Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ayvakyt

Document Subject

Generated Narrative: MedicinalProductDefinition mpf40cac7981e52d03bbfe471a7f88b25f

identifier: http://ema.europa.eu/identifier/EU/1/20/1473/004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AYVAKYT 25 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f40cac7981e52d03bbfe471a7f88b25f

identifier: http://ema.europa.eu/identifier/EU/1/20/1473/004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ayvakyt

Attesters

What is in this leaflet

1. What AYVAKYT is and what it is used for
2. What you need to know before you take AYVAKYT
3. How to take AYVAKYT
4. Possible side effects
5. How to store AYVAKYT
6. Contents of the pack and other information

What AYVAKYT is AYVAKYT is a medicine containing the active substance avapritinib.

What AYVAKYT is used for AYVAKYT is used in adults to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL), after at least one systemic therapy. These are disorders in which the body produces too many mast cells, a type of white blood cell. Symptoms are caused when too many mast cells enter various organs of your body, such as the liver, bone marrow or spleen. These mast cells also release substances such as histamine which cause various general symptoms that you may be experiencing as well as damage to involved organs. ASM, SM-AHN and MCL are collectively referred to as advanced systemic mastocytosis (AdvSM).

AYVAKYT is also used for the treatment of adults with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment. This is a disorder in which your body has many abnormal mast cells. Mast cells are the white blood cells responsible for allergic reactions. These cells may be in any tissue in your body but are often found in your skin, your intestines and your bone marrow. These abnormal mast cells can cause symptoms such as severe allergic reactions, diarrhoea, rash and difficulty thinking.

How AYVAKYT works AYVAKYT stops the activity of a group of proteins in the body called kinases. Mast cells in patients with AdvSM and ISM usually have changes (mutations) in the genes involved in making specific kinases associated with the growth and spread of these cells.

If you have any questions about how AYVAKYT works or why this medicine has been prescribed for you, please ask your doctor.

Do not take AYVAKYT:

• if you are allergic to avapritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYVAKYT:

• if you have suffered a vascular aneurysm (bulging and weakening of a blood vessel wall) or bleeding in your brain in the last year.
• if you have low platelet counts.
• If you are taking a medicine that thins the blood to prevent blood clots such as warfarin or phenprocoumon.

Take special care with this medicine:

• You may develop symptoms such as severe headache, vision problems, severe sleepiness, or severe weakness on one side of your body (signs of bleeding in your brain). If these occur, contact your doctor immediately and temporarily stop treatment. For patients with AdvSM, your doctor will evaluate your platelet counts before you start treatment and monitor them as needed during your treatment with avapritinib.
• Treatment with this medicine may lead to a higher risk of bleeding in patients with AdvSM. Avapritinib can cause bleeding in the digestive system such as stomach, rectum, or intestine. Tell your doctor if you had or have any bleeding problems. Before you start taking avapritinib your doctor may decide to do blood tests. Get medical help immediately, if you get the following symptoms: passing blood in the stools or passing black stools, stomach pain, coughing/vomiting up blood.
• You may also develop memory loss, changes in memory, or be confused (signs of a cognitive effect). Avapritinib can sometimes change how you think and how you remember information. Contact your doctor in case you experience these symptoms or in case a family member, caregiver or someone who knows you notices that you are getting forgetful or confused.
• During treatment with this medicine, tell your doctor straight away if you put on weight very quickly, develop swelling of your face or limbs, have difficulty breathing or become short of breath. This medicine may cause your body to retain water (severe fluid retention can occur in patients with AdvSM).
• Avapritinib may cause abnormality of your heart rhythm. Your doctor may conduct tests to evaluate these problems during your treatment with avapritinib. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking this medicine.
• You may get severe stomach and bowel problems (diarrhoea, nausea and vomiting) if you have AdvSM. Get medical help immediately if you experience these symptoms.
• You may become more sensitive to the sun while taking this medicine. It is important to cover sun-exposed areas of skin and use sunscreen with high sun protection factor (SPF).

While you are taking avapritinib, your doctor will ask you to have regular blood tests and weigh you regularly if you have AdvSM.

For more information see section 4. Children and adolescents
AYVAKYT has not been studied in children and adolescents under age 18. Do not give this medicine to children or adolescents under the age of 18 years.

Other medicines and AYVAKYT Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. AYVAKYT may affect the way other medicines work, and certain other medicines may affect how this medicine works.

Tell your doctor or pharmacist before taking AYVAKYT if you are taking any of the following medicines:

The following medicines can increase the effects of avapritinib and may increase its side effects:

• Boceprevir used to treat hepatitis C
• Cobicistat, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir used to treat HIV infections/AIDS
• Clarithromycin, erythromycin, telithromycin used to treat bacterial infections
• Itraconazole, ketoconazole, posaconazole, voriconazole used to treat serious fungal infections
• Conivaptan used to 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
• Carbamazepine, phenytoin, fosphenytoin, primidone, phenobarbital used to treat epilepsy
• St. John s wort (Hypericum perforatum) an herbal medicine used for depression
• Bosentan used to treat high blood pressure
• Efavirenz and etravirine used to treat HIV infections/AIDS
• Modafinil used to treat sleep disorders
• Dabrafenib used to treat certain cancers
• Nafcillin used to treat certain bacterial infections
• Dexamethasone used to reduce inflammation

This medicine may affect how well the following medicines work or increase their side effects:

• Alfentanil used to control pain during operations and medical procedures
• Atazanavir used to treat HIV infection/AIDS
• Midazolam used for anaesthesia, sedation or to decrease anxiety
• Simvastatin used to treat high cholesterol
• Sirolimus, tacrolimus used to prevent organ transplant rejection

Ask your doctor or pharmacist for advice before taking any medicine.

AYVAKYT with food and drink You should not drink grapefruit juice or eat grapefruit while on treatment with AYVAKYT.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy This medicine is not recommended for use during pregnancy unless clearly necessary. Avoid becoming pregnant while being treated with this medicine as it may harm your unborn baby. Your doctor will discuss with you the potential risks of taking AYVAKYT during pregnancy.

Your doctor may check if you are pregnant before you start treatment with this medicine.

Women who are able to become pregnant should use effective contraception during treatment and for at least 6 weeks after completion of treatment. Males with female partners who are able to become pregnant should use effective contraception during treatment and for at least 2 weeks after completion of treatment. Talk to your doctor about effective contraception methods that may be right for you.

Breast-feeding Tell your doctor if you are breast-feeding or planning to breast-feed. It is not known if AYVAKYT passes into breast milk. You should not breast-feed during treatment with this medicine and for at least 2 weeks following the last dose. Talk to your doctor about the best way to feed your baby during this time.

Fertility AYVAKYT may cause fertility problems in males and females. Talk to your doctor if this is a concern for you.

Driving and using machines AYVAKYT may cause symptoms that affect your ability to concentrate and react (see section 4). Therefore, AYVAKYT may influence the ability to drive and use machines. Take special care when driving a car or operating machines if you experience these side effects.

AYVAKYT contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Which strength of AYVAKYT to use
The recommended dose of AYVAKYT will depend on your illness see below.
AYVAKYT is available in different strength tablets. The strengths are 25 mg, 50 mg, 100 mg, 200 mg and 300 mg. Your doctor will advise you about the strength and number of tablets you should take:

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 dose, temporarily stop, or permanently stop treatment. Do not change your dose or stop taking AYVAKYT unless your doctor tells you to.

Swallow the AYVAKYT tablet(s) whole with a glass of water, on an empty stomach. Do not eat for at least 2 hours before and at least 1 hour after taking AYVAKYT.

If you vomit after taking a dose of AYVAKYT, do not take an extra dose. Take your next dose at your scheduled time.

If you take more AYVAKYT than you should If you have accidentally taken too many tablets, talk to your 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 remember unless your next scheduled dose is due within 8 hours. Take the next dose at your regular time.
Do not take two doses within 8 hours to make up for a forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most serious side effects in patients with AdvSM Some side effects may be serious. Tell your doctor straight away if you get any of the following (see also section 2.):

• 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 (signs of a cognitive effect)

Other side effects in patients with AdvSM may include Very common (may affect more than 1 in 10 people):

• altered taste
• memory loss, changes in memory, or confusion (cognitive effects)
• 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 associated with easy bruising or bleeding
• blood tests showing decrease in red blood cells (anaemia) and white blood cells

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• decreased sensation, numbness, tingling, or increased sensitivity to pain in arms and legs
• bleeding in your brain
• increased tear production
• nose bleed
• shortness of breath
• heartburn
• increased fluid in the abdomen
• dryness affecting eyes, lips, mouth and skin
• constipation, flatulence (gas)
• abdominal (belly) pain
• gastrointestinal bleed
• rash
• hair loss
• 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

Uncommon (may affect up to 1 in 100 people):

• fluid around the heart
• red or itchy skin
• blood tests showing decreased kidney function

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 (insomnia)

• flushing

• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and outer carton after EXP . The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the bottle is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What AYVAKYT contains

• The active substance is avapritinib. Each film-coated tablet contains 25 mg avapritinib.

• The other ingredients are:

• The tablet core contains: microcrystalline cellulose, copovidone, croscarmellose sodium and magnesium stearate (see section 2 AYVAKYT contains sodium ).

• The tablet coating contains: talc, macrogol 3350, poly(vinyl alcohol), and titanium dioxide (E171).

What AYVAKYT looks like and contents of the pack AYVAKYT 25 mg film-coated tablets are round, white tablets of 5 mm diameter, debossed with BLU on one side and 25 on the other.

AYVAKYT is supplied in a bottle containing 30 film-coated tablets. Each carton contains one bottle.

Keep the desiccant canister in the bottle.

Marketing Authorisation Holder and Manufacturer Blueprint Medicines (Netherlands) B.V. Gustav Mahlerplein 2 1082 MA Amsterdam Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien, , esk
republika, Danmark, Deutschland, Eesti, Espa a, France, Hrvatska, Ireland, sland, ,
Swixx Biopharma S.M.S.A.
: +30 214 444 9Italia, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarorsz g, Malta, Nederland, Norge, sterreich, Polska, Portugal, Rom nia, Slovenija, Slovensk
republika, Suomi/Finland, Sverige, United Kingdom (Northern Ireland) Blueprint Medicines (Netherlands) B.V., NL Tel/ T l/ Te / Tlf/ S mi/ Puh: +31 85 064 4e-mail: MedinfoEurope@blueprintmedicines.com

This leaflet was last revised in

This medicine has been given conditional approval .
This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: