Resources for your patients and your practice

Prescription Process

Follow these steps to complete a prescription for JYNARQUE™ (tolvaptan)

JYNARQUE PRESCRIPTION PROCESS

1. Getting ready to treat

1. GETTING READY TO TREAT WITH JYNARQUE

Complete these one-time steps to set up your practice for prescribing JYNARQUE

Enroll in the JYNARQUE REMS Program

Prescribers enroll and certify in the JYNARQUE REMS Program

Create labs account

Establish an account for your practice with either Quest or LabCorp to facilitate compliance with REMS for your patients treated with JYNARQUE, making tests available at no cost

2. Preparing for your patient's visit

2. PREPARING FOR YOUR PATIENT'S VISIT

Once you're set up to prescribe JYNARQUE, you can begin the prescription process with your patients

Order baseline hepatic tests

Baseline liver testing is required prior to enrolling a patient in the JYNARQUE REMS program

Enroll patients in the JYNARQUE REMS Program

Prepare the REMS Patient Enrollment Form for your patient to sign by completing the HCP section first, either online at JYNARQUErems.com or by downloading a paper copy that can be submitted by fax

3. Counseling your patient

3. COUNSELING YOUR PATIENT

When your patient comes in for their appointment, you'll need to talk with them about the benefits and risks of treatment with JYNARQUE, including possible adverse events. At this point your patients must sign the REMS Patient Enrollment Form

Share patient education materials

A number of helpful resources—including the JYNARQUE REMS Patient Guide, a JYNARQUE Patient Brochure, and a JYNARQUE Getting Started Guide—are available for you to download and share with your patients

Obtain your patient's signature on the Patient Consent Form to enroll in MyPASS™

My Personalized ADPKD Support Service (MyPASS) is offered by Otsuka to help patients throughout their treatment with JYNARQUE. Completed paper forms should be sent with the Prescription Referral Form to the preferred REMS-certified Specialty Pharmacy (see next step below)

4. Prescribing JYNARQUE

4. PRESCRIBING JYNARQUE

JYNARQUE is exclusively available through 3 REMS-certified pharmacies: AllianceRx, Avella™, and PANTHERx®

Submit Prescription

E-prescribe or fax a completed Prescription Referral Form to one of the preferred REMS-certified Specialty Pharmacies

More Access Resources

MORE ACCESS RESOURCES

Additional Resources

Additional Resources

Disease progression

Disease Progression

Learn about the methods and importance of imaging kidneys in patients with ADPKD

FDA guidance

FDA Guidance

In 2016 the FDA provided a recommendation for the use of total kidney volume (TKV) as a prognostic enrichment biomarker to select patients with ADPKD at a high risk of progressive decline in renal function for inclusion in interventional clinical trials1

Medscape

Medscape

Learn more about ADPKD at Medscape, a leading online destination for physicians and healthcare professionals worldwide

ADPKD
=autosomal dominant polycystic kidney disease.

 

*

Assumes one 28-day supply prescription per month. If more than one prescription is filled in a calendar month, patient may pay more than $10 in that month. Offer is not transferable. Patients are not eligible if they are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE. Only valid in US and Puerto Rico. Offer void where prohibited by law, taxed or restricted. Other restrictions may apply. This program is not health insurance. Otsuka America Pharmaceutical, Inc. has the right to rescind, revoke or amend this program at any time without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage and that you will report the value received if required by your insurance provider. When you use this program, you are certifying that you understand and comply with the program rules, terms and conditions.

JYNARQUE Copay Savings Information

IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE (tolvaptan)

IMPORTANT SAFETY INFORMATION:

WARNING: RISK OF SERIOUS
LIVER INJURY

WARNING: RISK OF SERIOUS LIVER INJURY

  • JYNARQUE (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported
  • Measure transaminases (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 Risk Evaluation and Mitigation Strategy program called the JYNARQUE REMS Program

CONTRAINDICATIONS:

  • History, signs or symptoms of significant liver impairment or injury. This contraindication does not apply to uncomplicated polycystic liver disease
  • Taking strong CYP3A inhibitors
  • With uncorrected abnormal blood sodium concentrations
  • Unable to sense or respond to thirst
  • Hypovolemia
  • Hypersensitivity (e.g., anaphylaxis, rash) to JYNARQUE or any component of the product
  • Uncorrected urinary outflow obstruction
  • Anuria

Serious Liver Injury: JYNARQUE can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. To reduce the risk of significant or irreversible liver injury, assess ALT, AST and bilirubin prior to initiating JYNARQUE, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter.

Hypernatremia, Dehydration and Hypovolemia: JYNARQUE therapy increases free water clearance which can lead to dehydration, hypovolemia and hypernatremia. Instruct patients to drink water when thirsty, and throughout the day and night if awake. Monitor for weight loss, tachycardia and hypotension because they may signal dehydration. Ensure abnormalities in sodium concentrations are corrected before initiating therapy. If serum sodium increases above normal or the patient becomes hypovolemic or dehydrated and fluid intake cannot be increased, suspend JYNARQUE until serum sodium, hydration status and volume status parameters are within the normal range.

Inhibitors of CYP3A: Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure. Use with strong CYP3A inhibitors is contraindicated; dose reduction of JYNARQUE is recommended for patients taking moderate CYP3A inhibitors. Patients should avoid grapefruit juice beverages while taking JYNARQUE.

Adverse Reactions: Most common observed adverse reactions with JYNARQUE (incidence >10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia.

Other Drug Interactions:

  • Strong CYP3A Inducers: Co-administration with strong CYP3A inducers reduces exposure to JYNARQUE. Avoid concomitant use of JYNARQUE with strong CYP3A inducers
  • OATP1B1/3 and OAT3 Transporter Substrates: Patients who take JYNARQUE should avoid concomitant use with OATP1B1/B3 and OAT3 substrates (e.g., statins, bosentan, glyburide, nateglinide, repaglinide, methotrexate, furosemide), as the plasma concentrations of these substrates may be increased.
  • BCRP Transporter Substrates: Tolvaptan is an inhibitor of BCRP. Patients who take JYNARQUE, should avoid concomitant use with BCRP substrates (e.g., rosuvastatin)
  • V2-Receptor Agonist: Tolvaptan interferes with the V2-agonist activity of desmopressin (dDAVP). Avoid concomitant use of JYNARQUE with a V2-agonist.

Pregnancy and Lactation: Based on animal data, JYNARQUE may cause fetal harm. In general, JYNARQUE should be discontinued during pregnancy. Advise women not to breastfeed during treatment with JYNARQUE.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION:

JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

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IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE (tolvaptan)
IMPORTANT SAFETY INFORMATION and INDICATION for JYNARQUE (tolvaptan)

IMPORTANT SAFETY INFORMATION:

WARNING: RISK OF SERIOUS
LIVER INJURY

WARNING: RISK OF SERIOUS LIVER INJURY

  • JYNARQUE (tolvaptan) can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported
  • Measure transaminases (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 Risk Evaluation and Mitigation Strategy program called the JYNARQUE REMS Program

CONTRAINDICATIONS:

  • History, signs or symptoms of significant liver impairment or injury. This contraindication does not apply to uncomplicated polycystic liver disease
  • Taking strong CYP3A inhibitors
  • With uncorrected abnormal blood sodium concentrations
  • Unable to sense or respond to thirst
  • Hypovolemia
  • Hypersensitivity (e.g., anaphylaxis, rash) to JYNARQUE or any component of the product
  • Uncorrected urinary outflow obstruction
  • Anuria

Serious Liver Injury: JYNARQUE can cause serious and potentially fatal liver injury. Acute liver failure requiring liver transplantation has been reported in the post-marketing ADPKD experience. Discontinuation in response to laboratory abnormalities or signs or symptoms of liver injury (such as fatigue, anorexia, nausea, right upper abdominal discomfort, vomiting, fever, rash, pruritus, icterus, dark urine or jaundice) can reduce the risk of severe hepatotoxicity. To reduce the risk of significant or irreversible liver injury, assess ALT, AST and bilirubin prior to initiating JYNARQUE, at 2 weeks and 4 weeks after initiation, then monthly for 18 months and every 3 months thereafter.

Hypernatremia, Dehydration and Hypovolemia: JYNARQUE therapy increases free water clearance which can lead to dehydration, hypovolemia and hypernatremia. Instruct patients to drink water when thirsty, and throughout the day and night if awake. Monitor for weight loss, tachycardia and hypotension because they may signal dehydration. Ensure abnormalities in sodium concentrations are corrected before initiating therapy. If serum sodium increases above normal or the patient becomes hypovolemic or dehydrated and fluid intake cannot be increased, suspend JYNARQUE until serum sodium, hydration status and volume status parameters are within the normal range.

Inhibitors of CYP3A: Concomitant use of JYNARQUE with drugs that are moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, indinavir/ritonavir, ritonavir, and conivaptan) increases tolvaptan exposure. Use with strong CYP3A inhibitors is contraindicated; dose reduction of JYNARQUE is recommended for patients taking moderate CYP3A inhibitors. Patients should avoid grapefruit juice beverages while taking JYNARQUE.

Adverse Reactions: Most common observed adverse reactions with JYNARQUE (incidence >10% and at least twice that for placebo) were thirst, polyuria, nocturia, pollakiuria and polydipsia.

Other Drug Interactions:

  • Strong CYP3A Inducers: Co-administration with strong CYP3A inducers reduces exposure to JYNARQUE. Avoid concomitant use of JYNARQUE with strong CYP3A inducers
  • OATP1B1/3 and OAT3 Transporter Substrates: Patients who take JYNARQUE should avoid concomitant use with OATP1B1/B3 and OAT3 substrates (e.g., statins, bosentan, glyburide, nateglinide, repaglinide, methotrexate, furosemide), as the plasma concentrations of these substrates may be increased.
  • BCRP Transporter Substrates: Tolvaptan is an inhibitor of BCRP. Patients who take JYNARQUE, should avoid concomitant use with BCRP substrates (e.g., rosuvastatin)
  • V2-Receptor Agonist: Tolvaptan interferes with the V2-agonist activity of desmopressin (dDAVP). Avoid concomitant use of JYNARQUE with a V2-agonist.

Pregnancy and Lactation: Based on animal data, JYNARQUE may cause fetal harm. In general, JYNARQUE should be discontinued during pregnancy. Advise women not to breastfeed during treatment with JYNARQUE.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

INDICATION:

JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.