Lazcluze 240 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lazcluze 80 mg film-coated tablets

Lazcluze 240 mg film-coated tablets

lazertinib

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

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 a cancer 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 cancer medicine, to treat adults who have a type of lung cancer called «non-small cell lung cancer». It is used when the cancer is advanced (cure is unlikely) and has certain genetic changes (exon 19 deletion mutation or exon 21 substitution mutation) in a gene called EGFR.

There is a separate patient information leaflet for amivantamab. Please read it before starting treatment.

The EGFR gene produces a protein, EGFR, which is involved in the growth and survival of cells. Mutations (changes) in the EGFR gene alter the shape of this protein, which can cause cancer cells to grow and spread throughout the body. The active substance in Lazcluze, lazertinib, works by blocking the defective protein and may help slow down or stop the growth of the lung cancer. It may also help reduce tumor size. Lazertinib targets EGFR protein mutations known to cause cancer, while having less effect on normal EGFR proteins.

2. What you need to know before starting to take 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 are unsure, consult your doctor, pharmacist, or nurse before taking Lazcluze.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Lazcluze if:

• you have previously had lung inflammation (a condition called "interstitial lung disease" or "pneumonitis").

Immediately inform your doctor if you experience any of the following adverse effects (for more information, see section 4 "Serious adverse effects"):

• Skin problems. To reduce the risk of skin problems, avoid sunlight, wear protective clothing, apply sunscreen, regularly use moisturizing creams on your skin and nails, and use an anti-dandruff shampoo while taking this medicine. You must continue doing this for 2 months after stopping treatment. Your doctor may recommend starting one or more medicines to prevent skin problems, may treat you with medication(s), or 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 can be life-threatening, so healthcare professionals will monitor you for possible symptoms.
• When used together with another medicine called amivantamab, serious adverse effects that may be life-threatening (due to blood clots forming in the veins) can occur. Your doctor will give you additional medicines to help prevent blood clots during treatment and will monitor you for possible symptoms.
• Eye problems. If you experience vision problems or eye pain, contact your doctor or nurse immediately. If you wear contact lenses and develop any new eye symptoms, stop using them and inform your doctor immediately.

Children and adolescents

Lazcluze has not been studied in children and 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 need to take any other medicines. This is because Lazcluze may affect how other medicines work. In addition, other medicines may affect how Lazcluze works.

The following medicines may reduce the effectiveness of Lazcluze:

• Carbamazepine or phenytoin (antiepileptic used to treat seizures or epileptic fits)
• Rifampicin (used to treat tuberculosis)
• St. John’s wort (a herbal remedy used to treat anxiety and mild depression)
• 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 the effectiveness of other medicines and/or increase the risk of adverse effects from these medicines:

• Tizanidine (used to relax muscles)
• Cyclosporine, sirolimus, or tacrolimus (used to suppress 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 syndrome)
• Quinidine (used to treat malaria)
• Sunitinib (used to treat gastrointestinal stromal tumours, renal cell carcinoma, and pancreatic neuroendocrine tumours)

This list of medicines is not exhaustive. Inform your healthcare provider about all medicines you are taking. Your doctor will advise you on the best treatment for you.

Pregnancy

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• This medicine may be harmful to 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 can become pregnant, you must use an effective method of contraception during treatment and for 3 weeks after stopping it.
• Male patients whose partner can become pregnant must use effective contraception methods, such as condoms, and must not donate sperm during treatment with Lazcluze and for 3 weeks after stopping treatment.

Breast-feeding

Do not breast-feed during treatment with Lazcluze and for 3 weeks after stopping treatment, as it is unknown whether there is a risk to the baby.

Driving and using machines

The effect of Lazcluze on the ability to drive and use machines is minor. If you feel tired after taking Lazcluze, do not drive or operate machinery.

Lazcluze contains sodium

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

3. How to take Lazcluze

Follow exactly the instructions for using this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

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

How to take it

• Lazcluze is taken orally.
• Swallow the tablet whole. Do not crush, split, or chew the tablet.
• You may take this medicine 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 adverse effects.

If you forget to take Lazcluze

If you forget a dose, take it as soon as you remember. However, if there are less than 12 hours

until your next dose, do not take the missed dose. Take your next dose at the scheduled time.

If you stop taking Lazcluze

Do not stop taking this medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

The following adverse effects have been reported in clinical studies with Lazcluze in combination with amivantamab. Immediately inform your doctor if you notice any of the following serious adverse 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 sharp chest pain, difficulty breathing, rapid breathing, leg pain, and swelling in 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 discontinue treatment with Lazcluze if you experience this adverse effect.
• Signs of inflammation of the cornea (front part of the eye), such as red eyes, eye pain, vision problems, or sensitivity to light.
• Eye problems—such as vision disturbances or eyelash growth.

Immediately inform your doctor if you notice any of the serious adverse effects listed above.

Other adverse effects

If you experience any type of adverse effect, consult your doctor. These include:

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

• nail problems
• signs of infusion reaction to amivantamab
• low levels of the protein "albumin" in the blood
• hepatic toxicity
• swelling due to fluid accumulation in the body
• mouth sores
• nerve damage that may cause tingling, numbness, pain, or loss of pain sensation
• feeling very tired
• diarrhea
• constipation
• decreased appetite
• low calcium levels in the blood
• feeling sick
• muscle spasms
• low potassium levels in the blood
• feeling dizzy
• muscle pain
• vomiting
• fever
• stomach pain

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

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

Reporting of adverse effects

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

5. Storage of Lazcluze

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 packaging (aluminum foil of the blister, inner carton, outer carton, bottle and container) after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must 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. Contents of the container and additional information

Composition of Lazcluze

• 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."

Tablet coating: polyethylene glycol grafted polyvinyl alcohol copolymer (E1209), polyvinyl alcohol (E1203), glycerol 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).

Appearance of the product and contents of the container

Lazcluze 80 mg is presented as yellow, oval-shaped, film-coated tablets, 14 mm long, engraved 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 presented as red-purple, oval-shaped, film-coated tablets, 20 mm long, engraved 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 in bottles of 30 tablets.

Only certain 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

Other sources of information

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