Jynarque

Jynarque is a prescription medication used to prevent worsening of kidney function in patients with autosomal dominant polycystic kidney disease (ADPKD) who are at risk for rapid decline. Jynarque belongs to a group of drugs called vasopressin 2 receptor antagonists, which work to block the action of vasopressin and slow the growth of cysts in the kidney.

This medication comes in tablet form and is taken 2 times per day: once upon waking and once 8 hours later.

Common side effects of Jynarque include increased urination, thirst, and dry mouth. Jynarque can also cause drowsiness. Do not drive or operate heavy machinery until you know how Jynarque affects you.

Jynarque is a prescription medication used to prevent worsening of kidney functions in patients with ADPKD who are at risk for rapid decline.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Jynarque. See the “Jynarque Precautions” section.

Common side effects of Jynarque include the following:

• increased urination
• thirst
• dry mouth
• feeling tired
• diarrhea
• dizziness
• indigestion
• decreased appetite

This is not a complete list of Jynarque side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that get transported from the bloodstream into cells by OATP molecules to get metabolized, such as
  • atorvastatin (Lipitor)
  • bilirubin
  • digoxin (Lanoxin)
  • empagliflozin (Jardiance)
  • ezetimibe (Zetia)
  • fexofenadine (Allegra)
  • fluvastatin (Lescol)
  • glyburide (DiaBeta)
  • lovastatin (Mevacor)
  • methotrexate (Rheumatrex)
  • olmesartan (Benicar)
  • pitavastatin (Livalo)
  • pravastatin (Pravachol)
  • repaglinide (Prandin)
  • rifampin
  • rosuvastatin (Crestor)
  • simvastatin (Zocor)
  • levothyroxine (Synthroid)
  • telmisartan (Micardis)
  • valsartan (Diovan)
• medications that use an enzyme called BCRP, such as rosuvastatin (Crestor)
• desmopressin

This is not a complete list of Jynarque drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Jynarque including the following:

• Liver injury. Tell your healthcare provider right away if you have some or all of the following symptoms of liver injury:
  • feeling tired
  • loss of appetite
  • nausea
  • right upper stomach pain or tenderness
  • vomiting
  • fever
  • rash
  • itching
  • dark urine
  • jaundice (yellowing of the skin or white part of the eyes)

Jynarque can cause drowsiness. Do not drive or operate heavy machinery until you know how Jynarque affects you.

Do not take Jynarque if you:

• are allergic to Jynarque or to any of its ingredients
• have a history of liver problems or have signs or symptoms of liver problems, excluding polycystic liver disease
• have been told that the amount of sodium (salt) in your blood is too high or too low
• are dehydrated
• cannot feel if you are thirsty or cannot replace fluids by drinking
• are unable to urinate

Grapefruit and grapefruit juice may interact with Jynarque and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Jynarque, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Jynarque or to any of its ingredients
• have liver problems
• have a history of sodium levels that are too low
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Jynarque. In animal studies, some babies were born with problems when pregnant animals were given larger than normal doses. Your doctor will determine if the benefits of taking Jynarque outweigh the risks.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jynarque crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jynarque.

Take Jynarque exactly as prescribed.

Jynarque comes in tablet form and is taken twice every day. The first dose should be taken when you wake up, and the second dose should be taken 8 hours later.

Be sure to drink plenty of water while taking Jynarque to be sure you do not get thirsty or become dehydrated.

Do not drink grapefruit juice while taking Jynarque, as it could cause you to have too much Jyranrque in your blood.

If you miss a dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Jynarque at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication

Your doctor will increase or decrease your dosage regimen of Jynarque over time depending on your response. You will take a higher dose of Jynarque upon waking followed by a lower dose 8 hours later.

If you take too much Jynarque, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Jynarque at room temperature.

Keep this and all medicines out of the reach of children.

WARNING: RISK OF SERIOUS LIVER INJURY

Jynarque can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported.

Measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter. Prompt action in response to laboratory abnormalities, signs, or symptoms indicative of hepatic injury can mitigate, but not eliminate, the risk of serious hepatotoxicity.

Because of the risks of serious liver injury, Jynarque is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Jynarque REMS Program.