TOLVAPTAN (INHERITED KIDNEY DISEASE) - ORAL

TOLVAPTAN (INHERITED KIDNEY DISEASE) - ORAL

PHONETIC PRONUNCIATION: (tol-VAP-tan)

COMMON BRAND NAME(S): Jynarque

GENERIC NAME(S): tolvaptan

Uses

USES: This medication is used by people who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This inherited kidney problem leads to the growth of fluid-filled sacs (cysts) in your kidneys. Over time, the cysts grow in size, which can damage the way your kidneys work and lead to kidney failure. Tolvaptan belongs to a class of drugs known as vasopressin receptor antagonists. It works by slowing the growth of kidney cysts caused by ADPKD. This effect helps protect your kidneys from damage and failure. Different brands of this medication have different uses. Do not change brands of this medication unless directed by your doctor.


How to use TOLVAPTAN (INHERITED KIDNEY DISEASE) - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using tolvaptan and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually 2 times a day (once when you wake up and once 8 hours later). To prevent losing too much body water (dehydration), always have water ready to drink while taking tolvaptan. Drink water when you are thirsty and throughout the day and night if awake. Stop taking this medication and tell your doctor right away if you have vomiting or diarrhea, or if you cannot drink enough water for any reason. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Side Effects

SIDE EFFECTS: See also Warning section. Increased urination and thirst are common side effects. Dry mouth, loss of appetite, or upset stomach may also occur. If any of these effects bother you or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Loss of too much body water (dehydration) can occur. The risk is increased if you have vomiting or diarrhea that doesn't stop, and you cannot drink normally. Tell your doctor right away if you notice any symptoms of dehydration, such as fast heartbeat or dizziness/lightheadedness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking tolvaptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, gout, inability to make urine (anuria), abnormal sodium (salt) levels in the blood. To prevent loss of too much body water (dehydration) while taking this medication, you must be able to replace fluids by drinking. Before taking this medication, tell your doctor if you are not able to drink normally or if you cannot feel if you are thirsty. (See also How to Use section.) This drug may make you dizzy, especially if you are also taking medication(s) for high blood pressure. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: desmopressin. Other medications can affect the removal of tolvaptan from your body, which may affect how tolvaptan works. Examples include azole antifungals (such as ketoconazole, itraconazole), boceprevir, cobicistat, HIV protease inhibitors (such as lopinavir, ritonavir), macrolide antibiotics (such as clarithromycin, erythromycin), ribociclib, rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telaprevir, among others.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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OTSUKA 45 mg or 15 mg

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OTSUKA 45 mg or 15 mg

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OTSUKA 60 mg or 30 mg

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OTSUKA 60 mg or 30 mg

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OTSUKA 90 mg or 30 mg

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OTSUKA 90 mg or 30 mg

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Faq for TOLVAPTAN (INHERITED KIDNEY DISEASE) - ORAL

Tolvaptan is an oral medication used to treat autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys.

Tolvaptan works by blocking the effects of vasopressin hormone on the kidneys, which helps to reduce the accumulation of fluid in the cysts and slow down the progression of the disease.

The common side effects of Tolvaptan may include thirst, increased urination, dry mouth, weakness, dizziness, and constipation. However, it is essential to discuss any side effects with your doctor.

Tolvaptan is usually taken twice daily with food. It is essential to follow the dosage instructions provided by your doctor and not to exceed the recommended dose.

The effects of Tolvaptan may vary from person to person. It may take several weeks to several months before you notice any significant improvement in your symptoms. It is important to continue taking the medication as prescribed by your doctor.

Yes, Tolvaptan can cause an increase in liver enzyme levels, which may lead to liver problems. Regular monitoring of liver function is necessary during the treatment. It is also important to avoid excessive fluid intake while taking Tolvaptan to prevent dehydration.

Tolvaptan is not recommended during pregnancy or breastfeeding, as its safety in these conditions has not been established. It is important to discuss your pregnancy or breastfeeding plans with your doctor before starting Tolvaptan.

If you miss a dose of Tolvaptan, take it as soon as you remember. However, if it is close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

It is generally recommended to avoid alcohol while taking Tolvaptan, as it can increase the risk of liver damage or liver problems.


Warning

WARNING: Tolvaptan may rarely cause serious (possibly fatal) liver disease. Careful monitoring by your doctor may decrease your risk. Lab/medical tests (such as liver function, kidney function, uric acid/sodium/potassium blood levels) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the JYNARQUE REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.