Rybrevant

What is Rybrevant?

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 Rybrevant is safe and effective in children.

Description

Amivantamab-vmjw is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa. RYBREVANT (amivantamab-vmjw) injection for intravenous infusion is a sterile, preservative-free, colorless to pale yellow solution in single-dose vials. The pH is 5.7.

Each RYBREVANT vial contains 350 mg (50 mg/mL) amivantamab-vmjw, EDTA disodium salt dihydrate (0.14 mg), L-histidine (2.3 mg), L-histidine hydrochloride monohydrate (8.6 mg), L-methionine (7 mg), polysorbate 80 (4.2 mg), sucrose (595 mg), and water for injection, USP.

 Mechanism of Action

Amivantamab-vmjw is a bispecific antibody that binds to the extracellular domains of EGFR and MET.

In in vitro and in vivo studies amivantamab-vmjw was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively.

What should I tell my healthcare provider before using Rybrevant?

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

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

How should I use Rybrevant?

• 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 of Rybrevant 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.

What should I avoid while taking Rybrevant?

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.

What are the possible side effects of Rybrevant?

Rybrevant may cause serious side effects, including:

• 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 of Rybrevant:
  • 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 with Rybrevant. 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 lightYour healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems during treatment with Rybrevant. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.

The most common side effects of Rybrevant 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 with Rybrevant if you have serious side effects.
These are not all of the possible side effects of Rybrevant.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Rybrevant

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about Rybrevant that is written for health professionals.

What are the ingredients in Rybrevant?

Active ingredient: amivantamab-vmjw

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

Label

PRINCIPAL DISPLAY PANEL – 7 ML VIAL CARTON