Active Ingredient: Nirogacestat
Nirogacestat is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 150 milligrams nirogacestat, 2 times daily.
The recommended dosage of nirogacestat is 150 mg administered orally twice daily until disease progression or unacceptable toxicity.
Instruct patients to swallow nirogacestat tablets whole and not to break, crush, or chew prior to swallowing.
If a patient vomits or misses a dose, instruct the patient to take the next dose at its scheduled time.
The recommended dose modifications for nirogacestat for selected severe adverse reactions are summarized in the table below. For other severe adverse reactions, life-threatening adverse reactions, or persistent intolerable Grade 2 adverse events, withhold drug until resolved to Grade ≤ 1 or baseline. Only restart at a dose of 100 mg twice daily after considering the potential benefit and likelihood of recurrence of the adverse reaction. Permanently discontinue nirogacestat for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose.
Recommended Dose Modifications for Adverse Reactions:
| Adverse Reaction | Severity | Nirogacestat Dosage Modifications |
|---|---|---|
| Diarrhea persisting for ≥ 3 days despite maximal medical therapy | Grades 3 or 4 | Withhold nirogacestat until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
| ALT or AST increased | Grade 2 (≥ 3 to 5 × ULN) | Withhold nirogacestat until ALT, AST, or both are resolved to < 3 × ULN or baseline, then restart at a dose of 100 mg twice daily. |
| Grades 3 or 4 (> 5 × ULN) | Permanently discontinue. | |
| Hypophosphatemia persisting for ≥ 3 days despite maximal replacement therapy | Grades 3 or 4 | Withhold nirogacestat until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
| Hypokalemia despite maximal replacement therapy | Grades 3 or 4 | Withhold nirogacestat until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
Nirogacestat may be taken with or without food.
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