Krazati – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Krazati, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What KRAZATI is and what it is used for
KRAZATI contains the active substance adagrasib and belongs to a group of medicines known as antineoplastic agents, cancer medicines.
KRAZATI is used to treat adults with a type of lung cancer called non -small cell lung cancer (NSCLC) when it is advanced or has spread to other parts of the body.
KRAZATI is used when previous treatments were not effective in stopping the growth of the cancer, and when the cancer cells have mutations (change s) that allow them to produce an abnormal form of a protein called KRAS G12C. Your doctor will test for this change in your cancer cells beforehand to make sure that KRAZATI is right for you.
How does KRAZATI work?
The abnormal KRAS G12C protein make s the cancer cells grow out of control. The active substance in KRAZATI, adagrasib , attaches to this abnormal protein and stops it from working, which may slow down or stop the growth of the cancer.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
⚠️ 2. What you need to know before you take KRAZATI
Do not take KRAZATI
- if you are allergic to adagrasib or any of the other ingredients of this medicine (listed in section 6).
24 – if you are taking any of the following medicines as they may cause serious and/or life – threatening side effects:
- alfuzosin (used to treat benign prostatic hyperplasia)
- amiodarone ( used to treat heart problems)
- cisapride (used to treat symptoms of night time heartburn and other gastrointestinal disorders
- pimozide, quetiapine (antipsychotic medicines)
- quinidine ( used to treat malaria and heart problems)
- ergotamine, dihydroergotamine (used to treat migraines)
- lovastatin, simvastatin (used to lower cholesterol levels)
- sildenafil ( for the treatment of pulmonary arterial hypertension)
- triazolam (used to treat insomnia)
- sirolimus, tacrolimus (used to prevent rejection of transplanted organs)
- ticagrelor (used to prevent heart attack and stroke)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking KRAZATI .
KRAZATI may affect your liver. Your doctor may carry out some tests before you begin taking KRAZATI , once a month for the first 3 months of your treatment and as considered necessary by your doctor . Based on the results of these tests, y our dose of KRAZATI may be either reduced, interrupted , or stopped.
Talk to your doctor before you take KRAZATI if you:
- have heart or circulatory problems,
- experience or have experienced abnormal electrical activity of the heart that affects its rhythm or
- take any heart medicines that carry a risk of heart rhythm problems , see “ Other medicines and KRAZATI” Your doctor will decide if this medicine is suitable for you and may monitor your heart with an electrocardiogram (ECG; a test which measures the electrical activity of the heart) and adjust your dose of KRAZATI accordingly.
Talk to your doctor during your treatment if you:
- develop problems such as diarrhoea, feeling sick ( nausea), and vomiting. Your doctor may decide to reduce or interrupt the dose or stop treatment with KRAZATI.
- feel dizzy or develop any heart problems such as a fast or irregular heartbeat.
Serious and potentially fatal skin reactions (such as Stevens– Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms) have been reported in association with KRAZATI .
Stop using KRAZATI and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions (which may include reddish non -elevated, target -like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, and enlarged lymph nodes. These serious skin rashes can be preceded by fever and flu -like symptoms).
Children and adolescents
KRAZATI has not been studied in children or adolescents. Treatment with KRAZATI is not recommended in persons under 18 years of age.
25 Other medicines and KRAZATI Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal supplements and medicines obtained without prescription. This is because KRAZATI can affect how some other medicines work , and some other medicines can affect how KRAZATI works.
See ‘ Do not take KRAZATI’ if you are taking any medicines that might interact with KRAZATI.
Certain medicines and herbal supplements may reduce how well KRAZATI works by decreasing the amount of KRAZATI in the blood. These medicines include:
- Rifampicin (used to treat tuberculosis and other infections )
- Carbamazepine, phenobarbital , phenytoin (used to treat epilepsy)
- St John’s Wort ( Hypericum perforatum; available as either a medicine or a herbal supplement and is used to treat depression) Certain medicines may increase the risk of side effects of KRAZATI by increasing the levels of KRAZATI in the blood . These medicines include :
- Itraconazole, ketoconazole . posaconazole, or voriconazole (used to treat fungal infections)
- Clarithromycin , telithromycin, or troleandomycin (used to treat bacterial infections)
- Ritonavir (used with other medications to treat HIV infection) KRAZATI may increase the side effects of some medicines by increasing the amount of these medicines in the blood. Examples of these medicines include:
- Warfarin (used to treat blood clots). Your doctor may need to monitor the time your blood takes to clot (pro thrombin time or INR test) .
Some medicines may cause a change in the electrical conduction in your heart , particularly when taken with KRAZATI. Examples include:
- some medicines for heart rhythm disorders (e.g. amiodarone, disopyramide, dofetilide, dronedarone, flecainide, hydroquinidine , ibutilide , nifekalant , procainamide , quinidine , sotalol)
- some medicines to treat bacterial or fungal infections (e.g. azithromycin, ciprofloxacin, clarithromycin, erythromycin, levofloxacin, moxifloxacin , roxithromycin, fluconazole) or malaria (e.g. chloroquine, halofantrine, hydroxychloroquine)
- some medicines used to treat gastrointestinal disorders (e.g., chlorpromazine, domperidone , droperidol , and ondansetron for nausea; loperamide for diarrhoea )
- some medicines used to treat schizophrenia and mood disorders (e.g. chlorprothixene, citalopram , escitalopram , haloperidol, sulpiride )
- others (e.g. anagrelide and cilostazol to prevent blood clots ; bepridil for high blood pressure; donepezil for Alzheimer’s disease; methadone for pain and opioid addiction; pimozide for tics associated with Tourette’s Disorder ; terfenadine for allergic rhinitis ; terodiline for bladder incontinence) Talk with your doctor if you are taking these or any other medicines.
KRAZATI with food and drink Drinking certain brands of grapefruit juice and in large amounts whilst you start taking KRAZATI may increase your chance of getting side effects by increasing the levels of KRAZATI in the blood .
Pregnancy
If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
26 Do not take KRAZATI if you are pregnant, or suspect you are pregnant, unless advised by your doctor. The effects of KRAZATI in pregnant women are not known.
Contraception Women who can become pregnant must use an effective method of contraception to avoid becoming pregnant during treatment with KRAZATI and for at least 5 days following the last dose . Talk to your doctor about the most suitable contraception for you.
Breast -feeding Do not breast -feed your baby whilst you are being treated with KRAZATI . It is not known if this medicine passes to the baby via breast milk.
Driving and using machines
KRAZATI has a minor influence on the ability to drive and use machines. If you feel dizzy , a spinning sensation or tiredness do not drive, use machine s or take part in activities where this puts yourself or others at risk.
💊 3. How to take KRAZATI
You will be prescribed this medicine by a doctor experienced in the use of anti -cancer medicines.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take The recommended dose is three 200 mg tablets (600 mg in total) taken twice daily .
Do not change your dose unless your doctor or pharmacist tells you to.
Your doctor may decrease the dose or stop your medicine depending on how well you tolerate it.
How to take Take the medicine at the same time each day.
You can take the medicine with or without food.
Swallow the tablets whole with water.
If you cannot swallow tablets whole:
- Place your dose of KRAZATI in half a glass (not less than 120 mL) of still, room temperature drinking water, without crushing the tablets. Do not use any other liquids, including acidic beverages (e.g. fruit juices).
- Swirl gently until the mixture looks white with small pieces of tablet. Do not to chew the pieces.
- Drink the mixture immediately.
- Rinse the glass with an additional half a glass of water and drink it immediately to make sure that you have taken the full dose of KRAZATI.
If you take more KRAZATI than you should
Contact your doctor, pharmacist or nurse immediately if you take more tablets than recommended.
If you vomit after taking KRAZATI If you vomit after taking a dose, do not take an extra dose. Take your next dose at your next scheduled time.
If you forget to take KRAZATI
If you miss a dose, take it as soon as possible. If you miss your dose by more than 4 hours, skip that dose and take your usual dose at the next scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking KRAZATI
Do not stop taking this medicine. Talk to your doctor first. It is important to take this medicine every day, for as long as your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people) and serious possible side effects of
KRAZATI are:
- QT prolongation, a heart conduction abnormality that can lead to a life -threatening heart rhythm Tell your doctor immediately if you develop:
- chest pain
- shortness of breath
- a fast heart rate or pounding heartbeat.
Your doctor may monitor your heart with an ECG (electrocardiogram) and may decide to either reduce the dose of KRAZATI or stop your treatment (see section 2).
- Increased levels of certain liver enzymes (ALT, AST) and bilirubin (a substance in the liver that can cause yellowing of the skin and eyes) are signs of liver problems. Your doctor should do blood tests to check how well your liver is working and may decide to either reduce or interrupt the dose or stop treatment with KRAZATI (see section 2).
Other possible side effects of KRAZATI may include:
Very common (may affect more than 1 in 10 people)
- low levels of red blood cell counts (anaemia) which can cause tiredness and pale skin
- low blood sodium levels which can cause headache, tiredness, fits and coma
- loss of appetite
- feeling dizzy, a spinning sensation
- a sign of worsening kidney problems (creatinine increased)
- feeling sick (nausea)
- diarrhoea
- vomiting
- abnormal blood test results indicate high levels of lipase and/or amylase in your blood stream
- tiredness, weakness
- swelling especially of the ankles and feet due to fluid retention
Common (may affect up to 1 in 10 people )
- inflammation in the lungs causing shortness of breath and cough (pneumonitis )
- low levels of lymphocytes (a type of white blood cell; lymphocytopenia) 28 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 via 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. How to store KRAZATI
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 bottle label and carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater 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 KRAZATI contains
- The active substance is adagrasib. Each film -coated tablet contains 200 mg adagrasib.
- The other ingredients are:
Tablet core Microcrystalline cellulose (E 460), m annitol (E 421), crospovidone, silica colloidal anhydrous (E 551), m agnesium stearate (vegetable).
Film -coating Hypromellose, titanium dioxide (E 171), p olydextrose (E 1200), talc (E 553b), maltodextrin, medium chain triglycerides (vegetable).
What KRAZATI looks like and contents of the pack
KRAZATI film-coated tablets are white to off -white and oval shaped, with a stylised ‘M’ on one side and ‘200’ marked on the other side.
The medicine comes in white opaque plastic bottles with white, child resistant lid and a heat -induction seal. Each bottle contains two silica gel desiccant packet s which must be kept in the bottle to help protect your tablets from moisture. They must not be swallowed.
The pack sizes are bottles with either 120 or 180 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland 29 Manufacturer Swords Laboratories Unlimited Company T/A Bristol -Myers Squibb Pharmaceutical Operations External Manufacturing Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgique/België/Belgien N.V. Bristol -Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11 [email protected] Lietuva Swixx Biopharma UAB Tel: + 370 52 369140 [email protected] България Swixx Biopharma EOOD Teл.: + 359 2 4942 480 [email protected] Luxembourg/Luxemburg N.V. Bristol -Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11 [email protected] Česká republika Bristol -Myers Squibb spol. s r.o.
Tel: + 420 221 016 111 [email protected] Magyarország Bristol -Myers Squibb Kft.
Tel.: + 36 1 301 9797 [email protected] Danmark Bristol -Myers Squibb Denmark Tlf: + 45 45 93 05 06 [email protected] Malta A.M. Mangion Ltd Tel: + 356 23976333 [email protected] Deutschland Bristol -Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 89 121 42 350) [email protected] Nederland Bristol -Myers Squibb B.V.
Tel: + 31 (0)30 300 2222 [email protected] Eesti Swixx Biopharma OÜ Tel: + 372 640 1030 [email protected] Norge Bristol -Myers Squibb Norway AS Tlf: + 47 67 55 53 50 [email protected] Ελλάδα Bristol -Myers Squibb A.E.
Τηλ: + 30 210 6074300 [email protected] Österreich Bristol -Myers Squibb GesmbH Tel: + 43 1 60 14 30 [email protected] España Bristol -Myers Squibb, S.A.
Tel: + 34 91 456 53 00 [email protected] Polska Bristol -Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400 [email protected] France Bristol -Myers Squibb SAS Tél: + 33 (0)1 58 83 84 96 [email protected] Portugal Bristol -Myers Squibb Farmacêutica Portuguesa, S.A.
Tel: + 351 21 440 70 00 [email protected] 30 Hrvatska Swixx Biopharma d.o.o.
Tel: + 385 1 2078 500 [email protected] România Bristol -Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19 [email protected] Ireland Bristol -Myers Squibb Pharmaceuticals uc Tel: 1 800 749 749 (+ 353 (0)1 483 3625) [email protected] Slovenija Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100 [email protected] Ísland Vistor ehf.
Sími: + 354 535 7000 [email protected] Slovenská republika Swixx Biopharma s.r.o.
Tel: + 421 2 20833 600 [email protected] Italia Bristol -Myers Squibb S.r.l.
Tel: + 39 06 50 39 61 [email protected] Suomi/Finland Oy Bristol -Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 230 [email protected] Κύπρος Bristol -Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300) medinfo .greece@ bms.com Sverige Bristol -Myers Squibb Aktiebolag Tel: + 46 8 704 71 00 [email protected] Latvija Swixx Biopharma SIA Tel: + 371 66164750 [email protected] This leaflet was last revised in month YYYY.
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/ .
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Krazati (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1744).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.