Tolvaptan (tolvaptan)

• Autosomal dominant polycystic kidney disease (ADPKD) (Jynarque): adults at risk of rapidly getting worse ADPKD (an inherited disease where cysts grow in the kidneys), to slow the loss of kidney function.
• Low blood sodium (hyponatremia) (Samsca): people with serious low blood sodium when the body has a normal or high amount of fluid, including people with heart failure or SIADH (a condition where the body holds on to too much water); this means very low sodium, or lower sodium that causes symptoms and did not get better with drinking less fluid.

A prescription is required. Your prescriber decides whether Tolvaptan is right for you.

Taken by mouth.

Samsca is started in a hospital, where blood sodium can be checked closely. Jynarque is taken at home: we ship it to your door, and your prescriber orders regular liver blood tests.

Storage: Store the tablets at room temperature. Keep them out of the reach of children.

Before the first dose, your prescriber may ask for:

• Jynarque: blood tests for liver function (ALT, AST and bilirubin)
• Jynarque: a blood test for sodium; sodium problems must be corrected before starting
• Jynarque: you, your prescriber and your pharmacy must be enrolled in a restricted program (the Tolvaptan for ADPKD Shared System REMS)
• Samsca: it is started in a hospital, so your blood sodium can be checked closely

Important safety information: Jynarque has a boxed warning about serious liver injury, and it is only available through a restricted program (REMS). Samsca has a boxed warning that it must be started in a hospital because raising blood sodium too fast can cause serious nerve damage, and that it must not be used for ADPKD outside that program.

Jynarque is available only through the Tolvaptan for ADPKD Shared System REMS, a safety program the FDA requires. MedRx Infusion is certified to dispense it.

Read the Medication Guide and the full Tolvaptan prescribing information, and ask your prescriber or our pharmacists about side effects. Our pharmacists are on call 24 hours a day.

Health plans often require prior authorization for Tolvaptan. Our intake team checks your coverage and works with your prescriber’s office on the paperwork before your first delivery.

The manufacturer runs a support program, Otsuka Patient Support, that may help eligible patients with costs and access.

Offices can call (844) 671-2600 or fax a referral to (844) 671-2601. Use the Nephrology Referral Form (PDF).

The manufacturer also publishes Jynarque prescription, referral and REMS forms.