Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - alunbrig

Document Subject

Generated Narrative: MedicinalProductDefinition mp7b67c4d38704991f22e7013a4909f813

identifier: http://ema.europa.eu/identifier/EU/1/18/1264/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Alunbrig 30 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7b67c4d38704991f22e7013a4909f813

identifier: http://ema.europa.eu/identifier/EU/1/18/1264/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - alunbrig

Attesters

What is in this leaflet

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

Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor. Alunbrig is used to treat adults with advanced stages of a lung cancer called non-small cell lung cancer. It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK).

How Alunbrig works

The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells. Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.

Do not take Alunbrig

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

Warnings and precautions

Talk to your doctor before taking Alunbrig or during treatment if you have:

• lung or breathing problems Lung problems, some severe, are more frequent within the first 7 days of treatment. Symptoms may be similar to symptoms from lung cancer. Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever.
• high blood pressure
• a slow heartbeat (bradycardia)
• vision disturbance Inform your doctor of any visual disturbance that occurs during treatment, such as seeing flashes of light, blurry vision or light hurting your eyes.
• muscle problems Report any unexplained muscle pain, tenderness or weakness to your doctor.
• pancreas problems Tell your doctor if you have upper abdominal pain, including abdominal pain that gets worse with eating and may spread to the back, weight loss or nausea.
• liver problems Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
• high blood sugar
• sensitivity to sunlight Limit your time in the sun during treatment and for at least 5 days after your last dose. When you are in the sun, wear a hat, protective clothing, a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater. These will help to protect against potential sunburn.

Tell your doctor if you have kidney problems or you are on dialysis. Symptoms of kidney problems may include, nausea, changes in volume or frequency of urination, abnormal blood tests (see section 4).

Your doctor may need to adjust your treatment or stop Alunbrig temporarily or permanently. See also the beginning of section 4. Children and adolescents

Alunbrig has not been studied in children or adolescents. Treatment with Alunbrig is not recommended in persons under 18 years of age.

Other medicines and Alunbrig

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

The following medicines can affect or be affected by Alunbrig:

• ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections
• indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection
• clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections
• nefazodone: a medicine to treat depression
• St. John s wort: a herbal product used to treat depression
• carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain conditions
• phenobarbital, phenytoin: medicines to treat epilepsy
• rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections
• digoxin: a medicine to treat heart problems
• dabigatran: a medicine to inhibit blood clotting
• colchicine: a medicine to treat gout attacks
• pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels
• methotrexate: a medicine to treat severe joint inflammation, cancer and the skin disease psoriasis
• sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation
• efavirenz, etravirine: medicines to treat HIV infection
• modafinil: a medicine to treat narcolepsy
• bosentan: a medicine to treat pulmonary hypertension
• nafcillin: a medicine to treat bacterial infections
• alfentanil, fentanyl: medicines to treat pain
• quinidine: a medicine to treat irregular heart rhythm
• cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune system

Alunbrig with food and drink

Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.

Pregnancy

Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby. If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy.

Women of childbearing age being treated with Alunbrig should avoid becoming pregnant. Effective non-hormonal contraception must be used during treatment and for 4 months after stopping Alunbrig. Ask your doctor about the birth control methods that may be right for you.

Breast-feeding

Do not breast-feed during treatment with Alunbrig. It is unknown if brigatinib passes into breast milk and could potentially harm the baby.

Fertility

Men receiving treatment with Alunbrig are advised not to father a child during treatment and to use effective contraception during treatment and for 3 months after stopping treatment.

Driving and using machines

Alunbrig may cause visual disturbances, dizziness or tiredness. Do not drive or use machines during treatment if such signs occur.

Alunbrig contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Alunbrig 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.

The recommended dose is

One 90 mg tablet once daily for the first 7 treatment days; thereafter, one 180 mg tablet once daily. Do not change the dose without talking to your doctor. Your doctor may adjust your dose according to your needs and this may require use of a 30 mg tablet to achieve the new recommended dose. Treatment initiation pack

At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack. To help you start treatment each treatment initiation pack consists of an outer pack with two inner packs containing

• 7 Alunbrig 90 mg film-coated tablets
• 21 Alunbrig 180 mg film-coated tablets The required dose is printed on the treatment initiation pack.

Method of use

• Take Alunbrig once daily at the same time each day.
• Swallow the tablets whole, with a glass of water. Do not crush or dissolve the tablets.
• The tablets can be taken with or without food.
• If you vomit after taking Alunbrig, do not take any more tablets until your next scheduled dose.

Do not swallow the desiccant canister contained in the bottle.

If you take more Alunbrig than you should

Tell your doctor or pharmacist right away if you have taken more tablets than recommended.

If you forget to take Alunbrig

Do not take a double dose to make up for a forgotten dose. Take your next dose at your regular time.

If you stop taking Alunbrig

Do not stop taking Alunbrig before talking to your doctor.

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

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

Tell your doctor or pharmacist immediately if you have any of the following serious side effects:

Very common (may affect more than 1 in 10 people):

• high blood pressure Tell your doctor if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
• vision problems Tell your doctor if you experience any visual disturbances, such as seeing flashes of light, blurry vision or light hurting eyes. Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
• increased blood level of creatine phosphokinase in tests may indicate muscle damage, such as of the heart. Tell your doctor if you have any unexplained muscle pain, tenderness or weakness.
• increased blood levels of amylase or lipase in tests may indicate inflammation of the pancreas Tell your doctor if you have upper abdominal pain, including abdominal pain that gets worse with eating and may spread to the back, weight loss or nausea.
• increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests -may indicate liver cell damage. Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
• increased blood sugar Tell your doctor if you are feeling very thirsty, need to urinate more than usual, feeling very hungry, sick to your stomach, weak or tired, or confused.

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

• lung inflammation Tell your doctor if you have any new or worsening lung or breathing problems, including chest pain, cough, and fever, especially within the first week of taking Alunbrig, as they may be a sign of serious lung problems.
• slow heartbeat Tell your doctor if you have chest pain or discomfort, changes in heartbeat, dizziness, light-headedness or fainting.
• sensitivity to sunlight Tell your doctor if you develop any skin reaction. See also section 2, Warnings and precautions .

Uncommon (may affect up to 1 in 100 people)

• inflammation of pancreas which may cause severe and persistent stomach pain, with or without nausea and vomiting (pancreatitis)

Other possible side effects are: Tell your doctor or pharmacist if you notice any of the following side effects

Very common (may affect more than 1 in 10 people):

• lung infection (pneumonia)
• cold-like symptoms (upper respiratory tract infection)
• reduced number of red blood cells (anaemia), in blood tests
• reduced number of white blood cells, called neutrophils and lymphocytes, in blood tests
• increased blood clotting time shown by test of activated partial thromboplastin time
• blood tests may show increased blood level of;

• insulin
• calcium

• blood tests may show reduced blood level of;

• phosphorus
• magnesium
• sodium
• potassium

• decreased appetite
• headache
• symptoms such as numbness, tingling, prickling sensation, weakness or pain in hands or feet (peripheral neuropathy)
• dizziness
• cough
• shortness of breath
• diarrhoea
• nausea
• vomiting
• abdominal (belly) pain
• constipation
• inflammation of the mouth and lips (stomatitis)
• increased level of the enzyme alkaline phosphatase in blood tests may indicate organ malfunction or injury
• rash
• skin itching
• joint or muscle pain (including muscle spasms)
• increased level of creatinine in blood tests may indicate reduced kidney function
• fatigue
• tissue swelling caused by excess fluid
• fever

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

• low platelet counts in blood tests, which may increase the risk of bleeding and bruising
• difficulty sleeping (insomnia)
• memory impairment
• change in sense of taste
• abnormal electrical activity of the heart (prolonged electrocardiogram QT interval)
• rapid heartbeat (tachycardia)
• palpitations
• dry mouth
• indigestion
• flatulence
• increased level of lactate dehydrogenase in blood tests may indicate tissue breakdown
• increased level of bilirubin in blood tests
• dry skin
• musculoskeletal chest pain
• pain in arms and legs
• muscle and joint stiffness
• chest pain and discomfort
• pain
• increased level of cholesterol in blood tests
• weight loss

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 either the bottle label or blister 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 waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Alunbrig contains

• The active substance is brigatinib. Each 30 mg film-coated tablet contains 30 mg brigatinib. Each 90 mg film-coated tablet contains 90 mg brigatinib. Each 180 mg film-coated tablet contains 180 mg brigatinib.

• The other excipients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide (see also section 2 Alunbrig contains lactose and Alunbrig contains sodium ).

What Alunbrig looks like and contents of the pack

Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg). They are convex on the upper and lower side.

Alunbrig 30 mg:

• Each 30 mg tablet contains 30 mg brigatinib.
• The film-coated tablets are approximately 7 mm in diameter with U3 on one side and plain on the other side.

Alunbrig 90 mg:

• Each 90 mg tablet contains 90 mg brigatinib.
• The film-coated tablets are approximately 15 mm long with U7 on one side and plain on the other side.

Alunbrig 180 mg:

• Each 180 mg tablet contains 180 mg brigatinib.
• The film-coated tablets are approximately 19 mm long with U13 on one side and plain on the other side.

Alunbrig is available in plastic foil strips (blisters) packed in a carton with:

• Alunbrig 30 mg: 28, 56 or 112 film-coated tablets
• Alunbrig 90 mg: 7 or 28 film-coated tablets
• Alunbrig 180 mg: 28 film-coated tablets

Alunbrig is available in plastic bottles with child resistant screw top closures. Each bottle contains one canister of a desiccant and is packed in a carton with:

• Alunbrig 30 mg: 60 or 120 film-coated tablets
• Alunbrig 90 mg: 7 or 30 film-coated tablets
• Alunbrig 180 mg: 30 film-coated tablets

Keep the desiccant canister in the bottle.

Alunbrig is available as a treatment initiation pack. Each pack consists of an outer carton with two inner cartons containing:

• Alunbrig 90 mg film-coated tablets 1 plastic foil strip (blister), containing 7 film-coated tablets
• Alunbrig 180 mg film-coated tablets 3 plastic foil strips (blisters), containing 21 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma A/S Delta Park 2665 Vallensbaek Strand Denmark

Manufacturer

Takeda Austria GmbH St. Peter-Strasse 4020 Linz
Austria

Takeda Ireland Limited Bray Business Park Kilruddery
Co. Wicklow
A98 CDIreland

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

Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com
Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com

esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com

Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com

Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com

Malta Drugsales Ltd
Tel: +356 21419safety@drugsalesltd.com

Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com

Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com

Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com

Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com

sterreich Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com

Espa a Takeda Farmac utica Espa a, S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com

Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com

France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com

Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com

Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com

Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com

Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com

Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com

Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com

Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

A.POTAMITIS MEDICARE LTD : +357 22583a.potamitismedicare@cytanet.com.cy

Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com

Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com

United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 3333 000 medinfoEMEA@takeda.com

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.