Patient leaflet - Ayvakyt 100 mg film-coated tablets
1. What AYVAKYT is and what it is used for
YT
any other medicines. AY certain other medicines
Tell your doctor or ph the following medicin
The following medicine side effects:
- Boceprevir – used t
- Cobicistat, indinavir,
What AYVAKYT is
AYVAKYT is a medicine containing the active subst
What AYVAKYT is used for
AYVAKYT is used in adults to treat:
a type of digestive tract cancer called gastroint when it cannot be treated with surgery (unrese parts of the body (metastatic) and that has a sp gene for platelet-derived growth factor recepto
ance avapritinib.
estinal stromal tumour (GIST), ctable) or has spread to other ecific mutation (D842V) in the r alpha (PDGFRA) protein kinase.
infections/AIDS
- Clarithromycin, eryt
- Itraconazole, ketoco fungal infections
- Conivaptan – used t
The following medicine
- Rifampicin – used t
- Carbamazepine, ph treat epilepsy
- St. John’s wort (Hyp
- aggressive systemic mastocytosis (ASM), syste haematological neoplasm (SM-AHN), or mast c disorders in which the body produces too many blood cell. Symptoms are caused when too ma organs of your body, such as the liver, bone ma cells also release substances such as histamin symptoms that you may be experiencing as we ASM, SM-AHN and MCL are collectively referre mastocytosis (AdvSM).
How AYVAKYT works
mic mastocytosis with associated ell leukaemia (MCL). These are mast cells, a type of white ny mast cells enter various rrow or spleen. These mast e which cause various general ll as damage to involved organs. d to as advanced systemic
depression
- Bosentan – used to
- Efavirenz and etravi
- Modafinil – used to
- Dabrafenib – used t
- Nafcillin – used to tr
- Dexamethasone – u
Avapritinib may increas
- Pimozide - used to t
AYVAKYT stops the activity of a group of proteins in cells in patients with AdvSM or cells that make up (mutations) in the genes involved in making specifi growth and spread of these cells.
If you have any questions about how AYVAKYT wor prescribed for you, please ask your doctor.
2. What you need to know before you take AYV
the body called kinases. Mast the cancer usually have changes c kinases associated with the ks or why this medicine has been
AKYT
- Amiodarone - used
- Citalopram, escitalo
- Ondansetron - used - Ethinyl estradiol - h
Ask your doctor or phar
AYVAKYT with food an
You should not drink gr AYVAKYT.
Do not take AYVAKYT:
if you are allergic to avapritinib or any of the ot
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking AYV
- if you have suffered a vascular aneurysm (b vessel wall) or bleeding in your brain in the la
- if you have low platelet counts.
if you are taking a medicine that thins the b
her ingredients of this medicine
AKYT:
ulging and weakening of a blood st year.
lood to prevent blood clots
Pregnancy, breast-fee
If you are pregnant or b have a baby, ask your d
Pregnancy
This medicine is not re necessary. Avoid becom may harm your unborn taking AYVAKYT during such as warfarin, phenprocoumon, rivaroxa edoxaban or another medicine that thins the
Take special care with this medicine:
You may develop symptoms such as severe he severe sleepiness, or severe weakness on o bleeding in your brain). If these occur, contac temporarily stop treatment. For patients with Ad your platelet counts before you start treatment during your treatment with avapritinib.
ban, dabigatran, apixaban, blood to prevent blood clots.
adache, vision problems, ne side of your body (signs of t your doctor immediately and vSM, your doctor will evaluate and monitor them as needed
Your doctor may check medicine.
Women who are able to treatment and for at lea partners who are able t during treatment and fo doctor about effective c
Breast-feeding
Tell your doctor if you a
- Treatment with this medicine may lead to a hig can cause bleeding in the digestive system suc intestine. In patients with GIST, avapritinib can well as bleeding of the tumour. Tell your doctor problems. Before you start taking avapritinib yo tests. Get medical help immediately, if you get t blood in the stools or passing black stools, stom up blood.
You may also develop memory loss, changes
(signs of a cognitive effect). Avapritinib can s and how you remember information. Contact yo
her risk of bleeding. Avapritinib h as stomach, rectum or also cause bleeding in the liver, as if you had or have any bleeding ur doctor may decide to do blood he following symptoms: passing ach pain, coughing/vomiting in memory, or be confused ometimes change how you think ur doctor in case you experience
if AYVAKYT passes into with this medicine and doctor about the best w
Fertility
AYVAKYT may cause fer this is a concern for yo
Driving and using ma
AYVAKYT may cause sy these symptoms or in case a family member, c you notices that you are getting forgetful or con
- During treatment with this medicine, tell your d weight very quickly, develop swelling of you breathing or become short of breath. This m retain water (severe fluid retention).
Avapritinib may cause abnormality of your he
aregiver or someone who knows fused.
octor straight away if you put on r face or limbs, have difficulty edicine may cause your body to art rhythm. Your doctor may
section 4). Therefore, A Take special care when side effects.
AYVAKYT contains so
This medicine contains essentially “sodium-fre
luate these problems during your treatment with avapritinib u feel dizzy, faint, or have abnormal heartbeats while taking stomach and bowel problems (diarrhoea, nausea and ical help immediately if you experience these symptoms. ore sensitive to the sun while taking this medicine. It is un-exposed areas of skin and use sunscreen with high sun F).
.
3. How to take AYVAKYT
Always take this medicine exactly as your doctor or pha with your doctor or pharmacist if you are not sure.
Which strength of AYVAKYT to use
The recommended dose of AYVAKYT will depend on you AYVAKYT is available in different strength tablets. The st 100 mg, 200 mg and 300 mg. Your doctor will advise yo apritinib, your doctor will ask you to have regular blood test d regularly.
ee section 4.
nts studied in children and adolescents under age 18. Do not ildren or adolescents under the age of 18 years.
AYVAKYT macist if you are taking, have recently taken or might take
s. number of tablets you should take:
Treatment of GIST
The recommended dose is 300 mg by mouth once daily
Treatment of AdvSM
The recommended dose is 200 mg by mouth once daily
If you have liver problems, your doctor may start you on
VAKYT may affect the way other medicines work, and may affect how this medicine works.
armacist before taking AYVAKYT if you are taking any of es:
s can increase the effects of avapritinib and may increase it
o treat hepatitis C lopinavir, nelfinavir, ritonavir, saquinavir – used to treat HIV
s
If you get side effects, your doctor may change your dos permanently stop treatment. Do not change your dose o unless your doctor tells you to.
Swallow the AYVAKYT tablet(s) whole with a glass of wa Do not eat for at least 2 hours before and at least 1 hou
If you vomit after taking a dose of AYVAKYT, do not take next dose at your scheduled time.
If you take more AYVAKYT than you should hromycin, telithromycin – used to treat bacterial infections nazole, posaconazole, voriconazole – used to treat serious
o treat low blood sodium levels (hyponatraemia)
s can reduce the effects of avapritinib:
o treat tuberculosis (TB) and some other bacterial infections enytoin, fosphenytoin, primidone, phenobarbital – used to ericum perforatum) – an herbal medicine used for treat high blood pressure rine – used to treat HIV infections/AIDS treat sleep disorders
o treat certain cancers eat certain bacterial infections sed to reduce inflammation e the side effects of the following medicines: reat psychosis and Tourette disorder to treat heart rhythm problems pram - used to treat depression to treat nausea or vomiting ormonal oral contraceptive macist for advice before taking any medicine.
d drink apefruit juice or eat grapefruit while on treatment with ding and fertility reast-feeding, think you may be pregnant or are planning to octor or pharmacist for advice before taking this medicine.
commended for use during pregnancy unless clearly ing pregnant while being treated with this medicine as it baby. Your doctor will discuss with you the potential risks of pregnancy.
- dryness affecting eyes, lips, mouth and skin
- heartburn
- change in hair colour
- rash
- swelling (e.g. feet, ankle, face, eye, joint)
- tiredness
- blood tests showing decrease in red blood cells (ana
- blood tests showing increased stress on the liver an a substance produced by the liver
Common (may affect up to 1 in 10 people):
if you are pregnant before you start treatment with this become pregnant should use effective contraception durin st 6 weeks after completion of treatment. Males with femal
o become pregnant should use effective contraception r at least 2 weeks after completion of treatment. Talk to you ontraception methods that may be right for you.
re breast-feeding or planning to breast-feed. It is not known
g e r
- red, or painful eye, blurry vision
- dehydration
- low albumin in the blood
- depression
- anxiety
- trouble falling asleep (insomnia)
- bleeding in your brain
- decreased sensation, numbness, tingling, or increas and legs
- feeling weak or unusually sleepy
- speech disorder or hoarse voice breast milk. You should not breast-feed during treatment for at least 2 weeks following the last dose. Talk to your ay to feed your baby during this time.
tility problems in males and females. Talk to your doctor if u.
chines mptoms that affect your ability to concentrate and react (se
e
- movement disorder
- headache
- tremor
- bleeding in the eye
- increased sensitivity to light
- increased blood pressure
- shortness of breath
- stuffy nose
- cough including cough that produces mucus
- gastrointestinal bleed
- increased fluid in the abdomen
YVAKYT may influence the ability to drive and use machines. driving a car or operating machines if you experience these dium less than 1 mmol sodium (23 mg) per tablet, that is to say e”.
- constipation, flatulence (gas)
- difficulty swallowing
- painful mouth, lips or tongue, thrush
- increase in saliva production
- red or itchy skin
- skin discolouration
hair loss
rmacist has told you. Check r illness – see below.
rengths are 25 mg, 50 mg, u about the strength and
- pain
- muscle spasms
- blood in urine
- fever or feeling of genera
- changes in the electric a
- weight gain or loss
- blood tests showing low bleeding
- blood tests showing alter
.
.
a lower dose of AYVAKYT.
- blood tests showing decr
- blood tests showing incre
Uncommon (may affect up t
- bleeding in the tumour
- fluid around the heart
- bleeding in the liver
Other side effects in patien Very common (may affect m
- altered taste
e, temporarily stop, or r stop taking AYVAKYT ter, on an empty stomach. r after taking AYVAKYT.
an extra dose. Take your
- cognitive effects includin in mental function, or dif
- diarrhoea
- nausea, retching and vom
- change in hair colour
- swelling (e.g. feet, ankle,
- tiredness
- blood tests showing low bleeding
- blood tests showing decr
If you have accidentally taken too many tablets, talk to You may require medical attention.
If you forget to take AYVAKYT
If you miss a dose of AYVAKYT, take it as soon as you re scheduled dose is due within 8 hours. Take the next dos Do not take two doses within 8 hours to make up for a f
4. Possible side effects
your doctor straight away.
member unless your next e at your regular time. orgotten dose.
Common (may affect up to 1
- headache
- dizziness
- decreased sensation, nu and legs
- bleeding in your brain
- increased tear production - irritation and redness of t
- nose bleed
- fluid around your lungs
Like all medicines, this medicine can cause side effects gets them.
Most serious side effects
Some side effects may be serious. Tell your doctor s any of the following (see also section 2.):
- severe headache, vision problems, severe sleepines side of your body (signs of bleeding in your brain)
memory loss, changes in memory, or confusion (sign
, although not everybody traight away if you get s, severe weakness on one s of a cognitive effect)
- shortness of breath
- heartburn
- increased fluid in the abd
- dryness affecting eyes, li
- constipation
- abdominal (belly) pain
- gastrointestinal bleed
- rash
- red or itchy skin
- hair loss
Other side effects in patients with GIST may include Very common (may affect more than 1 in 10 people):
- decreased appetite
- memory loss, changes in memory, or confusion (cog
- dizziness
- altered taste
- increased tear production
- abdominal (belly) pain
- nausea, retching and vomiting
diarrhoea
nitive effects)
- joint pain
- weight gain
- changes in the electric a
- bruising
- blood tests showing incre a substance produced by
- blood tests showing alter - decreased appetite - depression
- difficulty in thinking clear emia) and white blood cells d high levels of bilirubin,
Uncommon (may affect up t
- fluid around the heart - increased sensitivity to li
Reporting of side effects
If you get any side effects, ta possible side effects not liste via the Yellow Card Scheme Yellow Card in the Google Pl help provide more informatio ed sensitivity to pain in arms
5. How to store AYVAKYT
Keep this medicine out of th
Do not use this medicine aft outer carton after ”EXP”. The
This medicine does not requ
l discomfort ctivity of the heart blood platelets, often associated with easy bruising or ed amounts of blood minerals
W
A p eased kidney function ased break down of muscle
o 1 in 100 people):
ts with AdvSM may include ore than 1 in 10 people):
A c
K
M
B
G
1
N g memory loss, changes in memory, confusion, changes ficulty in learning or making decisions iting face, eye, joint)
blood platelets, often associated with easy bruising or ease in red blood cells (anaemia) and white blood cells
F H
B T e
T in 10 people):
mbness, tingling, or increased sensitivity to pain in arms he eyes
T T T i n omen ps, mouth and skin ctivity of the heart ased stress on the liver and high levels of bilirubin, the liver ed levels of potassium, phosphate, and uric acid ly and paying attention
o 1 in 100 people):
ght lk to your doctor or pharmacist. This includes any d in this leaflet. You can also report side effects directly at https://yellowcard.mhra.gov.uk/ or search for MHRA ay or Apple App Store. By reporting side effects you can n on the safety of this medicine.
e sight and reach of children.
er the expiry date which is stated on the bottle label and expiry date refers to the last day of that month.
ire any special storage conditions.
Do not use this medicine if y tampering.
Do not throw away any medi pharmacist how to throw aw help protect the environmen
6. Contents of the pack a
ou notice that the bottle is damaged or shows signs of cines via wastewater or household waste. Ask your ay medicines you no longer use. These measures will t.
nd other information
What AYVAKYT contains
- The active substance is a avapritinib.
The other ingredients are
The tablet core contai croscarmellose sodiu contains sodium”).
vapritinib. Each film-coated tablet contains 100 mg
:
ns: microcrystalline cellulose, copovidone, m and magnesium stearate (see section 2 “AYVAKYT
- The tablet coating contains: talc, macrogol 3350, poly( titanium dioxide (E171).
- The printing ink contains: Shellac glaze 45% (20% est Brilliant blue FCF (E133), titanium dioxide (E171), blac propylene glycol.
hat AYVAKYT looks like and contents of the pack
YVAKYT 100 mg film-coated tablets are round, white tablets rinted with blue ink “BLU” on one side and “100” on the oth
vinyl alcohol), and erified) in ethanol, k iron oxide (E172) and of 9 mm diameter, er.
YVAKYT is supplied in a bottle containing 30 film-coated tab ontains one bottle.
eep the desiccant canister in the bottle.
arketing Authorisation Holder and Manufacturer lueprint Medicines (Netherlands) B.V.
ustav Mahlerplein 2
082 MA Amsterdam etherlands
lets. Each carton or any information about this medicine, please contact the older:
lueprint Medicines (Netherlands) B.V., NL el: +31 85 064 4001
-mail: MedinfoEurope@blueprintmedicines.com his leaflet was last revised in July 2026
Marketing Authorisation his medicine has been given ‘conditional approval’. his means that there is more evidence to come about this m he Medicines and Healthcare products Regulatory Agency ( nformation on this medicine at least every year and this leafl ecessary.
edicine.
MHRA) will review new et will be updated as
60004700-XX