Transcript
Onscreen text:
PATIENT STORIES
GLORIA
For US Healthcare Professionals Only
Real Patient
[AYVAKIT 25mg logo]
AYVAKIT® (avapritinib) is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).
Limitations of Use: AYVAKIT is not recommended for the treatment of patients with ISM with platelet counts of <50 x 109/L.
Please see additional Important Safety Information near the end of this video. Visit AYVAKITPI.com to see the full Prescribing Information for AYVAKIT.
Gloria:
My name is Gloria. I am from Springfield, Missouri. My husband and I have lived here for 28 years. Michael and I love to travel. We've been to all of the United States except five. I was diagnosed with indolent systemic mastocytosis in 2002.
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Gloria
Springfield, MO
Diagnosed with indolent systemic mastocytosis (ISM) in 2002
Gloria does not provide medical advice. Gloria was paid by Blueprint Medicines.
Gloria:
Looking back, my first symptom was fatigue. Extreme fatigue. I'm the caregiver for my husband who had been diagnosed with a brain tumor, and I had to do all the driving. I thought that's why I was so fatigued. It upset me that I couldn't do things sometimes because I was too tired, too fatigued, and the heat limits me.
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... I couldn't do things because I was too tired, too fatigued ...
Gloria:
So I can't do a lot outside in the summer. I just felt like I was going to fall, at any moment. I was confused because I didn't know what type of doctor to go to. I knew something was physically wrong, but I didn't know what.
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... I knew something was physically wrong, but I didn't know what...
Gloria:
And then, I noticed spots on my thighs, and I went to the dermatologist.
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These are example patient images and may not represent all patients.
Gloria:
He biopsied one of my reddish-brown spots, and when it came back positive for systemic mastocytosis, he said, "I'm sending you to an oncologist." I saw her, and she said, "I'm sending you to an allergist."
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I was scared. I didn't know what to do, especially when they said it was rare. I was scared.
Gloria:
I was scared. I didn't know what to do, especially when they said it was rare. I was scared. There are many triggers with this disease, or it can just happen. And I would get hives that itched so bad. Really, really bad. I would get red. The flushing would be sometimes over my entire body, but mostly my face and my chest area. Itchy and painful. Hot. Extremely hot, all the time. GI issues are explosive. They come on suddenly. I never knew when I was going to have a reaction that would lead to anaphylaxis, so I had to be very careful.
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No matter what I did, I could go into a reaction at any time ...
Gloria:
No matter what I did, I could go into a reaction at any time, take my over-thecounter meds, religiously, same time every day, and I would still have GI issues. I would still have a reaction. They didn't always progress to anaphylaxis, but they were miserable. That interrupts our travel life. We find the closest hospital; we make sure we stay nearby ... it just affects your life daily. My local allergist told me about AYVAKIT.
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AYVAKIT is the first and only FDA-approved treatment for adults with ISM.
AYVAKIT is not recommended for patients with low platelet counts (<50 x 109/L).
Gloria:
Starting AYVAKIT has really helped me manage my symptoms.
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In a clinical trial, patients receiving AYVAKIT had greater symptom reduction vs placebo at 24 weeks. Both groups continued best supportive care. Symptoms evaluated included brain fog, headache, dizziness, spots, itching, flushing, abdominal pain, nausea, bone pain and fatigue.
Gloria:
Deciding to take AYVAKIT is the best decision I could have made with my doctor.
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Deciding to take AYVAKIT is the best decision I could have made with my doctor.
Gloria:
With AYVAKIT, I can treat the source of ISM. Mastocytosis messed with the wrong girl.
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Treat the source of ISM
Images and voices of patient and spouse used with consent.
Indication and Important Safety Information (Voice-over):
INDICATION
AYVAKIT® (avapritinib) is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).
Limitations of Use: AYVAKIT is not recommended for the treatment of patients with ISM with platelet counts of less than 50,000 per microliter.
IMPORTANT SAFETY INFORMATION
Cognitive adverse reactions can occur in patients receiving AYVAKIT and occurred in 7.8% of patients with ISM who received AYVAKIT plus best supportive care (BSC) versus 7% of patients who received placebo plus BSC; less than 1% were Grade 3. Depending on the severity, withhold AYVAKIT and then resume at the same dose, or permanently discontinue AYVAKIT.
AYVAKIT may cause photosensitivity reactions. In all patients treated with AYVAKIT in clinical trials (n=1049), photosensitivity reactions occurred in 2.5% of patients. Advise patients to limit direct ultraviolet exposure during treatment with AYVAKIT and for one week after discontinuation of treatment.
AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective contraception during treatment with AYVAKIT and for 6 weeks after the final dose. Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks following the final dose.
The most common adverse reactions (greater than or equal to 10%) in patients with ISM were eye edema, dizziness, peripheral edema, and flushing.
Avoid coadministration of AYVAKIT with strong or moderate CYP3A inhibitors or inducers. If contraception requires estrogen, limit ethinyl estradiol to less than or equal to 20 micrograms unless a higher dose is necessary.
AYVAKIT is available in 25mg tablets.
To report suspected adverse reactions, contact Blueprint Medicines Corporation at 1-888-258-7768 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please click here to see the full Prescribing Information for AYVAKIT.
06/2025 USAVA25.0061.1
