Tolvaptan

tablets
15 mg / 30 mg / 45 mg / 60 mg / 90 mg
Therapeutic equivalent of JYNARQUE®†

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing tolvaptan prescription with a copay savings card.

Restrictions and eligibility requirements apply. See Terms and Conditions below for full details.

Download copay savings card
for tolvaptan tablets
15 mg / 30 mg / 45 mg / 60 mg / 90 mg

Tolvaptan

tablets
15 mg / 30 mg / 45 mg / 60 mg / 90 mg
Therapeutic equivalent of JYNARQUE®†

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing tolvaptan prescription with a copay savings card.

Download copay savings card
for tolvaptan tablets
15 mg / 30 mg / 45 mg / 60 mg / 90 mg

Restrictions and eligibility requirements apply.
See Terms and Conditions below for full details.

Full prescribing information including boxed warning and medication guide set forth below or in links:

Tolvaptan tablets 15 mg / 30 mg / 45 mg / 60 mg / 90 mg

Full prescribing information including boxed warning and medication guide set forth below or in links:

Tolvaptan tablets 15 mg / 30 mg / 45 mg / 60 mg / 90 mg

Because of the risk of serious liver problems tolvaptan tablets are only available through a restricted distribution program called the Tolvaptan for ADPKD Shared System REMS (Risk Evaluation and Mitigation Strategy) Program.

About the Tolvaptan for ADPKD Shared System REMS Program

  • Before you start treatment with tolvaptan tablets, you must enroll in the Tolvaptan for ADPKD Shared System REMS Program. Talk to your healthcare provider about how to enroll in the program.
  • Tolvaptan tablets can only be dispensed by a certified pharmacy that participates in the Tolvaptan for ADPKD Shared System REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.
  • For information about the Tolvaptan for ADPKD Shared System REMS program, call toll free at 1-866-244-9446 or visit www.tolvaptanadpkdsharedrems.com

Using your tolvaptan copay savings card is simple:

  1. Download or print the copay savings card and present it at the pharmacy. Visit www.tolvaptancopay.com or call toll free at 844-586-7849 if you need assistance or more information on how to use the card.
  2. Ensure that your prescription is being filled with tolvaptan tablets manufactured and distributed by Apotex to access savings under the program.

By participating in the Apotex copay savings program for tolvaptan tablets, you agree to abide by the Terms and Conditions below:

  • You may not use the Apotex copay savings program if you have prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program, or other federal or state healthcare programs including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as "La Reforma de Salud").
  • You may not use the Apotex copay savings program if you are uninsured or have no prescription drug coverage for tolvaptan tablets.
  • The Apotex copay savings program is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs (i.e. you have no cost-sharing obligation).
  • Offer not available for residents of California or Massachusetts or where prohibited by law.
  • This offer is good only in the U.S. and Puerto Rico.
  • You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • If eligible, commercially insured patients may pay as little as $0* out-of-pocket cost with the tolvaptan copay savings card toward each fill, and the program will pay up to $400 per 30-day supply of the remaining cost after primary insurance coverage, up to $4,800 per calendar year.
  • The Apotex copay savings program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Apotex copay savings program will be accepted only at participating pharmacies.
  • The Apotex copay savings program is not health insurance.
  • Apotex reserves the right, at its sole discretion, to amend, to rescind, revoke, or terminate the offer at any time.
  • There are no membership fees for this savings program.
  • If you receive co-payment assistance under the Apotex copay savings program, your personal information will be used to process payment for your prescription under such program through an Apotex vendor.
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about tolvaptan tablets?

Tolvaptan tablets can cause serious side effects, including:

Serious liver problems. Tolvaptan tablets can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Stop taking tolvaptan tablets and call your healthcare provider right away if you get any of the following symptoms:

  • feeling tired
  • loss of appetite
  • nausea
  • right upper stomach (abdomen) pain or tenderness

What are tolvaptan tablets?

  • Tolvaptan tablets are prescription medicine used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

It is not known if tolvaptan tablets are safe and effective in children.

 
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about tolvaptan tablets?

Tolvaptan tablets can cause serious side effects, including:

Serious liver problems. Tolvaptan tablets can cause serious liver problems that can lead to the need for a liver transplant or can lead to death. Stop taking tolvaptan tablets and call your healthcare provider right away if you get any of the following symptoms:

  • feeling tired
  • loss of appetite
  • nausea
  • right upper stomach (abdomen) pain or tenderness
  • vomiting
  • fever
  • rash
  • yellowing of the skin and white part of the eye (jaundice)
  • dark urine

To help reduce your risk of liver problems, your healthcare provider will do a blood test to check your liver:

  • before you start taking tolvaptan tablets
  • at 2 weeks and 4 weeks after you start treatment with tolvaptan tablets
  • then monthly for 18 months during treatment with tolvaptan tablets
  • and every 3 months from then on

It is important to stay under the care of your healthcare provider during treatment with tolvaptan tablets.

Because of the risk of serious liver problems tolvaptan tablets are only available through a restricted distribution program called the Tolvaptan for ADPKD Shared System REMS Program.

  • Before you start treatment with tolvaptan tablets, you must enroll in the Tolvaptan for ADPKD Shared System REMS Program. Talk to your healthcare provider about how to enroll in the program.
  • Tolvaptan tablets can only be dispensed by a certified pharmacy that participates in the Tolvaptan for ADPKD Shared System REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy.

Do not take tolvaptan tablets if you:

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

Tell your healthcare provider about all your medical conditions, including if you:

  • have a history of sodium (salt) levels that are too low.
  • are pregnant or plan to become pregnant. It is not known if tolvaptan will harm your unborn baby. Tell your healthcare provider if you become pregnant or think that you may be pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if tolvaptan passes into your breast milk. Do not breastfeed during your treatment with tolvaptan tablets. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

  • Taking tolvaptan tablets with certain medicines could cause you to have too much tolvaptan in your blood. Tolvaptan tablets should not be taken with certain medications. Your healthcare provider can tell you if it is safe to take tolvaptan tablets with other medicines.
  • Do not start taking a new medicine without talking to your healthcare provider.

Tolvaptan tablets may cause serious side effects, including:

  • Too much sodium in your blood (hypernatremia) and loss of too much body fluid (dehydration). In some cases, dehydration can lead to extreme loss of body fluid called hypovolemia. You should drink water when you are thirsty and throughout the day and night. Stop taking tolvaptan tablets and call your healthcare provider if you cannot drink enough water for any reason, such as not having access to water, or vomiting or diarrhea. Tell your healthcare provider if you get any of the following symptoms:
    • dizziness
    • fainting
    • weight loss
    • a change in the way your heart beats
    • feeling confused or weak

What should you avoid while taking tolvaptan tablets?

Do not drink grapefruit juice during treatment with tolvaptan tablets. This could cause you to have too much tolvaptan in your blood.

The most common side effects of tolvaptan tablets are:

  • thirst and increased fluid intake.
  • making large amounts of urine, urinating often, and urinating at night.

These are not all the possible side effects of tolvaptan. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for tolvaptan tablets.

What are tolvaptan tablets?

  • Tolvaptan tablets are prescription medicine used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

It is not known if tolvaptan tablets are safe and effective in children.