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.
