ISM

For U.S. residents only ages 18+

ISM

AdvSM

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Taking AYVAKIT® (avapritinib) for Advanced Systemic Mastocytosis

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How to take AYVAKIT for Advanced Systemic Mastocytosis (AdvSM)

The recommended dose of AYVAKIT is 200 mg orally once daily. Your doctor may change, temporarily stop, or permanently stop treatment with AYVAKIT if you develop side effects.

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One 200-mg AYVAKIT tablet

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Taken one time each day

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

Take AYVAKIT exactly as prescribed by your doctor. Do not change your dose or stop taking AYVAKIT unless your doctor tells you to. Before taking AYVAKIT, tell your doctor about all of your medical conditions and the medicines you take.

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.

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Want to learn more about AYVAKIT® (avapritinib)?

What is AYVAKIT?
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Before taking AYVAKIT, tell your doctor:

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

How often will my doctor monitor my blood counts?

Monitoring blood counts by collecting regular samples is part of tracking your response to treatment and potential side effects. Your doctor will monitor your blood counts before you start treatment and throughout the treatment course according to the following schedule:

Chart with icons of blood droplet in laboratory vial, showing how doctor monitors blood counts according to the following schedule: Start of treatment, week 2, week 4, week 6, week 8.

Starting Treatment

Chart with icons of blood droplet in laboratory vial, showing how doctor monitors blood counts according to the following schedule: Start of treatment, week 2, week 4, week 6, week 8.

Week 2

Chart with icons of blood droplet in laboratory vial, showing how doctor monitors blood counts according to the following schedule: Start of treatment, week 2, week 4, week 6, week 8.

Week 4

Chart with icons of blood droplet in laboratory vial, showing how doctor monitors blood counts according to the following schedule: Start of treatment, week 2, week 4, week 6, week 8.

Week 6

Chart with icons of blood droplet in laboratory vial, showing how doctor monitors blood counts according to the following schedule: Start of treatment, week 2, week 4, week 6, week 8.

Week 8

After 8 weeks, your doctor will determine how frequently to monitor your blood platelet counts.

Monitoring how you are feeling

Your doctor will also discuss with you monitoring and tracking side effects that may occur during treatment with AYVAKIT.

How does AYVAKIT work?

About 95% of patients with AdvSM have the KIT D816V mutation which can lead to the uncontrolled growth of abnormal mast cells.

Healthy Individuals

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Normal levels of mast cells

The body makes mast cells as part of an inflammatory response to keep us healthy.

AdvSM

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Abnormal levels of mast cells

In patients with AdvSM, abnormal mast cells are overproduced and can build up in parts of the body.

The overproduction of mast cells can cause you to experience the symptoms and organ damage observed in AdvSM. You do not have to have the KIT D816V mutation to be prescribed AYVAKIT.

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AYVAKIT targets an underlying mutation to help slow the growth of mast cells.

A mutation is a change to a gene, which may lead to diseases.

People who care for you can help

Your doctor will want to know if you are experiencing any cognitive symptoms or other serious side effects while on treatment. Work with your doctor to come up with a list of questions that can help you monitor for any cognitive effects, such as how often in the past week you:

  • Had trouble finding your way to a familiar place
  • Lost your wallet or keys
  • Had to search for words
  • Seemed confused or lost
  • Forgotten why you walked into a room
  • Written lists to keep from forgetting things
  • Found it difficult to keep track of what you were doing

Enlist the help of a caregiver, friend, or family member to go through the questions with you periodically. You should both be looking for changes in your answers so that you can alert your doctor immediately if you think you are having cognitive effects.

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Get resources to help on your treatment journey

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

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1-on-1 support

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Financial assistance options

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Helpful resources

For more information

Visit YourBlueprint.com

or call us at 1-888-258-7768 Monday–Friday, 8 AM–8 PM
Eastern Time (ET)

Co-Pay Assistance Program

You may be eligible to
pay as little as $0
for your prescription.†

Co-pay assistance card for reduced co-pay with a similar look to a health insurance card.
†Up to an annual maximum benefit of $25,000. Terms and conditions apply.

For those who qualify, this program covers:

  • Co-pay
  • Co-insurance
  • Deductible expenses
Sign up for co-pay card

Read the terms and conditions, or call us at
1-888-BLUPRNT (1-888-258-7768) to learn more.

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INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). AYVAKIT is not recommended for the treatment of AdvSM 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. Your healthcare provider will check your platelet counts before and during treatment with AYVAKIT.

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 AdvSM include: fluid retention or swelling, diarrhea, nausea, tiredness or weakness, and changes in certain blood tests.

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. Your healthcare provider will check your platelet counts before and during treatment with AYVAKIT.

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). AYVAKIT is not recommended for the treatment of AdvSM in people with low platelet counts (less than 50 x 109/L).

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

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with advanced systemic mastocytosis (AdvSM), including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). AYVAKIT is not recommended for the treatment of AdvSM 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. Your healthcare provider will check your platelet counts before and during treatment with AYVAKIT.

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 AdvSM include: fluid retention or swelling, diarrhea, nausea, tiredness or weakness, and changes in certain blood tests.

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.