Lazcluze 240 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or 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.

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

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

If you are not sure, talk to your doctor, pharmacist, or nurse before taking Lazcluze.

Talk to your doctor, pharmacist, or nurse before taking Lazcluze:

• if you have suffered from inflammation of your lungs (a condition called ‘interstitial lung disease’ or ‘pneumonitis’).

Tell your doctor straight away if you have any of the following (see ‘Serious side effects’ in section 4 for more information):

• Skin problems. To reduce the risk and severity of skin problems, wear protective clothing, apply broad-spectrum UVA/UVB sunscreen, and use moisturisers (ceramide-based or other formulations that provide long-lasting skin hydration and without drying components are preferred) regularly on your face and whole body (except scalp), while taking this medicine. You will need to keep out of the sun and continue doing this for 2 months after you stop treatment. Your doctor may recommend that you start an antibiotic(s) and an antiseptic to wash your hands and feet to reduce the risk and severity of skin problems, and may treat you with a medicine(s), or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment.
• Sudden difficulty in breathing, cough, or fever that may suggest inflammation of the lungs. The condition may be life-threatening, therefore healthcare professionals will monitor you for potential symptoms.
• When used with another drug called amivantamab; 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 the course of your treatment and will monitor you for potential symptoms.
• Eye problems. If you have vision problems or eye pain, contact your doctor or nurse straight away. If you use contact lenses and have any new eye symptoms, stop using contact lenses and tell your doctor straight away.

Lazcluze has not been studied in children or adolescents. Do not give this medicine to children or young people under the age of 18 years.

Tell your doctor, or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Lazcluze can affect the way some medicines work. Also, some other medicines can affect the way Lazcluze works.

The following medicines may reduce how well Lazcluze works:

• Carbamazepine or phenytoin (anti-epileptic used to treat seizures or fits)
• Rifampicin (used to treat tuberculosis)
• St. John’s wort (a herbal product used to treat mild depression and anxiety)
• Bosentan (used to treat pulmonary arterial hypertension)
• Efavirenz (used for treatment and prevention of HIV-1 infection)
• Modafinil (used for sleep disorders).

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

• Tizanidine (used to relax muscles)
• Cyclosporine or sirolimus or tacrolimus (used to suppress the immune system)
• Everolimus (used to treat hormone receptor-positive advanced breast cancer, neuroendocrine tumours of pancreatic, gastrointestinal or lung origin and renal cell carcinoma)
• Pimozide (used in patients with Tourette’s Disorder)
• 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. Tell your healthcare provider about all medicines that you are taking. Your doctor will talk to you about the best treatment for you.

• Tell your doctor before you are given this medicine if you are pregnant, think you might be pregnant, or are planning to have a baby.
• It is possible that this medicine may harm an unborn baby. If you become pregnant during treatment, tell your doctor straight away. You and your doctor will decide whether you should continue taking Lazcluze.
• If you can become pregnant, you should use effective birth control (contraception) during treatment and up to 3 weeks after treatment.
• Male patients with a partner who can become pregnant must use effective contraception, such as a condom, and not donate sperm during treatment with Lazcluze and for 3 weeks after completing treatment.

Do not breast-feed during treatment with Lazcluze and for 3 weeks after stopping treatment. This is because it is not known if there is a risk to your baby.

Lazcluze has minor influence on the ability to drive and use machines. If you feel tired after taking Lazcluze, do not drive or use machines.

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

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

• Lazcluze is taken by mouth.
• Swallow the tablet whole. Do not crush, split, or chew the tablet.
• You can take this medicine with or without food.
• Do not take an additional dose if you vomit after taking Lazcluze. Wait until your next dose is due.

If you take more than the normal dose, contact your doctor. You may have an increased risk of side effects.

If you forget a dose, take it as soon as you remember it. However, if it is less than 12 hours until your next dose is due, skip the missed dose. Take your next normal dose at its scheduled time.

Do not stop taking this medicine unless your doctor tells you to.

The following side effects have been reported in clinical studies with Lazcluze in combination with amivantamab. Tell your doctor straight away if you notice 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. Tell your doctor if your skin problems get worse.
• Blood clots in the veins, especially in the lungs or legs. Symptoms may include sharp chest pain, shortness of breath, rapid breathing, leg pain, and swelling of your arms or legs.

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

• Signs of inflammation and scarring in the lungs - such as sudden difficulty in breathing, shortness of breath, cough, or fever. This could lead to permanent damage. Your doctor may wish to stop treatment with Lazcluze if you develop this side effect.
• Signs of inflamed cornea (front part of your eye) - such as eye redness, eye pain, problems with vision, or sensitivity to light.
• Eye problems – such as problems with vision or growth of eyelashes.

Tell your doctor straight away if you notice the serious side effects listed above.

Talk to your doctor if you get any other side effects. These can include:

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

• nail problems
• signs of a reaction to the infusion of amivantamab
• low level of the protein ‘albumin’ in the blood
• liver toxicity
• swelling caused by fluid build up in the body
• sores in the mouth
• nerve damage that may cause tingling, numbness, pain or loss of pain sensation
• feeling very tired
• diarrhoea
• constipation
• decreased appetite
• low level of calcium in the blood
• feeling sick
• muscle spasms
• low level of potassium in the blood
• feeling dizzy
• muscle aches
• vomiting
• fever
• stomach pain.

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

• haemorrhoids
• redness, swelling, peeling or tenderness, mainly on the hands or feet
• low level of magnesium in the blood
• itchy rash (hives).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is lazertinib (as mesylate monohydrate). Each 80 mg film-coated tablet contains 80 mg of lazertinib. Each 240 mg film-coated tablet contains 240 mg of lazertinib.
• The other ingredients are:
  Tablet core: hydrophobic colloidal silica, croscarmellose sodium (E468), microcrystalline cellulose (E460 (i)), mannitol (E421), and magnesium stearate (E572). See section 2 “Lazcluze contains sodium”.
  Film coating: macrogol poly(vinyl alcohol) grafted 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).

Lazcluze 80 mg is supplied as yellow, 14-mm long, oval, film-coated tablets, debossed with “LZ” on one side and “80” on the other side. Lazcluze 80 mg is available in cartons of 56 film-coated tablets (two cardboard wallet packs of 28 tablets each).

Lazcluze 240 mg is supplied as reddish purple, 20-mm long, oval, film-coated tablets, debossed with “LZ” on one side and “240” on the other side. Lazcluze 240 mg is available in cartons of 14 film-coated tablets (one cardboard wallet pack of 14 tablets) or cartons of 28 film-coated tablets (two cardboard wallet packs of 14 tablets each).

Not all pack sizes may be marketed.

For information in large print, tape, CD or Braille, telephone 0800 7318450.