Patient leaflet - Lazcluze 80 mg film coated tablets
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 with ‘amivantamab’, another cancer medicine to tre adults with a type of lung cancer called ‘non-small cell lung cancer’. I used when the cancer is advanced (unlikely to be cured) and has go through certain changes (exon 19 deletion or exon 21 substitution
at
t is ne
symptoms, stop using contact lenses and tell your doctor s
Children and adolescents
Lazcluze has not been studied in children or adolescents. D medicine to children or young people under the age of 18 ye
Other medicines and Lazcluze
Tell your doctor, or pharmacist if you are taking, have recentl or might take any other medicines. This is because Lazcluze the way some medicines work. Also, some other medicines c way Lazcluze works.
mutation) in a gene called ‘EGFR’ (epidermal growth factor receptor) A separate patient information leaflet is available for amivantamab. P read it before you start treatment.
The EGFR gene makes a protein, EGFR, that is involved in cell grow and survival. Mutations (changes) in the EGFR gene change the sha this protein, which may cause cancer cells to grow and spread in the body. The active substance in Lazcluze, lazertinib, works by blocking faulty protein and may help to slow or stop your lung cancer from gro It may also help to reduce the size of the tumour. Lazertinib targets mutations in EGFR proteins that are known to cause cancer, while h
.
lease
th
pe of
the
wing.
aving
The following medicines may reduce how well Lazcluze work
- Carbamazepine or phenytoin (anti-epileptic used to treat s
- Rifampicin (used to treat tuberculosis)
- St. John’s wort (a herbal product used to treat mild depre anxiety)
- Bosentan (used to treat pulmonary arterial hypertension)
- Efavirenz (used for treatment and prevention of HIV-1 infe
- Modafinil (used for sleep disorders).
Lazcluze may affect how well other medicines work and/or in risk of side effects of these medicines:
- Tizanidine (used to relax muscles)
less effect on normal EGFR proteins.
2 What you need to know before you take
Do not take Lazcluze
Lazcluze Pregnancy
- Tell your doctor before you are given this medicine think you might be pregnant, or are planning to hav
of this
before taking
uze:
dition called
owing (see
- It is possible that this medicine may harm an unbo become pregnant during treatment, tell your docto You and your doctor will decide whether you shoul Lazcluze.
- If you can become pregnant, you should use effect (contraception) during treatment and up to 3 week
- Male patients with a partner who can become preg effective contraception, such as a condom, and no during treatment with Lazcluze and for 3 weeks aft treatment.
:
ems, wear reen, and use ovide long-referred)
e taking this doing this mmend that nds and feet reat you with ologist) if you
Breast‑feeding
Do not breast-feed during treatment with Lazcluze a stopping treatment. This is because it is not known if baby.
Driving and using machines
Lazcluze has minor influence on the ability to drive a If you feel tired after taking Lazcluze, do not drive or
Lazcluze contains sodium
This medicine contains less than 1 mmol sodium (2
get skin reactions during treatment.
- Sudden difficulty in breathing, cough, or fever that may sug inflammation of the lungs. The condition may be life-threate therefore healthcare professionals will monitor you for pote symptoms.
- When used with another drug called amivantamab; life-thre effects (due to blood clots in the veins) may occur. Your do you additional medicines to help prevent blood clots during of your treatment and will monitor you for potential sympto
Eye problems. If you have vision problems or eye pain, conta or nurse straight away. If you use contact lenses and have
gest
ning,
ntial
atening side ctor will give the course ms.
ct your doctor any new eye
is to say essentially “sodium-free”.
3 How to take Lazcluze
Always take this medicine exactly as your doctor or you. Check with your doctor or pharmacist if you are
How much to take
- The recommended dose is 240 mg each day with
- If you experience certain side effects, your doctor
traight away.
o not give this ars.
y taken,
can affect an affect the
to 160 mg or 80 mg each day.
How to take
- Lazcluze is taken by mouth.
- Swallow the tablet whole. Do not crush, split, or ch
You can take this medicine with or without food.
- Do not take an additional dose if you vomit after ta until your next dose is due.
If you take more Lazcluze than you should
If you take more than the normal dose, contact your
s:
eizures or fits)
ssion and
ction)
crease the
an increased risk of side effects.
If you forget to take Lazcluze
If you forget a dose, take it as soon as you remembe if it is less than 12 hours until your next dose is due, Take your next normal dose at its scheduled time.
If you stop taking Lazcluze
Do not stop taking this medicine unless your doctor If you have any further questions on the use of this m
- Cyclosporine or sirolimus or tacrolimus (used to suppr immune system)
- Everolimus (used to treat hormone receptor-positive adva cancer, neuroendocrine tumours of pancreatic, gastrointes 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, re carcinoma and pancreatic neuroendocrine tumours). This is not a complete list of medicines. Tell your healthcare
ess the
nced breast tinal or lung
nal cell
provider
doctor, pharmacist, or nurse.
about all medicines that you are taking. Your doctor will talk t the best treatment for you.
o you about
if you are pregnant, e a baby.
4 Possible side effects
Like all medicines, this medicine can cause
rn baby. If you r straight away. d continue taking
ive birth control s after treatment. nant must use t donate sperm er completing
everybody gets them.
Serious side effects
The following side effects have been reporte Lazcluze in combination with amivantamab. if you notice the following serious side effec Very common (may affect more than 1 in 1
- Skin problems - such as rash (including ac and redness. Tell your doctor if your skin p
- Blood clots in the veins, especially in the l nd for 3 weeks after there is a risk to your
nd use machines. use machines.
3 mg) per tablet, that
include sharp chest pain, shortness of bre and swelling of your arms or legs. Common (may affect up to 1 in 10 people):
- Signs of inflammation and scarring in the l difficulty in breathing, shortness of breath, lead to permanent damage. Your doctor m Lazcluze if you develop this side effect.
- Signs of inflamed cornea (front part of you eye pain, problems with vision, or sensitivi
- Eye problems – such as problems with visi Tell your doctor straight away if you notice th pharmacist has told not sure.
amivantamab.
may reduce your dose
above.
Other side effects
Talk to your doctor if you get any other side Very common (may affect more than 1 in 1
- nail problems
- signs of a reaction to the infusion of amiva
- low level of the protein ‘albumin’ in the blo
- liver toxicity
- swelling caused by fluid build up in the bo
- sores in the mouth ew the tablet.
king Lazcluze. Wait
doctor. You may have
- nerve damage that may cause tingling, nu 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 r it. However,
skip the missed dose.
tells you to.
edicine, ask your
- muscle aches
- vomiting
- fever
- stomach pain.
Common (may affect up to 1 in 10 people):
- haemorrhoids
- redness, swelling, peeling or tenderness,
- low level of magnesium in the blood
- itchy rash (hives).
Reporting of side effects
side effects, although not
5 How to store Lazcluze
Keep this medicine out of the sight d in clinical studies with Tell your doctor straight away ts:
0 people):
ne), dry skin, itching, pain, roblems get worse.
ungs or legs. Symptoms may
Do not use this medicine after the e container (blister foil, inner wallet, o The expiry date refers to the last da This medicine does not require any Do not throw away any medicines v Ask your pharmacist how to throw a These measures will help protect th ath, rapid breathing, leg pain, ungs - such as sudden cough, or fever. This could ay wish to stop treatment with r eye) - such as eye redness, ty to light.
on or growth of eyelashes. e serious side effects listed
6 Contents of the pack a
What Lazcluze contains
- The active substance is lazertinib 80 mg film-coated tablet contains film-coated tablet contains 240 mg
The other ingredients are:
Tablet core: hydrophobic colloidal microcrystalline cellulose (E460 (i stearate (E572). See section 2 “La Film coating: macrogol poly(vinyl a effects. These can include: 0 people):
ntamab od dy
polyvinyl alcohol (E1203), glycerol titanium dioxide (E171), and talc ( contains yellow iron oxide (E172). iron oxide (E172) and black iron o
What Lazcluze looks like and
Lazcluze 80 mg is supplied as yello tablets, debossed with “LZ” on one Lazcluze 80 mg is available in carto (two cardboard wallet packs of 28 t Lazcluze 240 mg is supplied as red mbness, pain or loss of pain film-coated tablets, debossed with “
other side. Lazcluze 240 mg is avail tablets (one cardboard wallet pack o 28 film-coated tablets (two cardboar Not all pack sizes may be marketed
Marketing Authorisation Holder
Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire mainly on the hands or feet
HP12 4EG
UK
Manufacturer
Janssen Cilag SpA Via C. Janssen, Borgo San Michele Latina 04100
Italy
If you get any side effects, talk to your docto This includes any possible side effects not li You can also report side effects directly via t at: www.mhra.gov.uk/yellowcard, or search f Google Play or Apple App Store. By reportin provide more information on the safety of thi
r, pharmacist, or nurse. sted in this leaflet.
he Yellow Card Scheme or MHRA Yellow Card in the g side effects, you can help s medicine.
For information in large telephone 0800 731845
This leaflet was last revised in 0
and reach of children.
xpiry date which is stated on the uter wallet and carton) after EXP. y of that month.
special storage conditions. ia wastewater or household waste. way medicines you no longer use. e environment.
nd other information
(as mesylate monohydrate). Each 80 mg of lazertinib. Each 240 mg of lazertinib.
silica, croscarmellose sodium (E468), )), mannitol (E421), and magnesium zcluze contains sodium”.
lcohol) grafted copolymer (E1209), monocaprylocaprate type I (E471), E553b). Each 80 mg tablet also Each 240 mg tablet also contains red xide (E172).
contents of the pack w, 14-mm long, oval, film-coated side and “80” on the other side. ns of 56 film-coated tablets ablets each).
dish purple, 20-mm long, oval,
LZ” on one side and “240” on the able in cartons of 14 film-coated f 14 tablets) or cartons of d wallet packs of 14 tablets each). .
print, tape, CD or Braille, 0.
6/2026.
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