ISM

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ISM

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What to Know About AYVAKIT® (avapritinib)

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AYVAKIT is the first and only FDA-approved treatment for adults with indolent systemic mastocytosis (ISM)

AYVAKIT is not recommended for the treatment of ISM in people with low platelet counts (less than 50 x 109/L).

Clinical Trial Results

AYVAKIT is clinically proven to help reduce the symptoms of ISM

The efficacy and safety of AYVAKIT was studied in a randomized, placebo-controlled clinical trial with 212 adults over 24 weeks. Each patient had moderate to severe ISM symptoms, despite taking at least 2 symptom-directed therapies. 141 received AYVAKIT and 71 received placebo. Both AYVAKIT- and placebo-treated patients continued their best supportive care.

Graphic indicating clinical trial results
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Patients who took AYVAKIT had a reduction in their overall ISM symptoms

In the clinical trial, patients were asked to report the severity of 11 symptoms on a scale from 0 (none) to 10 (worst). These numbers were then combined to produce a total symptom score, a tool to help measure the efficacy of AYVAKIT.

In the trial, patients taking AYVAKIT plus best supportive care reported a significantly lower total symptom score compared with patients taking placebo plus best supportive care.

Individual results may vary. It is important to note that having a response to treatment does not mean a person’s ISM has been cured.

AYVAKIT plus best supportive care reduced overall symptoms of ISM

Patients' total symptom score was reduced by 15.3 points with AYVAKIT vs. 9.6 points with placebo at 24 weeks.

AYVAKIT + BEST SUPPORTIVE CARE

(N=141)

-15.3

average point reduction in total symptom score

PLACEBO + BEST SUPPORTIVE CARE

(N=71)

-9.6

average point reduction in total symptom score

AYVAKIT plus best supportive care significantly reduced symptoms of ISM,* including:

*Reduction of total symptom score does not imply impact on each symptom

  • Brain fog
  • Dizziness
  • Headache
  • Fatigue
  • Flushing
  • Bone pain
  • Itching
  • Spots on the skin
  • Abdominal pain
  • Diarrhea
  • Nausea

*Reduction of total symptom score does not imply impact on each symptom

Other results from the clinical trial

68% of patients on AYVAKIT plus best supportive care saw a reduction of KIT D816V frequency in their blood by at least half vs. 6% on placebo plus best supportive care at 24 weeks

68%

of patients

AYVAKIT + BEST SUPPORTIVE CARE
(N=118)

6%

of patients

PLACEBO + BEST SUPPORTIVE CARE
(N=63)

More patients on AYVAKIT plus best supportive care saw a reduction by at least half of mast cells in the bone marrow or no buildup of mast cells vs. placebo plus best supportive care at 24 weeks

53%

of patients

AYVAKIT + BEST SUPPORTIVE CARE
(N=106)

23%

of patients

PLACEBO + BEST SUPPORTIVE CARE
(N=57)

Over half the patients on AYVAKIT plus best supportive care had achieved at least a 50% reduction in serum tryptase vs. placebo plus best supportive care at 24 weeks

54%

of patients

AYVAKIT + BEST SUPPORTIVE CARE
(N=141)

0%

of patients

PLACEBO + BEST SUPPORTIVE CARE
(N=71)

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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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.