Jynarque rems status form 2025

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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 reporting procedures for adverse events related to liver injury. The form is to be filled out by certified prescribers or their delegates and includes patient and prescriber information, as well as authorization for continued treatment.

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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.

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