Lazcluze

Package leaflet: Information for the patient

Lazcluze 80 mg film-coated tablets, 240 mg film-coated tablets

lazertinib

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

What this leaflet contains

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

1. What Lazcluze is and what it is used for

Lazcluze is an anticancer medicine that contains the active substance “lazertinib”. It belongs to a
group of medicines called “protein kinase inhibitors”.
Lazcluze is used in combination with “amivantamab”, another anticancer medicine, to treat adults with
a type of lung cancer called “non-small cell lung cancer”. It is used when the cancer is at an advanced stage (difficult to cure) and has specific genetic changes (exon 19 deletion or exon 21 substitution mutation) in a gene called EGFR.
A separate patient information leaflet is available for amivantamab. Please read it before starting treatment.
The EGFR gene produces a protein, EGFR, which is involved in cell growth and survival. Mutations (changes) in the EGFR gene alter the shape of this protein, potentially leading to the growth and spread of cancer cells in the body. The active substance in Lazcluze, lazertinib, works by blocking the abnormal protein and may help slow down or stop the growth of your lung cancer. It may also help reduce the size of the tumour. Lazertinib targets mutated EGFR proteins known to cause cancer, while having minimal effect on normal EGFR proteins.

2. What you need to know before taking Lazcluze

Do not take Lazcluze

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

If you have any doubts, consult your doctor, pharmacist, or nurse before taking Lazcluze.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Lazcluze:

• if you have ever had lung inflammation (a condition called “interstitial lung disease” or “pneumonitis”).

Contact your doctor immediately if you experience any of the following symptoms (see
“Serious unwanted effects” in section 4 for more information):

• Skin problems. To reduce the risk of skin problems, avoid sunlight, wear protective clothing, apply sunscreen, regularly use moisturizers on your skin and nails, and use anti-dandruff shampoo while taking this medicine. You should continue doing this for 2 months after stopping treatment. Your doctor may recommend starting therapy with one or more medicines to prevent skin problems, may treat you with one or more medicines, or may refer you to a skin specialist (dermatologist) if you develop skin reactions during treatment.
• Sudden difficulty breathing, cough, or fever, which may indicate lung inflammation. This condition could be potentially life-threatening; therefore, healthcare professionals will monitor you for the appearance of potential symptoms.
• When used together with another medicine called amivantamab; potentially life-threatening side effects (due to blood clots in the veins) may occur. Your doctor will give you additional medicines to help prevent blood clots during treatment and will monitor you for the appearance of potential symptoms.
• Eye problems. If you experience vision problems or eye pain, contact your doctor or nurse immediately. If you wear contact lenses and develop new eye symptoms, stop using contact lenses and contact your doctor immediately.

Children and adolescents
Lazcluze has not been studied in children or adolescents. Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Lazcluze
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Lazcluze may affect how some medicines work. In addition, some other medicines may affect the action of Lazcluze.
The following medicines may reduce the effectiveness of Lazcluze:

• Carbamazepine or phenytoin (antiepileptic medicines used to treat seizures or convulsions)
• Rifampicin (used to treat tuberculosis)
• St John’s wort (a herbal remedy used to treat mild depression and anxiety)
• Bosentan (used to treat pulmonary arterial hypertension)
• Efavirenz (used for the treatment and prevention of HIV-1 infection)
• Modafinil (used for sleep disorders)

Lazcluze may affect how other medicines work and/or increase the risk of side effects from these medicines:

• Tizanidine (used to relax muscles)
• Cyclosporine, sirolimus, or tacrolimus (used to reduce the activity of the immune system)
• Everolimus (used to treat advanced hormone receptor-positive breast cancer, pancreatic, gastrointestinal, or lung neuroendocrine tumours, and renal cell carcinoma)
• Pimozide (used in patients with Tourette’s syndrome)
• Quinidine (used to treat malaria)
• Sunitinib (used to treat gastrointestinal stromal tumour, renal cell carcinoma, and pancreatic neuroendocrine tumours).

This is not a complete list of medicines. Inform your healthcare provider about all medicines you are taking. Your doctor will discuss the best treatment approach for you.
Pregnancy

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, inform your doctor before receiving this medicine.
• This medicine may harm the unborn baby. If you become pregnant during treatment, inform your doctor immediately. You and your doctor will decide whether you should continue taking Lazcluze.
• If you are able to become pregnant, you must use an effective method of birth control (contraception) during treatment and for 3 weeks after treatment ends.
• Male patients with a partner who can become pregnant must use an effective contraceptive method, such as a condom, and must not donate sperm during treatment with Lazcluze and for 3 weeks after completing treatment.

Breast-feeding
Do not breast-feed during treatment with Lazcluze and for 3 weeks after stopping treatment. This is because it is unknown whether there is a risk to your baby.
Driving and using machines
Lazcluze has a minor influence on the ability to drive and use machines. If you feel tired after taking Lazcluze, do not drive or operate machinery.
Lazcluze contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Lazcluze

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How much Lazcluze to take

• The recommended dose is 240 mg daily in combination with amivantamab.
• If you experience certain side effects, your doctor may reduce the dose to 160 mg or 80 mg daily.

How to take Lazcluze

• Lazcluze is taken orally.
• Swallow the tablet whole. Do not crush, split, or chew the tablet.
• This medicine can be taken with or without food.
• Do not take an additional dose if you vomit after taking Lazcluze. Wait until the time of your next scheduled dose.

If you take more Lazcluze than you should
If you take more than the prescribed dose, contact your doctor. You may have an increased risk of
experiencing side effects.
If you forget to take Lazcluze
If you forget a dose, take it as soon as you remember. However, if less than 12 hours remain
before your next scheduled dose, do not take the missed dose. Take your next dose at the
regularly scheduled time.
If you stop taking Lazcluze
Do not stop taking this medicine unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

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

Serious side effects
The following serious side effects have been reported in clinical studies with Lazcluze in combination with amivantamab. Inform your doctor immediately if you experience any of the following serious side effects:

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

• Skin problems such as rash (including acne), dry skin, itching, pain, and redness. Inform your doctor if your skin problems worsen.
• Blood clots in the veins, especially in the lungs or legs. Symptoms may include sudden chest pain, shortness of breath, rapid breathing, leg pain, and swelling of the arms or legs.

Common (may affect up to 1 in 10 people):

• Signs of inflammation and scarring in the lungs, such as sudden difficulty breathing, shortness of breath, cough, or fever. This could lead to permanent damage. Your doctor may decide to stop treatment with Lazcluze if you experience this side effect.
• Signs of inflammation of the cornea (front part of the eye), such as eye redness, eye pain, vision problems, or sensitivity to light.
• Eye problems such as vision disturbances or abnormal eyelash growth. Inform your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
If you experience any other side effect, speak to your doctor. These may include:

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

• nail problems
• signs of a reaction to amivantamab infusion
• low levels of the protein “albumin” in the blood
• liver toxicity
• swelling due to fluid accumulation in the body
• mouth ulcers
• nerve damage that may cause tingling, numbness, pain, or loss of pain sensation
• feeling extremely tired
• diarrhoea
• constipation
• loss of appetite
• low levels of calcium in the blood
• feeling unwell
• muscle spasms
• low levels of potassium in the blood
• dizziness
• muscle pain
• vomiting
• fever
• stomach ache

Common (may affect up to 1 in 10 people):

• haemorrhoids
• redness, swelling, peeling, or tenderness, especially on the hands or feet
• low levels of magnesium in the blood
• itchy rash (urticaria)

Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lazcluze

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container (aluminum blister sheet,
inner carton, outer carton, bottle and box) after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lazcluze contains

• The active substance is lazertinib (as monohydrate mesylate). Each 80 mg film-coated tablet contains 80 mg of lazertinib. Each 240 mg film-coated tablet contains 240 mg of lazertinib.
• The other components are: Tablet core: colloidal anhydrous silica, sodium croscarmellose (E468), microcrystalline cellulose (E460(i)), mannitol (E421), and magnesium stearate (E572). See section 2 “Lazcluze contains sodium”. Film coating: poly(vinyl alcohol) graft copolymer macrogol (E1209), polyvinyl alcohol (E1203), glyceryl monocaprylocaprate type I (E471), titanium dioxide (E171), and talc (E553b). Each 80 mg tablet also contains yellow iron oxide (E172). Each 240 mg tablet also contains red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Lazcluze and contents of the pack
Lazcluze 80 mg is supplied as yellow, oval-shaped, film-coated tablets, 14 mm in length, imprinted with “LZ” on one side and “80” on the other. Lazcluze 80 mg is available in packs of 56 film-coated tablets (two cardboard boxes containing 28 tablets each) or in bottles of 60 or 90 tablets.
Lazcluze 240 mg is supplied as purple-red, oval-shaped, film-coated tablets, 20 mm in length, imprinted with “LZ” on one side and “240” on the other. Lazcluze 240 mg is available in packs of 14 film-coated tablets (one cardboard box of 14 tablets), packs of 28 film-coated tablets (two cardboard boxes containing 14 tablets each), or bottles of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Cilag SpA
Via C. Janssen,
Borgo San Michele
Latina 04100
Italy

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

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

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