AYVAKYT 200 mg film-coa – patient leaflet, side effects, dosage

1. What AYVAKYT is and what it is used for

T

Tell your doctor or phar any other medicines. AY certain other medicines

Tell your doctor or pha the following medicin

The following medicine side effects:

• Boceprevir – used to

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 receptor

  ance avapritinib.

  estinal stromal tumour (GIST), ctable) or has spread to other ecific mutation (D842V) in the alpha (PDGFRA) protein kinase.

  • Cobicistat, indinavir, infections/AIDS
  • Clarithromycin, eryt
  • Itraconazole, ketoco fungal infections
  • Conivaptan – used t

The following medicine

• Rifampicin – used to
• Carbamazepine, phe treat epilepsy
• aggressive systemic mastocytosis (ASM), syste haematological neoplasm (SM-AHN), or mast ce 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 ll 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

• St. John’s wort (Hyp depression
• Bosentan – used to
• Efavirenz and etravir
• Modafinil – used to
• Dabrafenib – used t
• Nafcillin – used to tr
• Dexamethasone – u

Avapritinib may increas

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

• Alfentanil, fentanyl –procedures
• Sirolimus, tacrolimu - Dihydroergotamine,
• Pimozide - used to t
• Amiodarone - used t
• Citalopram, escitalo
• Ondansetron - used
• Ethinyl estradiol - ho

Ask your doctor or phar

Do not take AYVAKYT:

• if you are allergic to avapritinib or any of the oth

  (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 bl

  er ingredients of this medicine

  AKYT:

  ulging and weakening of a blood st year.

  ood to prevent blood clots

  AYVAKYT with food an

  You should not drink gr AYVAKYT.

  Pregnancy, breast-fee

  If you are pregnant or b have a baby, ask your d

  Pregnancy 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, contact 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 your doctor immediately and vSM, your doctor will evaluate and monitor them as needed

  This medicine is not rec necessary. Avoid becom may harm your unborn taking AYVAKYT during

  Your doctor may check medicine.

  Women who are able to treatment and for at lea partners who are able t

• Treatment with this medicine may lead to a hig can cause bleeding in the digestive system suc intestine. In patients with GIST, avapritinib can a liver, as well as bleeding of the tumour. Tell you bleeding problems. Before you start taking avap do blood tests. Get medical help immediately, if passing blood in the stools or passing black sto vomiting up blood.

• You may also develop memory loss, changes i

  (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 lso cause bleeding in the r doctor if you had or have any ritinib your doctor may decide to you get the following symptoms: ols, stomach pain, coughing/ n memory, or be confused ometimes change how you think ur doctor in case you experience

  treatment and for at lea about effective contrace

  Breast-feeding

  Tell your doctor if you a if AYVAKYT passes into with this medicine and doctor about the best w

  Fertility these symptoms or in case a family member, ca 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 me retain water (severe fluid retention).

  regiver or someone who knows fused.

  octor straight away if you put on r face or limbs, have difficulty dicine may cause your body to

  AYVAKYT may cause fer this is a concern for you

  se abnormality of your heart rhythm. Your doctor may 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).

  .

  Driving and using machines

  AYVAKYT may cause symptoms that affect your ability to section 4). Therefore, AYVAKYT may influence the ability Take special care when driving a car or operating machi side effects.

  AYVAKYT contains sodium

  This medicine contains less than 1 mmol sodium (23 m essentially “sodium-free”.

  apritinib, your doctor will ask you to have regular blood eighed regularly.

  e section 4.

  nts studied in children and adolescents under age 18. Do not ildren or adolescents under the age of 18 years.

  YVAKYT 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.

  rmacist before taking AYVAKYT if you are taking any of es:

  s can increase the effects of avapritinib and may increase it treat hepatitis C

  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 lopinavir, nelfinavir, ritonavir, saquinavir – used to treat HIV 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:

  treat tuberculosis (TB) and some other bacterial infections nytoin, fosphenytoin, primidone, phenobarbital – used to ericum perforatum) – an herbal medicine used for treat high blood pressure ine – 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:

  used to control pain during operations and medical s, ciclosporin – used to prevent organ transplant rejection ergotamine – used to treat migraines and cluster headache reat psychosis and Tourette disorder

  o treat heart rhythm problems pram - used to treat depression to treat nausea or vomiting rmonal oral contraceptive macist for advice before taking any medicine.

  s

  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 sleepiness side of your body (signs of bleeding in your brain)
  • memory loss, changes in memory, or confusion (sign 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.

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 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.

if you are pregnant before you start treatment with this become pregnant should use effective contraception during st 6 weeks after completion of treatment. Males with femal

o get pregnant should use effective contraception during

e

• 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):

st 2 weeks after completion of treatment. Talk to your docto ption methods that may be right for you.

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.

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 tility problems in males and females. Talk to your doctor if .

  concentrate and react (see to drive and use machines. nes if you experience these

  1. g)

     per tablet, that is to say

     • shortness of breath
     • stuffy nose
     • cough including cough th
     • gastrointestinal bleed
     • increased fluid in the abd
     • constipation, flatulence (g
     • difficulty swallowing
     • painful mouth, lips or ton
     • increase in saliva product

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

rmacist has told you. Check r illness – see below.

rengths are 25 mg, 50 mg, u about the strength and

• red or itchy skin
• skin discolouration
• hair loss
• pain
• muscle spasms
• blood in urine
• fever or feeling of general
• changes in the electric ac
• weight gain or loss
• blood tests showing low b bleeding

.

.

a lower dose of AYVAKYT.

• blood tests showing alter
• 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

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

e, temporarily stop, or r stop taking AYVAKYT ter, on an empty stomach. r after taking AYVAKYT.

an extra dose. Take your

Very common (may affect m

• altered taste
• cognitive effects including changes in mental functio
• diarrhoea
• nausea, retching and vom
• change in hair colour
• swelling (e.g. feet, ankle,
• tiredness
• blood tests showing low b bleeding

If you have accidentally taken too many tablets, talk to y 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

our doctor straight away.

member unless your next e at your regular time. orgotten dose.

• blood tests showing decr

Common (may affect up to 1

• headache
• dizziness
• decreased sensation, num and legs
• bleeding in your brain
• increased tear production
• irritation and redness of t

, although not everybody traight away if you get

, severe weakness on one s of a cognitive effect)

• nose bleed
• fluid around your lungs - shortness of breath
• heartburn
• increased fluid in the abd
• dryness affecting eyes, lip
• constipation
• abdominal (belly) pain
• gastrointestinal bleed
• rash
• red or itchy skin nitive effects)
• hair loss
• joint pain
• weight gain
• changes in the electric ac
• bruising
• blood tests showing incre a substance produced by
• blood tests showing alter - decreased appetite - depression emia) and white blood cells d high levels of bilirubin,
• difficulty in thinking clearl

Uncommon (may affect up t

• fluid around the heart - increased sensitivity to lig

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 Pla ed sensitivity to pain in arms

help provide more informatio

5. How to store AYVAKYT

Keep this medicine out of the

Do not use this medicine afte and outer carton after ”EXP”.

• speech disorder or hoarse voice
• movement disorder
• headache
• tremor
• bleeding in the eye
• increased sensitivity to light

• increased blood pressure

  at produces mucus omen as)

  gue, thrush ion

  6.

  W

  -

  • discomfort tivity of the heart lood platelets, often associated with easy bruising or

W

A

8

A ed amounts of blood minerals eased kidney function ased break down of muscle

o 1 in 100 people):

ts with AdvSM may include

c

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M

B

G

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ore than 1 in 10 people):

memory loss, changes in memory, confusion, n, or difficulty in learning or making decisions iting face, eye, joint)

lood platelets, often associated with easy bruising or

H

B T e

T

T T ease in red blood cells (anaemia) and white blood cells in 10 people):

bness, tingling, or increased sensitivity to pain in arms he eyes

T in n omen s, mouth and skin tivity of the heart ased stress on the liver and high levels of bilirubin, the liver ed levels of potassium, phosphate, and uric acid y and paying attention

o 1 in 100 people):

ht 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 y or Apple App Store. By reporting side effects you can n on the safety of this medicine.

sight and reach of children.

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 requi

Do not use this medicine if y tampering.

Do not throw away any medi pharmacist how to throw aw help protect the environment

re any special storage conditions.

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 .

Contents of the pack and other information

hat AYVAKYT contains

The active substance is avapritinib. Each film-coated table avapritinib.

The other ingredients are:

• The tablet core contains: microcrystalline cellulose, copo sodium and magnesium stearate (see section 2 “AYVAK

• The tablet coating contains: talc, macrogol 3350, poly(

  t contains 200 mg vidone, croscarmellose YT contains sodium”). vinyl alcohol), and titanium dioxide (E171).

• The printing ink contains: Shellac glaze 45% (20% est

  Brilliant blue FCF (E133), titanium dioxide (E171), black propylene glycol.

hat AYVAKYT looks like and contents of the pack

YVAKYT 200 mg film-coated tablets are oval, white tablets o mm in width, printed with blue ink “BLU” on one side and “

YVAKYT is supplied in a bottle containing 30 film-coated tabl

erified) in ethanol, iron oxide (E172) and f 16 mm in length and 200” on the other.

ets. Each carton 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 or any information about this medicine, please contact the M

arketing Authorisation older:

lueprint Medicines (Netherlands) B.V., NL el: +31 85 064 4001

-mail: MedinfoEurope@blueprintmedicines.com his leaflet was last revised in July 2026 his medicine has been given ‘conditional approval’. his means that there is more evidence to come about this m

edicine.

he Medicines and Healthcare products Regulatory Agency (M formation on this medicine at least every year and this leafl ecessary.

HRA) will review new et will be updated as

60004701-XX