (if you are taking Samsca);
• if you also use desmopressin (dDAVP), or a diuretic or "water pill";
• liver problems; or
• kidney disease or urination problems.

It is not known if Jynarque will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

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

Jynarque may cause serious side effects. Contact your doctor immediately if you experience:

• weakness, or feeling light-headed (like you might faint);
• irregular heartbeats;
• weight loss;
• dehydration—dizziness, confusion, feeling very thirsty, urinating less; or
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Samsca is used to treat low sodium levels in your blood, but it can be dangerous if your sodium level increases too quickly. Inform your doctor or caregivers right away if you have any of these signs that your hyponatremia is improving too quickly:

• difficulties with speech or muscle control;
• trouble swallowing;
• difficulty moving your arms and legs;
• drowsiness, confusion, mood changes; or
• a seizure.

Common side effects of Jynarque may include:

• dry mouth;
• increased thirst or urination;
• hunger, fruity breath odor;
• constipation; or
• weakness.

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

Samsca: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

Jynarque: Skip the missed dose and use your next dose at the regular time.

• Do not use two doses at one time.

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

Avoid drinking alcohol.

Grapefruit may interact with Jynarque and cause side effects. Avoid consuming grapefruit products.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medicines work less effectively.

Many drugs can affect Jynarque, and some drugs should not be used together. Tell your doctor about all other medicines you are taking. This includes prescription and over-the-counter medicines, vitamins, and Herbal products. Not all possible interactions are listed here.

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