Generic Name
Tolvaptan
Brand Names
Jynarque, Samsca
FDA approval date: May 19, 2009
Classification: Vasopressin V2 Receptor Antagonist
Form: Tablet, Kit
What is Jynarque (Tolvaptan)?
JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease . JYNARQUE is a selective vasopressin V 2 -receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Approved To Treat
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Related Clinical Trials
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease
Summary: Autosomal dominant polycystic kidney disease is the most common genetic cause of kidney failure. The only approved treatment for ADPKD - tolvaptan - is limited in its use by massive therapy-associated polyuria. This trial tests if the SGLT2-inhibitor dapagliflozin slows down the loss of kidney function in ADPKD.
The German ADPKD Tolvaptan Treatment Registry is a Prospective, Observational, Multicentric Study of Patients Suffering From ADPKD That Are Considered for Tolvaptan Treatment.
Summary: The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric study of patients suffering from ADPKD that are considered for tolvaptan treatment. All ADPKD patients that are evaluated for treatment indication, or that are planned to be treated with tolvaptan, or that are already treated with tolvaptan are eligible. This registry is designed to provide real-world data ...
A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
Summary: To evaluate the safety of tolvaptan in pediatric subjects with ARPKD
Related Latest Advances
Brand Information
Jynarque (tolvaptan)
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 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
Because of the risks of serious liver injury, JYNARQUE is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the Tolvaptan for ADPKD Shared System REMS
1INDICATIONS AND USAGE
JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
2DOSAGE FORMS AND STRENGTHS
JYNARQUE (tolvaptan) is supplied as non-scored, blue, shallow-convex, immediate release tablets, debossed with "OTSUKA" and the tablet strength (mg) on one side as follows:
3CONTRAINDICATIONS
JYNARQUE is contraindicated in patients:
- With a 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 tolvaptan or any component of the product
- Uncorrected urinary outflow obstruction
- Anuria
4ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Serious Liver Injury
- Hypernatremia, Dehydration and Hypovolemia
- Drug Interactions with Inhibitors of CYP3A
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. JYNARQUE has been studied in over 3000 patients with ADPKD. Long-term, placebo-controlled safety information of JYNARQUE in ADPKD is principally derived from two trials where 1,413 subjects received tolvaptan and 1,098 received placebo for at least 12 months across both studies.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of tolvaptan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatobiliary Disorders: Liver failure requiring transplant
Immune System Disorders: Anaphylaxis
5OVERDOSAGE
Single oral doses up to 480 mg (4 times the maximum recommended daily dose) and multiple doses up to 300 mg once daily for 5 days have been well tolerated in trials in healthy subjects. There is no specific antidote for tolvaptan intoxication. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst, and dehydration/hypovolemia.
No mortality was observed in rats or dogs following single oral doses of 2000 mg/kg (maximum feasible dose). A single oral dose of 2000 mg/kg was lethal in mice, and symptoms of toxicity in affected mice included decreased locomotor activity, staggering gait, tremor and hypothermia.
In patients with suspected JYNARQUE overdosage, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended. Continue replacement of water and electrolytes until aquaresis abates. Dialysis may not be effective in removing JYNARQUE because of its high binding affinity for human plasma protein (>98%).
6DESCRIPTION
JYNARQUE contains tolvaptan, a selective vasopressin V2-receptor antagonist in immediate release tablets for oral administration available in 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strengths. Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1
Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and FD&C Blue No. 2 Aluminum Lake as colorant.
7CLINICAL STUDIES
JYNARQUE was shown to slow the rate of decline in renal function in adult patients at risk of rapidly progressing ADPKD in two trials: TEMPO 3:4 in patients at earlier stages of disease and REPRISE in patients at later stages. The findings from these trials, when taken together, suggest that JYNARQUE slows the loss of renal function progressively through the course of the disease.
8PATIENT COUNSELING INFORMATION
As part of patient counseling, healthcare providers must review the JYNARQUE Medication Guide with every patient
9PRINCIPAL DISPLAY PANEL - Kit Carton - 45 mg and 15 mg
56 Tablets
NDC 59148-087-28
JYNARQUE
45 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
10PRINCIPAL DISPLAY PANEL - Kit Carton - 60 mg and 30 mg
56 Tablets
NDC 59148-088-28
JYNARQUE
60 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
11PRINCIPAL DISPLAY PANEL - Kit Carton - 90 mg and 30 mg
56 Tablets
NDC 59148-089-28
JYNARQUE
90 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
12PRINCIPAL DISPLAY PANEL - 15 mg Tablet Label
NDC 59148-082-13
Rx only
JYNARQUE
15 mg
DISPENSE THE ENCLOSED MEDICATION
30 tablets
13PRINCIPAL DISPLAY PANEL - 30 mg Tablet Label
NDC 59148-083-13
Rx only
JYNARQUE
30 mg
DISPENSE THE ENCLOSED MEDICATION
30 tablets
14PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Carton
NDC 59148-082-13
JYNARQUE
15 mg
DISPENSE THE ENCLOSED MEDICATION
30 tablets
15PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Carton
NDC 59148-083-13
JYNARQUE
30 mg
DISPENSE THE ENCLOSED MEDICATION
30 tablets
16PRINCIPAL DISPLAY PANEL - 45-15 mg Sleeve
1
14 Tablets
NDC 59148-087-07
JYNARQUE
45 mg
Instructions to the right
- Using thumbnail, press and hold down perforated button.
- While holding button down, pull out foil package.
- Push tablet through foil.
- Push weekly pack into carton.
DISPENSE THE ENCLOSED
2
17PRINCIPAL DISPLAY PANEL - 60-30 mg Sleeve
1
14 Tablets
NDC 59148-088-07
JYNARQUE
60 mg
Instructions to the right
- Using thumbnail, press and hold down perforated button.
- While holding button down, pull out foil package.
- Push tablet through foil.
- Push weekly pack into carton.
DISPENSE THE ENCLOSED
2
18PRINCIPAL DISPLAY PANEL - 90-30 mg Sleeve
1
14 Tablets
NDC 59148-089-07
JYNARQUE
90 mg
Instructions to the right
- Using thumbnail, press and hold down perforated button.
- While holding button down, pull out foil package.
- Push tablet through foil.
- Push weekly pack into carton.
DISPENSE THE ENCLOSED
2
19PRINCIPAL DISPLAY PANEL - 15-15 mg Sleeve
1
14 Tablets
NDC 59148-079-07
JYNARQUE
15 mg
Instructions to the right
- Using thumbnail, press and hold down perforated button.
- While holding button down, pull out foil package.
- Push tablet through foil.
- Push weekly pack into carton.
DISPENSE THE ENCLOSED
2
20PRINCIPAL DISPLAY PANEL - 30-15 mg Sleeve
1
14 Tablets
NDC 59148-080-07
JYNARQUE
30 mg
Instructions to the right
- Using thumbnail, press and hold down perforated button.
- While holding button down, pull out foil package.
- Push tablet through foil.
- Push weekly pack into carton.
DISPENSE THE ENCLOSED
2
21PRINCIPAL DISPLAY PANEL - Kit Carton - 30 mg and 15 mg
56 Tablets
NDC 59148-080-28
JYNARQUE
30 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
22PRINCIPAL DISPLAY PANEL - Kit Carton - 15 mg and 15 mg
56 Tablets
NDC 59148-079-28
JYNARQUE
15 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE TO EACH PATIENT
