Clinical Information

Safety Profile

Established safety profile from ENLIVEN

Please see full Indication and Important Safety Information.

Adverse reactions led to dose reductions or interruptions in 38% of patients; 13% discontinued treatment1

Most Common Adverse Reactions in Patients Receiving TURALIO1
20-percent-round
  • Increased LDH (92%)
  • Increased AST (88%)
  • Hair color changes (67%)
  • Fatigue (64%)
  • Increased ALT (64%)
  • Decreased neutrophils (44%)
  • Increased cholesterol (44%)
  • Increased ALP (39%)
  • Decreased lymphocytes (38%)
  • Eye edema (30%)
  • Decreased hemoglobin (30%)
  • Rash (28%)
  • Dysgeusia (26%)
  • Decreased phosphate (25%)
ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate transaminase; LDH, lactate dehydrogenase.
Serious Adverse Reactions + Permanent Discontinuation in Patients
Receiving TURALIO1
Serious Adverse Reactions Occurred In
serious-adverse-left serious-adverse-left
The most frequent (>1 patient)

Abnormal Liver Test
3.3% of patients

Hepatotoxicity
3.3% of patientsa

Permanent Discontinuation Due to
an Adverse Reaction Occurred In
serious-adverse-left serious-adverse-left
The most frequent (>1 patient)

Abnormal Liver Test
4.9% Increased ALT
4.9% Increased AST

Hepatotoxicity
3.3% of patientsa

aThe same 2 patients with hepatotoxicity who reported serious adverse reactions also discontinued the study.1

It is recommended to monitor liver tests prior to initiation
of TURALIO and at specified intervals during treatment.
Learn more about treating patients with TURALIO.

In addition to adverse event reporting, the trial also required liver function testing.

Hepatic Laboratory Abnormalities (≥10% All Grades or >2% Grade ≥3)b

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  • b Hepatic laboratory abnormalities (≥10% All Grades or >2% Grade ≥3) worsening from baseline in patients receiving TURALIO with a difference between arms
    of >5% compared to placebo through week 25 in ENLIVEN.
  • cEach test incidence is based on the number of patients who had both a baseline and at least one on-study measurement: TURALIO (n=61) and placebo (n=59).
  • dGraded per NCI CTCAE v 4.03.
Refer to TURALIO full Prescribing Information for additional adverse reaction and safety information.

TURALIO REMS Program TURALIO is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risk of hepatotoxicity.

  • To prescribe TURALIO, enroll in the TURALIO REMS Program and complete the prescriber training program
  • To receive TURALIO, patients must enroll in the TURALIO REMS patient registry by completing the Patient Enrollment Form with their healthcare provider
Learn more here or download TURALIO prescribing at a glance.