Amivantamab-vmjw injection is used to treat a certain type of non-small cell lung cancer (NSCLC) that spread to other parts of the body or cannot be removed by surgery, and has worsened either during or after treatment with platinum chemotherapy medications. Amivantamab-vmjw injection is in a class of medications called bispecific antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Amivantamab-vmjw injection comes as a solution (liquid) to be injected slowly into a vein by a doctor or nurse in a medical facility or infusion center. Initially, it is usually given once a day for 2 days in a row. After the initial 2 doses, it is usually given once every 2 weeks for as long as your treatment continues. The length of treatment depends on how well your body responds to the medication and the side effects that you experience.

A doctor or nurse will watch you closely while you are receiving the infusion and after the infusion to be sure you are not having a serious reaction to the medication. You may be given other medications to help prevent reactions to amivantamab-vmjw. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion: nausea, shortness of breath, fever, chills, flushing, chest pain, lightheadedness, nausea, or vomiting.

Your doctor may need to slow down your infusion, or interrupt or stop your treatment if you experience certain side effects. Talk to your doctor about how you are feeling during and after your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving amivantamab-vmjw injection,

• tell your doctor and pharmacist if you are allergic to amivantamab-vmjw, any other medications, or any of the ingredients in amivantamab-vmjw injection. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take..
• tell your doctor if you have or have ever had a lung disease other than lung cancer, or breathing problems.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving amivantamab-vmjw injection. You will need to have a pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with amivantamab-vmjw injection and for 3 months after your final dose. If you become pregnant while receiving amivantamab-vmjw injection, call your doctor. Amivantamab-vmjw injection may harm the fetus.
• tell your doctor if you are breastfeeding. Your doctor will tell you not to breastfeed during your treatment with amivantamab-vmjw injection and for 3 months after your final dose.
• you should know that amivantamab-vmjw may cause skin reactions, including some that may be severe. You should plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment with amivantamab-vmjw injection and for 2 months after your final dose. Your doctor may tell you to use an alcohol-free moisturizer if you develop dry or irritated skin. If you experience any of the following symptoms, call your doctor immediately: rash, itching, dry or cracking skin, or blistering, peeling, or shedding skin

Unless your doctor tells you otherwise, continue your normal diet.

Amivantamab-vmjw may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling, pain, or changes in the fingernails or toenails
• unusual tiredness or weakness
• swelling of the face, lips, or eyes
• swelling of the hands, feet, ankles, or lower legs
• bone, muscle, joint, arm, leg, neck, or back pain
• mouth sores
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• decreased appetite
• numbness, tingling, pain, or burning in arms or legs
• headache
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• new or worsening cough, shortness of breath, fever, or chest pain
• eye pain
• dry, red, teary, itchy, or painful eyes
• blurred vision
• vision changes
• sensitivity of eyes to light
• easy bruising or bleeding
• bleeding from gums or nose
• blood in urine or stool
• coughing up blood

Amivantamab-vmjw may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with amivantamab-vmjw. During your treatment, your doctor will order certain lab tests to check your body’s response to amivantamab-vmjw.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Rybrevant^®