Ayvakit Dosage

Recommended Administration

Administer AYVAKIT orally on an empty stomach, at least 1 hour before or 2 hours after a meal.

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.

GIST Harboring PDGFRA Exon 18 Mutations

Select patients for treatment with AYVAKIT based on the presence of a PDGFRA exon 18 mutation. An FDA-approved test for the detection of exon 18 mutations is not currently available.

The recommended dosage of AYVAKIT is 300 mg orally once daily in patients with GIST. Continue treatment until disease progression or unacceptable toxicity.

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.

Indolent Systemic Mastocytosis

The recommended dosage of AYVAKIT is 25 mg orally once daily in patients with ISM.

Dosage Modifications for Adverse Reactions

The recommended dosage reductions and modifications for adverse reactions are provided in Tables 1 and 2.

Concomitant Use of Strong and 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:

• GIST: 100 mg orally once daily
• AdvSM: 50 mg orally once daily

For ISM, avoid concomitant use of AYVAKIT with strong or moderate CYP3A inhibitors.

Dosage Modifications for Severe Hepatic Impairment

A modified starting dosage of AYVAKIT is recommended for patients with severe hepatic impairment (Child-Pugh Class C):

• GIST: 200 mg orally once daily
• AdvSM: 100 mg orally once daily
• ISM: 25 mg orally every other day