GO ALL IN PREPARED

Recommendations for managing potential
risks of INREBIC® treatment

GO ALL IN PREPARED

Recommendations for managing potential
risks of INREBIC® treatment

Management of encephalopathy, including Wernicke’s encephalopathy (WE)1

MEASURING

  • Assess thiamine levels prior to starting INREBIC®
  • Do not start INREBIC® in patients with thiamine deficiency
  • Replete thiamine prior to treatment initiation

MONITORING

  • Assess thiamine levels periodically during INREBIC® treatment and as clinically indicated; replete thiamine during treatment if thiamine levels are low
  • Monitor for signs and symptoms of WE, which may include ataxia, mental status changes, and ophthalmoplegia (eg, nystagmus, diplopia)
  • Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including WE, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging

MANAGING

  • If encephalopathy is suspected, immediately discontinue treatment with INREBIC® and initiate parenteral thiamine treatment
  • Monitor until symptoms resolve or improve, and thiamine levels normalize

Management of select adverse reactions to INREBIC® using dose modifications1

Recommended dose modifications

ADVERSE REACTION DOSE MODIFICATION DOSE RESTART
Hematologic toxicity Grade 4
thrombocytopenia
Grade 3
thrombocytopenia with bleeding
Grade 4
neutropenia
Interrupt dose until toxicity has resolved to ≤Grade 2 or baseline Restart 100 mg daily below the last given dose
Nonhematologic toxicity ≥Grade 3 nausea, vomiting, or diarrhea not responding to supportive measures within 48 hours ≥Grade 3 other nonhematologic toxicities ≥Grade 3 ALT, AST, or bilirubin* Interrupt dose until toxicity has resolved to ≤Grade 1 or baseline Restart 100 mg daily below the last given dose

See US Prescribing Information for complete dosing information.

ALT, alanine aminotransferase; AST, aspartate aminotransferase.

*Monitor ALT, AST, and bilirubin (total and direct) more frequently following the dose reduction. If reoccurrence of a ≥Grade 3 elevation, discontinue treatment with INREBIC®.

Additional management guidance for gastrointestinal adverse reactions1

  • Consider providing appropriate prophylactic antiemetic therapy (eg, 5-HT3 receptor antagonists) during INREBIC® treatment
  • Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms
  • Administration of INREBIC® with a high-fat meal may reduce the incidence of nausea and vomiting
  • INREBIC® may be taken with or without food

Timing of gastrointestinal treatment-emergent adverse reactions (all grades) in the INREBIC® (400 mg qd) arm (n=96) for Cycles 1-62

INREBIC® adverse reactions graph
INREBIC® adverse reactions graph

Adverse reactions were coded using MedDRA version 20.1.

Patients icon

Most patients remained on INREBIC® in the pivotal trial1

  • Permanent discontinuations due to adverse reactions occurred in 14% of patients
  • The most frequent reasons for permanent discontinuation (≥2% of patients) included cardiac failure (3%),
    thrombocytopenia (2%), myocardial ischemia (2%), diarrhea (2%), and increased blood creatinine (2%)

Average daily dose of INREBIC® in the pivotal trial3

Limitations of analysis: This is a post-hoc analysis without intention to make statistical inferences.

Average daily dose during Cycles 1-6 for patients in the INREBIC® (400 mg qd) arm

Average INREBIC® daily dose graph
Average INREBIC® daily dose graph

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