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PDGFRA GIST

What to Know About AYVAKIT® (avapritinib)

AYVAKIT is a prescription medicine used to treat PDGFRA GIST in adults.

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AYVAKIT targets specific mutations to prevent the growth and spread of PDGFRA GIST cancer cells

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

Taking AYVAKIT
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Who is AYVAKIT for?

  • AYVAKIT is a prescription medicine used to treat adults with a stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST). Particularly, it's for those with a GIST that can't be treated with surgery or that has spread to other body parts, and that have a mutation in the platelet-derived growth factor receptor alpha (PDGFRA) gene.
  • Your healthcare provider will perform a test to make sure that you have this abnormal PDGFRA gene and that AYVAKIT is right for you.
  • It is not known if AYVAKIT is safe and effective in children.
Learn more about PDGFRA GIST

AYVAKIT was proven to work against GIST with a PDGFRA exon 18 mutation

AYVAKIT was studied in a clinical trial called NAVIGATOR. The trial included 43 people with PDGFRA exon 18 mutations, 38 of whom had the PDGFRA D842V mutation.

84% of 43 PEOPLE RESPONDED:

33 people (77%) had their tumors shrink by at least 30% (partial response)

3 people (7%) had their tumors completely disappear (complete response)

IN ADDITION:

6 people (14%) had no change in their tumor size (stable disease)

1 person (2%) had their tumor grow (progressive disease)

Pie chart showing how Ayvakit was proven to work against GIST with a PDGFRA exon 18 mutation.

For the 38 people with a PDGFRA D842V mutation, 89% responded. Thirty-one people (82%) had a partial response and 3 people (8%) had a complete response.

It’s important to note that a having a response does not mean the cancer has been cured.

Individual results may vary.

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Is AYVAKIT right for you?

Before taking any medication, it’s important to understand its 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 doctor immediately 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.

Cognitive effects:

Cognitive side effects can happen during treatment with AYVAKIT and can be severe. Tell your doctor 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)
  • 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.

Common side effects to treatment were:

  • Fluid retention or swelling
  • Nausea
  • Tiredness or weakness
  • Trouble thinking
  • Vomiting
  • Decreased appetite
  • Diarrhea
  • Increased eye tearing
  • Stomach area (abdominal) pain
  • Constipation
  • Rash
  • Dizziness
  • Hair color changes
  • Changes in certain blood tests

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.

AYVAKIT may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with a certain type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST) that cannot be treated with surgery or that has spread to other parts of the body (metastatic), and that is caused by certain abnormal platelet-derived growth factor receptor alpha (PDGFRA) genes. Your healthcare provider will perform a test to make sure that you have this abnormal PDGFRA gene and that AYVAKIT is right for you. 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:

  • 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 estrogen-containing hormonal birth control or 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 GIST include: fluid retention or swelling, nausea, tiredness or weakness, trouble thinking, vomiting, decreased appetite, diarrhea, increased eye tearing, stomach area (abdominal) pain, constipation, rash, dizziness, hair color changes 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.

AYVAKIT is available in 100-mg, 200-mg and 300-mg tablets.

Please click here to see the full Prescribing Information and Patient Information for AYVAKIT.

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 AYVAKIT and tell your healthcare provider right away if you develop any symptoms such as severe headache, nausea, vomiting, vision changes, drowsiness, dizziness,

INDICATION & IMPORTANT SAFETY INFORMATION

Warning: AYVAKIT® (avapritinib) may cause serious side effects, including bleeding in your brain, cognitive effects, skin sensitivity to sunlight (photosensitivity), harm to your unborn baby.

IMPORTANT SAFETY INFORMATION & INDICATION

Warning: AYVAKIT® (avapritinib) may cause serious side effects, including bleeding in your brain, cognitive effects, skin sensitivity to sunlight (photosensitivity), harm to your unborn baby.

INDICATION

WHAT IS AYVAKIT® (avapritinib)?

AYVAKIT® (avapritinib) is a prescription medicine used to treat adults with a certain type of stomach, bowel, or esophagus cancer called gastrointestinal stromal tumor (GIST) that cannot be treated with surgery or that has spread to other parts of the body (metastatic), and that is caused by certain abnormal platelet-derived growth factor receptor alpha (PDGFRA) genes. Your healthcare provider will perform a test to make sure that you have this abnormal PDGFRA gene and that AYVAKIT is right for you. 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.

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:

  • 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
  • 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 estrogen-containing hormonal birth control or 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 GIST include: fluid retention or swelling, nausea, tiredness or weakness, trouble thinking, vomiting, decreased appetite, diarrhea, increased eye tearing, stomach area (abdominal) pain, constipation, rash, dizziness, hair color changes 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.

AYVAKIT is available in 100-mg, 200-mg and 300-mg tablets.

Please click here to see the full Prescribing Information and Patient Information for AYVAKIT.