Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - oxbryta

Document Subject

Generated Narrative: MedicinalProductDefinition mp7bc78483a72818d156f4ad97517abe5a

identifier: http://ema.europa.eu/identifier/EU/1/21/1622/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Oxbryta 500 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

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7bc78483a72818d156f4ad97517abe5a

identifier: http://ema.europa.eu/identifier/EU/1/21/1622/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - oxbryta

Attesters

What is in this leaflet

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

What Oxbryta is and how it works

Oxbryta contains the active substance voxelotor. Voxelotor works on a protein in red blood cells called haemoglobin to help it take up oxygen that red blood cells can deliver throughout the body.

Patients with the condition called sickle cell disease have an altered form of haemoglobin called sickle haemoglobin which is different from the normal haemoglobin. When the sickle haemoglobin gives up oxygen to the tissues, it sticks together to form long rods and causes red blood cells to alter their shape to that of a crescent moon making these cells rigid and sickled shape. Sickle red blood cells cannot deliver oxygen as well as healthy red blood cells and are also broken down more quickly, leading to lowered levels of red blood cells (haemolytic anaemia). By improving the way the altered haemoglobin holds onto oxygen, Oxbryta improves the function of red blood cells and prolongs their lifespan.

What Oxbryta is used for

Oxbryta, alone or together with hydroxycarbamide (also known as hydroxyurea), is used to treat haemolytic anaemia in adults and children from 12 years with sickle cell disease.

Do not take Oxbryta

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

Warnings and precautions

Talk to your doctor before taking Oxbryta if you have:

• severe kidney problems
• severe liver problems. Your doctor may need to adjust the dose of Oxbryta.

If you get any symptoms of allergic reactions, stop taking Oxbryta and talk to your doctor or get emergency medical help immediately. Symptoms are for example rash, including nettle rash (hives), shortness of the breath and swelling of the face.

Serious skin reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS), has been reported in association with Oxbryta treatment. Stop using Oxbryta and seek medical attention immediately if you notice any of the symptoms related to this serious skin reaction described in section 4. If you are receiving blood transfusions, talk to your doctor about possible difficulties with the interpretation of certain blood tests when taking this medicine.

Children under 12 years

This medicine is not recommended for children under 12 years due to lack of data in this age group.

Other medicines and Oxbryta

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines can affect how Oxbryta works or may make side effects more likely. In particular, tell your doctor if you take any of the following medicines:

• rifampicin (used to treat bacterial infections)
• phenobarbital, carbamazepine, phenytoin (used to treat epilepsy and other illnesses)
• sirolimus, tacrolimus (used to prevent organ rejection after transplantation)
• St John s wort (a herbal medicine to treat depression)
• alfentanil (a painkiller used during an operation with anaesthetics)

Tell your doctor that you are taking Oxbryta if you are having a medical procedure or surgery.

Pregnancy and breast-feeding

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

• Pregnancy Your doctor will help you to decide whether you should stop taking Oxbryta during pregnancy.

• Breast-feeding Do not breast-feed while taking Oxbryta because it is not known if voxelotor passes into breast milk and could affect the baby.

Driving and using machines

Oxbryta has no or negligible influence on the ability to drive and use machines.

Oxbryta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose of three tablets, that is to say essentially sodium-free .

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

The recommended dose for adults and children from 12 years is: Three 500 mg tablets taken once daily by mouth.

Swallow the tablets whole with one glass of water, with or without food. Do not cut, crush or chew the tablets because of bad taste.

If you take more Oxbryta than you should

Contact your doctor immediately.

If you forget to take Oxbryta

Continue with your normal dosing schedule on the next day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Oxbryta

Do not stop taking this medicine without your doctor s advice. It is important to take Oxbryta daily.

If you have any further questions on the use of this medicine, ask your doctor.

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

Stop taking Oxbryta and inform your doctor or get emergency medical help immediately if you experience any of the following serious side effects: Uncommon (may affect up to 1 in 100 people)

• allergic reactions Symptoms are for example rash, including nettle rash (hives), shortness of breath and swelling of the face.

Not known (frequency cannot be estimated from the available data)

• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects may occur with the following frequency: Very common (may affect more than 1 in 10 people)

• headache
• diarrhoea
• abdominal (belly) pain
• nausea
• rash

Reporting of side effects If you get any side effects, talk to your doctor. 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 and 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 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 Oxbryta contains

• The active substance is voxelotor. One tablet contains 500 mg voxelotor.
• The other ingredients are:

• microcrystalline cellulose (E460)
• croscarmellose sodium (E468)
• sodium laurilsulfate (E487)
• silica, colloidal anhydrous (E551)
• magnesium stearate (E470b)
• polyvinyl alcohol (E1203)
• titanium dioxide (E171)
• polyethylene glycol (E1521)
• talc (E553b)
• iron oxide yellow (E172)

What Oxbryta looks like and contents of the pack

Light yellow to yellow, oval-shaped, biconvex, film-coated tablets, debossed with GBT 500 on one side. Tablet dimensions: approximately 18 mm 10 mm.

Oxbryta is packaged in a plastic bottle with a child-resistant cap. Each bottle contains 90 film-coated tablets. The bottle also contains coil and a silica gel desiccant canister to help keep your medicine dry. The bottle is delivered in a carton.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium

Manufacturer

Global Blood Therapeutics Netherlands B.V. Strawinskylaan 31077ZX Amsterdam Netherlands

Or

Pfizer Service Company BV Hoge Wei 1930 Zaventem Belgium

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

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4
,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36 1 488 37 esk republika Pfizer, spol. s r.o.
Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o., Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka
Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige
Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: +371 670 35 This leaflet was last revised in MM/YYYY.

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