ALUNBRIG 30 mg FILM-COATED TABLETS

2. What you need to know before you take Alunbrig

Do not take Alunbrig

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

Warnings and precautions

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

• lung or breathing problems

Lung problems, some of which are serious, are more common in the first seven days of treatment. The symptoms can be similar to those of lung cancer. Tell your doctor if you get new symptoms or if they get worse, including shortness of breath, chest pain, cough, and fever.

• high blood pressure
• slow heart rate (bradycardia)
• vision problems

Tell your doctor about any vision changes you notice during treatment, such as seeing flashing lights, blurred vision, or if light hurts your eyes.

• muscle problems

Tell your doctor if you have any weakness, discomfort, or muscle pain without a clear cause.

• pancreas problems

Talk to your doctor if you have stomach pain, including stomach pain that gets worse when eating and can spread to the back, weight loss, or nausea.

• liver problems

Talk to your doctor if you have pain in the right side of the stomach area, if you have yellowing of the skin or whites of the eyes, or dark urine.

• high blood sugar
• sensitivity to sunlight

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

Tell 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 section 4).

Your doctor may need to adjust your treatment or stop using 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 people 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 may affect Alunbrig or be affected by it:

• ketoconazole, itraconazole, voriconazole:medicines for treating fungi
• indinavir, nelfinavir, ritonavir, saquinavir:medicines for treating HIV
• clarithromycin, telithromycin, troleandomycin:medicines for treating bacterial infections
• nefazodone:a medicine for treating depression
• St. John's Wort:a herbal medicine used for treating depression
• carbamazepine:a medicine for treating epilepsy, manic/depressive episodes, and certain types of pain
• phenobarbital, phenytoin:medicines for treating epilepsy
• rifabutin, rifampicin:medicines for treating tuberculosis or certain infections
• digoxin:a medicine for treating heart problems
• dabigatran:a medicine for inhibiting blood clotting
• colchicine:a medicine for treating gout attacks
• pravastatin, rosuvastatin:medicines for reducing high cholesterol levels
• methotrexate:a medicine for treating severe joint inflammation, cancer, and skin disease psoriasis
• sulfasalazine:a medicine for treating severe intestinal inflammation and rheumatic joint inflammation
• efavirenz, etravirine:medicines for treating HIV
• modafinil:a medicine for treating narcolepsy
• bosentan:a medicine for treating pulmonary hypertension
• nafcillin:a medicine for treating bacterial infections
• alfentanil, fentanyl:medicines for treating pain
• quinidine:a medicine for treating people with an irregular heart rhythm
• cyclosporin, sirolimus, tacrolimus:medicines for suppressing the immune system

Taking Alunbrig with food and drinks

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

Pregnancy

Do not useAlunbrig during pregnancy unless the benefits outweigh the risks to 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 who are taking Alunbrig should avoid becoming pregnant. You must use effective non-hormonal contraception during treatment and for 4 months after stopping Alunbrig. Ask your doctor about suitable contraceptive methods for you.

Breast-feeding

Do not breast-feedduring treatment with Alunbrig. It is not known whether brigatinib passes into breast milk, and there is a possibility of harming the baby.

Fertility

Men who receive 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, and fatigue. Do not drive or use machines during treatment if you experience these symptoms.

Alunbrig contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Alunbrig contains sodium

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

3. How to take Alunbrig

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is

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

Do not change the dose without consulting your doctor. Your doctor may adjust the dose based on your needs, which may involve using a 30 mg tablet to achieve the new recommended dose.

Initial treatment package

At the start of your treatment with Alunbrig, your doctor may prescribe an initial treatment package. To facilitate the start of treatment, each initial treatment package consists of an outer package containing two inner packages that contain:

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

The required dose is printed on the initial treatment package.

Method of administration

• 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 another tablet until the next scheduled dose.

Do not ingest the desiccant container in the bottle.

If you take moreAlunbrig than you should

Tell 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 forgotten doses. Take your next dose when it is scheduled.

If you stop taking Alunbrig

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

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

4. Possible side effects

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

Tell your doctor or pharmacist immediatelyif you get any of the following serious side effects:

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

• high blood pressure

Talk to your doctor if you have headaches, dizziness, blurred vision, chest pain, or shortness of breath.

• vision problems

Talk to your doctor if you experience any vision changes, such as seeing flashing lights, blurred vision, or if light hurts your eyes. Your doctor may stop your treatment with Alunbrig and refer you to an eye specialist.

• increased creatine phosphokinase levels in blood tests: may indicate muscle damage, for example, to the heart. Talk to your doctor if you have weakness, discomfort, or muscle pain without a clear cause.

• increased amylase or lipase levels in blood tests: may indicate pancreas inflammation.

Talk to your doctor if you have stomach pain, including stomach pain that gets worse when eating and can spread to the back, weight loss, or nausea.

• increased liver enzyme levels in blood tests (aspartate aminotransferase and alanine aminotransferase): may indicate liver cell damage. Talk to your doctor if you have pain in the right side of the stomach area, if you have yellowing of the skin or whites of the eyes, or dark urine.
• high blood sugar

Talk to your doctor if you feel very thirsty, need to urinate more often than usual, are very hungry, feel nauseous, or feel weak, tired, or disoriented.

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

• lung inflammation

Talk to your doctor if you have new or worsening respiratory or lung problems, including chest pain, cough, and fever, especially during the first week of treatment with Alunbrig, as they may be a symptom of serious lung problems.

• slow heart rate

Talk to your doctor if you have chest discomfort or pain, changes in heart rhythm, dizziness, lightheadedness, or fainting.

• sensitivity to sunlight

Talk to your doctor if you have any skin reaction.

See also section 2, "Warnings and precautions".

Uncommon(may affect up to 1 in 100 people)

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

Other possible side effects:

Talk to 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 symptoms (infection of the upper respiratory tract)
• reduced red blood cell count (anemia) in blood tests
• reduced white blood cell count, including neutrophils and lymphocytes in blood tests
• increased blood clotting time measured by the activated partial thromboplastin time test
• increased levels in the blood of:

– insulin

– calcium

• reduced levels in the blood of:

• phosphorus
• magnesium
• sodium
• potassium
• decreased appetite
• headache
• symptoms such as numbness, tingling, prickling, 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)
• increased levels of the enzyme alkaline phosphatase in blood tests (may indicate organ damage or failure)
• rash
• itching of the skin
• muscle or joint pain (including muscle spasms)
• increased creatinine levels in blood tests (may indicate reduced kidney function)
• fatigue
• inflammation of tissues caused by excess fluid
• fever

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

• low platelet count in blood tests that can increase the risk of bleeding and bruising
• difficulty sleeping (insomnia)

• memory disorders
• change in taste
• abnormal heart rhythm (prolonged QT interval on the electrocardiogram)
• fast heart rate (tachycardia)
• palpitations
• dry mouth
• indigestion
• flatulence
• increased lactate dehydrogenase levels in blood tests (may indicate tissue breakdown)
• increased bilirubin levels in blood tests
• dry skin
• musculoskeletal chest pain
• pain in arms and legs
• muscle and joint stiffness
• chest discomfort or pain
• pain
• increased cholesterol levels in blood tests
• weight loss

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alunbrig

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 label of the bottle or blister and carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Alunbrig Composition

• The active ingredient is brigatinib.

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

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

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

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

Appearance of Alunbrig and Package Contents

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

Alunbrig 30 mg:

• Each 30 mg tablet contains 30 mg of brigatinib.
• Film-coated tablets are 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 are approximately 15 mm long 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 are approximately 19 mm long with "U13" engraved on one side and smooth on the other side.

Alunbrig is available in plastic strips (blister packs) packaged in a box 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 a child-resistant screw cap. Each bottle contains a desiccant and is packaged in a box 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 container inside the bottle.

Alunbrig is available in a starter pack. Each pack contains an outer box with two inner boxes containing:

• Alunbrig 90 mg film-coated tablets

1 plastic strip (blister pack) 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 Authorization Holder

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

Takeda Austria GmbH

St. Peter-Strasse 25

4020 Linz

Austria

Takeda Ireland Limited

Bray Business Park

Kilruddery

Co. Wicklow

A98 CD36

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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