Lumykras 120 mg comprimidos recubiertos con pelicula

Prospect: information for the patient

LUMYKRAS 120 mg film-coated tablets

LUMYKRAS 240 mg film-coated tablets

sotorasib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

LUMYKRAS contains the active ingredient sotorasib and belongs to a group of medicationsknown as antineoplastic agents (cancer medications).

LUMYKRAS is used to treat adult patients with a type of lung cancer called non-small cell lung cancer (NSCLC) in advanced stages and 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 cancer cells have a genetic modification that allows them to produce an abnormal form of protein calledKRAS G12C. Your doctor will study beforehand if your type of cancer cells have this modification to ensure that LUMYKRAS is suitable for you.

How does LUMYKRAS work?

The abnormal proteinKRAS G12Ccontributes to the uncontrolled growth of cancer cells.LUMYKRAS binds to the protein and stops its functioning. This may slow down or stop cancer growth.

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

Do not take LUMYKRAS

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

Warnings and precautions

Consult 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 carry out blood tests to check how your liver is working, and may decide to reduce the dose of LUMYKRAS or stop treatment.

Inform your doctor if you have ever had other lung problems. Some lung complications may worsen during treatment with LUMYKRAS, as it may cause the lungs to become inflamed during treatment. Symptoms may be similar to those of lung cancer. Inform 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 individuals under 18 years.

Other medicines and LUMYKRAS

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those available over the counter, vitamins and herbal supplements. This is because LUMYKRAS may affect the way 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 the following:

• dexlansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol sódico or rabeprazol (medicines called «proton pump inhibitors»)
• ranitidina, famotidina, cimetidina (medicines called «H2 receptor antagonists»)

• Rifampicina (used to treat tuberculosis)
• Medicines to treat epilepsy called phenitoína, phenobarbital or carbamazepina (also used to treat neuralgia)
• Hierba de San Juan (herbal medicine used to treat depression)
• Enzalutamida (used to treat prostate cancer)

LUMYKRAS may reduce the effectiveness of the following medicines:

• Medicines to treat acute pain, such as alfentanilo or fentanilo
• Medicines used in organ transplants to prevent organ rejection, such as ciclosporina, sirólimus, everólimus or tacrólimus
• Medicines used to reduce high blood pressure, such as amlodipino and manidipino
• Medicines used to reduce cholesterol levels, such as simvastatina, atorvastatina or lovastatina
• Midazolam (used to treat acute crises or as a sedative before or during surgery or medical procedures)

• Medicines used to treat heart rhythm problems, such as dronedarona or amiodarona
• Medicines called anticoagulants that prevent blood clotting, such as rivaroxabán or apixabán

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

• Medicines used to treat certain cancers or inflammatory diseases, such as metotrexato, mitoxantrona, topotecán or lapatinib
• Medicines used to treat heart failure, such as digoxin
• Medicines used to reduce cholesterol, such as rosuvastatina

Contraception

If you take LUMYKRAS while taking oral contraceptives, the oral contraceptives may not be effective. In addition, you should 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, breastfeeding and fertility

Pregnancy

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

You should not become pregnant while taking this medicine, as the effects of LUMYKRAS on pregnant women are unknown and it may harm the baby. If you are fertile, you should 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 the components of LUMYKRAS pass into breast milk and may harm the baby.

Driving and operating machinery

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

LUMYKRAS contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with 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».

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not modify the dose of LUMYKRAS or stop taking it unless your doctor or pharmacist instructs you to do so. Your doctor or pharmacist may reduce the dose or interrupt 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:

• Insert the daily dose of LUMYKRAS into a medium-sized 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).
• Gently stir until the tablets break into small pieces (they will not dissolve completely). The mixture will have a color between pale yellow and bright yellow.
• Drink the mixture immediately.
• Fill the glass with water again to the middle and drink it immediatelyto ensure you take the complete dose of LUMYKRAS.
• If you do not drink the entire mixture immediately, stir it again before finishing drinking it. 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 a medication to reduce stomach acid, such as a proton pump inhibitor or an H2 receptor antagonist, take LUMYKRAS with an acidic beverage (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 4hours before or 10hours after taking said medication (see section2).

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 normal dose. If more than 6 hours have passed since the usual dose time, do not take it. Take the next dose at the usual time the next day.

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

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

Other possible side effects of LUMYKRAS may include:

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

• Diarrhea
• Feeling dizzy (nausea)
• Fatigue
• Vomiting
• Constipation
• Abdominal pain
• Joint pain
• Back pain
• Shortness of breath
• Cough
• Anemia, which can cause fatigue, with a low red blood cell count in the blood
• Decreased appetite

Common (may affect up to 1 in 10 people)

• Headache
• Fever
• High levels of certain enzymes, including blood enzymes, observed in tests (high levels of alkaline phosphatase, bilirubin, and gamma-glutamyltransferase)
• Liver damage
• Pulmonary interstitial disease, an inflammation of the lungs
• Changes in blood tests (decreased levels of potassium in the blood)

Uncommon (may affect up to 1 in 100 people)

• Renal problems, including renal insufficiency
• Inflammation of the liver (hepatitis)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD or EXP. The expiration date is the last day of the month indicated.

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated..

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of LUMYKRAS

• The active ingredient is sotorasib. Each film-coated tablet contains

120 mg or 240 mg ofsotorasib.

-The other components are:

• Celulosa, microcristalina (E460(i))
• Lactosa monohydrate
• Croscarmelosa sodium (E468)
• Estearate of magnesium (E470b)

-The tablets are coated with:

• Alcohol polyvinyl (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 120mg film-coated tablets

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

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

LUMYKRAS 240mg film-coated tablets

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

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

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

Netherlands

Marketing authorisation holder

Amgen Europe B.V.,

Minervum 7061,

4817 ZK Breda,

Netherlands

Responsible person for manufacturing

Amgen NV,

Telecomlaan 5-7,

1831 Diegem,

Belgium

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:{month YYYY}.

This medicinal product has been authorised under a «conditional approval». This type of approval means that more information is expected to be obtained about this medicinal product.

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

Other sources of information

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

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.