Ayvakit Dosage

Generic name: avapritinib 100mg
Dosage form: tablet, film coated
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com. Last updated on May 24, 2023.

Recommended Administration

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.

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.

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.

Table 1: Recommended Dosage Reductions for AYVAKIT for Adverse Reactions
Dose Reduction Level	Dosage in patients with GIST*	Dosage in patients with AdvSM†
* Permanently discontinue AYVAKIT in patients with GIST who are unable to tolerate a dose of 100 mg once daily. † Permanently discontinue AYVAKIT in patients with AdvSM who are unable to tolerate a dose of 25 mg once daily.
First dose reduction	200 mg once daily	100 mg once daily
Second dose reduction	100 mg once daily	50 mg once daily
Third dose reduction	-	25 mg once daily

Table 2: Recommended Dosage Modifications for AYVAKIT for Adverse Reactions
Adverse Reaction	Severity*	Dosage Modification
* Severity as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
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 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 [see Drug Interactions (7.1)]:

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) [see Use in Specific Populations (8.7)]:

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