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Uses

What is Ayvakit used for?

Ayvakit is commonly used for the following conditions.

  • Gastrointestinal stromal tumor, which is a cancer that forms in the walls of the digestive tract
  • Certain types of mastocytosis, which is a blood disorder where too many mast cells, a type of white blood cell, build up in your body  

Navigating Systemic Mastocytosis: What to Know About Ayvakit.

Ayvakit may also be used for other conditions as determined by your healthcare provider.

How does Ayvakit work (mechanism of action)?

Ayvakit works by blocking kinase proteins that help certain cells grow. These proteins can have changes (mutations) that make them too active, leading to excess growth or tumors. Ayvakit targets these proteins, helping to block the growth of cells that have these changes.

How is Ayvakit supplied (dosage forms)?

Ayvakit is available in the following dosage forms that are taken by mouth.

  • 25 mg oral tablets
  • 50 mg oral tablets
  • 100 mg oral tablets
  • 200 mg oral tablets
  • 300 mg oral tablets

How should I store Ayvakit?

Ayvakit should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Ayvakit?

The most common side effects of Ayvakit are listed below. These side effects may vary depending on the condition that is being treated. Tell your healthcare provider if you have any of these side effects that bother you.

  • Fluid retention
  • Nausea and vomiting
  • Tiredness or feeling unusually weak
  • Confusion or other brain problems (see below)
  • Low appetite
  • Diarrhea or constipation
  • Watery eyes
  • Stomach pain
  • Rash
  • Dizziness
  • Changes in your hair color
  • Fluid buildup around your eyes
  • Swelling of your feet, legs, or arms
  • Flushing

There may be other side effects of Ayvakit that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ayvakit?

While less common, the most serious side effects of Ayvakit are described below, along with what to do if they happen.

Severe Allergic Reactions. Ayvakit may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Bleeding in the brain. While rare, bleeding in the brain (intracranial hemorrhage) may occur while taking Ayvakit, which can be life-threatening. Get help right away if you have any of the following symptoms of a possible brain bleed.

  • Headache
  • Nausea or vomiting
  • Changes in vision
  • Confusion or unusual changes in mood or behavior

Confusion or other brain problems. Ayvakit can affect your brain and lead to problems with thinking and memory. Call your healthcare provider right away if you have confusion or any of the following symptoms of brain problems.

  • Sleepiness
  • Forgetfulness or getting lost 
  • Trouble with thinking or finding words
  • Unusual changes in mood or behavior
  • Seeing or hearing things that others do not see or hear, also called hallucinations

Sensitivity to Sunlight. Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking Ayvakit. This is called photosensitivity. Use sunscreen and wear a hat and clothes that cover your skin if you need to be in the sunlight during Ayvakit treatment and for a week after your last dose. Exposing your skin to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your healthcare provider right away if any of these happen.

Warnings & Precautions

Who should not take Ayvakit?

Allergies to Ingredients. People who are allergic to any of the following should not take Ayvakit.

  • Ayvakit
  • Avapritinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ayvakit.

What should I know about Ayvakit before taking it?

Do not take Ayvakit unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Ayvakit with other people, even if they have the same condition as you. It may harm them.

Keep Ayvakit out of the reach of children.

Ayvakit can affect your thinking and cause sleepiness. Do not drive or do other activities that require clear thinking and alertness until you know how Ayvakit affects you.

Ayvakit can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.

Ayvakit can cause harm to an unborn baby. If you or your partner are able to get pregnant, use effective birth control while taking Ayvakit and for 6 weeks after your last dose. 

Ayvakit may affect your ability to get pregnant or father a child. Talk with your healthcare provider if you have concerns about this.

What should I tell my healthcare provider before using Ayvakit?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ayvakit is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

Other Medicines and Supplements. Ayvakit may interact with other medicines and supplements. Before taking Ayvakit, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Ayvakit can cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider may give you a pregnancy test to make sure you are not pregnant before starting Ayvakit.

Breastfeeding. It is not known if Ayvakit passes into breast milk. Do not breastfeed while taking Ayvakit and for at least 2 weeks after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Ayvakit?

For more information about Ayvakit, you can visit the manufacturer’s website at www.ayvakit.com or call them at 888-258-7768.

Interactions

Does Ayvakit interact with foods or drinks?

Ayvakit should be taken on an empty stomach. Avoid taking Ayvakit within 1 hour before a meal or within 2 hours after a meal.

Your healthcare provider may recommend avoiding grapefruit and grapefruit juice while taking Ayvakit. Grapefruit may raise the levels of certain medicines in your body, including Ayvakit, which can increase the risk of side effects.

It is unknown if drinking alcohol will affect Ayvakit. The risk of sleepiness or dizziness may be increased if you drink alcohol while taking Ayvakit.

Does Ayvakit interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ayvakit.

  • Itraconazole (Sporanox, Tolsura) or fluconazole (Diflucan), which are medicines used for fungal infections
  • Rifampin, which is a medicine used to treat an infection called tuberculosis
  • Efavirenz, which is a medicine used to treat HIV
  • A blood thinner, which is a medicine used to treat or prevent blood clots

Many other medicines may alter the blood levels of Ayvakit. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ayvakit. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally take too much Ayvakit?

If you or someone else has taken too much Ayvakit, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ayvakit?

If you miss a dose, take it as soon as possible unless your next dose is due in the next 8 hours. In that case, skip the missed dose and only take the next dose. Do not take double or extra doses. 

If you vomit after taking a dose of Ayvakit, do not take another dose to make up for it. Just take your next dose as scheduled.