Medically reviewed by Drugs.com. Last updated on Oct 19, 2021.
Patient Selection for GIST Harboring PDGFRA Exon 18 Mutations
Select patients for treatment with AYVAKIT based on the presence of a PDGFRA exon 18 mutation [see Clinical Studies (14.1)]. An FDA-approved test for the detection of exon 18 mutations is not currently available.
Recommended Dosage for GIST Harboring PDGFRA Exon 18 Mutations
The recommended dosage of AYVAKIT is 300 mg orally once daily in patients with GIST. Continue treatment until disease progression or unacceptable toxicity.
Recommended Dosage for Advanced Systemic Mastocytosis
The recommended dosage of AYVAKIT is 200 mg orally once daily in patients with AdvSM. Continue treatment until disease progression or unacceptable toxicity.
Modify dosage for adverse reactions as outlined in Table 2 [see Dosage and Administration (2.5)].
Administer AYVAKIT orally on an empty stomach, at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3)].
Do not make up for a missed dose within 8 hours of the next scheduled dose.
Do not repeat dose if vomiting occurs after AYVAKIT but continue with the next scheduled dose.
Dosage Modifications for Adverse Reactions
The recommended dose reductions and dosage modifications for adverse reactions are provided in Tables 1 and 2.
|Dose Reduction||GIST (starting dose 300 mg)*||AdvSM (starting dose 200 mg)†|
|First||200 mg once daily||100 mg once daily|
|Second||100 mg once daily||50 mg once daily|
|Third||-||25 mg once daily|
|Adverse Reaction||Severity*||Dosage Modification|
|Patients with GIST or AdvSM|
|Intracranial Hemorrhage [see Warnings and Precautions (5.1)]||Any grade||Permanently discontinue AYVAKIT.|
|Cognitive Effects [see Warnings and Precautions (5.2)]||Grade 1||Continue AYVAKIT at same dose or reduced dose or withhold until improvement to baseline or resolution. Resume at same dose or reduced dose.|
|Grade 2 or Grade 3||Withhold AYVAKIT until improvement to baseline, Grade 1, or resolution. Resume at same dose or reduced dose.|
|Grade 4||Permanently discontinue AYVAKIT.|
|Other [see Adverse Reactions (6.1)]||Grade 3 or Grade 4||Withhold AYVAKIT until improvement to less than or equal to Grade 2. Resume at same dose or reduced dose, as clinically appropriate.|
|Patients with AdvSM|
|Thrombocytopenia [see Warnings and Precautions (5.1)]||<50 × 109/L||Interrupt AYVAKIT until platelet count is ≥ 50 × 109/L, then resume at reduced dose (per Table 1). If platelet counts do not recover above 50 × 109/L, consider platelet support.|
Concomitant Use of Strong or Moderate CYP3A Inhibitors
Avoid concomitant use of AYVAKIT with strong or moderate CYP3A inhibitors. If concomitant use with a moderate CYP3A inhibitor cannot be avoided, the starting dosage of AYVAKIT is as follows [see Drug Interactions (7.1)]:
- GIST: 100 mg orally once daily
- AdvSM: 50 mg orally once daily
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