LUMYKRAS 240 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

LUMYKRAS 120 mg film-coated tablets

LUMYKRAS 240mg film-coated tablets

sotorasib

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet contains information on how to report side effects.

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.

Contents of the pack

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

1. What is LUMYKRAS and what is it 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 a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced and has spread to other parts of the body.

LUMYKRAS is used when previous treatments have not been effective in stopping the growth of the cancer and if the cancer cells have a genetic modification that allows them to produce an abnormal form of a protein called KRAS G12C. Your doctor will check beforehand if your type of cancer cells have this modification to make sure that LUMYKRAS is suitable for you.

How does LUMYKRAS work?

The abnormal KRAS G12Cprotein contributes to the uncontrolled growth of cancer cells. LUMYKRAS binds to the protein and stops its function. This can slow down or stop the growth of the cancer.

If you have any questions about how LUMYKRAS works or why you have been prescribed this medicine, ask your doctor, pharmacist, or nurse.

2. What you need to know before you take LUMYKRAS

Do not take LUMYKRAS

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking LUMYKRAS.

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

Tell your doctor if you have ever had other lung problems. Some lung complications may worsen during treatment with LUMYKRAS, as it can cause inflammation of the lungs during treatment. The symptoms can be similar to those of lung cancer. Tell your doctor immediately if you experience any new symptoms or if any 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 in patients under 18 years of age.

Other medicines and LUMYKRAS

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those that can be bought without a prescription, vitamins, and herbal supplements. This is because LUMYKRAS may affect how some 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 the following:

• dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, or rabeprazole (medicines called "proton pump inhibitors")
• ranitidine, famotidine, cimetidine (medicines called "H2 receptor antagonists")

• Rifampicin (used to treat tuberculosis)
• Medicines to treat epilepsy called phenytoin, phenobarbital, or carbamazepine (also used to treat neuralgia)
• St. John's Wort (herbal medicine used to treat depression)
• Enzalutamide (used to treat prostate cancer)

LUMYKRAS may reduce the effectiveness of the following medicines:

• Medicines 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 or 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 called 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 levels, such as rosuvastatin

Contraception

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

Pregnancy, breast-feeding, and fertility

Pregnancy

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 taking this medicine.

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

Breast-feeding

Do not breast-feed during treatment with this medicine and for 7 days after the last dose. This is because it is not known whether the components of LUMYKRAS pass into breast milk and may harm the baby.

Driving and using machines

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

LUMYKRAS contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

LUMYKRAS contains sodium

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

3. How to take LUMYKRAS

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Do not change the dose of LUMYKRAS or stop taking it unless your doctor or pharmacist tells you to. Your doctor or pharmacist may reduce the dose or stop treatment based on how you tolerate it.

• The recommended dose is 960 mg (eight 120 mg tablets or four 240 mg tablets) once a day. You should take your daily dose of LUMYKRAS orally once a day, always at the same time.
• LUMYKRAS can be taken with or without food.
• Swallow the tablets whole. You can disperse the tablets in water, but do not chew, crush, or divide them.
• If you cannot swallow the LUMYKRAS tablets whole:

• Put the daily dose of LUMYKRAS in half a glass (at least 120 ml) of water at room temperature without crushing the tablets. Do not use any other liquid, including acidic beverages (e.g., fruit juice).
• Stir carefully until the tablets break 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 with water again and drink it immediately to make sure you take the full dose of LUMYKRAS.
• If you do not drink the entire mixture immediately, stir it again before finishing it. Drink the entire mixture before 2 hours after preparation.

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

If you need to take any medicine to reduce stomach acid, such as a proton pump inhibitor or an H2 receptor antagonist, take LUMYKRAS with an acidic drink (such as cola). Alternatively, you can take a local antacid (such as magnesium hydroxide or calcium carbonate) and, in that case, you should take LUMYKRAS 4 hours before or 10 hours after taking the antacid (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 it has been less than 6 hours, take the normal dose. If it has been more than 6 hours since the usual time of the dose, do not take it. Take the next dose at the usual time the next day.

4. Possible side effects

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

The very common and serious side effects of LUMYKRAS are increased levels of certain liver enzymes (AST/ALT) in the blood, which is a sign of liver problems. Your doctor may perform blood tests to check if your liver is working properly and may 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)
• Fatigue
• Vomiting
• Constipation
• Stomach pain
• Joint pain
• Back pain
• Shortness of breath
• Cough
• Low levels of red blood cells in the blood (anemia), which can cause fatigue
• Decreased appetite

Common (may affect up to 1 in 10 people)

• Headache
• Fever
• High levels of some enzymes, including blood enzymes, seen in tests (high levels of alkaline phosphatase, bilirubin, and gamma-glutamyltransferase)
• Liver damage
• Inflammation of the lungs called "interstitial lung disease"
• Changes in blood tests (decreased levels of potassium in the blood)

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 effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of LUMYKRAS

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 carton and blister after EXP. The expiry date refers to the last day of the month.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.

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 no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information Composition of LUMYKRAS

Composition of LUMYKRAS

• The active ingredient is sotorasib. Each film-coated tablet contains 120 mg or 240 mg of sotorasib.
• The other ingredients 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 and Package Contents

LUMYKRAS 120 mg film-coated tablets

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

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

LUMYKRAS 240 mg film-coated tablets

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

Netherlands

Manufacturer

Amgen NV,

Telecomlaan 5-7,

1831 Diegem,

Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:{month YYYY}.

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

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

Other sources of information

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

The leaflet for this medicinal product can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.