Patient Information Leaflet

Alunbrig 30Film-coated tablets

Alunbrig 90Film-coated tablets

Alunbrig 180Film-coated tablets

brigatinib

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What is Alunbrig and what it is used for

2.What you need to know before taking Alunbrig

3.How to take Alunbrig

4.Possible side effects

5.Storage of Alunbrig

6.Contents of the pack and additional information

Alunbrig contains the active ingredient brigatinib, a type of cancer medication called a tyrosine kinase inhibitor. Alunbrig is used for the treatment of alung cancerin adults in advanced stages known as non-small cell lung cancer. It is administered to patients whose cancer is related to an abnormal form of a lymphoma anaplastic kinase gene (ALK).

How Alunbrig works

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

Do not take Alunbrig

• if you areallergicto brigatinib or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor before starting Alunbrig or during treatment if you experience:

• lung or respiratory problems

Lung problems, some of which are severe, are more common in the first seven days of treatment. Symptoms may be similar to those of lung cancer. Inform your doctor if new symptoms appear or worsen, including shortness of breath, lack of air, chest pain, cough, and fever.

• high blood pressure
• slow heart rate (bradycardia)
• visual disturbances

Inform your doctor of any visual disturbances you experience during treatment, such as seeing flashing lights, blurred vision, or if light hurts your eyes.

• muscle problems

Inform your doctor of any unexplained weakness, discomfort, or muscle pain.

• pancreas problems

Consult your doctor if you experience upper abdominal pain, including pain that worsens with eating and may radiate to the back, weight loss, or nausea.

• liver problems

Consult your doctor if you experience right upper quadrant abdominal pain, yellowing of the skin or sclerae, or dark urine.

• hyperglycemia
• sensitivity to sunlight

Limit your exposure to sunlightduring treatment and for at least 5days after the last dose.When exposed to sunlight, use a hat, protective clothing, broad-spectrum UVA/UVB sunscreen, and lip balm with a sun protection factor (SPF) of 30 or higher. This will help protect you from potential sunburns.

Inform your doctor if you have kidney problems or are on dialysis. Symptoms related to kidney problems include nausea, changes in urine volume or frequency, or abnormalities in blood tests (see section4).

Your doctor may need to adjust your treatment or discontinue Alunbrig temporarily or permanently. See also the beginning of section4.

Children and adolescents

Alunbrig has not been studied in children or adolescents. Do not recommend treatment with Alunbrig in individuals under 18years of age.

Other medications and Alunbrig

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The following medications may affect Alunbrig or be affected by it:

• ketoconazole, itraconazole, voriconazole:antifungal medications
• indinavir, nelfinavir, ritonavir, saquinavir:antiretroviral medications for HIV
• clarithromycin, telithromycin, troleandomycin:antibacterial medications
• nefazodone:an antidepressant medication
• St. John's Wort:a plant-based medication used to treat depression
• carbamazepine:a medication for epilepsy, manic-depressive episodes, and certain pains
• phenobarbital, phenytoin:antiepileptic medications
• rifabutin, rifampicin:medications for tuberculosis or certain infections
• digoxin:a medication for heart problems
• dabigatran:a medication to inhibit blood coagulation
• colchicine:a medication for gout attacks
• pravastatin, rosuvastatin:medications to reduce elevated cholesterol levels
• methotrexate:a medication for severe inflammatory arthritis, cancer, and skin psoriasis
• sulfasalazine:a medication for severe inflammatory bowel disease and rheumatoid arthritis
• efavirenz,etravirine:antiretroviral medications for HIV
• modafinil:a medication for narcolepsy
• bosentan:a medication for pulmonary hypertension
• nafcillin:a medication for bacterial infections
• alfentanil, fentanyl:medications for pain relief
• quinidine:a medication for irregular heart rhythms
• cyclosporine, sirolimus, tacrolimus:immunosuppressive medications

Alunbrig with food and beverages

Avoid consuming grapefruit products during treatment, as they may alter the amount of brigatinib in your body.

Pregnancy

Do not use Alunbrig during pregnancy, unless the benefits outweigh the risks for the baby. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about the risks of using Alunbrig during pregnancy.

Women of childbearing age taking Alunbrig should avoid becoming pregnant. Effective non-hormonal contraception is required during treatment and for 4months after discontinuing Alunbrig. Ask your doctor for suitable contraceptive methods.

Breastfeeding

Do not breastfeedduring treatment with Alunbrig. The effects of brigatinib on breast milk and potential harm to the baby are unknown.

Fertility

Men receiving Alunbrig treatment are advised not to father children during treatment and to use effective contraception during treatment and for 3 months after discontinuing treatment.

Driving and operating machinery

Alunbrig may cause visual disturbances, dizziness, and fatigue. Do not drive or operate machinery if these symptoms occur.

Alunbrig contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult them before taking this medication.

Alunbrig contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is

One 90 mg tablet once a day for the first seven days of treatment; afterwards, one 180 mg tablet once a day.

Do not change the dose without consulting your doctor. Your doctor may adjust the dose according to your needs, which may require the use of a 30 mg tablet to achieve the new recommended dose.

Initial Treatment Pack

At the beginning of your treatment with Alunbrig, your doctor may prescribe an initial treatment pack. To facilitate the start of treatment, each initial treatment pack consists of an outer pack with two inner packs containing:

• 7film-coated tablets of Alunbrig 90mg
• 21film-coated tablets of Alunbrig 180mg

The required dose appears printed on the initial treatment pack.

Administration Form

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

Do not ingest the desiccant container in the bottle.

If you take moreAlunbrig than you should

Inform your doctor or pharmacist immediately if you have taken more tablets than recommended.

If you forget to takeAlunbrig

Do not take a double dose to make up for the missed dose. Take your next dose when it is scheduled.

If you interrupt treatment with Alunbrig

Do not stop your treatment with Alunbrig without consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor or pharmacist immediatelyif you experience any of the following serious side effects:

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

• high blood pressure

Consult your doctor if you experience headaches, dizziness, blurred vision, chest pain, or shortness of breath.

• vision problems

Consult your doctor if you experience any visual disturbances, such as seeing flashing lights, blurred vision, or if light bothers your eyes. Your doctor may stop your treatment with Alunbrig and refer you to an ophthalmologist.

• increased levels of creatine phosphokinase in blood tests: may indicate muscle damage, for example, of the heart. Consult your doctor if you experience weakness, pain, or discomfort in your muscles without apparent cause.

• increased levels of amylase or lipase in blood tests: may indicate pancreatitis.

Consult your doctor if you experience upper abdominal pain, including abdominal pain that worsens with eating and may extend to the back, weight loss, or nausea.

• increased levels of liver enzymes in blood tests (aspartate aminotransferase and alanine aminotransferase): may indicate liver cell damage. Consult your doctor if you experience right upper quadrant abdominal pain, yellowing of the skin or sclerae, or dark urine.
• increased blood sugar

Consult your doctor if you feel thirsty, need to urinate more frequently than usual, feel hungry, experience nausea, or feel weak, tired, or disoriented.

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

• pulmonary inflammation

Consult your doctor if you experience new or worsening respiratory or pulmonary problems, including chest pain, cough, and fever, especially during the first week of treatment with Alunbrig, as they may be a sign of severe pulmonary problems.

• slow heart rate

Consult your doctor if you experience chest pain, changes in heart rhythm, dizziness, lightheadedness, or fainting.

• sensitivity to sunlight

Consult your doctor if you experience any skin reaction.

See also section2, “Warnings and precautions”.

Rare(may affect up to 1 in 100people)

• pancreatitis, which can cause severe abdominal pain and may be accompanied by nausea and vomiting

Other possible side effects:

Consult your doctor or pharmacist if you notice any of the following side effects

Very common(mayafectar a más de 1de cada 10people):

• lung infection (pneumonia)
• symptoms of the common cold (upper respiratory tract infection)
• reduction in the number of red blood cells (anemia) in blood tests
• reduction in the number of white blood cells, called neutrophils and lymphocytes, in blood tests
• increase in the time it takes for blood to clot, measured with the activated partial thromboplastin time test
• in blood tests, an increase in the level of:

‑insulin

‑calcium

• in blood tests, a decrease in the level of:

- phosphorus

- magnesium

- sodium

- potassium

• decreased appetite
• headache
• symptoms such as numbness, tingling, pins and needles, weakness, or pain in the hands or feet (peripheral neuropathy)
• dizziness
• cough
• shortness of breath
• diarrhea
• nausea
• vomiting
• abdominal pain (stomach)
• constipation
• inflammation of the mouth or lips (stomatitis)
• increase in the level of alkaline phosphatase in blood tests (may indicate organ damage or insufficiency)
• skin rash
• itching of the skin
• pain in muscles or joints (including muscle spasms)
• increase in the level of creatinine in blood tests (may indicate a decrease in kidney function)
• fatigue
• inflammation of tissues caused by excess fluid
• fever

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

• low platelet count in blood tests, which may increase the risk of bleeding and bruising
• difficulty sleeping (insomnia)

• memory disorders
• change in sense of taste
• abnormal heart rhythm (prolongation of the QT interval on the electrocardiogram)
• rapid heart rate (tachycardia)
• palpitations
• dry mouth
• indigestion
• flatulence
• increase in the level of lactate dehydrogenase in blood tests (may indicate tissue degradation)
• increase in the level of bilirubin in blood tests
• dry skin
• chest pain (musculoskeletal)
• pain in arms and legs
• stiffness of muscles and joints
• chest pain
• pain
• increase in the level of cholesterol in blood tests
• weight loss

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label of the bottle or blister pack and the carton packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Alunbrig

• The active ingredient is brigatinib.

Each film-coated tablet of 30 mg contains 30 mg of brigatinib.

Each film-coated tablet of 90 mg contains 90 mg of brigatinib.

Each film-coated tablet of 180 mg contains 180 mg of brigatinib.

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

Appearance of Alunbrig and contents of the pack

Alunbrig film-coated tablets are oval (90 mg and 180 mg) or round (30 mg) and are white to off-white. They are convex on both the top and bottom.

Alunbrig 30 mg:

• Each 30 mg tablet contains 30 mg of brigatinib.
• Film-coated tablets of approximately 7 mm in diameter with “U3” engraved on one side and smooth on the other side.

Alunbrig 90 mg:

• Each 90 mg tablet contains 90 mg of brigatinib.
• Film-coated tablets of approximately 15 mm in length with “U7” engraved on one side and smooth on the other side.

Alunbrig 180 mg:

• Each 180 mg tablet contains 180 mg of brigatinib.
• Film-coated tablets of approximately 19 mm in length with “U13” engraved on one side and smooth on the other side.

Alunbrig is available in plastic strips (blister packs) packaged in a carton with:

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

Alunbrig is available in plastic bottles with a child-resistant safety closure. Each bottle contains a desiccant and is packaged in a carton with:

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

Keep the desiccant packet inside the bottle.

Alunbrig is available in a treatment initiation pack format. Each pack contains an outer carton with two inner cartons containing the following:

• Alunbrig 90 mg film-coated tablets.

1 plastic strip (blister) with 7 film-coated tablets.

• Alunbrig 180 mg film-coated tablets.

3 plastic strips (blister packs) with 21 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbæk Strand

Denmark

Responsible for manufacturing:

Takeda Austria GmbH

St. Peter-Strasse 25

4020 Linz

Austria

Takeda Ireland Limited
Bray Business Park
Kilruddery
Co. Wicklow
A98 CD36
Ireland

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.