30 mg, 90 mg, 180 mg film-coated tablets
brigatinib
1. What Alunbrig is and what it is used for
Alunbrig contains the active substance brigatinib, which belongs to a class of anticancer medicines called kinase inhibitors. Alunbrig is used to treat adults in the advanced stage of a form of lung cancer called non-small cell lung cancer. It is given to patients whose lung cancer is due to an abnormal form of a gene called anaplastic lymphoma kinase ( ALK ).
How Alunbrig works
The abnormal gene produces a protein, a so-called kinase, which stimulates the growth of cancer cells. Alunbrig blocks the effect of this protein and thus slows down the growth and spread of cancer.
2. What you need to know before taking Alunbrig
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 cautions
Talk to your doctor before taking Alunbrig or during treatment if you have:
- problems with the lungs or breathing
- Lung problems, sometimes severe, are more common during the first 7 days of treatment. The symptoms may be similar to those of lung cancer. Tell your doctor about any new or worsening symptoms such as breathing problems, shortness of breath, chest pain, cough, or fever.
- high blood pressure
- slow pulse ( bradycardia )
- visual impairment
- Inform your doctor about any visual disturbances that occur during treatment such as flashes of light, blurred vision, or photosensitivity.
- muscle problem
- Report any unexplained pain, soreness, or weakness in the muscles to the doctor.
- problems with the pancreas
- liver problem
- high blood sugar
Tell your doctor if you have kidney problems or are being treated with dialysis.
Your doctor may need to adjust or stop treatment with Alunbrig, temporarily or permanently. See also beginning of section 4.
Children and young people
Alunbrig has not been studied in children and adolescents. Treatment with Alunbrig is not recommended for 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 or be affected by Alunbrig:
- ketoconazole, itraconazole, voriconazole: for the treatment of fungal infections
- indinavir, nelfinavir, ritonavir, saquinavir: for the treatment of HIV – infection
- clarithromycin, telithromycin, troleandomycin: for the treatment of bacterial infections
- nefazodone: for the treatment of depression
- St. John’s wort: traditional herbal medicine for the treatment of mild depression
- carbamazepine: for the treatment of epilepsy, euphoric/depressive episodes, and certain pain conditions
- phenobarbital, phenytoin: for the treatment of epilepsy
- rifabutin, rifampicin to treat tuberculosis and some other infections you
- digoxin: for the treatment of heart problems
- dabigatran: a medicine that prevents blood clots
- colchicine: for the treatment of gout
- pravastatin, rosuvastatin: to lower elevated cholesterol levels
- methotrexate: for the treatment of severe arthritis, cancer, and psoriasis
- sulfasalazine: for the treatment of severe intestinal inflammation or rheumatoid arthritis
- efavirenz, etravirine: for the treatment of HIV – infection
- modafinil: for the treatment of narcolepsy
- bosentan: for the treatment of high blood pressure in the blood vessels of the lungs ( pulmonary hypertension )
- nafcillin: for the treatment of bacterial infections
- alfentanil, fentanyl: for the treatment of pain
- quinidine: for the treatment of irregular heartbeat
- cyclosporine, sirolimus, tacrolimus: to inhibit the immune system.
Alunbrig with food and drink
Avoid all grapefruit products during treatment as these may alter the amount of brigatinib in the body.
Pregnancy, breastfeeding, and fertility
Pregnancy
Alunbrig is not recommended during pregnancy unless the benefit outweighs the risks to the baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Alunbrig during pregnancy.
Fertile women treated with Alunbrig should avoid becoming pregnant. An effective non-hormonal contraceptive must be used during treatment and for 4 months after the end of treatment. Ask your doctor about suitable contraceptive methods for you.
Breast-feeding
You should not breast-feed during treatment with Alunbrig. It is not known if brigatinib can pass into breast milk and possibly harm the baby.
Fertility
Men treated with Alunbrig should not have children during treatment and should use an effective contraceptive during treatment and for 3 months after the end of treatment.
Driving and using machines
Alunbrig can cause visual disturbances, dizziness, and fatigue. Do not drive or use machines during treatment if you experience such symptoms.
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.
3. How to take Alunbrig
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
One 90 mg tablet once daily for the first 7 days of treatment, then a 180 mg tablet once daily.
Do not change the dose without talking to your doctor. Your doctor may adjust someone to suit you and this may mean that you need to take a 30 mg tablet to get the new recommended dose.
Starter packaging
When you begin treatment with Alunbrig your doctor may prescribe a starter pack.
How to take Alunbrig
- Take Alunbrig once a day at the same time each day.
- Swallow the tablets whole with a glass of water. The tablets must not be crushed or dissolved.
- You can take the tablets with or without food.
- If you vomit after taking Alunbrig, do not take more tablets until it is time for the next dose according to the usual schedule.
Do not swallow the desiccant container in the jar.
If you use more Alunbrig than you should
Tell your doctor or pharmacist immediately 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 the next dose at the usual time.
If you stop taking Alunbrig
Do not stop taking Alunbrig without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following serious side effects, talk to your doctor or pharmacist immediately :
Very common (may affect more than 1 user in 10):
- high blood pressure tells your doctor if you get a headache, dizziness, blurred vision, chest pain, or shortness of breath.
- vision problem tells your doctor if you experience visual disturbances such as flashes of light, blurred vision, or photosensitivity. Your doctor may stop treatment with Alunbrig and refer you to an ophthalmologist.
- the increased amount of creatine phosphokinase in blood tests – may indicate muscle damage, e.g. in the heart. Tell your doctor if you experience unexplained pain, soreness, or weakness in the muscles.
- the increased amount of amylase or lipase in blood tests – may indicate inflammation of the pancreas. Tell your doctor if you get pain in the upper abdomen, even stomach pain that gets worse when you eat and can spread to the back if you lose weight or get nauseous.
- the increased amount of liver enzymes ( aspartate aminotransferase, alanine aminotransferase ) in blood tests – may indicate damage to liver cells. Tell your doctor if you get pain in the right side of your stomach, if your skin or the whites of your eyes turn yellow or if your urine becomes dark.
- high blood sugar tells your doctor if you feel very thirsty, need to urinate more often than before, are very hungry, feel unwell, feel weak or tired, or are confused.
Common (may affect up to 1 in 10 people):
- pneumonia till your doctor if you experience new or worsening lung or respiratory problems, such as chest pain, cough, and fever, especially during the first week of taking Alunbrig. It can be a sign of serious lung problems.
- slow pulseTell your doctor if you experience pain or discomfort in your chest, altered pulse(heart rhythm), feeling dizzy, dizzy, or fainting. See also section 2, “Warnings and Precautions”.
Uncommon (may affect up to 1 in 100 people):
- inflammation of the pancreas, which can cause severe and persistent abdominal pain, with or without nausea and vomiting ( pancreatitis )
Other possible side effects are:
Talk to your doctor or pharmacist if you notice any of these side effects are
Very common (may affect more than 1 user in 10):
- pneumonia ( CAP )
- cold symptoms (upper respiratory tract infection)
- decreased number of red blood cells ( anemia )
- decreased number of white blood cells called neutrophils and lymphocytes in blood samples
- prolonged blood coagulation time demonstrated by the activated partial thromboplastin time test
- an increased amount of insulin in the blood
- decreased amount of phosphorus in the blood
- decreased amount of magnesium in the blood
- the increased amount of calcium in the blood
- decreased amount of sodium in the blood
- decreased amount of potassium in the blood
- decreased appetite
- headache
- symptoms such as numbness and tingling, weakness or pain in hands or feet ( peripheral neuropathy )
- dizziness
- cough
- shortness of breath
- diarrhea
- nausea
- vomiting
- abdominal pain (stomach pain)
- constipation
- inflammation of the mouth and lips ( stomatitis )
- the increased amount of enzyme alkaline phosphatase in the blood – may indicate a malfunctioning or damaged organ
- rash
- itching of the skin
- joint or muscle aches (including muscle spasms)
- the increased amount of creatinine in the blood – may indicate an impaired renal function
- fatigue
- swelling due to fluid retention
- fever.
Common (may affect up to 1 in 10 people):
- low platelet count in blood samples, which may increase the risk of bleeding and bruising
- difficulty sleeping (insomnia)
- impaired memory
- altered sense of taste
- Abnormal electrical activity in the heart (prolonged QT interval on ECG )
- rapid heartbeat ( tachycardia )
- palpitation
- dry mouth
- indigestion
- intestinal gases
- the increased amount of lactate dehydrogenase in the blood – may indicate tissue degradation
- an increased amount of bilirubin in the blood
- dry skin
- sun sensitivity
- musculoskeletal chest pain
- pain in arms and legs
- stiffness in muscles and joints
- pain and discomfort in the chest
- pain
- increased cholesterol in the blood
- weight loss.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 which is stated on either the can label or on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- 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 lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide.
What the medicine looks like and the contents of the pack
Alunbrig film-coated tablets are white to off-white, oval (90 mg and 180 mg), or round (30 mg). The top and bottom are convex.
Alunbrig 30 mg:
- Each 30 mg tablet contains 30 mg of brigatinib.
- The film-coated tablets are approximately 7 mm in diameter, with “U3” embossed on one side and smooth on the other side.
Alunbrig 90 mg:
- Each 90 mg tablet contains 90 mg of brigatinib.
- The film-coated tablets are approximately 15 mm long, with “U7” embossed on one side and smooth on the other side.
Alunbrig 180 mg:
- Each 180 mg tablet contains 180 mg of brigatinib.
- The film-coated tablets are approximately 19 mm long, with “U13” embossed on one side and smooth on the other side.
Alunbrig is packed in plastic foil card (blister) 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 packed in a plastic jar with a child-resistant closure in the form of a screw cap. Each jar contains a container of desiccant and is packed in a carton of:
- 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
Leave the desiccant container in the jar.
Alunbrig is available as a starter pack. Each package consists of an outer carton with two inner cartons containing:
- Alunbrig 90 mg film-coated tablets1 plastic foil map (blister) with 7 film-coated tablets
- Alunbrig 180 mg film-coated tablets3 plastic foil maps (blisters) with 21 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
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
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTakeda BelgiumTel / Tel: +32 2 464 06 11takeda‑belgium@takeda.com | LithuaniaTakeda, UABTel: +370 521 09 070 |
| BulgariaTakade BulgariaTel .: + 359 2 958 27 36;+ 359 2 958 15 29 | Luxembourg / LuxemburgTakeda BelgiumTel / Tel: +32 2 464 06 11takeda‑belgium@takeda.com |
| Czech RepublicTakeda Pharmaceuticals Czech Republic sroTel: + 420 234722722 | HungaryTakeda Pharma Kft.Tel: +361 2707030 |
| DenmarkTakeda Pharma A / STel: +45 46 77 11 11 | MaltaTakeda Italia SpATel: +39 06 502601 |
| GermanyTakeda GmbHTel: +49 (0) 800 825 3325medinfo@takeda.de | The NetherlandsTakeda Nederland bvTel: +31 23 56 68 777nl.medical.info@takeda.com |
| EestiTakeda Pharma ASTel: +372 6177 669 | NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com |
| GreeceTAKEDA ΕΛΛΑΣ Α.ΕTηλ: +30 210 6387800gr.info@takeda.com | AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800‑20 80 50 |
| SpainTakeda Pharmacéutica España SATel: +34 917 90 42 22spain@takeda.com | PolandTakeda Pharma sp. z ootel. + 48 22 608 13 00 |
| FranceTakeda France SASTel. +33 1 40 67 33 00medinfoEMEA@takeda.com | PortugalTakeda Pharmaceuticals Portugal, Lda.Tel: + 351 21 120 1457 |
| CroatiaTakeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96 | RomaniaTakeda Pharmaceuticals SRLTel: +40 21 335 03 91 |
| IrelandTakeda Products Ireland LimitedTel: +44 (0) 1628 537 900 | SloveniaTakeda GmbH, Podružnica SlovenijaTel: + 386 (0) 59 082 480 |
| IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is | Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600 |
| ItalyTakeda Italia SpATel: +39 06 502601 | Finland / FinlandTakeda OyTel. +358 20 746 5000infoposti@takeda.com |
| ΚύπροςA. POTAMITIS MEDICARE LTDTηλ: +357 22583333info@potamitismedicare.com | |
| LatviaTakeda Latvia SIATel: +371 67840082 | United KingdomTakeda UK LtdTel: +44 (0) 1628 537 900 |