Taking AYVAKIT^® (avapritinib) for Indolent Systemic Mastocytosis

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How do I take AYVAKIT?

One 25 mg tablet

Taken once a day or as directed

On an empty stomach, at least 1 hour before or at least 2 hours after a meal

The recommended dose of AYVAKIT is 25 mg orally once daily in adults with Indolent Systemic Mastocytosis (ISM).

If you miss a dose of AYVAKIT, take it as soon as you remember, unless your next scheduled dose is due within 8 hours. Then, take the next dose at your regular time. If you vomit after taking a dose of AYVAKIT, do not take an extra dose. Take your next dose at your next scheduled time.

Talk to your doctor if you have questions about your treatment. Take AYVAKIT exactly as prescribed by your doctor. Do not stop taking AYVAKIT unless your doctor tells you to.

Before taking AYVAKIT, tell your doctor:

All your medical conditions, including if you have a history of bulging or weakening of a blood vessel wall (aneurysm) or bleeding in your brain, history of stroke within the last year, have low platelet counts
All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
If you have or have had liver problems
If you are pregnant or plan to become pregnant
If you are breastfeeding or plan to breastfeed

How often will my doctor monitor my blood counts?

Your doctor will discuss with you when it is necessary to monitor your blood counts.

Monitoring how you are feeling

Your doctor may change your dose, temporarily stop, or permanently stop treatment with AYVAKIT if you develop certain side effects. Call your doctor for medical advice about side effects.

What are the ingredients in the AYVAKIT 25 mg tablet?

The active ingredient is avapritinib. The tablets also contain inactive ingredients:

Copovidone
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose

The tablet coating consists of polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

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Living with ISM symptoms

You may have been managing symptoms with multiple treatments that help relieve individual symptoms. Previously there were no FDA-approved therapies for ISM.

How does AYVAKIT work?

About 95% of patients with ISM have a gene mutation called KIT D816V. This gene mutation can lead to the uncontrolled growth and buildup of mast cells, which can lead to symptoms of ISM. AYVAKIT works by selectively targeting the KIT D816V gene mutation to help slow the growth of mast cells.

You do not need to have the KIT D816V gene mutation to be prescribed AYVAKIT.

Is it time to consider a treatment that targets an underlying cause of ISM in about 95% of patients?

Tracking symptoms with your doctor

It is important to keep your scheduled follow-up visits with your healthcare provider. Your doctor will monitor your condition while taking AYVAKIT and you both can create a treatment plan that is right for you.

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Is AYVAKIT right for you?

Before taking any medication, it’s important to understand its benefits and risks. Always consult with your doctor regarding questions about treatment with AYVAKIT.

AYVAKIT may cause serious side effects, including:

Bleeding in your brain:

Serious bleeding in the brain may happen during treatment with AYVAKIT and may lead to death. Stop taking AYVAKIT and tell your healthcare provider right away if you develop any symptoms such as severe headache, vomiting, drowsiness, dizziness, confusion, or severe weakness on one or more side of your body. Bleeding in the brain has not been seen in people treated with AYVAKIT for ISM.

Cognitive effects:

Cognitive side effects can happen during treatment with AYVAKIT and can be severe. Tell your healthcare provider if you develop any new or worsening cognitive symptoms including forgetfulness, confusion, getting lost, trouble thinking, drowsiness, trouble staying awake (somnolence), word-finding problems, seeing objects or hearing things that are not there (hallucinations), or a change in mood or behavior.

Skin sensitivity to sunlight (photosensitivity):

Your skin may be sensitive to the sun or other forms of light (photosensitivity) during treatment with AYVAKIT. Avoid or limit exposure to direct sunlight, sunlamps, and other sources of ultraviolet radiation during treatment and for 1 week after stopping treatment with AYVAKIT. Use sunscreen or wear clothes that cover your skin if you need to be out in the sun.

Other side effects of AYVAKIT for ISM:

The most common side effects of AYVAKIT in people with ISM include: swelling around your eyes, dizziness, swelling of your arms and legs, and flushing.

These are not all of the possible side effects of AYVAKIT. Inform your doctor about any side effects you experience.

Do not drive or operate hazardous machinery if you have confusion or trouble thinking during treatment with AYVAKIT.

Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with AYVAKIT if you develop certain side effects. AYVAKIT may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider may temporarily stop, or permanently stop treatment with AYVAKIT if you develop certain side effects.

These are not all of the possible side effects of AYVAKIT. Call your doctor for medical advice about side effects.

Get resources to help on your treatment journey

YourBlueprint^® is a patient support program designed to assist you with personalized support right from the start of your treatment with AYVAKIT by providing: