Patient leaflet - Ayvakyt 50 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 cell leukaemia (MCL). These are disorders in which mast cells, a type of white blood cell. Symptoms ar cells enter various organs of your body, such as the These mast cells also release substances such as
mic mastocytosis (ASM), ical neoplasm (SM-AHN), or mast the body produces too many e caused when too many mast liver, bone marrow or spleen. histamine which cause various general symptoms that you may be experiencing a organs.
s well as damage to involved
ASM, SM-AHN and MCL are collectively referred to mastocytosis (AdvSM).
as advanced systemic
How AYVAKYT works
AYVAKYT stops the activity of a group of proteins in cells in patients with AdvSM usually have changes in making specific kinases associated with the gro
the body called kinases. Mast (mutations) in the genes involved wth and spread of these cells.
If you have any questions about how AYVAKYT wor
ks or why this medicine has been prescribed for you, please ask your doctor.
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
AKYT:
if you have suffered a vascular aneurysm (b
ulging and weakening of a blood st year.
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 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 eva you start treatment and monitor them as neede avapritinib.
your doctor immediately and luate your platelet counts before d during your treatment with
Treatment with this medicine may lead to a hig
her risk of bleeding. Avapritinib h as stomach, rectum, or
can cause bleeding in the digestive system suc intestine. Tell your doctor if you had or have any start taking avapritinib your doctor may decide help immediately, if you get the following sympt or passing black stools, stomach pain, coughing
bleeding problems. Before you to do blood tests. Get medical oms: passing blood in the stools /vomiting up blood.
You may also develop memory loss, changes i
n memory, or be confused
(signs of a cognitive effect). Avapritinib can s 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
ometimes change how you think 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).
dicine may cause your body to
Avapritinib may cause abnormality of your he
art rhythm. Your doctor may g your treatment with avapritinib.
conduct tests to evaluate these problems durin
Tell your doctor if you feel dizzy, faint, or have a this medicine.
bnormal heartbeats while taking
You may get severe stomach and bowel prob
lems (diarrhoea, nausea and vomiting). Get medical help immediately if you
experience these symptoms. hile taking this medicine. It is nd use sunscreen with high sun
You may become more sensitive to the sun w important to cover sun-exposed areas of skin a protection factor (SPF).
While you are taking av You will also be weighe
apritinib, your doctor will ask you to have regular blood tests d regularly.
.
3. How to take AYVAKYT
For more information se
e section 4.
Always take this medicine exactly as your doctor or pha with your doctor or pharmacist if you are not sure.
rmacist has told you. Check
Children and adolesce
nts
AYVAKYT has not been give this medicine to ch
studied in children and adolescents under age 18. Do not ildren or adolescents under the age of 18 years.
Other medicines and
AYVAKYT
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.
Which strength of AYVAKYT to use
AYVAKYT is available in different strength tablets. The st 100 mg, 200 mg and 300 mg. Your doctor will advise yo number of tablets you should take:
rengths are 25 mg, 50 mg, u about the strength and
Treatment of AdvSM
The recommended dose is 200 mg by mouth once daily
.
Tell your doctor or pha the following medicin
rmacist before taking AYVAKYT if you are taking any of es:
The following medicine side effects:
s can increase the effects of avapritinib and may increase it
s
Boceprevir – used t
o treat hepatitis C
Cobicistat, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir – used to treat HIV infections/AIDS
Clarithromycin, eryt
hromycin, 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 medicine
s 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
treat high blood pressure
Efavirenz and etravi
rine – used to treat HIV infections/AIDS treat sleep disorders
- Modafinil – used to
Dabrafenib – used t
o treat certain cancers
Nafcillin – used to tr
eat certain bacterial infections
Dexamethasone – u
sed to reduce inflammation
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 o unless your doctor tells you to.
e, temporarily stop, or r stop taking AYVAKYT
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
ter, on an empty stomach. r 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 You may require medical attention.
our doctor straight away.
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, alth
ough not everybody gets them.
Avapritinib may increas
e the side effects of the following medicines:
Pimozide - used to t
reat psychosis and Tourette disorder
Amiodarone - used t
o treat heart rhythm problems
Citalopram, escitalo
pram - used to treat depression
Ondansetron - used - Ethinyl estradiol - ho
to treat nausea or vomiting rmonal oral contraceptive
Most serious side effects
Some side effects may be serious. Tell your doctor s any of the following (see also section 2.):
traight away if you get
severe headache, vision problems, severe sleepines
s, 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)
Ask your doctor or phar
macist for advice before taking any medicine.
AYVAKYT with food an
d drink
You should not drink gr
apefruit juice or eat grapefruit while on treatment with
AYVAKYT.
Pregnancy, breast-fee
ding and fertility
If you are pregnant or b have a baby, ask your d
reast-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
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 pregnancy.
Your doctor may check medicine.
if 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 femal
e
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 a if AYVAKYT passes into with this medicine and doctor about the best w
re breast-feeding or planning to breast-feed. It is not known 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.
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 ma
chines
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-fre
less than 1 mmol sodium (23 mg) per tablet, that is to say e”.
Other side effects may include
Very common (may affect more than 1 in 10 people):
- altered taste
cognitive effects including memory loss, changes in
memory, confusion, changes decisions
in mental function, or difficulty in learning or making
- 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 assoc
iated 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 increas
ed 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 an
d 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
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
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.
5. How to store AYVAKYT
Keep this medicine out of th
e sight and reach of children.
Do not use this medicine aft outer carton after ”EXP”. The
er the expiry date which is stated on the bottle label and expiry date refers to the last day of that month.
This medicine does not requ
ire any special storage conditions.
Do not use this medicine if y tampering.
ou notice that the bottle is damaged or shows signs of
Do not throw away any medi pharmacist how to throw aw help protect the environmen
cines via wastewater or household waste. Ask your ay medicines you no longer use. These measures will t.
6. Contents of the pack an
d other information
What AYVAKYT contains
The active substance is a
vapritinib. Each film-coated tablet contains 50 mg avapritinib.
The other ingredients are
:
The tablet core contai
ns: microcrystalline cellulose, copovidone, m and magnesium stearate (see section 2 “AYVAKYT
croscarmellose sodiu contains sodium”).
The tablet coating co
ntains: talc, macrogol 3350, poly(vinyl alcohol), and 1).
titanium dioxide (E17
What AYVAKYT looks like a
nd contents of the pack
AYVAKYT 50 mg film-coated debossed with “BLU” on one
tablets are round, white tablets of 6 mm diameter, side and “50” on the other.
AYVAKYT is supplied in a bot contains one bottle.
tle containing 30 film-coated tablets. Each carton
Keep the desiccant canister
in the bottle.
Marketing Authorisation H
older and Manufacturer
Blueprint Medicines (Netherl Gustav Mahlerplein 2
ands) B.V.
1082 MA Amsterdam
Netherlands
For any information about th Holder:
is medicine, please contact the Marketing Authorisation
Blueprint Medicines (Netherl Tel: +31 85 064 4001 e-mail: MedinfoEurope@blue
ands) B.V., NL printmedicines.com
This leaflet was last revise
d in July 2026
This medicine has been give
n ‘conditional approval’.
This means that there is mor The Medicines and Healthca information on this medicine necessary.
e evidence to come about this medicine.
re products Regulatory Agency (MHRA) will review new at least every year and this leaflet will be updated as
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