Active Ingredient: Avapritinib
Avapritinib is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 25 milligrams avapritinib, once daily.
For ISM, the recommended dose of avapritinib is 25 mg orally once daily, on an empty stomach. This once daily 25 mg dose is also the maximum recommended dose that must not be exceeded in patients with ISM. Treatment of ISM should be continued until disease progression or unacceptable toxicity occurs.
Concomitant use of avapritinib with strong or moderate CYP3A inhibitors must be avoided.
If a dose of avapritinib is missed, the patient should make up for the missed dose unless the next scheduled dose is within 8 hours. If the dose has not been taken at least 8 hours prior to the next dose, then that dose must be omitted and the patient should resume treatment with the next scheduled dose.
If vomiting occurs after taking a dose of avapritinib, the patient must not take an additional dose but continue with the next scheduled dose.
Irrespective of indication, interruption of treatment with or without dose reduction may be considered to manage adverse reactions based on severity and clinical presentation.
The dose should be adjusted as recommended, based on safety and tolerability.
Dose reductions and modifications for adverse reactions are provided below.
Recommended dose reductions for avapritinib for adverse reactions:
25 mg once every other day.
ISM patients requiring dose reduction below 25 mg once every other day must discontinue treatment.
Recommended dose modifications for avapritinib for adverse reactions:
| Adverse reaction | Severity* | Dose modification |
|---|---|---|
| Intracranial haemorrhage | All Grades | Permanently discontinue avapritinib. |
| Cognitive effects** | Grade 1 | Continue at the same dose, reduce dose or interrupt until improvement to baseline or resolution. Resume at the same dose or at a reduced dose. |
| Grade 2 or Grade 3 | Interrupt therapy until improved to baseline, Grade 1, or resolution. Resume at the same dose or at a reduced dose. | |
| Grade 4 | Permanently discontinue avapritinib. | |
| Other adverse reactions | Grade 3 or Grade 4 | Interrupt therapy until less than or equal to Grade 2. Resume at the same dose or at a reduced dose, if warranted. |
* The severity of adverse reactions graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and 5.0
** Adverse reactions with impact on Activities of Daily Living (ADLs) for Grade 2 or higher adverse reactions
The avapritinib tablets must be taken on an empty stomach at least 1 hour before or at least 2 hours after a meal.
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