Amivantamab-vmjw Injection

Amivantamab-vmjw injection is used in combination with other chemotherapy medications as a first treatment for certain types of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Amivantamab-vmjw injection is also used alone and in combination with other chemotherapy medications to treat certain types of NSCLC that has spread to nearby tissues or to other parts of the body, and has worsened either during or after treatment with other 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 a week for 4 or 5 weeks, and then once every 2 or 3 weeks for as long as your doctor recommends that you receive treatment. 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 injection. 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 delay or permanently stop your treatment if you experience these side effects.

Your doctor may also decrease your dose of amivantamab-vmjw injection, interrupt or permanently stop your treatment, or treat you with additional medications depending on your response to the medication and any side effects that you experience. 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 or breathing problems; a blood clot in your legs, arms, or lungs; dry skin or other skin problems; or vision or eye 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. Your doctor may also tell you to take a certain medication to prevent or treat skin reactions or may send you to see dermatologist (skin doctor). If you experience any of the following symptoms, call your doctor immediately: rash, itching, dry or cracking skin, or blistering, peeling, or shedding skin
• your should know that amivantamab-vmjw can cause eye problems. If you experience any of the following symptoms, call your doctor immediately: dry, teary, or itchy eyes; eye pain or redness; blurred vision; sensitivity to light; or other visual changes. Your doctor may send to you to an ophthalmologist (eye doctor). If you have any eye problem and wear contact lenses, you should stop wearing them and not wear them again until you see an eye doctor.
• you should know that amivantamab-vmjw may cause serious or life-threatening blood clots in the lungs or legs when it is taken with lazertinib (Lazcluze). Your doctor will probably tell you to take another medication to prevent blood clots for the first 4 months of treatment with amivantamab-vmjw injection and lazertinib. If you experience any of the following symptoms during your treatment, call your doctor immediately or get emergency medical treatment: chest pain; shortness of breath; swelling of a leg or arm; leg pain; redness, discoloration, or warmth in the legs or arms.

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

If you miss an appointment to receive amivantamab-vmjw injection, call your doctor as soon as possible.

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 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
• hemorrhoids
• difficulty falling asleep or staying asleep

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
• 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 (https://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^®