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.
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
Warnings and precautions
Consult your doctor before starting Alunbrig or during treatment if you experience:
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.
Inform your doctor of any visual disturbances you experience during treatment, such as seeing flashing lights, blurred vision, or if light hurts your eyes.
Inform your doctor of any unexplained weakness, discomfort, or muscle pain.
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.
Consult your doctor if you experience right upper quadrant abdominal pain, yellowing of the skin or sclerae, or dark urine.
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:
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:
The required dose appears printed on the initial treatment pack.
Administration Form
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):
Consult your doctor if you experience headaches, dizziness, blurred vision, chest pain, or shortness of breath.
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.
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.
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):
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.
Consult your doctor if you experience chest pain, changes in heart rhythm, dizziness, lightheadedness, or fainting.
Consult your doctor if you experience any skin reaction.
See also section2, “Warnings and precautions”.
Rare(may affect up to 1 in 100people)
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):
‑insulin
‑calcium
- phosphorus
- magnesium
- sodium
- potassium
Common(may affect up to 1in 10people):
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
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.
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:
Alunbrig 90 mg:
Alunbrig 180 mg:
Alunbrig is available in plastic strips (blister packs) packaged in a carton with:
Alunbrig is available in plastic bottles with a child-resistant safety closure. Each bottle contains a desiccant and is packaged in a carton with:
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:
1 plastic strip (blister) with 7 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:
België/Belgique/Belgien Takeda Belgium NV Tel: +32 2 464 06 11 | Lietuva Takeda, UAB Tel: +370 521 09 070 |
?????? ?????? ???????? ???? ???.: +359 2 958 27 36 | Luxembourg/Luxemburg Takeda Belgium NV Tel: +32 2 464 06 11 |
Ceská republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 722 | Magyarország Takeda Pharma Kft. Tel.: +36 1 270 7030 |
Danmark Takeda Pharma A/S Tlf: +45 46 77 10 10 | Malta Drugsales Ltd Tel: +356 21419070 |
Deutschland Takeda GmbH Tel: +49 (0)800 825 3325 | Nederland Takeda Nederland B.V. Tel: +31 20 203 5492 |
Eesti Takeda Pharma AS Tel: +372 6177 669 | Norge Takeda AS Tlf: +47 800 800 30 |
Ελλάδα TakedaΕΛΛΑΣ Α.Ε. Tηλ: +30 210 6387800 | Österreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800‑20 80 50 |
España Takeda Farmacéutica España, S.A. Tel: +34 917 90 42 22 | Polska Takeda Pharma Sp. z o.o. Tel.: +48223062447 |
France Takeda France SAS Tél: + 33 1 40 67 33 00 | Portugal Takeda Farmacêuticos Portugal, Lda. Tel: + 351 21 120 1457 |
Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96 | România Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91 |
Ireland Takeda Products Ireland Ltd Tel: 1800 937 970 | Slovenija Takeda Pharmaceuticals farmacevtska družba d.o.o. Tel: + 386 (0) 59 082 480 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600 |
Italia Takeda Italia S.p.A. Tel: +39 06 502601 | Suomi/Finland Takeda Oy Puh/Tel: 0800 774 051 |
Κύπρος A.POTAMITIS MEDICARE LTD Tηλ: +357 22583333 | Sverige Takeda Pharma AB Tel:020 795 079 |
Latvija Takeda Latvia SIA Tel: +371 67840082 | United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0)3333 000 181 |
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.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.