Pronunciation:

am-i-VAN-ta-mab - wmjw

Brand Names:

• Rybrevant

Dosage Forms:

• Solution

Classifications:

Pharmacologic—

Amivantamab

Uses of This Medicine:

Amivantamab-vmjw injection is used alone to treat non-small cell lung cancer (NSCLC) that has spread (metastatic) or cannot be removed by surgery or radiation (locally advanced) in patients who have an abnormal epidermal growth factor receptor (EGFR) gene (exon 20 insertion mutations) and have received other cancer medicines (eg, platinum) but did not work well. This medicine is also used in combination with carboplatin and pemetrexed as a first-line treatment for metastatic or locally advanced NSCLC in patients who have an abnormal EGFR gene (exon 20 insertion mutations). Your doctor will perform a test before you take this medicine.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amivantamab-vmjw injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amivantamab-vmjw injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Lung or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you other medicines (eg, allergy medicine, fever medicine, steroid) before you receive this medicine to help prevent unwanted effects.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, or lightheadedness or fainting after receiving this medicine.

Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, trouble breathing, or thickening of bronchial secretions. These may be symptoms of a lung problem (eg, interstitial lung disease, pneumonitis).

This medicine may cause serious skin reactions (eg, dermatitis acneiform, toxic epidermal necrolysis). Check with your doctor right away if you have acne, blistering, crusting, irritation, itching, or reddening of the skin, chills, cough, cracked, dry, or scaly skin, diarrhea, itching, joint or muscle pain, peeling or loosening of the skin, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swelling, or unusual tiredness or weakness.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps, outdoors and tanning beds for at least 2 months after the last dose.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

bleeding gums

blistering, crusting, irritation, itching, or reddening of the skin

blood in the urine

bloody nose

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

chest pain or tightness

chills

cough

coughing or spitting up blood

cracked, dry, or scaly skin

dry, itching skin

fever

flushing

headache

loosening of the fingernails

muscle or bone pain

nausea and vomiting

nerve pain

rash with flat lesions or small raised lesions on the skin

redness or soreness around the fingernails

sneezing

swelling

trouble breathing

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Less common

Anxiety

dizziness or lightheadedness

fainting

fast heartbeat

general feeling of discomfort or illness

thickening of bronchial secretions

Rare

Blistering, peeling, or loosening of the skin

blurred vision or other change in vision

diarrhea

eye redness, irritation, or pain

red irritated eyes

red skin lesions, often with a purple center

sensitivity of the eye to light

sore throat

sores, ulcers, or white spots in the mouth or on the lips

tearing

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Canker sores

chapped, red, or swollen lips

constipation

decreased appetite

difficulty in moving

lack or loss of strength

muscle aches, cramps, or stiffness

pain in the arms or legs

pain in the joints

redness, swelling, or soreness of the tongue

scaling, redness, burning, pain, or other signs of inflammation of the lips

stomach pain

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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