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This medication guide provides information about the Jynarque brand of Jynarque. Samsca is another brand of tolvaptan that is not covered in this medication guide.
Jynarque (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 Jynarque.
Jynarque may also be used for purposes not listed in this medication guide.
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.
Jynarque 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.
You should not use Jynarque if you are allergic to Jynarque, 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 Jynarque will harm an unborn baby. Tell your doctor if you are pregnant.
You should not breastfeed while using 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.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Grapefruit may interact with Jynarque and lead to unwanted side effects. Avoid the use of grapefruit products.
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.
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.
Further informationRemember, 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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Jynarque (www.drugs.com/mtm/jynarque.html).
Note: This document contains side effect information about tolvaptan. Some of the dosage forms listed on this page may not apply to the brand name Jynarque.
In SummaryCommon side effects of Jynarque include: polyuria, increased thirst, pollakiuria, and xerostomia. Other side effects include: constipation, fever, hyperglycemia, increased serum alanine aminotransferase, and anorexia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to tolvaptan: oral tablet
Oral route (Tablet)
Samsca® should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too-rapid correction of hyponatremia (eg, greater than 12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death. Slower rates of correction may be advisable in susceptible patients (eg, those with severe malnutrition, alcoholism, or advanced liver disease).Samsca® Not For Use For Autosomal Dominant Polycystic Kidney Disease (ADPKD): Because of the risk of hepatoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS.
Oral route (Tablet)
Warning: Risk Of Serious Liver Injury:Jynarque(TM) (tolvaptan) 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(TM) is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Jynarque(TM) REMS Program.
Along with its needed effects, tolvaptan (the active ingredient contained in Jynarque) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking tolvaptan:
More common
Less common
Incidence not known
Some side effects of tolvaptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to tolvaptan: oral kit, oral tablet
CardiovascularCommon (1% to 10%): Intracardiac thrombus, ventricular fibrillation, orthostatic hypotension
GastrointestinalVery common (10% or more): Dry mouth (up to 13%), nausea
Common (1% to 10%): Constipation, ischemic colitis, gastrointestinal bleeding, diarrhea
GeneralThe most frequently reported side effects included thirst, dry mouth (up to 13%), asthenia, constipation, pollakiuria or polyuria and hyperglycemia.
GenitourinaryCommon (1% to 10%): Blood in urine
Uncommon (0.1% to 1%): Urethral hemorrhage, vaginal hemorrhage
HematologicCommon (1% to 10%): Prolonged prothrombin time, disseminated intravascular coagulation
MusculoskeletalCommon (1% to 10%): Rhabdomyolysis
Nervous systemCommon (1% to 10%): Cerebrovascular accident, syncope, dizziness, headache
Uncommon (0.1% to 1%): Dysgeusia
Postmarketing reports: Osmotic demyelination syndrome
RenalVery common (10% or more): Pollakiuria and polyuria (11%)
Uncommon (0.1% to 1%): Renal impairment
RespiratoryCommon (1% to 10%): Pulmonary embolism, respiratory failure
MetabolicCommon (1% to 10%): Hyperglycemia, anorexia, diabetic ketoacidosis, dehydration, hyperkalemia, decreased appetite, creatinine increased, hypernatremia, hypoglycemia, hyperuricemia
DermatologicCommon (1% to 10%): Ecchymosis, pruritus
Uncommon (0.1% to 1%): Pruritic rash
HepaticCommon: Alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin increased
HypersensitivityPostmarketing reports: Hypersensitivity reactions including anaphylactic shock and generalized rash
OtherVery common (10% or more): Thirst (up to 18%)
Common (1% to 10%): Asthenia, pyrexia, malaise
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Jynarque (www.drugs.com/mtm/jynarque.html).
March 31, 2021
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March 27, 2021
January 25, 2021
February 23, 2021
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