AYVAKYT – one tablet, 25 mg once-daily dosing1
Managing your patients taking AYVAKYT1
The recommended starting dose for patients with ISM is 25 mg once daily
AYVAKYT should be taken as follows:1
One tablet orally
One time each day
On an empty stomach, at least 1 hour before or 2 hours after a meal
- The recommended starting dose for patients with ISM is 25 mg once daily
- Patients with ISM must not exceed the recommended starting dose of 25 mg once daily
- Treatment should continue until disease progression or unacceptable toxicity occurs
- Concomitant use of AYVAKYT with strong or moderate CYP3A inhibitors should be avoided
Additional instructions:
- AYVAKYT tablets should be swallowed whole with a glass of water
- Do not take an extra dose if vomiting occurs after taking a dose
- Do not make up for the missed dose within 8 hours of the next scheduled dose
Interruption of treatment with or without dose reduction may be considered to manage adverse reactions based on severity and clinical presentation1
The dose should be adjusted based on safety and tolerability1
In 141 patients who received AYVAKYT at recommended dose of 25 mg in Part 2 the PIONEER study, no intracranial haemorrhages were reported. Cognitive effects occurred in 2.8% of patients – all Grade 1 or 2; no patients permanently discontinued treatment due to cognitive effects1
Please refer to the Recommended dose modifications for patients experiencing adverse reactions1
Recommended dose reductions from the 25 mg once-daily starting dose1
| Dose reduction | Starting dose (25 mg) |
| First | 25 mg once every other day |
| Second | Discontinue |
A modified starting dose is recommended for patients with severe hepatic impairment: 25 mg orally every other day. Patients requiring dose reduction below 25 mg once every other day must discontinue treatment
Dose modifications in clinical trials1
PIONEER
Patients with ISM treated with 25 mg AYVAKYT (n=141):
<1%
Treatment discontinuation due to adverse reactions
