Jynarque rems status form 2026

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The document outlines the JYNARQUE (Tolvaptan) REMS Patient Status Form, which must be completed regularly for patients undergoing treatment. It details the submission schedule, liver function monitoring requirements, and procedures for reporting serious adverse events related to liver injury. The form is to be filled out by certified prescribers or their delegates and emphasizes the importance of compliance with REMS requirements.

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Click ‘Get Form’ to open the JYNARQUE REMS Patient Status Form in our editor.
Begin by filling out the 'Patient Information' section. Enter the patient's first name, last name, birthdate, and address details. Ensure all required fields marked with an asterisk (*) are completed.
Next, move to the 'Prescriber Information' section. Fill in your first and last name, National Provider Identifier No. (NPI), contact details, and practice/facility name as applicable.
In the 'Patient Liver Monitoring and Authorization' section, confirm if liver function assessments have been conducted during the reporting period by selecting 'Yes' or 'No'. Also indicate if the patient is authorized to continue receiving JYNARQUE.
Proceed to the 'Serious Adverse Events Reporting' section. Indicate whether the patient has experienced any serious liver injury events. Complete your signature, print your name, and provide the submission date.
Once all sections are filled out accurately, submit the form via fax or online through our platform for timely processing.

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What is the rems program for tolvaptan?

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

What drugs are on the rems list?

The branded and generic drug products subject to this REMS include all the following: Oral dosage forms containing: codeine and codeine analogs, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, oxycodone, oxymorphone, pentazocine, tapentadol, tramadol. Intranasal butorphanol.

Is jynarque an orphan drug?

Otsuka received Health Canadas approval for JYNARQUE in February 2015, and it was granted orphan drug designation by the European Commission (EC) in August 2013.

Is Jynarque a REMS drug?

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.

Is jynarque a specialty drug?

JYNARQUE is available exclusively through 3 REMS-certified specialty pharmacies. Specialty pharmacies are different from traditional pharmacies. Unlike other medications that are picked up in traditional pharmacies, JYNARQUE will be delivered directly to your door by a specialty pharmacy.

jynarque patient status form

JYNARQUE REMS Patient Enrollment Form JYNARQUE REMS login JYNARQUE REMS provider Enrollment JYNARQUE REMS provider login Tolvaptan REMS Program Tolvaptan ADPKD Shared REMS SAMSCA REMS JYNARQUE prescription referral Form