Lazcluze

Pronunciation: laz-kluez
Generic name: lazertinib
Dosage form: tablets (80 mg, 240 mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 21, 2024.

What is Lazcluze?

Lazcluze (lazertinib) is a first-line treatment for certain EGFR-mutated non-small lung cancer (NSCLC) in adults, it helps people live longer by increasing the time before the cancer progresses. Lazcluze is a tyrosine kinase inhibitor (TKI) that is more selective for EGFR mutations and is active in the brain.

Lazcluze is used with Rybrevant (amivantamab-vmjw) as a multitargeted treatment regimen that directly targets both of the common EGFR mutations.

Lacluze is a once-daily tablet taken with or without food.

What is Lazcluze used for?

Lazcluze is used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery. The NSCLC must have epidermal growth factor receptor (EGFR) mutations, exon 19 deletions, or exon 21 L858R substitutions, which an FDA-approved test has detected. It is to be used in combination with amivantamab (Rybrevant) infusions.

Lazcluze FDA approval was received on August 20, 2024, after positive results from the MARIPOSA clinical trial. Lazcluze plus Rybrevant helped increase the time it took before cancer progressed or death occurred by 30%. For Lazcluze plus Rybrevant, the median progression-free survival (PFS) was 23.7 months compared to Rybrevant with osimertinib which was 16.6 months.

How does Lazcluze work?

Tyrosine kinase inhibitors are enzymes in cancerous cells that control how fast the cells grow and divide. Normally they turn on and off as needed but in some gene mutations, the tyrosine kinase inhibitors stay switched on and this causes cancer cells to multiply uncontrollably. Lazcluze is a tyrosine kinase inhibitor (TKI) that works by blocking the enzymes (tyrosine kinase inhibitors) in cancerous cells which control how fast the cells grow and divide. By blocking TKIs, Lazcluze stops cancer cells from multiplying uncontrollably which can slow cancer progression. Lazcluze is called a targeted therapy, it is not chemotherapy.

Lazcluze side effects

Common Lazcluze side effects when used with amivantamab

The most common side effects for Lazcluze (with amivantamab) were rash, feeling very tired, diarrhea, constipation, feeling sick (nausea), COVID-19, sores in the mouth, bleeding, infected skin around the nail, infusion-related reaction (for Rybrevant), muscle and joint pain, decreased appetite, swelling of feet, hands, face or all of your body (edema), unusual feeling in the skin such as tingling or crawling (paresthesia), dry or itchy skin, and also changes in blood tests. These side effects occurred in 20% or more of patients when used together with amivantamab.

Serious Lazcluze side effects

Lazcluze may cause serious side effects, including blood clots, lung problems, skin problems, and eye problems.

Blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) are serious, but common, and may lead to death. Your healthcare provider will start you on medicine to prevent blood clots for the first four months of treatment. Tell your healthcare provider immediately if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.

Lung problems may be caused by this medicine, which may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider immediately if you get any new or worsening lung symptoms, including shortness of breath, cough, or fever.

Skin problems. Lazcluze may cause severe rash, including redness, raised acne-like bumps, itching, and dry skin. You may use alcohol-free (such as isopropanol-free, ethanol-free) moisturizing cream to reduce the risk of skin problems. Limit sun exposure during and for 2 months after treatment with Lazcluze. Wear protective clothing and use sunscreen. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may recommend that you start a medicine to prevent skin problems, may treat you with a medicine(s), or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with this medicine.

Eye problems. This medicine may cause eye problems such as inflamed cornea (front part of your eye). Tell your healthcare provider immediately if you get symptoms such as eye redness, eye pain, new or worsening problems with vision, and sensitivity to light. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems during treatment with Lazcluze. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What to avoid

This medicine can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with Lazcluze. Wear protective clothing and use sunscreen during treatment.

Warnings

Embryo-Fetal Toxicity: Lazcluze can cause fetal harm. Patients of reproductive potential should be informed of the potential risk to a fetus and advised to use effective contraception.

Before taking this medicine

Tell your healthcare provider about all of your medical conditions, including if you:

have a history of lung or breathing problems

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Lazcluze can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with Lazcluze.
You should use effective birth control (contraception) during treatment and for 3 weeks after your last dose of Lazcluze.
Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Lazcluze.

Males who have female partners who are able to become pregnant:

You should use effective birth control during treatment and for 3 weeks after your last dose of Lazcluze.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Lazcluze passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose of this medicine.

How should I take this medicine?

Take Lazcluze tablets once daily, with or without food. Do not crush, cut, or chew the tablets.

On the day you receive Rybrevant (amivantamab), take Lazcluze tablets any time before receiving the Rybrevant infusion.

Take Lazcluze exactly as your healthcare provider tells you to take it.

Lazcluze Dosing Information

The recommended Lazcluze dosage is 240 mg orally once daily with or without food, given in combination with amivantamab.

Continue treatment until disease progression or unacceptable toxicity.

Take Lazcluze any time before amivantamab when given on the same day.

Anticoagulant prophylaxis should be administered to prevent venous thromboembolic events (VTE) for the first four months of treatment.

The dose may be modified due to adverse reactions.

Lazcluze Tablets: 80 mg and 240 mg.

What should I do if I miss a dose?

If you miss a dose of Lazcluze and:

it has been less than 12 hours, take the missed dose.
it has been more than 12 hours, skip the dose and take your next dose at your regularly scheduled time.

If you vomit a dose of Lazcluze, do not take an extra dose. Take your next dose at your regularly scheduled time.

Lazcluze may be given in combination with other anti-cancer medicines. If you have any questions about these medicines, ask your healthcare provider.

Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lazcluze and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Tell your healthcare professional if you take medicines that are strong and moderate CYP3A4 inducers, as they should not be taken with Lazcluze.

Not all possible drug interactions are listed here.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ingredients

Active ingredient: lazertinib mesylate

Inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and silica hydrophobic colloidal. The tablet coating consists of glycerol monocaprylocaprate type I, iron oxide black (in 240 mg strength tablets), iron oxide red (in 240 mg strength tablets), iron oxide yellow (in 80 mg strength tablets), macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol- partially hydrolyzed, talc, and titanium dioxide.