ISM

For U.S. residents only ages 18+

ISM

AdvSM

PDGFRA GIST

Starting Treatment for Indolent Systemic Mastocytosis (ISM)

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Patient Portrayal

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What comes next in your treatment journey

Once you’ve been prescribed AYVAKIT, it’s important to understand your coverage, know the financial assistance options available and learn how you’ll receive your treatment.

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Will my prescription be covered?

Over 98% of all commercial insurance plans and 99% of Medicare plans offer coverage for AYVAKIT. Approximately 93% of patients with commercial insurance paid $0 per month with help from their insurance and the YourBlueprint Co-Pay Card* when they accessed AYVAKIT through our network of specialty pharmacies.

*Data on coverage and co-pay assistance is as of August 2023. Cost-sharing data is for those patients with commercial insurance.

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Exploring financial assistance options

We offer several programs to help you navigate payment for your prescription if needed. With the Co-pay Assistance Program, you may be eligible to pay $0 for your prescription.

For those who qualify, this program covers:

  • Co-pay
  • Co-insurance
  • Deductible expenses

Up to an annual maximum benefit of $25,000. Terms and conditions apply.

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Receiving your prescription

Once you’ve been prescribed AYVAKIT, your doctor sends your prescription to an eligible pharmacy or to YourBlueprint®. The pharmacy will verify your insurance coverage and work directly with your healthcare provider to obtain prior authorization if needed. Then, when coverage is approved, your pharmacy will contact you to communicate your out-of-pocket costs and arrange for delivery or pickup of your medication.

How do I take AYVAKIT?

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One 25 mg tablet

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Taken once a day or as directed

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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. Especially tell your healthcare provider if you take medicines that prevent blood clots.
  • 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

While taking AYVAKIT, it’s important to track your symptoms and any side effects you experience. Keep your scheduled follow-up visits with your doctor so they can monitor your condition while taking AYVAKIT.

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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.

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Discover a treatment that targets an underlying cause of ISM in about 95% of patients.

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.

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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, nausea, vomiting, vision changes, 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.

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Want to know more about what may be possible with AYVAKIT?

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INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with indolent systemic mastocytosis (ISM). AYVAKIT is not recommended in people with low platelet counts (less than 50 X 109/L).

It is not known if AYVAKIT is safe and effective in children.

IMPORTANT SAFETY INFORMATION

AYVAKIT® (avapritinib) 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, nausea, vomiting, vision changes, 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.

Before taking AYVAKIT, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of bulging or weakening of a blood vessel wall (aneurysm) or bleeding in your brain
  • have a history of stroke within the last year
  • have low platelet counts
  • have or have had liver problems
  • are pregnant or plan to become pregnant. AYVAKIT can cause harm to your unborn baby
  • Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start AYVAKIT. You should use effective birth control (contraception) during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AYVAKIT.
  • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 6 weeks after the final dose of AYVAKIT.
  • are breastfeeding or plan to breastfeed. It is not known if AYVAKIT passes into your breast milk. Do not breastfeed during treatment with AYVAKIT and for at least 2 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AYVAKIT may affect the way other medicines work, and certain other medicines may affect how AYVAKIT works. Especially tell your healthcare provider if you take medicines that prevent blood clots.

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

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.

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.

These are not all of the possible side effects of AYVAKIT. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for AYVAKIT.

IMPORTANT SAFETY INFORMATION

AYVAKIT® (avapritinib) 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, nausea, vomiting, vision changes, 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.

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with indolent systemic mastocytosis (ISM). AYVAKIT is not recommended in people with low platelet counts (less than 50 X 109/L).

It is not known if AYVAKIT is safe and effective in children.

INDICATION & IMPORTANT SAFETY INFORMATION

AYVAKIT® (avapritinib) 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

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with indolent systemic mastocytosis (ISM). AYVAKIT is not recommended in people with low platelet counts (less than 50 X 109/L).

It is not known if AYVAKIT is safe and effective in children.

IMPORTANT SAFETY INFORMATION

AYVAKIT® (avapritinib) 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, nausea, vomiting, vision changes, 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.

Before taking AYVAKIT, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of bulging or weakening of a blood vessel wall (aneurysm) or bleeding in your brain
  • have a history of stroke within the last year
  • have low platelet counts
  • have or have had liver problems
  • are pregnant or plan to become pregnant. AYVAKIT can cause harm to your unborn baby
  • Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start AYVAKIT. You should use effective birth control (contraception) during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with AYVAKIT.
  • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 6 weeks after the final dose of AYVAKIT.
  • are breastfeeding or plan to breastfeed. It is not known if AYVAKIT passes into your breast milk. Do not breastfeed during treatment with AYVAKIT and for at least 2 weeks after the final dose of AYVAKIT. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AYVAKIT may affect the way other medicines work, and certain other medicines may affect how AYVAKIT works. Especially tell your healthcare provider if you take medicines that prevent blood clots.

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

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.

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.

These are not all of the possible side effects of AYVAKIT. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for AYVAKIT.