Patient information: uses, side effects, how to take - Lazcluze

What is LAZCLUZE?

LAZCLUZE in combination with amivantamab is a prescription medicine for the first-line treatment of adults with non-small cell lung cancer (NSCLC) that:

has spread to other parts of the body (metastatic) or cannot be removed by surgery, and
has a certain abnormal epidermal growth factor receptor "EGFR" gene(s).

Your healthcare provider will perform a test to make sure that LAZCLUZE is right for you.

It is not known if LAZCLUZE is safe and effective in children.

Before taking LAZCLUZE, tell your healthcare provider about all of your medical conditions, including if you:

have a history of lung or breathing problems
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.
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 LAZCLUZE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

LAZCLUZE may affect the way other medicines work, and other medicines may affect how LAZCLUZE works.

You should not start or stop any medicine before you talk with your healthcare provider that prescribed LAZCLUZE.

How should I take LAZCLUZE?

Take LAZCLUZE exactly as your healthcare provider tells you to take it.
Take LAZCLUZE 1-time each day. On the day amivantamab is also given, take LAZCLUZE any time before receiving the amivantamab infusion.
You can take LAZCLUZE with or without food.
Swallow LAZCLUZE tablets whole. Do not crush, cut, or chew the tablets.
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.
Your healthcare provider may give you medicines in addition to LAZCLUZE to reduce the risk and severity of skin and nail reactions.
LAZCLUZE may be given in combination with other anti-cancer medicines. If you have any questions about these medicines, ask your healthcare provider.

What should I avoid while taking LAZCLUZE?

LAZCLUZE 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 broad-spectrum UVA/UVB sunscreen during treatment with LAZCLUZE.

What are the possible side effects of LAZCLUZE?

LAZCLUZE may cause serious side effects, including:

blood clot 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 reduce the risk of blood clots for the first four months of treatment. Tell your healthcare provider right away 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. LAZCLUZE may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away 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. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may start you on an antibiotic for the first 3 months of treatment followed by an antibiotic lotion for your scalp for the next 9 months. During treatment with LAZCLUZE, you should apply a non-comedogenic (does not clog pores) skin moisturizer (ceramide-based or other types of moisturizers that provide long-lasting skin hydration and does not include drying ingredients) on your face and whole body (except scalp) and wash your hands and feet every day with 4% chlorhexidine solution. Your healthcare provider may treat you with a medicine(s) or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with LAZCLUZE. See "What should I avoid while taking LAZCLUZE?"
liver problems. LAZCLUZE may cause severe liver problems, including increased liver function tests. Your healthcare provider will do blood tests to check your liver before you start and during treatment with LAZCLUZE. Tell your healthcare provider right away if you get any symptoms of liver problems, including pain on the right side of your stomach area (abdomen), dark or brown (tea colored) urine, or yellowing of your skin or the white part of your eyes.
eye problems. LAZCLUZE may cause eye problems such as inflamed cornea (front part of your eye). Tell your healthcare provider right away 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.

The most common side effects of LAZCLUZE in combination with amivantamab include:

rash
infected skin around the nail
infusion-related reaction (amivantamab)
muscle and joint pain
sores in the mouth
swelling of hands, ankles, feet, face, or all of your body
unusual feeling in the skin (such as tingling or crawling)

feeling very tired
diarrhea
constipation
COVID-19
bleeding
decreased appetite
itchy skin
nausea
changes in certain blood tests

LAZCLUZE may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider may temporarily stop, decrease your dose or completely stop your treatment with LAZCLUZE if you have serious side effects.

These are not all of the possible side effects of LAZCLUZE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LAZCLUZE?

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

Keep LAZCLUZE and all medicines out of the reach of children.

General information about the safe and effective use of LAZCLUZE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LAZCLUZE for a condition for which it was not prescribed. Do not give LAZCLUZE to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about LAZCLUZE that is written for health professionals.

What are the ingredients in LAZCLUZE?

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.

Product of Belgium

Manufactured for: Janssen Biotech, Inc., Horsham, PA 19044, USA

For patent information: www.janssenpatents.com

For more information, call 1-800-526-7736 or go to www.lazcluze.com

Lazcluze (Lazertinib): Uses, Side Effects and Dosage