JYNARQUE- tolvaptan kit JYNARQUE- tolvaptan tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

TOLVAPTAN (UNII: 21G72T1950) (TOLVAPTAN - UNII:21G72T1950)

Disponible depuis:

Otsuka America Pharmaceutical, Inc.

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 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 [see Warnings and Precautions (5.1)] - Taking strong CYP 3A inhibitors - With uncorrected abnormal blood sodium concentrations [see Warnings and Precautions (5.3)] - Unable to sense or respond to thirst [see Warnings and Precautions (5.3)] - Hypovolemia [see Warnings and Precautions (5.3)] - Hypersensitivity (e.g., anaphylaxis, rash) to tolvaptan or any component of the product [see Adverse Reactions (6)] - Uncorrected urinary outflow obstruction - Anuria Risk Summary Available data with JYNARQUE use in pregnant women are insufficient to determine if there is a drug associated risk of adverse developmental outcomes. In embryo-fetal development studies, pregnant rats a

Descriptif du produit:

JYNARQUE (tolvaptan) is supplied as non-scored, blue, shallow-convex, immediate release tablets, debossed with "OTSUKA" and the tablet strength (mg) on one side. JYNARQUE (tolvaptan) 15 mg tablets are triangular, 30 mg tablets are round, 45 mg tablets are square, 60 mg tablets are rectangular, and 90 mg tablets are pentagonal. JYNARQUE (tolvaptan) tablets are supplied as: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP controlled Room Temperature].

Statut de autorisation:

New Drug Application

Notice patient

JYNARQUE- TOLVAPTAN TABLET
Otsuka America Pharmaceutical, Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Issued: 10/2020
MEDICATION GUIDE
JYNARQUE® (jin-AR-kew)
(tolvaptan)
Tablets
What is the most important information I should know about JYNARQUE?
JYNARQUE can cause serious side effects, including:
•
Serious liver problems. JYNARQUE can cause serious liver problems that
can lead to the need for a
liver transplant or can lead to death. Stop taking JYNARQUE 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
•
itching
•
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 JYNARQUE
•
at 2 weeks and 4 weeks after you start treatment with JYNARQUE
•
then monthly for 18 months during treatment with JYNARQUE
•
and every 3 months from then on
It is important to stay under the care of your healthcare provider
during treatment with JYNARQUE.
Because of the risk of serious liver problems JYNARQUE is only
available through a restricted distribution
program called the JYNARQUE Risk Evaluation and Mitigation Strategy
(REMS) Program.
•
Before you start treatment with JYNARQUE, you must enroll in the
JYNARQUE REMS Program.
Talk to your healthcare provider about how to enroll in the program.
•
JYNARQUE can only be dispensed by a certified pharmacy that
participates in the JYNARQUE
REMS Program. Your healthcare provider can give you information on how
to find a certified
pharmacy.
What is JYNARQUE?
JYNARQUE is a 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 JYNARQUE is safe and effective in children.
Do no

Résumé des caractéristiques du produit

JYNARQUE- TOLVAPTAN
JYNARQUE- TOLVAPTAN TABLET
OTSUKA AMERICA PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JYNARQUE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JYNARQUE.
JYNARQUE (TOLVAPTAN) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: RISK OF SERIOUS LIVER INJURY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
JYNARQUE (TOLVAPTAN) CAN CAUSE SERIOUS AND POTENTIALLY FATAL LIVER
INJURY. ACUTE LIVER
FAILURE REQUIRING LIVER TRANSPLANTATION HAS BEEN REPORTED (5.1)
MEASURE TRANSAMINASES AND BILIRUBIN BEFORE INITIATING TREATMENT, AT 2
WEEKS AND 4
WEEKS AFTER INITIATION, THEN CONTINUING MONTHLY FOR THE FIRST 18
MONTHS AND EVERY 3
MONTHS THEREAFTER (5.1)
JYNARQUE IS AVAILABLE ONLY THROUGH A RESTRICTED DISTRIBUTION PROGRAM
CALLED THE
JYNARQUE REMS PROGRAM (5.2)
INDICATIONS AND USAGE
JYNARQUE is a selective vasopressin V -receptor antagonist indicated
to slow kidney function decline in
adults at risk of rapidly progressing autosomal dominant polycystic
kidney disease (ADPKD) (1)
DOSAGE AND ADMINISTRATION
Recommended dosage (2.1)
INITIAL DOSAGE
TITRATION STEP
TARGET DOSAGE
1st Dose
45 mg
1st Dose
60 mg
1st Dose
90 mg
2nd Dose
(8 hours later)
15 mg
2nd Dose
(8 hours later)
30 mg
2nd Dose
(8 hours later)
30 mg
TOTAL DAILY DOSE
60 mg
TOTAL DAILY DOSE
90 mg
TOTAL DAILY DOSE
120 mg
Dose adjustment is recommended for patients taking moderate CYP 3A
inhibitors (2.4, 5.4, 7.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg, 45 mg, 60 mg and 90 mg (3)
CONTRAINDICATIONS
History of signs or symptoms of significant liver impairment or
injury, does not include uncomplicated
polycystic liver disease (4)
Concomitant use of strong CYP 3A inhibitors is contraindicated (4)
Uncorrected abnormal blood sodium concentrations (4, 5.3)
Unable to sense or respond to thirst (4)
Hypovolemia (4)
Hypersensitivity to tolvaptan or any of its components (4)
Uncorrected urinary outflow obstruction (4)
Anuria (4)
WARNINGS