Lumykras 240 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

LUMYKRAS 120 mg film-coated tablets

LUMYKRAS 240 mg film-coated tablets

sotorasib

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What LUMYKRAS is and what it is used for
2. What you need to know before taking LUMYKRAS
3. How to take LUMYKRAS
4. Possible adverse reactions
5. How to store LUMYKRAS
6. Contents of the pack and other information

1. What LUMYKRAS is and what it is used for

LUMYKRAS contains the active substance sotorasib and belongs to a group of medicines called antineoplastic agents (cancer medicines).

LUMYKRAS is used to treat adult patients with an advanced type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body.

LUMYKRAS is used when previous treatments have not been effective in stopping cancer growth and if the cancer cells have a genetic modification that enables them to produce an abnormal protein called KRAS G12C. Your doctor will first test whether your cancer cells have this genetic modification to ensure that LUMYKRAS is suitable for you.

How does LUMYKRAS work?

The abnormal KRAS G12C protein contributes to the uncontrolled growth of cancer cells. LUMYKRAS binds to this protein and stops its activity. This may slow down or halt cancer growth.

If you have any questions about how LUMYKRAS works or why it has been prescribed for you, consult your doctor, pharmacist, or nurse.

2. What you need to know before starting to take LUMYKRAS

Do not take LUMYKRAS

• if you are allergic to sotorasib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take LUMYKRAS.

Inform your doctor, pharmacist, or nurse if you have a history of liver problems. Your doctor may perform blood tests to monitor how well your liver is working and may decide to reduce the dose of LUMYKRAS or discontinue treatment.

Inform your doctor if you have ever had other lung problems. Some lung complications may worsen during treatment with LUMYKRAS, as this medicine can cause inflammation of the lungs. Symptoms may be similar to those of lung cancer. Inform your doctor immediately if you develop any new symptoms or if existing symptoms worsen, including difficulty breathing, shortness of breath, cough with or without mucus, or fever.

Children and adolescents

LUMYKRAS has not been studied in children or adolescents. Treatment with LUMYKRAS is not recommended for patients under 18 years of age.

Other medicines and LUMYKRAS

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription, vitamins, and herbal supplements. This is because LUMYKRAS may affect how certain medicines work, and vice versa.

The following medicines may reduce the effectiveness of LUMYKRAS:

• Medicines to reduce stomach acid and treat stomach ulcers, indigestion, and heartburn (see section 3), such as:

• dexlansoprazole, esomeprazole, lansoprazole, omeprazole, sodium pantoprazole, or rabeprazole (medicines known as "proton pump inhibitors")

• ranitidine, famotidine, cimetidine (medicines known as "H2 receptor antagonists")

• Rifampicin (used to treat tuberculosis)

• Medicines used to treat epilepsy called phenytoin, phenobarbital, or carbamazepine (also used to treat neuralgia)

• St. John’s wort (a herbal remedy used to treat depression)

• Enzalutamide (used to treat prostate cancer)

LUMYKRAS may reduce the effectiveness of the following medicines:

• Medicines used to treat acute pain, such as alfentanil or fentanyl

• Medicines used in organ transplants to prevent organ rejection, such as cyclosporine, sirolimus, everolimus, or tacrolimus

• Medicines used to lower high blood pressure, such as amlodipine and manidipine

• Medicines used to lower cholesterol levels, such as simvastatin, atorvastatin, or lovastatin

• Midazolam (used to treat acute seizures or as a sedative before or during surgery or medical procedures)

• Medicines used to treat heart rhythm problems, such as dronedarone or amiodarone

• Medicines known as anticoagulants that prevent blood clotting, such as rivaroxaban or apixaban

LUMYKRAS may increase the risk of side effects with the following medicines:

• Medicines used to treat certain cancers or inflammatory diseases, such as methotrexate, mitoxantrone, topotecan, or lapatinib
• Medicines used to treat heart failure, such as digoxin
• Medicines used to lower cholesterol, such as rosuvastatin

Contraception

If you are taking LUMYKRAS while also taking oral contraceptives, the oral contraceptives may not be effective. You should also use another reliable method of contraception, such as a barrier method (e.g., condom), to prevent pregnancy while taking this medicine. Talk to your doctor about appropriate contraceptive methods for you and your partner.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You must not become pregnant while taking this medicine, as the effects of LUMYKRAS in pregnant women are unknown and it could harm the baby. If you are a woman of childbearing potential, you must use highly effective contraceptive methods during treatment and for at least 7 days after stopping treatment.

Breastfeeding

Do not breastfeed during treatment with this medicine or for 7 days after the last dose. This is because it is unknown whether components of LUMYKRAS pass into breast milk and could harm the baby.

Driving and using machines

LUMYKRAS has no major influence on the ability to drive and use machines.

LUMYKRAS contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

LUMYKRAS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take LUMYKRAS

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not change the dose of LUMYKRAS or stop taking it unless instructed by your doctor or pharmacist. Your doctor or pharmacist may reduce the dose or interrupt treatment depending on how well you tolerate it.

• The recommended dose is 960 mg (eight 120 mg tablets or four 240 mg tablets) once daily. You should take your daily dose of LUMYKRAS orally once a day, always at the same time.

• LUMYKRAS may be taken with or without food.

• Swallow the tablets whole. You may disperse the tablets in water, but do not chew, crush, or divide them.

• If you cannot swallow LUMYKRAS tablets whole:

• Place the daily dose of LUMYKRAS in half a glass (at least 120 ml) of room temperature tap water without crushing the tablets. Do not use any other liquid, including acidic drinks (e.g., fruit juice).

• Gently stir until the tablets break apart into small pieces (they will not dissolve completely). The mixture will have a pale to bright yellow color.

• Drink the mixture immediately.

• Rinse the glass by filling it again halfway with water and drink it immediately to ensure you take the full dose of LUMYKRAS.

• If you do not drink the entire mixture immediately, stir it again before finishing. Drink the entire mixture within two hours of preparation.

• If necessary, your doctor may recommend that LUMYKRAS be administered through a feeding tube.

If you need to take any medication to reduce stomach acidity, such as a proton pump inhibitor or an H2-receptor antagonist, take LUMYKRAS with an acidic drink (such as cola). Alternatively, you may take a local antacid (such as magnesium hydroxide or calcium carbonate), in which case you must take LUMYKRAS 4 hours before or 10 hours after taking that medication (see section 2).

If you take more LUMYKRAS than you should

If you take more tablets than recommended, contact your doctor, pharmacist, or nurse immediately.

If you vomit after taking LUMYKRAS

If you vomit after taking a dose of LUMYKRAS, do not take an additional dose. Take the next dose at the usual time.

If you forget to take LUMYKRAS

If you have forgotten to take a dose of LUMYKRAS at the usual time and less than 6 hours have passed, take the dose as normal. If more than 6 hours have passed since the usual dosing time, do not take the missed dose. Take the next dose at the usual time on the following day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The very common and serious possible side effects of LUMYKRAS are increased blood levels of certain liver enzymes (AST/ALT), which is a sign of liver problems. Your doctor may perform blood tests to check whether your liver is functioning properly and might decide to reduce the dose of LUMYKRAS or stop treatment (see section 2).

Other possible side effects of LUMYKRAS may include:

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

• Diarrhea
• Feeling sick (nausea)
• Tiredness
• Vomiting
• Constipation
• Stomach pain
• Joint pain
• Back pain
• Shortness of breath
• Cough
• Low red blood cell count (anemia), which may cause fatigue
• Decreased appetite

Common (may affect up to 1 in 10 people)

• Headache
• Fever
• Elevated levels of certain enzymes, including blood enzymes, observed in laboratory tests (high levels of alkaline phosphatase, bilirubin, and gamma-glutamyl transferase)
• Liver damage
• Inflammation of the lungs called "interstitial lung disease"
• Changes in blood tests (low blood potassium levels)

Uncommon (may affect up to 1 in 100 people)

• Kidney problems, including kidney failure
• Inflammation of the liver (hepatitis)

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of LUMYKRAS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after CAD or EXP. The expiry date is the last day of the month indicated.

Do not use this medicine after the expiry date stated on the carton and bottle after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Package contents and other information Composition of LUMYKRAS

Composition of LUMYKRAS

• The active substance is sotorasib. Each film-coated tablet contains 120 mg or 240 mg of sotorasib.

• The other components are:

• Microcrystalline cellulose (E460(i))

• Lactose monohydrate

• Sodium croscarmellose (E468)

• Magnesium stearate (E470b)

• The tablets are coated with:

• Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b) and yellow iron oxide (E172)

See "LUMYKRAS contains lactose" and "LUMYKRAS contains sodium" in section 2.

Appearance of the product and contents of the pack

LUMYKRAS 120 mg film-coated tablets

Each film-coated tablet is a yellow, oblong, film-coated tablet, marked with "AMG" on one side and "120" on the other.

• LUMYKRAS is supplied in blisters containing 8 film-coated tablets in pack sizes of 240 film-coated tablets (1 carton containing 30 blisters) and multiple packs containing 720 (3 × 240) film-coated tablets.
• LUMYKRAS is supplied in bottles containing 120 film-coated tablets in pack sizes of 240 film-coated tablets (1 carton containing 2 bottles).

LUMYKRAS 240 mg film-coated tablets

Each film-coated tablet is a yellow, oval, film-coated tablet, marked with "AMG" on one side and "240" on the other.

• LUMYKRAS is supplied in pre-scored unit dose blisters containing 8 film-coated tablets in pack sizes of 120 film-coated tablets (1 carton containing 15 blisters).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

The Netherlands

Marketing Authorization Holder

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

The Netherlands

Manufacturer

Amgen NV,

Telecomlaan 5-7,

1831 Diegem,

Belgium

More information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: {month YYYY}.

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

The European Medicines Agency will review new information on this medicinal product at least once a year, and this summary will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

This summary can be found on the European Medicines Agency's website in all languages of the European Union/European Economic Area.