Amivantamab is used to treat non-small cell lung cancer that has an abnormal "EGFR" gene and has spread to other parts of the body (metastatic) or cannot be removed with surgery. Your doctor will make sure you have the correct tumor type to be treated with amivantamab.

Amivantamab is given after other treatments did not work or stopped working.

Amivantamab may also be used for purposes not listed in this medication guide.

Amivantamab can cause skin reactions. Avoid sunlight while you are receiving amivantamab and for 2 months after your last dose.

Amivantamab is injected into a vein by a healthcare provider, usually every 2 to 4 weeks.

amivantamab is injected slowly over several hours.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You may need frequent vision exams.

May cause rash, itching, and dry skin. Use only alcohol-free cream or lotion to treat dry skin.

Usual Adult Dose for Non-Small Cell Lung Cancer:

Weeks 1 to 4:
-Less than 80 kg: 1050 mg IV once a week for 4 doses
-At least 80 kg: 1400 mg IV once a week for 4 doses

Week 5 onwards:
-Less than 80 kg: 1050 mg IV every 2 weeks
-At least 80 kg: 1400 mg IV every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Infusion Rates for 1050 mg Dose:
-Week 1 (split dose infusion):
---Day 1 (350 mg dose):
-----Initial rate: 50 mL/hour
-----Subsequent rate: 75 mL/hour
---Day 2 (700 mg dose):
-----Initial rate: 50 mL/hour
-----Subsequent rate: 75 mL/hour
-Week 2 (1050 mg dose): 85 mL/hour
-Subsequent weeks (1050 mg dose): 125 mL/hour

Infusion Rates for 1400 mg Dose:
-Week 1 (split dose infusion):
---Day 1 (350 mg dose):
-----Initial rate: 50 mL/hour
-----Subsequent rate: 75 mL/hour
---Day 2 (1050 mg dose):
-----Initial rate: 35 mL/hour
-----Subsequent rate: 50 mL/hour
-Week 2 (1400 mg dose): 65 mL/hour
-Week 3 (1400 mg dose): 85 mL/hour
-Subsequent weeks (1400 mg dose): 125 mL/hour

Comments:
-The dose should be based on baseline body weight; dose adjustments are not needed for subsequent body weight changes.
-The initial dose should be administered as a split infusion in Week 1, on Day 1 and Day 2.
-Before the initial infusion on Week 1 (Days 1 and 2), premedication should be administered to reduce the risk of infusion-related reactions.
---An antihistamine and antipyretic should be administered before all infusions.
---A glucocorticoid is required for Week 1 (Days 1 and 2) doses only and should be used as needed for subsequent infusions.
-The initial infusion rate may be increased to the subsequent infusion rate after 2 hours without an infusion-related reaction.

Use: For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by US FDA-approved test, whose disease has progressed on/after platinum-based chemotherapy

Tell your doctor if you have ever had lung problems other than cancer.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use birth control while using amivantamab and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 3 months after your last dose.

Call your doctor for instructions if you miss an appointment for your amivantamab injection.

In a medical setting an overdose would be treated quickly.

Amivantamab can cause skin reactions. Avoid sunlight and tanning beds during treatment and for 2 months after your last dose. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

If you have problems with your eyes, avoid wearing contact lenses until your symptoms can be checked by an eye doctor.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your care provider if you feel nauseated, light-headed, short of breath, chilled or feverish, or if you have chest discomfort.

Amivantamab may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, itching, watery eyes, sensitivity to light;

• vision changes;

• dark floating spots in your field of vision (floaters);

• skin changes such as acne, itching, or dryness; or

• lung problems (may be similar to symptoms of your cancer)--new or worsening cough, fever, or shortness of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of amivantamab may include:

• a reaction during the injection;

• cough, shortness of breath;

• feeling very tired;

• rash;

• infection of the a skin around your nails;

• swelling anywhere in your body;

• nausea, vomiting, constipation;

• mouth sores;

• joint or muscle pain; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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