sotorasib: package leaflet

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

LUMYKRAS is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) when it is advanced and has spread to other parts of the body.

LUMYKRAS is used when previous treatments were not effective in stopping the growth of the cancer, and when the cancer cells have a genetic change that allows them to produce an abnormal form of protein called KRAS G12C. Your doctor will test your cancer cells for this change beforehand to make sure that LUMYKRAS is right for you.

How does LUMYKRAS work?

The abnormal KRAS G12C protein, acts to help make cancer cells grow out of control. LUMYKRAS attaches to the protein and stops it from working, which may slow down or stop the growth of the cancer.

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

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

Talk to your doctor, pharmacist or nurse before taking LUMYKRAS.

Tell your doctor, pharmacist or nurse if you have a history of liver problems. Your doctor may carry out blood tests to check your liver function, and may decide to either reduce the dose of LUMYKRAS or stop your treatment.

Tell your doctor if you have ever had any other lung problems. Some lung problems may get worse during treatment with LUMYKRAS, as LUMYKRAS may cause inflammation of the lungs during treatment. Symptoms may be similar to those from lung cancer. Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.

Children and adolescents

LUMYKRAS has not been studied in children or adolescents. Treatment with LUMYKRAS is not recommended in persons 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 medicines obtained without a prescription, vitamins and herbal supplements.
This is because LUMYKRAS can affect the way some other medicines work, and some other medicines can affect the way LUMYKRAS works.

The following medicines may reduce how well LUMYKRAS works:
- Medicines used to reduce stomach acid and to treat stomach ulcers, indigestion and heartburn (see section 3) such as:
- dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, 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 nerve pain)
- St. John’s wort (herbal medicine used to treat depression)
- Enzalutamide (used to treat prostate cancer)

LUMYKRAS may reduce how well the following medicines work:
- Medicines used to treat severe pain, such as alfentanil or fentanyl
- Medicines used in organ transplantation to prevent organ rejection, such as cyclosporine, sirolimus, everolimus or tacrolimus
- Medicines used to reduce high blood pressure, such as amlodipine and manidipine
- Medicines used to reduce 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 stop your blood clotting, such as rivaroxaban or apixaban

LUMYKRAS may increase the risk for side effects with the following medicines:
- Medicines used to treat certain cancers or inflammatory conditions, 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 take LUMYKRAS whilst using oral contraceptives, the oral contraceptives may be ineffective.
In addition, you should use another reliable method of birth control such as a barrier method (e.g.
condom) so you do not become pregnant while you are taking this medicine. Talk to your doctor about the right 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 because the effects of LUMYKRAS in pregnant women are not known, it could harm the baby. If you are able to become pregnant, you must use highly effective contraception while on treatment and for at least 7 days after stopping treatment.

Breast-feeding

Do not breast-feed while taking this medicine and for 7 days after the last dose. This is because it is not known whether the ingredients in LUMYKRAS pass into breast milk and could therefore harm your baby.

Driving and using machines

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

LUMYKRAS 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.

LUMYKRAS contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not change your dose or stop taking LUMYKRAS unless your doctor or pharmacist tells you to.
Your doctor or pharmacist may decrease the dose or stop your medicine depending on how well you tolerate it.
- The recommended dose is 960 mg (eight 120 mg tablets or four 240 mg tablets) once a day.
Take your daily dose of LUMYKRAS by mouth once a day, at the same time each day.
- 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 split the tablets.
- If you cannot swallow LUMYKRAS tablets whole:
- Place your daily dose of LUMYKRAS in half a glass (not less than 120 mL) of plain, 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 tablets are in small pieces (the tablets will not dissolve completely).
The appearance of the mixture may range from pale to bright yellow.
- Drink the mixture right away.
- Rinse the glass with an additional half a glass of water and drink right away to make sure that you have taken the full dose of LUMYKRAS.
- If you do not drink all of the mixture immediately, stir the mixture again before you finish drinking it. Drink all of the mixture within two hours of preparation.
- If necessary, your doctor may recommend you receive LUMYKRAS through a feeding tube.

If you need to take a medicine 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 may use a local antacid (such as magnesium hydroxide or calcium carbonate) and, in that case, LUMYKRAS should be taken either 4 hours before or 10 hours after that medicine (see section 2).

If you take more LUMYKRAS than you should

Contact your doctor, pharmacist or nurse immediately if you take more tablets than recommended.

If you vomit after taking LUMYKRAS

If you vomit after taking a dose of LUMYKRAS, do not take an extra dose. Take your next dose at your regular scheduled time.

If you forget to take LUMYKRAS

If you forget to take a dose of LUMYKRAS at your regular scheduled time, and less than 6 hours have passed, take your dose as normal. If more than 6 hours have passed from your regular scheduled time, do not take the dose. Take your next dose at your regular scheduled time the next day.

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

Very common and serious possible side effects of LUMYKRAS are increased blood levels of certain liver enzymes (AST/ALT), which are a sign of liver problems. Your doctor may do blood tests to check how well your liver is working and may decide to either reduce the dose of LUMYKRAS or stop your treatment (see section 2).

Other possible side effects of LUMYKRAS may include:

Very common (may affect more than 1 in 10 people)
- Diarrhoea
- Feeling sick (nausea)
- Feeling tired
- Vomiting
- Constipation
- Stomach pain
- Joint pain
- Back pain

• Shortness of breath
• Cough
• Low red blood cell count (anaemia) which may cause tiredness and 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 (increased alkaline phosphatase, bilirubin and gamma-glutamyltransferase)
- Liver injury
- Inflammation of the lungs called “interstitial lung disease”
- Changes to blood tests (decreased blood levels of potassium)

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 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.

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 that 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 that month.

This medicine does not require any special storage conditions.

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.

What LUMYKRAS contains

• The active substance is sotorasib. Each film-coated tablet contains 120 mg or 240 mg of sotorasib.
• The other ingredients are:
• Cellulose, microcrystalline (E460(i))
• Lactose monohydrate
• Croscarmellose sodium (E468)
• Magnesium stearate (E470b)
• The tablets are coated with:
• Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and iron oxide yellow (E172)

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

What LUMYKRAS looks like and contents of the pack

LUMYKRAS 120 mg film-coated tablets

Each film-coated tablet is supplied as a yellow, oblong-shaped, film-coated tablet, with “AMG” on one side and “120” on the other side.

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

LUMYKRAS 240 mg film-coated tablets

Each film-coated tablet is supplied as a yellow, oval-shaped, film-coated tablet, with “AMG” on one side and “240” on the other side.

• LUMYKRAS is provided in perforated 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,
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.,
Minervum 7061,
4817 ZK Breda,
The Netherlands

Manufacturer
Amgen NV,
Telecomlaan 5-7,
1831 Diegem,
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien s.a. Amgen n.v.
Tél/Tel: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg s.a. Amgen
Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf.: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606
Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

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 web site:
https://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.