Patient leaflet - Ayvakyt 25 mg film-coated tablets
1. What AYVAKYT is and what it is used for
What AYVAKYT is
AYVAKYT is a medicine containing the active substa
nce avapritinib.
What AYVAKYT is used for
AYVAKYT is used in adults to treat aggressive syste systemic mastocytosis with associated haematolog mast cell leukaemia (MCL). These are disorders in many mast cells, a type of white blood cell. Sympto mast cells enter various organs of your body, such spleen. These mast cells also release substances s various general symptoms that you may be experie
mic mastocytosis (ASM), ical neoplasm (SM-AHN), or which the body produces too ms are caused when too many as the liver, bone marrow or uch as histamine which cause ncing as well as damage to involved organs.
ASM, SM-AHN and MCL are collectively referred to mastocytosis (AdvSM).
as advanced systemic
AYVAKYT is also used for the treatment of adults wi mastocytosis (ISM) with moderate to severe sympt symptomatic treatment. This is a disorder in which mast cells. Mast cells are the white blood cells res These cells may be in any tissue in your body but a intestines and your bone marrow. These abnormal
th indolent systemic oms inadequately controlled on your body has many abnormal ponsible for allergic reactions. re often found in your skin, your mast cells can cause symptoms such as severe allergic reactions, diarrhoea, rash a
nd difficulty thinking.
How AYVAKYT works
AYVAKYT stops the activity of a group of proteins in cells in patients with AdvSM and ISM usually have involved in making specific kinases associated wit cells.
the body called kinases. Mast changes (mutations) in the genes h the growth and spread of these
If you have any questions about how AYVAKYT work prescribed for you, please ask your doctor.
s or why this medicine has been
2. What you need to know before you take AYV
AKYT
Do not take AYVAKYT:
if you are allergic to avapritinib or any of the oth
er ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking AYV ‑ if you have suffered a vascular aneurysm (b
AKYT:
ulging and weakening of a blood vessel wall) or bleeding in your brain in the la ‑ if you have low platelet counts.
st year.
‑ if you are taking a medicine that thins the bl such as warfarin, phenprocoumon, rivaroxab edoxaban or another medicine that thins the
ood to prevent blood clots an, dabigatran, apixaban, blood to prevent blood clots.
Take special care with this medicine:
You may develop symptoms such as severe he
adache, vision problems, ne side of your body (signs of
severe sleepiness, or severe weakness on o bleeding in your brain). If these occur, contact temporarily stop treatment. Your doctor will eval
your doctor immediately and uate your platelet counts before you start treatment and monitor them as neede avapritinib.
d during your treatment with
Treatment with this medicine may lead to a hig
her risk of bleeding in patients he digestive system such as you had or have any bleeding ur doctor may decide to do blood he following symptoms: passing ach pain, coughing/vomiting up
with AdvSM. Avapritinib can cause bleeding in t stomach, rectum, or intestine. Tell your doctor if 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 blood.
You may also develop memory loss, changes i
n memory, or be confused
(signs of a cognitive effect). Avapritinib can s
ometimes change how you think and how you remember information. Contact yo these symptoms or in case a family member, ca you notices that you are getting forgetful or con
ur doctor in case you experience regiver or someone who knows fused.
During treatment with this medicine, tell your d
octor straight away if you put on r face or limbs, have difficulty
weight very quickly, develop swelling of you breathing or become short of breath. This me retain water (severe fluid retention can occur in
dicine may cause your body to patients with AdvSM).
Avapritinib may caus
e abnormality of your heart rhythm. Your doctor may uate these problems during your treatment with avapritinib. u feel dizzy, faint, or have abnormal heartbeats while taking
conduct tests to eval Tell your doctor if yo this medicine.
You may get severe
stomach and bowel problems (diarrhoea, nausea and vomiting) if you hav these symptoms.
e AdvSM. Get medical help immediately if you experience
You may become mo
re sensitive to the sun while taking this medicine. It is un-exposed areas of skin and use sunscreen with high sun
important to cover s protection factor (SP
F).
While you are taking av and weigh you regularly
apritinib, your doctor will ask you to have regular blood tests if you have AdvSM.
For more information se
e section 4.
Children and adolesce
nts
AYVAKYT has not been s give this medicine to ch
tudied in children and adolescents under age 18. Do not ildren or adolescents under the age of 18 years.
Other medicines and A
YVAKYT
Tell your doctor or phar any other medicines. AY certain other medicines
macist if you are taking, have recently taken or might take VAKYT may affect the way other medicines work, and may affect how this medicine works.
Tell your doctor or pha the following medicin
rmacist before taking AYVAKYT if you are taking any of es:
The following medicines side effects:
can increase the effects of avapritinib and may increase its
Boceprevir – used to
treat hepatitis C
Cobicistat, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir – used to treat HIV infections/AIDS
Clarithromycin, eryth
romycin, telithromycin – used to treat bacterial infections nazole, posaconazole, voriconazole – used to treat serious
- Itraconazole, ketoco fungal infections
Conivaptan – used t
o treat low blood sodium levels (hyponatraemia)
The following medicines
can reduce the effects of avapritinib:
Rifampicin – used to
treat tuberculosis (TB) and some other bacterial infections nytoin, fosphenytoin, primidone, phenobarbital – used to
- Carbamazepine, phe treat epilepsy
St. John’s wort (Hyp
ericum perforatum) – an herbal medicine used for depression
Bosentan – used to t
reat high blood pressure
Efavirenz and etravir
ine – used to treat HIV infections/AIDS reat sleep disorders
- Modafinil – used to t
Dabrafenib – used to
treat certain cancers
Nafcillin – used to tr
eat certain bacterial infections
Dexamethasone – u
sed to reduce inflammation
Avapritinib may increas
e the side effects of the following medicines: reat psychosis and Tourette disorder
- Pimozide – used to t
Amiodarone – used
to treat heart rhythm problems
Citalopram, escitalop
ram – used to treat depression
Ondansetron – used
to treat nausea or vomiting
Ask your doctor or phar
macist for advice before taking any medicine.
AYVAKYT with food an
d drink
You should not drink gra AYVAKYT.
pefruit juice or eat grapefruit while on treatment with
Pregnancy, breast‑fee
ding and fertility
If you are pregnant or br have a baby, ask your d
east-feeding, think you may be pregnant or are planning to octor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine is not rec necessary. Avoid becom may harm your unborn taking AYVAKYT during p
ommended 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 regnancy.
Your doctor may check i medicine.
f you are pregnant before you start treatment with this
Women who are able to treatment and for at lea partners who are able t during treatment and fo doctor about effective c
become pregnant should use effective contraception during st 6 weeks after completion of treatment. Males with female
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.
r
Breast-feeding
Tell your doctor if you ar if AYVAKYT passes into with this medicine and f doctor about the best w
e breast-feeding or planning to breast-feed. It is not known breast milk. You should not breast-feed during treatment or at least 2 weeks following the last dose. Talk to your ay to feed your baby during this time.
Fertility
AYVAKYT may cause fer this is a concern for you
tility problems in males and females. Talk to your doctor if .
Driving and using mac
hines
AYVAKYT may cause sy section 4). Therefore, AY Take special care when side effects.
mptoms that affect your ability to concentrate and react (see VAKYT may influence the ability to drive and use machines. driving a car or operating machines if you experience these
AYVAKYT contains sod
ium
This medicine contains essentially “sodium-free
less than 1 mmol sodium (23 mg) per tablet, that is to say ”.
3. How to take AYVAKYT
Always take this medicine exactly as your doctor or phar with your doctor or pharmacist if you are not sure.
macist has told you. Check
Which strength of AYVAKYT to use
AYVAKYT is available in different strength tablets. The str 100 mg, 200 mg and 300 mg. Your doctor will advise yo number of tablets you should take:
engths are 25 mg, 50 mg, u about the strength and
Treatment of AdvSM
The recommended dose is 200 mg by mouth once daily.
Treatment of ISM
The recommended dose is 25 mg by mouth once daily.
If you have liver problems, your doctor may start you on
a lower dose of AYVAKYT.
If you get side effects, your doctor may change your dos permanently stop treatment. Do not change your dose or
e, temporarily stop, or stop taking AYVAKYT unless your doctor tells you to.
Swallow the AYVAKYT tablet(s) whole with a glass of wat Do not eat for at least 2 hours before and at least 1 hour
er, on an empty stomach. after taking AYVAKYT.
If you vomit after taking a dose of AYVAKYT, do not take next dose at your scheduled time.
an extra dose. Take your
If you take more AYVAKYT than you should
If you have accidentally taken too many tablets, talk to y
our doctor straight away.
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
member unless your next e at your regular time. orgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, altho
ugh not everybody gets them.
Most serious side effects in patients with AdvSM Some side effects may be serious. Tell your doctor st any of the following (see also section 2.):
raight away if you get
severe headache, vision problems, severe sleepiness
, severe weakness on one side of your body (signs of bleeding in your brain)
memory loss, changes in memory, or confusion (sign
s of a cognitive effect)
Other side effects in patients with AdvSM may includ Very common (may affect more than 1 in 10 people):
e
- altered taste
cognitive effects including memory loss, changes in
memory, confusion, changes in mental function, or difficulty in learning o
r making decisions
- diarrhoea
- nausea, retching and vomiting
- change in hair colour
- swelling (e.g. feet, ankle, face, eye, joint)
- tiredness
blood tests showing low blood platelets, often associ
ated with easy bruising or bleeding
blood tests showing decrease in red blood cells (ana
emia) and white blood cells
Common (may affect up to 1 in 10 people):
- headache
- dizziness
decreased sensation, numbness, tingling, or increase
d sensitivity to pain in arms and legs
- bleeding in your brain
- increased tear production
- irritation and redness of the eyes
- nose bleed
- fluid around your lungs
- shortness of breath
- heartburn
- increased fluid in the abdomen
- dryness affecting eyes, lips, mouth and skin
- constipation
- abdominal (belly) pain
- gastrointestinal bleed
- rash
- red or itchy skin
- hair loss
- joint pain
- weight gain
- changes in the electric activity of the heart
- bruising
blood tests showing increased stress on the liver and
high levels of bilirubin, a substance produced by the liver
blood tests showing altered levels of potassium, pho - decreased appetite
sphate, and uric acid
- depression
- difficulty in thinking clearly and paying attention
Uncommon (may affect up to 1 in 100 people):
- fluid around the heart
- increased sensitivity to light
Side effects in patients with ISM may include Very common (may affect more than 1 in 10 people):
- swelling of arms and legs
Common (may affect up to 1 in 10 people):
trouble falling asleep (inso - flushing
mnia)
- red or itchy skin
- face swelling
blood test showing effect
on the bone (blood alkaline phosphatase increased)
Reporting of side effects
If you get any side effects, tal possible side effects not liste
k to your doctor or pharmacist. This includes any d in this leaflet. You can also report side effects directly via the Yellow Card Scheme a Yellow Card in the Google Pla help provide more informatio
t https://yellowcard.mhra.gov.uk/ or search for MHRA y or Apple App Store. By reporting side effects you can n on the safety of this medicine.
5. How to store AYVAKYT
Keep this medicine out of the
sight and reach of children.
Do not use this medicine afte and outer carton after ”EXP”.
r the expiry date which is stated on the bottle label The expiry date refers to the last day of that month.
This medicine does not requir
e any special storage conditions.
Do not use this medicine if yo tampering.
u notice that the bottle is damaged or shows signs of
Do not throw away any medic pharmacist how to throw awa help protect the environment.
ines via wastewater or household waste. Ask your y medicines you no longer use. These measures will
6. Contents of the pack an
d other information
What AYVAKYT contains
The active substance is av
apritinib. Each film-coated tablet contains 25 mg avapritinib.
The other ingredients are:
The tablet core contain croscarmellose sodium contains sodium”).
s: microcrystalline cellulose, copovidone, and magnesium stearate (see section 2 “AYVAKYT
The tablet coating cont
ains: talc, macrogol 3350, poly(vinyl alcohol), and titanium dioxide (E171)
.
What AYVAKYT looks like a
nd contents of the pack
AYVAKYT 25 mg film-coated t debossed with “BLU” on one
ablets are round, white tablets of 5 mm diameter, side and “25” on the other.
AYVAKYT is supplied in a bottl contains one bottle.
e containing 30 film-coated tablets. Each carton
Keep the desiccant canister i
n the bottle.
Marketing Authorisation Ho
lder and Manufacturer
Blueprint Medicines (Netherla Gustav Mahlerplein 2
nds) B.V.
1082 MA Amsterdam
Netherlands
For any information about thi Holder:
s medicine, please contact the Marketing Authorisation
Blueprint Medicines (Netherla
nds) B.V., NL
Tel: +31 85 064 4001 e-mail: MedinfoEurope@blue
printmedicines.com
This leaflet was last revised
in July 2026
This medicine has been given This means that there is mor The Medicines and Healthcar information on this medicine necessary.
‘conditional approval’.
e evidence to come about this medicine.
e products Regulatory Agency (MHRA) will review new at least every year and this leaflet will be updated as
60004698-XX