What is Ayvakit?
Ayvakit 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.
- 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 this medicine is safe and effective in children.
Before taking Ayvakit
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- 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 treatment.
- You should use effective birth control (contraception) during treatment, and for 6 weeks after the final dose. 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.
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.
- are breastfeeding or plan to breastfeed. It is not known if Ayvakit passes into your breast milk. Do not breastfeed during treatment, and for at least 2 weeks after the final dose. 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. Talk to your healthcare provider prior to starting a new medicine.
How should I take Ayvakit?
- Take Ayvakit exactly as your healthcare provider tells you to take it.
- Do not change your dose or stop taking Ayvakit unless your healthcare provider tells you to.
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Ayvakit if you develop side effects.
- Take Ayvakit 1 time each day.
- Take Ayvakit tablet(s) on an empty stomach at least 1 hour before, and at least 2 hours after a meal.
- If you miss a dose of Ayvakit, take it as soon as you remember unless your next scheduled dose is due within 8 hours. 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.
What to avoid
- Do not drive or operate heavy machinery, if you have confusion or trouble thinking during treatment with Ayvakit.
Ayvakit side effects
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, vomiting, drowsiness, dizziness, confusion, or severe weakness on one or more side of your body. If you have AdvSM, your healthcare provider will check your platelet counts before and during treatment with Ayvakit.
- Cognitive effects. Cognitive side effects are common with Ayvakit and can be severe. Tell your healthcare provider if you develop any new or worsening cognitive symptoms including:
- getting lost
- trouble thinking
- trouble staying awake (somnolence)
- word finding problems
- seeing objects or hearing things that are not there (hallucinations)
- change in mood or behavior
The most common side effects in people with GIST include:
- fluid retention or swelling
- muscle weakness
- decreased appetite
- increased eye tearing
- stomach area (abdominal) pain
- hair color changes
- changes in certain blood tests
The most common side effects in people with AdvSM include:
- fluid retention or swelling
- changes in certain blood tests
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you develop certain side effects.
Ayvakit may cause fertility problems in females and may decrease sperm production in males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Ayvakit?
- Store Ayvakit tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Ayvakit.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not take this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information that is written for health professionals.
What are the ingredients in Ayvakit?
Active ingredient: avapritinib
Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Film coat: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Blue printing ink: ammonium hydroxide, black iron oxide, esterified shellac, FD&C blue 1, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide.
More about Ayvakit (avapritinib)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: multikinase inhibitors
- FDA Approval History
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.