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 a certain abnormal epidermal growth factor receptor “EGFR” gene(s) and
• whose disease has worsened while on or after chemotherapy that contains platinum.

Your healthcare provider will perform a test to make sure that Rybrevant is right for you.
It is not known if this medicine is safe and effective in children.

• 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 to help reduce the risk of infusion-related reactions.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Before you start treatment, 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.
  • You should use effective birth control (contraception) during treatment and for 3 months after your final dose.
  • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.
• 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 final dose.

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

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

Serious side effects include:

• infusion-related reactions. Infusion-related reactions are common with Rybrevant and can be severe or serious. Tell your healthcare provider right away if you get any of the following symptoms during your infusion:
  • shortness of breath
  • fever
  • chills
  • nausea
  • flushing
  • chest discomfort
  • lightheadedness
  • vomiting
• 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.
• skin problems. Rybrevant may cause rash, itching, and dry skin. You may use alcohol-free moisturizing cream for dry skin. Tell your healthcare provider right away if you get any skin reactions. 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. 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
  • 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 eye problems during treatment. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.

The most common side effects include:

• rash
• infusion-related reactions
• 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 if you have serious side effects.
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with amivantamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.