Each pale-yellow oblong 200-mg tablet is debossed with “KDM” on one side and “200” on the other side.1
Not actual size.
Adverse reaction | Severitya | REZUROCK dose modifications | |
Hepatotoxicity | Grade 3 AST or ALT (5x to 20x ULN) or Grade 2 bilirubin (1.5x to 3x ULN) | Hold REZUROCK until recovery of bilirubin, ALT and AST to Grade 0-1, then resume REZUROCK at the recommended dose. | |
Grade 4 AST or ALT (>20x ULN) or Grade ≥3 bilirubin (>3x ULN) | Discontinue REZUROCK permanently. | ||
Other adverse reactions | Grade 3 | Hold REZUROCK until recovery to Grade 0-1, then resume REZUROCK at the recommended dose level. | |
Grade 4 | Discontinue REZUROCK permanently. |
Severitya | REZUROCK dose modifications | ||
Adverse reaction: Hepatotoxicity | |||
Grade 3 AST or ALT (5x to 20x ULN) or Grade 2 bilirubin (1.5x to 3x ULN) | Hold REZUROCK until recovery of bilirubin, ALT and AST to Grade 0-1, then resume REZUROCK at the recommended dose. | ||
Grade 4 AST or ALT (>20x ULN) or Grade ≥3 bilirubin (>3x ULN) | Discontinue REZUROCK permanently. | ||
Adverse reaction: Other adverse reactions | |||
Grade 3 | Hold REZUROCK until recovery to Grade 0-1, then resume REZUROCK at the recommended dose level. | ||
Grade 4 | Discontinue REZUROCK permanently. |
aBased on CTCAE v4.03.
Please see the full Prescribing Information for additional guidance for other populations.
Patients with mild to moderate renal impairment
Patients with severe renal impairment
Patients with moderate or severe hepatic impairment
Patients with mild hepatic impairment
Store REZUROCK tablets at room temperature (68 °F to 77 °F [20 °C to 25 °C]) in the original container.
REZUROCK should be dispensed to the patient in the original container only. Store in original container to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; cGVHD, chronic graft-versus-host disease; CTCAE, Common Terminology Criteria for Adverse Events; CYP3A, cytochrome P450 3A; MOA, mechanism of action; ULN, upper limit of normal.
Reference: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2023.