Due to the risks of liver injury, JYNARQUE® (tolvaptan) is available only through a REMS Program

The JYNARQUE Risk Evaluation and Mitigation Strategy (REMS) Program makes monitoring your patients to HELP mitigaTe the risk of liver injury a top priority

In clinical trials,

    Incidence of serious liver injury

    • 0.2% (3/1487) of JYNARQUE patients experienced serious hepatocellular injury (elevations of hepatic transaminases of at least 3 times ULN combined with elevated bilirubin at least 2 times the ULN) in a 3-year placebo-controlled trial and its open-label extension (in which patients’ liver tests were monitored every 4 months) compared to none of the placebo-treated patients

    Incidence of liver injury

    • 4.9% (80/1637) of JYNARQUE patients experienced ALT elevations >3 times the ULN at an increased frequency within the first 18 months after initiating treatment compared to 1.1 % (13/1166) of patients taking placebo in the two double-blind, placebo-controlled trials. ALT elevations usually resolved within 1 to 4 months after discontinuing treatment

    Patients should stop taking JYNARQUE and notify their HCP if they show signs or symptoms of liver injury.

    Enrollment takes just minutes* and ongoing support is available

    • Become enrolled by completing a one-time certification process 
    • JYNARQUE is only available through specialty pharmacies which deliver medication directly to patients. In addition to delivering the prescription, they also provide educational support tailored to their needs

    *Individual times may vary.

    get certified

    Get certified to prescribe JYNARQUE

    THE PURPOSE OF THE JYNARQUE REMS PROGRAM IS TO REDUCE THE RISK OF HEPATIC INJURY FOR PATIENTS TAKING JYNARQUE

    The JYNARQUE REMS Program includes the following steps:

    1. Prescribers enroll in the JYNARQUE REMS Program
    2. Prescribers order baseline hepatic tests and counsel patients
    3. Patients enroll in the JYNARQUE REMS Program
    4. Patients are monitored at 2 weeks and 4 weeks after treatment initiation, then monthly for 18 months, and every 3 months thereafter during treatment with JYNARQUE

     

     

    OTSUKA PATIENT LAB SUPPORT PROGRAM TO FACILITATE REMS COMPLIANCE

    A program that provides eligible, commercially insured patients who are taking JYNARQUE with no-cost hepatic testing required by the REMS program for the duration of therapy.

    Mobile Phlebotomy Collection Service is an additional offering for remote areas where patients can't find a local lab, or areas where neither Quest Diagnostics or LabCorp have a presence. Otsuka can arrange for a phlebotomist to visit the patients' residences for specimen collection.

    1. Risk Evaluation and Mitigation Strategies | REMS. US Food and Drug Administration website.
      https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems. Accessed May 15, 2020.
    REMS Enrollment Process, Icon

    The enrollment process
    takes just minutes*

    The enrollment process
    takes just minutes*

    The enrollment process
    takes just minutes*

    *Individual times may vary.

    Watch Video, Icon

    Hear from a peer about
    talking to patients about REMS

    INDICATION and IMPORTANT SAFETY INFORMATION

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

    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
    • 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).

    Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

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    INDICATION and IMPORTANT SAFETY INFORMATION
    INDICATION and IMPORTANT SAFETY INFORMATION

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

    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
    • 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).

    Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.