Alunbrig

Package leaflet: Information for the patient

Alunbrig 30 mg film-coated tablets, 90 mg film-coated tablets, 180 mg film-coated tablets

brigatinib
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Alunbrig is 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. How to store Alunbrig
6. Contents of the pack and other information

1. What Alunbrig is and what it is used for

Alunbrig contains the active substance brigatinib, a type of anticancer medicine called a kinase inhibitor. Alunbrig is used to treat adults with advanced-stage lung cancer known as non-small cell lung cancer. It is prescribed for patients whose lung cancer is associated with an abnormal form of a gene called anaplastic lymphoma kinase ( ALK ).
How Alunbrig works
The abnormal gene produces a protein known as kinase that stimulates the growth of cancer cells. Alunbrig blocks the action of this protein, thereby slowing down the growth and spread of the tumour.

2. What you should know before taking Alunbrig

Do not take Alunbrig

• if you are allergic to brigatinib or to 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 of which are serious, occur more frequently during the first 7 days of treatment. Symptoms may be similar to those of lung cancer. Inform your doctor

if you experience new symptoms or worsening of existing symptoms, including difficulty breathing, shortness of breath, chest pain, cough, and fever.

• high blood pressure
• slow heart rate (bradycardia)
• vision problems Inform your doctor if you experience vision problems during treatment, such as flashes of light, blurred vision, or eye discomfort caused by light.
• muscle problems Inform your doctor if you experience unexplained muscle pain, tenderness, or weakness.
• pancreas problems Inform your doctor if you have pain in the upper part of the abdomen, including abdominal pain that worsens when you eat and that may radiate to the back, weight loss, or nausea.
• liver problems Inform your doctor if you have pain on the right side of the stomach area, yellowing of the skin or whites of the eyes, or dark urine.
• high blood sugar levels
• sensitivity to sunlight Limit your time in the sun during treatment and for at least 5 days after your last dose. When exposed to sunlight, wear a hat, protective clothing, broad-spectrum sunscreen and lip balm that protect against both ultraviolet A (UVA) and ultraviolet B (UVB) rays, with a sun protection factor (SPF) of 30 or higher. This will help protect you from possible sunburn.

Inform your doctor if you have kidney problems or are on dialysis. Symptoms of kidney problems may include nausea, changes in the amount or frequency of urination, or abnormal laboratory test results (see section 4).
Your doctor may need to adjust your treatment with Alunbrig or temporarily or permanently discontinue it. 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 individuals under 18 years of age.
Other medicines and Alunbrig
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect or be affected by Alunbrig:

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

Alunbrig with food and drinks
Avoid any grapefruit-containing products during treatment, as they may alter the amount of brigatinib in your body.
Pregnancy
Alunbrig is not recommended during pregnancy unless the benefits outweigh the risks to the unborn child. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking Alunbrig.
Women of childbearing potential undergoing treatment with Alunbrig must avoid becoming pregnant. An effective non-hormonal contraceptive method must be used during treatment with Alunbrig and for 4 months after treatment has ended. Ask your doctor for advice on the most suitable contraceptive methods for you.
Breast-feeding
Do not breast-feed during treatment with Alunbrig. It is not known whether brigatinib passes into breast milk and may harm the baby.
Fertility
Men undergoing treatment with Alunbrig must not father a child during treatment and must use an effective contraceptive method during treatment and for 3 months after treatment ends.
Driving and using machines
Alunbrig may cause vision disturbances, dizziness, or fatigue. Do not drive or operate machinery during treatment if you experience these symptoms.
Alunbrig contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Alunbrig contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Alunbrig

Take this medicine exactly as prescribed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Recommended dose
One 90 mg tablet once daily for the first 7 days; then, one 180 mg tablet once
daily.
Do not change the dose without first discussing it with your doctor. Your doctor may adjust the dose according to your needs, which could require using a 30 mg tablet to achieve the new recommended dose.
Treatment initiation pack
When starting treatment with Alunbrig, your doctor may prescribe a treatment initiation pack. To help you start treatment, each treatment initiation pack consists of
an outer package containing two inner packages with:

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

Instructions for 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 may be taken with or without food.
• If you vomit after taking Alunbrig, do not take another tablet until your next scheduled dose.

Do not ingest the desiccant container inside the bottle.
If you take more Alunbrig than you should
If you have taken more tablets than recommended, inform your doctor or
pharmacist immediately.
If you forget to take Alunbrig
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you stop taking Alunbrig
Do not stop treatment with Alunbrig without first talking to your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or pharmacist immediately if any of the following serious side effects occur:

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

• high blood pressure Contact your doctor if you experience headache, dizziness, blurred vision, chest pain or shortness of breath.
• vision problems Contact your doctor if you have any visual disturbances such as flashes of light, blurred vision, or light sensitivity. Your doctor may decide to stop treatment with Alunbrig and refer you for an ophthalmologist examination.
• increased blood levels of creatine phosphokinase in laboratory tests – this may indicate muscle damage, for example to the heart. Contact your doctor if you experience unexplained muscle pain, tenderness or weakness.
• increased blood levels of amylase or lipase in laboratory tests – this may indicate inflammation of the pancreas. Contact your doctor if you experience pain in the upper abdomen, including abdominal pain that worsens after eating and may radiate to the back, weight loss, or nausea.
• increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in laboratory tests – this may indicate damage to liver cells. Contact your doctor if you experience pain on the right side of the abdomen, yellowing of the skin or whites of the eyes, or dark urine.
• increased blood sugar levels Contact your doctor if you feel very hungry or thirsty, need to urinate more often than normal, or experience stomach pain, weakness, fatigue, or confusion.

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

• inflammation of the lungs Contact your doctor if you notice new or worsening lung or breathing problems, including chest pain, cough, or fever, especially during the first week of treatment with Alunbrig, as these may indicate serious lung problems.
• slowed heart rate Contact your doctor if you experience chest pain or discomfort, changes in heartbeat, dizziness, lightheadedness, or fainting.
• sensitivity to sunlight Contact your doctor if you develop skin reactions. See also section 2, “Warnings and precautions”.

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

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

Other possible side effects are:
Contact 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 in the blood (anaemia) in laboratory tests
• reduced number of white blood cells in the blood, called neutrophils and lymphocytes, in laboratory tests
• prolonged blood clotting time shown by activated partial thromboplastin time test
• laboratory tests may show increased blood levels of:
  • insulin
  • calcium
• laboratory tests may show reduced blood levels 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
  • diarrhoea
  • nausea
  • vomiting
  • abdominal pain (stomach)
  • constipation
  • inflammation of the mouth and lips (stomatitis)
  • increased blood levels of alkaline phosphatase enzyme in laboratory tests – this may indicate organ dysfunction or injury
  • rash
  • itchy skin
  • muscle or joint pain (including muscle spasms)
  • increased blood levels of creatinine in laboratory tests – this may indicate reduced kidney function
  • fatigue
  • swelling of body tissues due to excess fluid
  • fever

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

• reduced number of platelets in laboratory tests, which may increase the risk of bleeding and bruising
• difficulty falling asleep (insomnia)
• memory impairment
• altered sense of taste
• abnormal electrical activity of the heart (prolongation of QT interval on electrocardiogram)
• fast heartbeat (tachycardia)
• palpitations
• dry mouth
• indigestion
• flatulence
• increased blood levels of lactate dehydrogenase in laboratory tests – this may indicate damage to body tissues
• increased blood levels of bilirubin in laboratory tests
• dry skin
• musculoskeletal chest pain
• pain in arms and legs
• stiffness of muscles and joints
• chest pain or discomfort
• pain
• increased blood cholesterol levels in laboratory tests
• weight loss

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alunbrig

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle or on the 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 dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Alunbrig contains

• The active substance 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 ingredients are monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate, talc, macrogol, polyvinyl alcohol and titanium dioxide (see also section 2, “Alunbrig contains lactose” and “Alunbrig contains sodium”).

Description of the appearance of Alunbrig and contents of the pack
Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg) or round (30 mg), convex on both sides.
Alunbrig 30 mg:

• Each 30 mg tablet contains 30 mg of brigatinib.
• The film-coated tablets are approximately 7 millimetres in length and are marked with “U3” on one side and unmarked on the other side.

Alunbrig 90 mg:

• Each 90 mg tablet contains 90 mg of brigatinib.
• The film-coated tablets are approximately 15 millimetres in length and are marked with “U7” on one side and unmarked on the other side.

Alunbrig 180 mg:

• Each 180 mg tablet contains 180 mg of brigatinib.
• The film-coated tablets are approximately 19 millimetres in length and are marked with “U13” on one side and unmarked on the other side.

Alunbrig is supplied in sealed plastic strips (blister packs) contained in a carton 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 also available in plastic bottles with child-resistant screw caps. Each bottle contains a desiccant container and is packaged in a carton 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 in the bottle.
Alunbrig is available as a starter pack. Each pack consists of an outer carton containing two inner cartons with:

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

Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: + 32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]
България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: + 359 2 958 27 36 Tél/Tel: + 32 2 464 06 11
[email protected] [email protected]
Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: + 36 1 270 7030
[email protected] [email protected]
Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: + 45 46 77 10 10 Tel: + 356 21419070
[email protected] [email protected]
Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: + 49 (0)800 825 3325 Tel: + 31 20 203 5492
[email protected] [email protected]
Eesti Norge
Takeda Pharma AS Takeda AS
Tel: + 372 6177 669 Tlf: + 47 800 800 30
[email protected] [email protected]
Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Τηλ: + 30 210 6387800 Tel: + 43 (0) 800-20 80 50
[email protected] [email protected]
España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: + 34 917 90 42 22 Tel.: + 48223062447
[email protected] [email protected]
France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: + 33 1 40 67 33 00 Tel: + 351 21 120 1457
[email protected] [email protected]
Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: + 385 1 377 88 96 Tel: + 40 21 335 03 91
[email protected] [email protected]
Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: + 386 (0) 59 082 480
[email protected] [email protected]
Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: + 354 535 7000 Tel: + 421 (2) 20 602 600
[email protected] [email protected]
Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: + 39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]
Κύπρος Sverige
A.POTAMITIS MEDICARE LTD Takeda Pharma AB
Τηλ: + 357 22583333 Tel: 020 795 079
[email protected] [email protected]
Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: + 371 67840082 Tel: + 44 (0) 3333 000 181
[email protected] [email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.