tolvaptan
Jynarque (tolvaptan) is a vasopressin-2 (V2) receptor antagonist that helps protect kidney function in adults with autosomal dominant polycystic kidney disease (ADPKD) who are at risk of their condition worsening quickly. It comes as a tablet that's taken by mouth twice a day, with doses spaced 8 hours apart. Treatment starts with a low dose and is slowly raised based on how you respond. Common side effects include feeling thirsty and needing to urinate often. Because this medication can cause serious liver damage, it's only available through a Risk Evaluation and Mitigation Strategy (REMS) program to make sure it's used safely.
What is Jynarque (tolvaptan)?
What is Jynarque (tolvaptan) used for?
- Protect kidney function in people with autosomal dominant polycystic kidney disease (ADPKD) at risk of their condition worsening quickly
How Jynarque (tolvaptan) works
Jynarque (tolvaptan) is a vasopressin-2 (V2) receptor antagonist. It blocks vasopressin, a hormone in the body, from attaching to the V2 receptor. This helps prevent cysts from growing on the kidneys in people with ADPKD, which protects kidney function by slowing kidney damage.
Drug facts
Side effects of Jynarque (tolvaptan)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Frequent urination (70%)
- Feeling very thirsty (64%)
- Dry mouth (16%)
- Tiredness (14%)
- Diarrhea (13%)
- Dizziness (11%)
- Indigestion (8%)
- Poor appetite (7%)
- Feeling bloated (5%)
- Dry skin (5%)
Less Common Side Effects
- Rash
- High uric acid levels
- Palpitations
Jynarque (tolvaptan) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Liver damage: tiredness, loss of appetite, nausea, stomach pain, vomiting, fever, rash, itching, yellowing of the skin or eyes, dark urine
The following Jynarque (tolvaptan) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
- High sodium level—confusion, increased thirst, muscle weakness, unusual weakness or fatigue, twitching muscles
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dry mouth
- Increase in amount of urine
- Increased thirst
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Pros and cons of Jynarque (tolvaptan)
Pros
- The only FDA-approved ADPKD treatment option to slow kidney function decline
- Comes as a tablet that's taken by mouth
- Can be taken with or without food
Cons
- Must be taken twice a day
- Can make you urinate more often
- Need to get blood work done regularly to check your liver
Pharmacist tips for Jynarque (tolvaptan)
- Check the shape of your Jynarque (tolvaptan) tablet before taking it to make sure you have the right dose. The 15 mg tablet is triangle-shaped, 30 mg tablet is round, 45 mg tablet is square, 60 mg tablet is rectangular, and 90 mg tablet is shaped like a pentagons (five sides).
- You can take Jynarque (tolvaptan) with or without food. If it upsets your stomach, try taking it with food to help ease discomfort.
- If you miss your dose of Jynarque (tolvaptan), take your next dose at the usual time. Don't double up to make up for the missed dose.
- Avoid grapefruit or grapefruit juice while taking Jynarque (tolvaptan) because they interact. Taking them together can cause your body to absorb more medication which can raise your risk for side effects.
- Jynarque (tolvaptan) will make you thirsty and urinate more. Keep a water bottle nearby and drink water regularly to avoid dehydration. If you feel lightheaded, dizzy, or faint, rehydrate quickly. If these symptoms don't go away, get medical attention right away.
- You'll need regular blood tests while taking Jynarque (tolvaptan), such as liver tests and electrolyte levels. Mark your test dates on your calendar so you don’t miss them.
- Jynarque (tolvaptan) interacts with many prescription and over-the-counter medications. Tell your care team about all medications you're taking before starting Jynarque (tolvaptan). Don't start any new medications without checking with your prescriber first.
- The safety of Jynarque (tolvaptan) during pregnancy isn’t fully known. Studies in animals found no harm at normal doses, but higher doses led to fetal loss and development problems. Let your prescriber or OB-GYN provider know right away if you're pregnant or thinking of becoming pregnant while you're taking this medication.
- It's not recommended to breastfeed while you're taking Jynarque (tolvaptan) because it has the potential to cause serious side effects. Speak with your prescriber if you have questions about the risks and benefits of taking this medication while breastfeeding.
Common questions about Jynarque (tolvaptan)
It's not exactly known how long it takes for Jynarque (tolvaptan) to work, since it helps prevent ADPKD from getting worse. But studies show it takes several years to slow the growth of kidney cysts. Talk to your prescriber if you have concerns about how quickly this medication works.
There's no set time for how long you need to take Jynarque (tolvaptan) for. Your prescriber will have you continue taking the medication as long as it's helping prevent worsening of your ADPKD and you're not having any serious side effects. The medication was studied in people who took it for 5 years, with the most benefit seen in the first year. Talk to your prescriber if you have questions about how long you should take this medication.
Talk to your prescriber if it's safe to drink alcohol while taking Jynarque (tolvaptan). This medication can cause dehydration, and alcohol can make it worse. Drinking alcohol can also damage your kidney and liver.
No. Jynarque (tolvaptan) isn't a diuretic. But like diuretics, it works in the kidneys to prevent water from being absorbed back into your body, which causes you to urinate more. Unlike commonly-used diuretics, such as furosemide (Lasix) and hydrochlorothiazide, Jynarque (tolvaptan) isn't approved for high blood pressure or swelling.
Yes, tiredness can happen with Jynarque (tolvaptan) and might also be a sign of dehydration from the medication. If you're feeling overly tired and it's affecting your ability to go about your day, speak to your prescriber.
Jynarque (tolvaptan) isn't a weight-loss medication. But because it works in the kidney to make you urinate more, it's possible to experience weight loss from fluid loss, or dehydration. If you notice weight loss along with headache, low blood pressure, or feeling faint, rehydrate quickly by drinking fluids. If your symptoms don't improve, get medical help right away.
Don't cut Jynarque (tolvaptan) in half unless your healthcare team says it's safe to do so. The pills don't have a score line (line in the middle of the tablet to cut), making them hard to split evenly. This could lead to taking the wrong dose. If you have trouble swallowing the tablets whole, talk to your prescriber.
While both Jynarque and Samsca contain tolvaptan as the active ingredient, they are used for different conditions. Jynarque is taken twice a day for ADPKD and is only available through a REMS program. Samsca is taken once a day for low sodium levels and doesn't require a REMS program, but treatment must be started in a hospital for closer monitoring. One brand should never be taken in the place of the other due to important differences in how they are prescribed and monitored. Speak to your prescriber if you have questions comparing these two medications.
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Risks and warnings for Jynarque (tolvaptan)
Jynarque (tolvaptan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Liver damage
Jynarque (tolvaptan) can cause serious liver problems that can lead to liver failure or death. Because of this risk, Jynarque (tolvaptan) is available only through the Jynarque REMS program. You'll need to get regular blood tests done to make sure your liver is working properly. Make sure you keep track of your lab appointments. Get medical attention right away if you notice tiredness, loss of appetite, nausea, stomach pain, vomiting, fever, rash, itching, yellowing of the skin or eyes, dark urine. If this happens, you might need to stop using the medication to prevent further liver damage.
High sodium levels, dehydration, and low blood volume
Jynarque (tolvaptan) makes you urinate more, which can put you at risk for dehydration, low blood volume, and high sodium levels. To help prevent this, stay hydrated by drinking fluids regularly, especially when you feel thirsty. Before starting Jynarque (tolvaptan), your prescriber will check your sodium level to make sure you have enough body fluids. Your fluid level must stay in the normal range to continue taking this medication. If you experience dry mouth, weight loss, high heart rate, or low blood pressure (feeling dizzy, lightheaded, or faint), rehydrate quickly and contact your prescriber because these could be signs of dehydration.
Interactions with other medications
Some medications, such as itraconazole, Kaletra (lopinavir/ritonavir), ritonavir (Norvir), can raise Jynarque (tolvaptan) levels in your body. This can put you at higher risk for serious side effects, such as liver problems. If you're taking a medication that affects Jynarque (tolvaptan) levels, your prescriber might need to make changes to one or both of your medications. Before starting Jynarque (tolvaptan), tell your care team about all prescription and over-the-counter medications you're taking. Don't start any new medications without checking with your prescriber to make sure they're safe to take together.
Jynarque (tolvaptan) dosage
Typical dosage for Jynarque (tolvaptan)
The typical starting dose is 45 mg by mouth when you wake up and 15 mg about 8 hours later. Your prescriber might raise your dose based on how you respond. The maximum recommended dose is 90 mg in the morning and 30 mg 8 hours later.
Your dose might differ if you're taking certain medications that interact with Jynarque (tolvaptan).
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How much does Jynarque (tolvaptan) cost?
$5,183.27
Jynarque (tolvaptan) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Jynarque (tolvaptan) will not be safe for you to take.
- History or signs or symptoms of severe liver problems (except for uncomplicated polycystic liver disease)
- Taking certain medications that interact with Jynarque (tolvaptan) (strong CYP3A inhibitors)
- Uncorrected abnormal blood sodium levels
- Unable to sense or respond to thirst
- Low blood volume
- Lack of urination due to blockage
- Inability to make urine
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