RYBREVANT (amivantamab-vmjw) Injection for NSCLC

RYBREVANT is an injection available as a prescription used to treat adults with non-small cell lung cancer (NSCLC) that:

• is metastatic (has spread to other parts of the body) or cannot be removed by surgery, and

• has an abnormal epidermal growth factor receptor “EGFR” gene(s) and

• whose disease has worsened while on chemotherapy or after chemotherapy that contains platinum.

Your doctor will do a test to make sure that RYBREVANT is right for you.

It is not known if RYBREVANT is safe to use in children.

40% of the people who were treated with RYBREVANT after chemotherapy that contains platinum saw their tumors disappear (3.7%) or get smaller (36%).

The median response time for people that were treated with RYBREVANT was 11.1 months.

• Half of the people responded to RYBREVANT for 11.1 months or longer, and half of them responded for less than 11.1 months

• 63% of the people treated with RYBREVANT responded for 6 months or longer

Before you receive RYBREVANT, tell your doctor about all of your medical conditions, including if you:

• have a history of lung or breathing problems

• are pregnant or planning to become pregnant. RYBREVANT can harm your unborn baby.

• Females who are able to become pregnant:
  • Your doctor will do a pregnancy test before you start treatment with RYBREVANT.
  • You should use contraception during treatment and for 3 months after your final dose of RYBREVANT.

• Tell your doctor right away if you think you might be pregnant during treatment with RYBREVANT.

• are breastfeeding or planning to breastfeed. It is not known if RYBREVANT can pass into your breast milk.

• Tell your doctor about all the medicines, prescriptions, over-the-counter medicines, vitamins, and herbal supplements that you take.

• RYBREVANT will be given to you by your doctor by intravenous infusion into your vein.

• Your doctor will decide the time between doses and how many treatments you will receive.

• Your doctor will also will give you medicines before each dose of RYBREVANT to help reduce the risk of infusion-related reactions.

The recommended dosage of RYBREVANT is based on body weight (Less than 80 kg – 1050 mg (3 vials) and Greater than or equal to 80 kg – 1400 mg (4 vials)).

Your doctor will administer RYBREVANT weekly for 4 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 2 weeks starting at Week 5.

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

• rash

• swelling of hands, ankles, feet, face, or all of your body

• infusion-related reactions

• sores in the mouth

• infected skin around the nail

• cough

• muscle and joint pain

• constipation

• shortness of breath

• vomiting

• nausea

• changes in certain blood tests

• feeling very tired

RYBREVANT may cause serious side effects, including:

• Infusion-related reactions: Infusion-related reactions are common when receiving treatment with RYBREVANT and can be severe or serious. Tell your doctor right away if you get any of the following symptoms during your infusion of RYBREVANT:
  • shortness of breath
  • flushing
  • fever
  • chest discomfort
  • chills
  • lightheadedness
  • nausea
  • vomiting

• Lung problems: RYBREVANT may cause lung problems that are serious and may lead to death. Symptoms may be similar to those symptoms of lung cancer. Tell your doctor right away if you get any new or worsening lung symptoms, including cough, shortness of breath, or fever.

• Skin problems: RYBREVANT may cause itching, rash, and dry skin. You may use a moisturizer for dry skin. Tell your doctor right away if you get any skin reactions. Your doctor may treat you with medicines or send you to see a dermatologist if you get skin reactions during treatment with RYBREVANT.

• Eye problems: RYBREVANT may cause serious eye problems. Tell your doctor right away if you get symptoms of eye problems which may include:
  • eye pain
  • changes in vision
  • dry eyes
  • itchy eyes
  • eye redness
  • excessive tearing
  • blurred vision
  • sensitivity to light

• Your doctor may send you to see an ophthalmologist if you get eye problems during treatment with RYBREVANT. You should not use contact lenses until your eye symptoms are checked by a doctor.

Active ingredient: amivantamab-vmjw
Inactive ingredients: L-methionine, EDTA disodium salt dihydrate, polysorbate 80, L-histidine, L-histidine hydrochloride monohydrate, sucrose, and water for injection.