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

What is RYBREVANT?

RYBREVANT is a prescription medicine used to treat 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 certain abnormal epidermal growth factor receptor (EGFR) gene(s):

in combination with lazertinib as a first-line treatment for non-small cell lung cancer (NSCLC)
in combination with carboplatin and pemetrexed as a second-line treatment for NSCLC in patients whose disease has worsened on or after treatment with an EGFR tyrosine kinase inhibitor (TKI)
in combination with carboplatin and pemetrexed as a first-line treatment for NSCLC
alone for the treatment of NSCLC whose disease has worsened on or after platinum-based chemotherapy.

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

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

Before you receive RYBREVANT, 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. RYBREVANT 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 RYBREVANT.
- You should use effective birth control (contraception) during treatment and for 3 months after your last dose of RYBREVANT.
- Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with RYBREVANT.
are breastfeeding or plan to breastfeed. It is not known if RYBREVANT passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of RYBREVANT.

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

How will I receive RYBREVANT?

RYBREVANT will be given to you by your healthcare provider by intravenous infusion into your vein.
Your healthcare provider will decide the time between doses as well as how many treatments you will receive.
Your healthcare provider will give you medicines before each dose of RYBREVANT to help reduce the risk of infusion-related reactions.
Your healthcare provider may give you medicines in addition to RYBREVANT to reduce the risk and severity of skin and nail reactions.
RYBREVANT may be given in combination with the medicines carboplatin and pemetrexed. If you have any questions about these medicines, ask your healthcare provider.
If your treatment with RYBREVANT is given in combination with the medicine lazertinib, you should take your dose of lazertinib by mouth anytime before your infusion with RYBREVANT.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What should I avoid while receiving RYBREVANT?

RYBREVANT can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment with RYBREVANT. Wear protective clothing and use broad-spectrum UVA/UVB sunscreen during treatment with RYBREVANT.

What are the possible side effects of RYBREVANT?

RYBREVANT may cause serious side effects, including:

infusion-related reactions. Infusion-related reactions are common but can be severe or serious and can include life-threatening (anaphylaxis) allergic reaction. Tell your healthcare provider right away if you get any of the following symptoms during your infusion of RYBREVANT:

shortness of breath, difficulty breathing, or wheezing
chest discomfort
swelling of your eyes, lips, or tongue
fever
chills
numbness of the tongue, lips, cheeks, or gums

flushing
skin rash, hives, or itching
nausea or vomiting
stomach cramps
lightheadedness, dizziness, or fainting
headache

lung problems. RYBREVANT 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.
blood clot problems. Blood clots are a serious, but common side effect of RYBREVANT, when given together with another drug called lazertinib, may cause blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) that may lead to death. Your healthcare provider will start you on medicine to reduce the risk of blood clots for the first 4 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.
skin problems. RYBREVANT can cause severe rash; including blisters, peeling, skin pain and sores, 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 RYBREVANT, 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 RYBREVANT. See " What should I avoid while receiving RYBREVANT? "
eye problems. RYBREVANT may cause eye problems. Tell your healthcare provider right away if you get symptoms of eye problems which may include:

eye pain
inflammation of eye lids
dry eyes
eye redness
blurred vision

changes in vision
itchy eyes
excessive tearing
sensitivity to light

Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get new or worsening eye problems during treatment with RYBREVANT. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.

The most common side effects of RYBREVANT when given in combination with lazertinib include:

rash
infected skin around the nail
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 a crawling feeling)
feeling very tired

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

The most common side effects of RYBREVANT when given in combination with carboplatin and pemetrexed include:

rash
infected skin around the nail
feeling very tired
nausea
sores in the mouth
constipation
swelling of hands, ankles, feet, face, or all of your body

decreased appetite
muscle and joint pain
vomiting
COVID-19
changes in certain blood tests

The most common side effects of RYBREVANT when given alone:

rash
infected skin around the nail
muscle and joint pain
shortness of breath
nausea
feeling very tired

swelling of hands, ankles, feet, face, or all of your body
sores in the mouth
cough
constipation
vomiting
changes in certain blood tests

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

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

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

General information about safe and effective use of RYBREVANT

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about RYBREVANT that is written for health professionals.

What are the ingredients of RYBREVANT?

Active ingredient: amivantamab-vmjw

Inactive ingredients: EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injection.

Product of Ireland

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA. U.S. License Number 1864

For patent information: www.janssenpatents.com

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

Rybrevant (Amivantamab): Uses, Side Effects and Dosage