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Rybrevant Faspro: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
1600 mg/10 mL, 20000 mg/10 mL, 2240 mg/14 mL, 28000 mg/14 mL, 2400 mg/15 mL, 30000 mg/15 mL, 3520 mg/22 mL, 44000 mg/22 mL
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Rybrevant Faspro

What is RYBREVANT FASPRO?

RYBREVANT FASPRO 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 certain abnormal epidermal growth factor receptor (EGFR) gene(s):

  • in combination with lazertinib as a first-line treatment for NSCLC
  • in combination with carboplatin and pemetrexed for NSCLC in people whose disease has worsened on or after treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • in combination with carboplatin and pemetrexed as a first-line treatment for NSCLC
  • alone for the treatment of NSCLC in people whose disease has worsened on or after platinum-based chemotherapy.

Your healthcare provider will perform a test to make sure that RYBREVANT FASPRO is right for you.

It is not known if RYBREVANT FASPRO is safe and effective in children.

Do not receive RYBREVANT FASPRO if you are allergic to hyaluronidase or any of the ingredients in RYBREVANT FASPRO. See the end of this leaflet for a complete list of ingredients in RYBREVANT FASPRO.

Before you receive RYBREVANT FASPRO, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of lung or breathing problems, other than cancer.

  • are pregnant or plan to become pregnant. RYBREVANT FASPRO 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 FASPRO.
    • You should use effective birth control (contraception) during treatment and for 3 months after your last dose of RYBREVANT FASPRO.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with RYBREVANT FASPRO.
  • are breastfeeding or plan to breastfeed. It is not known if RYBREVANT FASPRO passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of RYBREVANT FASPRO.

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

How will I receive RYBREVANT FASPRO?

  • RYBREVANT FASPRO will be given to you by your healthcare provider as an injection under the skin (subcutaneous injection), in the stomach area (abdomen).
  • RYBREVANT FASPRO is injected over about 5 minutes for each injection.
  • 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 FASPRO to help reduce the risk and severity of allergic and injection-related reactions.
  • Your healthcare provider may give you medicines in addition to RYBREVANT FASPRO to reduce the risk and severity of skin and nail reactions.
  • RYBREVANT FASPRO may be given in combination with the medicines, carboplatin and pemetrexed. If you have any questions about these medicines, ask your healthcare provider.
  • If your treatment with RYBREVANT FASPRO is given in combination with the medicine lazertinib, you should take your dose of lazertinib by mouth anytime before your injection with RYBREVANT FASPRO.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What should I avoid while receiving RYBREVANT FASPRO?

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

What are the possible side effects of RYBREVANT FASPRO?

RYBREVANT FASPRO may cause serious side effects, including:

  • allergic and injection-related reactions. Allergic and injection-related reactions are common and can be severe or serious. Tell your healthcare provider right away if you get any of the following symptoms during or after your injection of RYBREVANT FASPRO:
  • shortness of breath
  • fever
  • chills
  • flushing
  • chest discomfort
  • dizziness or lightheadedness
  • vomiting
  • lung problems. RYBREVANT FASPRO can cause lung problems that can 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
  • fever

  • blood clot problems. RYBREVANT FASPRO, when given in combination with lazertinib, can cause blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) that can lead to death. Your healthcare provider may start you on medicine to prevent blood clots for the first 4 months of treatment. Tell your healthcare provider right away if you get any signs and symptoms of blood clots, including:

    • swelling, pain or tenderness in the leg
    • sudden unexplained chest pain
    • shortness of breath
  • skin problems. RYBREVANT FASPRO can cause severe rash; including blisters, peeling, skin pain and sores, redness, raised acne-like bumps, itching, and dry skin. Your healthcare provider may start you on an antibiotic for the first 3 months of treatment followed by an antibiotic lotion for your scalp for the next 9 months. During treatment with RYBREVANT FASPRO, you should apply a non-comedogenic (does not clog pores) skin moisturizer (ceramide-based or other types of moisturizers that provide long-lasting skin hydration and does not include drying ingredients) on your face and whole body (except scalp) and wash your hands and feet every day with 4% chlorhexidine solution. 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 FASPRO. See "What should I avoid while receiving RYBREVANT FASPRO?"
  • eye problems. RYBREVANT FASPRO can cause eye problems. Tell your healthcare provider right away if you get symptoms of eye problems which may include:
  • eye pain
  • inflammation of eyelids
  • 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 new or worsening eye problems during treatment with RYBREVANT FASPRO. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.

The most common side effects of RYBREVANT FASPRO in combination with lazertinib include:

  • rash
  • infected skin around the nail
  • muscle and joint pain
  • feeling very tired
  • sores in the mouth
  • swelling of hands, ankles, feet, face, or all of your body
  • nausea
  • diarrhea
  • vomiting
  • constipation
  • decreased appetite
  • headache
  • changes in certain blood tests

The most common side effects observed with intravenous (IV) amivantamab, which may be experienced with RYBREVANT FASPRO are listed below.

The most common side effects of IV amivantamab in combination with lazertinib include:

  • rash
  • infected skin around the nail
  • infusion-related reactions
  • muscle and joint pain
  • sores in the mouth
  • swelling of hands, ankles, feet, face, or all of your body
  • unusual feeling in the skin (such as tingling or a crawling feeling)
  • feeling very tired
  • diarrhea
  • constipation
  • COVID-19
  • bleeding
  • dry skin
  • decreased appetite
  • itching
  • nausea
  • changes in certain blood tests

The most common side effects of IV amivantamab in combination with carboplatin and pemetrexed include:

  • rash
  • infected skin around the nail
  • infusion-related reactions
  • feeling very tired
  • nausea
  • sores in the mouth
  • constipation
  • swelling of hands, ankles, feet, face, or all of your body
  • decreased appetite
  • muscle and joint pain
  • vomiting
  • COVID-19
  • changes in certain blood tests

The most common side effects of IV amivantamab when given alone include:

  • rash
  • infusion-related reactions
  • infected skin around the nail
  • muscle and joint pain
  • shortness of breath
  • nausea
  • swelling of hands, ankles, feet, face, or all of your body
  • cough
  • feeling very tired
  • sores in the mouth
  • constipation
  • vomiting
  • changes in certain blood tests

Your healthcare provider may temporarily stop, decrease your dose or completely stop your treatment with RYBREVANT FASPRO if you have serious side effects.

These are not all of the possible side effects of RYBREVANT FASPRO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about safe and effective use of RYBREVANT FASPRO.

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 FASPRO that is written for health professionals.

What are the ingredients of RYBREVANT FASPRO?

Active ingredient: amivantamab and hyaluronidase-lpuj

Inactive ingredients: edetate disodium, glacial acetic acid, methionine, polysorbate 80, sodium acetate, sucrose, and Water for Injection.

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA. U.S. License Number 1864

Halozyme, Inc., San Diego, CA 92130, USA. U.S. License Number 2187

For patent information: www.janssenpatents.com

© Johnson & Johnson and its affiliates 2025–2026

For more information, call 1-800-526-7736 or go to www.RYBREVANT.com.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761433 · View the label on DailyMed

Revision date stated in the text: February 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Rybrevant Faspro

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Endoglycosidase
Active ingredients Amivantamab, Hyaluronidase (human recombinant)
Dosage form Injection
Route Subcutaneous
Marketing status not in the current FDA NDC Directory
Company (applicant) JANSSEN BIOTECH
FDA approval BLA 761433Biologics License Application (BLA) Approved December 17, 2025
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1600 mg/10 mL, 20000 mg/10 mL – 10 ml in 1 vial, single-dose / 1 in 1 carton NDC 57894-510-01
2240 mg/14 mL, 28000 mg/14 mL – 14 ml in 1 vial, single-dose / 1 in 1 carton NDC 57894-514-01
2400 mg/15 mL, 30000 mg/15 mL – 15 ml in 1 vial, single-dose / 1 in 1 carton NDC 57894-515-01
3520 mg/22 mL, 44000 mg/22 mL – 22 ml in 1 vial, single-dose / 1 in 1 carton NDC 57894-522-01

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.