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Medicine bottle

Starting AYVAKIT—one tablet, once-daily dosing1

The recommended dosage of AYVAKIT for Advanced SM is 200 mg orally once daily.

Do not initiate AYVAKIT in patients with platelet counts <50 x 109/L.

Treatment should continue until disease progression or unacceptable toxicity.

Do not take an additional dose if vomiting occurs after AYVAKIT has been taken, but continue with the next scheduled dose.

AYVAKIT is also available in dose strengths of 100 mg, 50 mg, and 25 mg for dose modification for adverse reactions or drug interactions (for example, CYP3A inhibitors).

Avoid coadministration of AYVAKIT with strong or moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce dose of AYVAKIT. Avoid coadministration of AYVAKIT with strong or moderate CYP3A inducers. If contraception requires estrogen, limit ethinyl estradiol to 20 mcg unless a higher dose is necessary.

Watch Dr. McCloskey video as he reviews information about managing patients who have started AYVAKIT® treatment
Watch Dr McCloskey review information about managing patients who have started treatment with AYVAKIT.
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Below is helpful information for starting treatment, monitoring treatment response, and recommended dose modifications for adverse reactions if necessary.
Patient monitoring

Patient monitoring for initiating and continuing treatment with AYVAKIT1

PLATELET MONITORING

A platelet count must be performed prior to initiation of therapy, during the first 8 weeks of treatment, and potentially longer depending on what is clinically indicated. AYVAKIT is not recommended for patients with platelet counts <50 x 109/L.1

Time on therapyMonitoring planTreatment plan
Prior to initiationPerform platelet count.AYVAKIT is not recommended in Advanced SM patients with platelet counts <50 x 109/L.
First 8 weeksPerform platelet count every 2 weeks regardless of baseline platelet count.

If platelet count <50 x 109/L occurs, interrupt AYVAKIT until platelet count is 50 x 109/L, then resume at reduced dose.

If platelet counts do not recover above 50 x 109/L, platelet support may be necessary.

After 8 weeksMonitor platelet counts:
  • Every 2 weeks if values are <75 x 109/L (or more frequently as clinically indicated)
  • Every 4 weeks if values are 75-100 x 109/L
  • As clinically indicated if values are >100 x 109/L

Monitor patients closely for risk factors of ICH which may include history of vascular aneurysm, ICH or cerebrovascular accident within the prior year, concomitant use of anticoagulant drugs, or thrombocytopenia.

If any ICH occurs, permanently discontinue AYVAKIT.

Manage platelet counts of <50 x 109/L by treatment interruption or dose reduction of AYVAKIT. Platelet support may be necessary.

Medicine bottle and tablet

It was common to modify AYVAKIT dosage1

MANY PATIENTS IN THE EXPLORER AND PATHFINDER TRIALS HAD THEIR DOSE REDUCED OR INTERRUPTED DUE TO ADVERSE REACTIONS1

AYVAKIT DOSE REDUCTIONS AND INTERRUPTIONS IN CLINICAL TRIALS1

Among patients with Advanced SM in clinical trials who started at 200 mg (N=80), many patients had their dose modified.

Adverse reactions requiring dosage interruption or dose reduction in >2% of patients who received AYVAKIT at 200 mg once daily:

  • Thrombocytopenia
  • Neutropenia
  • Anemia
  • Elevated blood alkaline phosphatase
  • Cognitive disorder
  • Peripheral edema
  • Periorbital edema
  • Fatigue
  • Arthralgia

RECOMMENDED DOSE REDUCTIONS FROM THE 200 MG ONCE-DAILY STARTING DOSE1
Recommended dose reductions for adverse reactions
Dose ReductionStarting Dose (200 mg)a
First100 mg once daily
Second50 mg once daily
Third25 mg once daily

aPermanently discontinue AYVAKIT in patients who are unable to tolerate a dose of 25 mg daily.


RECOMMENDED DOSE MODIFICATIONS FOR PATIENTS EXPERIENCING ADVERSE REACTIONS1
Adverse ReactionSeveritybDosage Modification
Intracranial HemorrhageAny GradePermanently discontinue AYVAKIT.
Cognitive EffectsGrade 1Continue 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 3Withhold AYVAKIT until improvement to baseline, Grade 1, or resolution. Resume at same dose or reduced dose.
Grade 4Permanently discontinue AYVAKIT.
Thrombocytopenia<50 x 109/LInterrupt AYVAKIT until platelet count is 50 x 109/L, then resume at reduced dose per the recommended reductions. If platelet counts do not recover above 50 x 109/L, consider platelet support.
OtherGrade 3 or Grade 4Withhold AYVAKIT until improvement to Grade 2. Resume at same dose or reduced dose, as clinically appropriate.

bSeverity as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Download

For further information on dose modifications and patient monitoring, review the Prescribing Information and download the AYVAKIT Dosing and Administration Guide

Patients

For patients experiencing adverse reactions, dose modification may be necessary1

For patients who experience certain adverse reactions, additional information is provided below and in the AYVAKIT Prescribing Information to help guide in modifying and managing their treatment.

Intracranial Hemorrhage (ICH)1
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Thrombocytopenia1
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Cognitive Effects1
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Other Adverse Reactions1
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