Patient leaflet - Alunbrig 30 mg film-coated tablets
1. What Alunbrig is and what it is used for
Alunbrig contains the active substance brigatinib, a type of cancer medicine called a kinase inhibitor. Alunbrig is used to treat adults with advanced stages of a lung cancer called non‑small cell lung cancer. It is given to patients whose lung cancer is related to an abnormal form of a gene called anaplastic lymphoma kinase (ALK).
How Alunbrig works
The abnormal gene produces a protein known as a kinase that stimulates the growth of the cancer cells. Alunbrig blocks the action of this protein and thus slows down the growth and spread of the cancer.
2. What you need to know before you take 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 precautions
Talk to your doctor before taking Alunbrig or during treatment if you have:
lung or breathing problems
Lung problems, some severe, are more frequent within the first 7 days of treatment. Symptoms may be similar to symptoms from lung cancer. Tell your doctor of any new or worsening symptoms including breathing discomfort, shortness of breath, chest pain, cough and fever.
- high blood pressure
- a slow heartbeat (bradycardia)
vision disturbance
Inform your doctor of any visual disturbance that occurs during treatment, such as seeing flashes of light, blurry vision or light hurting your eyes.
muscle problems
Report any unexplained muscle pain, tenderness or weakness to your doctor.
pancreas problems
Tell your doctor if you have upper abdominal pain, including abdominal pain that gets worse with eating and may spread to the back, weight loss or nausea.
liver problems
Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
- high blood sugar
sensitivity to sunlight
Limit your time in the sun during treatment and for at least 5 days after your last dose. When you are in the sun, wear a hat, protective clothing, a broad‑spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater. These will help to protect against potential sunburn.
Tell your doctor if you have kidney problems or you are on dialysis. Symptoms of kidney problems may include, nausea, changes in volume or frequency of urination, abnormal blood tests (see section 4). Your doctor may need to adjust your treatment or stop 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 persons 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 can affect or be affected by Alunbrig:
ketoconazole, itraconazole, voriconazole: medicines to treat fungal
infections
indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV
infection
clarithromycin, telithromycin, troleandomycin: medicines to treat
bacterial infections
- nefazodone: a medicine to treat depression
- St. John’s wort: a herbal product used to treat depression
carbamazepine: a medicine to treat epilepsy, euphoric/depressive
episodes and certain pain conditions
- phenobarbital, phenytoin: medicines to treat epilepsy
rifabutin, rifampicin: medicines to treat tuberculosis or certain other
infections
- digoxin: a medicine to treat heart problems
- dabigatran: a medicine to inhibit blood clotting
- colchicine: a medicine to treat gout attacks
pravastatin, rosuvastatin: medicines to lower elevated cholesterol
levels
methotrexate: a medicine to treat severe joint inflammation, cancer
and the skin disease psoriasis
sulfasalazine: a medicine to treat severe bowel and rheumatic joint
inflammation
- efavirenz, etravirine: medicines to treat HIV infection
- modafinil: a medicine to treat narcolepsy
- bosentan: a medicine to treat pulmonary hypertension
- nafcillin: a medicine to treat bacterial infections
- alfentanil, fentanyl: medicines to treat pain
- quinidine: a medicine to treat irregular heart rhythm
cyclosporine, sirolimus, tacrolimus: medicines to suppress the immune
system
Alunbrig with food and drink
Avoid any grapefruit products during treatment as they may change the amount of brigatinib in your body.
Pregnancy
Alunbrig is not recommended during pregnancy unless the benefit outweighs the risk to the baby. If you are pregnant or think you may be pregnant or are planning to have a baby, talk to your doctor to discuss the risks of taking Alunbrig during pregnancy.
Women of childbearing age being treated with Alunbrig should avoid becoming pregnant. Effective non‑hormonal contraception must be used during treatment and for 4 months after stopping Alunbrig. Ask your doctor about the birth control methods that may be right for you.
Breast‑feeding
Do not breast‑feed during treatment with Alunbrig. It is unknown if brigatinib passes into breast milk and could potentially harm the baby.
Fertility
Men receiving 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 or tiredness. Do not drive or use machines during treatment if such signs occur.
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.
Alunbrig contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’.
3. How to take Alunbrig
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
One 90 mg tablet once daily for the first 7 treatment days; thereafter, one 180 mg tablet once daily.
Do not change the dose without talking to your doctor. Your doctor may adjust your dose according to your needs and this may require use of a 30 mg tablet to achieve the new recommended dose.
Treatment initiation pack
At the beginning of your treatment with Alunbrig your doctor may prescribe a treatment initiation pack. To help you start treatment each treatment initiation pack consists of an outer pack with two inner packs containing
- 7 Alunbrig 90 mg film‑coated tablets
- 21 Alunbrig 180 mg film‑coated tablets
The required dose is printed on the treatment initiation pack.
Method of 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 can be taken with or without food.
If you vomit after taking Alunbrig, do not take any more tablets until
your next scheduled dose.
Do not swallow the desiccant canister contained in the bottle.
If you take more Alunbrig than you should
Tell your doctor or pharmacist right away 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 your next dose at your regular time.
If you stop taking Alunbrig
Do not stop taking Alunbrig before talking to 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 immediately if you have any of the following serious side effects:
Very common (may affect more than 1 in 10 people):
high blood pressure
Tell your doctor if you get headaches, dizziness, blurred vision, chest
pain or shortness of breath.
vision problems
Tell your doctor if you experience any visual disturbances, such as seeing
flashes of light, blurry vision or light hurting eyes. Your doctor may stop Alunbrig treatment and refer you to an ophthalmologist.
increased blood level of creatine phosphokinase in tests – may
indicate muscle damage, such as of the heart. Tell your doctor if you have any unexplained muscle pain, tenderness or weakness.
increased blood levels of amylase or lipase in tests – may indicate
inflammation of the pancreas
Tell your doctor if you have upper abdominal pain, including abdominal
pain that gets worse with eating and may spread to the back, weight loss or nausea.
increased blood levels of liver enzymes (aspartate aminotransferase,
alanine aminotransferase) in tests ‑may indicate liver cell damage. Tell your doctor if you have pain on the right side of your stomach area, yellowing of your skin or the whites of your eyes, or dark urine.
increased blood sugar
Tell your doctor if you are feeling very thirsty, need to urinate more than
usual, feeling very hungry, sick to your stomach, weak or tired, or confused.
Common (may affect up to 1 in 10 people):
lung inflammation
Tell your doctor if you have any new or worsening lung or breathing
problems, including chest pain, cough, and fever, especially within the first week of taking Alunbrig, as they may be a sign of serious lung problems.
slow heartbeat
Tell your doctor if you have chest pain or discomfort, changes in
heartbeat, dizziness, light‑headedness or fainting.
sensitivity to sunlight
Tell your doctor if you develop any skin reaction.
See also section 2, “Warnings and precautions”.
Uncommon (may affect up to 1 in 100 people)
inflammation of pancreas which may cause severe and persistent
stomach pain, with or without nausea and vomiting (pancreatitis)
Other possible side effects are:
Tell 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 (anaemia), in blood tests
reduced number of white blood cells, called neutrophils and
lymphocytes, in blood tests
increased blood clotting time shown by test of activated partial
thromboplastin time
blood tests may show increased blood level of;
- insulin
- calcium
blood tests may show reduced blood level of;
- phosphorus
- magnesium
- sodium
- potassium
- decreased appetite
- headache
symptoms such as numbness, tingling, prickling sensation, weakness or
pain in hands or feet (peripheral neuropathy)
- dizziness
- cough
- shortness of breath
- diarrhoea
- nausea
- vomiting
- abdominal (belly) pain
- constipation
- inflammation of the mouth and lips (stomatitis)
increased level of the enzyme alkaline phosphatase in blood tests– may
indicate organ malfunction or injury
- rash
- skin itching
- joint or muscle pain (including muscle spasms)
increased level of creatinine in blood tests– may indicate reduced kidney
function
- fatigue
- tissue swelling caused by excess fluid
- fever
Common (may affect up to 1 in 10 people):
low platelet counts in blood tests, which may increase the risk of
bleeding and bruising
- difficulty sleeping (insomnia)
- memory impairment
- change in sense of taste
abnormal electrical activity of the heart (prolonged electrocardiogram
QT interval)
- rapid heartbeat (tachycardia)
- palpitations
- dry mouth
- indigestion
- flatulence
increased level of lactate dehydrogenase in blood tests – may indicate
tissue breakdown
- increased level of bilirubin in blood tests
- dry skin
- musculoskeletal chest pain
- pain in arms and legs
- muscle and joint stiffness
- chest pain and discomfort
- pain
- increased level of cholesterol in blood tests
- weight loss
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on either the bottle label or 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 throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Alunbrig contains
The active substance is brigatinib.
Each 30 mg film‑coated tablet contains 30 mg brigatinib. Each 90 mg film‑coated tablet contains 90 mg brigatinib. Each 180 mg film‑coated tablet contains 180 mg brigatinib.
- The other excipients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), silica colloidal hydrophobic, magnesium stearate, talc, macrogol, polyvinyl alcohol, and titanium dioxide (see also section 2 ‘Alunbrig contains lactose’ and ‘Alunbrig contains sodium’) .
What Alunbrig looks like and contents of the pack
Alunbrig film‑coated tablets are white to off‑white, oval (90 mg and 180 mg) or round (30 mg). They are convex on the upper and lower side.
Alunbrig 30 mg:
- Each 30 mg tablet contains 30 mg brigatinib.
The film‑coated tablets are approximately 7 mm in diameter with “U3”
on one side and plain on the other side.
Alunbrig 90 mg:
- Each 90 mg tablet contains 90 mg brigatinib.
- The film‑coated tablets are approximately 15 mm long with “U7” on one side and plain on the other side.
Alunbrig 180 mg:
- Each 180 mg tablet contains 180 mg brigatinib.
- The film‑coated tablets are approximately 19 mm long with “U13” on one side and plain on the other side.
Alunbrig is available in plastic foil strips (blisters) packed in a carton 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 child resistant screw top closures. Each bottle contains one canister of a desiccant and is packed in a carton 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 canister in the bottle.
Alunbrig is available as a treatment initiation pack. Each pack consists of an outer carton with two inner cartons containing:
Alunbrig 90 mg film‑coated tablets
1 plastic foil strip (blister), containing 7 film‑coated tablets
Alunbrig 180 mg film‑coated tablets
3 plastic foil 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
Tel: +44 (0)3333 000181 medinfoemea@takeda.com
Manufacturer
Takeda Austria GmbH
St. Peter‑Strasse 25
4020 Linz
Austria
This leaflet was last revised in August 2023
DAL/Version No Product Commercial Name Project No Pass No Description
Drawing/50/53 Series No
CMO Name
128 Code
Minimum Type
Markets
Braille
Fonts
MySGS No:
Tech Spec Key PLFTXXXX
ALUNBRIG PIL GREAT BRITAIN (GXU) Multi 230727014936470
3
230727014936470 ALUNBRIG
197354v4
7412667 0 TC
Symbol Std, Times New Roman, Praxis LT Pro, Arial No
700 x 400mm
GREAT BRITAIN (GXU) 10.00pt
N/A
382992
N/A
0000
PCI - UK
PLFT0153E PIL
22 August 2023
PLFTXXXX 197354v4
DAL/Version No Product Commercial Name Project No Pass No Description
Drawing/50/53 Series No
CMO Name
128 Code
Minimum Type
Markets
Braille
Fonts
MySGS No:
Tech Spec Key PLFTXXXX
ALUNBRIG PIL GREAT BRITAIN (GXU) Multi 230727014936470 3
230727014936470 ALUNBRIG 197354v4
7412667 0 TC Symbol Std, Times New Roman, Praxis LT Pro, Arial No
700 x 400mm
GREAT BRITAIN (GXU) 10.00pt
N/A
382992
N/A
0000
PCI - UK
PLFT0153E PIL
22 August 2023