Rybrevant
Pronunciation: RYE–breh–vant
Generic name: amivantamab-vmjw
Dosage form: Intravenous infusion
Drug class: Miscellaneous bispecific antibodies
What is Rybrevant?
Rybrevant is used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastasized), cannot be removed by surgery, or has certain abnormal EGFR genes. It is given by IV infusion every 1 to 3 weeks.
Rybrevant is not chemotherapy it is a targeted treatment that targets the EGFR and MET receptors that cancer cells use to promote their growth. It is often used with chemotherapy treatments.
Rybrevant (amivantamab-vmjw) gained FDA approval on May 21, 2021. There is no generic or biosimilar.
FDA approvals and indications
Rybrevant is a prescription injection used to treat adults with NSCLC that has metastasized, cannot be removed by surgery, and has certain abnormal epidermal growth factor receptor (EGFR) genes:
- as a first-line treatment for NSCLC in combination with lazertinib
- as a first-line treatment for NSCLC in combination with carboplatin and pemetrexed
- as a second-line treatment for NSCLC in patients whose disease has worsened on or after treatment with an EGFR tyrosine kinase inhibitor (TKI), in combination with carboplatin and pemetrexed
- alone for the treatment of NSCLC in patients whose disease has worsened on or after platinum-based chemotherapy.
Your healthcare provider will perform a test to make sure that Rybrevant is right for you.
Side effects
The most common side effects of Rybrevant are:
- cough
- shortness of breath
- feeling very tired
- rash or itchy or dry skin
- decreased appetite
- infection of the skin around your nails
- swelling anywhere in your body
- nausea, vomiting, or constipation
- mouth sores
- joint or muscle pain
- abnormal blood tests
- COVID-19
- unusual feeling in the skin (such as tingling or a crawling feeling)
- infusion reactions.
Serious side effects and warnings
Rybrevant can cause the following serious side effects:.
- Infusion-related reactions. These are common but can be severe. The average time to onset of an infusion-related reaction is one hour from the start of the Rybrevant infusion and they are more likely to occur when Rybrevant is used alone, compared to use in combination with other treatments. Tell your healthcare provider 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 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.
- Blood clot problems. Blood clots are a serious, but common side effect of Rybrevant, when given together with another drug called lazertinib, may cause blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) that may lead to death. Your healthcare provider will start you on medicine to prevent blood clots for the first 4 months of treatment. Tell your healthcare provider right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.
- Skin problems. Rybrevant can cause severe rash; including blisters, peeling, skin pain and sores, redness, raised acne-like bumps, itching, and dry skin. You may use alcohol-free (such as isopropanol-free, ethanol-free) moisturizing cream to reduce the risk of skin problems. 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.
- 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
- changes in vision
- inflammation of eyelids
- itchy eyes
- dry eyes
- excessive tearing
- eye redness
- sensitivity to light
- blurred vision.
Rybrevant may harm an unborn baby.
Get emergency medical help if you have signs of an allergic reaction to Rybrevant, such as hives, difficulty 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).
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 the FDA at 1-800-FDA-1088.
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How does Rybrevant work?
Rybrevant (amivantamab) is a bispecific antibody that works by binding to 2 main targets:
- EGFR, which is a receptor that is often mutated in NSCLC. By binding to EGFR, Rybrevant blocks growth signals that would otherwise promote cancer cell proliferation
- MET (Mesenchymal-Epithelial Transition factor), another receptor that cancer cells often use, especially when developing resistance to EGFR-targeted therapies.
This dual approach allows Rybrevant to directly inhibit cancer cell growth and survival signaling, and potentially overcome resistance mechanisms that develop with single-target EGFR inhibitors.
Ryebrevant is specifically approved for patients with EGFR exon 20 insertion mutations, which are less responsive to earlier-generation EGFR inhibitors. These mutations account for about 4 to 40% of all EGFR mutations in NSCLC.
Rybrevant belongs to the drug class called bispecific antibodies.
Before taking this medicine
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, other than cancer
- are pregnant or plan to become pregnant
- are breastfeeding or intend to breastfeed.
Pregnancy
Rybrevant may harm an unborn baby. Females who can become pregnant may need a pregnancy test to make sure they are not pregnant before treatment. Use birth control while using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant or think you may be pregnant.
Breastfeeding
It is not known if Rybrevant passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of Rybrevant.
How is Rybrevant administered?
Rybrevant will be given to you by your healthcare provider as an intravenous infusion into your vein (see How is Rybrevant administered?). Your healthcare provider will decide the time between doses as well as how many treatments you will receive.
- It is usually given weekly initially then less frequently thereafter.
- Total infusion time is approximately 4-6 hours for day 1 and 6-8 hours for day 2. Subsequent infusion time is approximately 2 hours.
- Medicines such as an antihistamine, an antipyretic, and sometimes a glucocorticoid are usually given before each dose of Rybrevant to help reduce the risk of infusion-related reactions.
Rybrevant 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 is given with lazertinib, take it anytime before your infusion.
You may need frequent vision exams.
This medicine may cause rash, itching, and dry skin. Use only alcohol-free cream or lotion to treat dry skin.
Dosing information
The dosage is based on body weight and other treatments used.
Usual adult dose in combination with carboplatin and pemetrexed
Less than 80 kg:
- Weeks 1 through 4: Rybrevant 1400 mg IV
- Week 7 onwards: Rybrevant 1750 mg IV
Greater than or equal to 80 kg:
- Weeks 1 through 4: Rybrevant 1750 mg IV
- Week 7 onwards: Rybrevant 2100 mg IV
Administer Rybrevant weekly for 4 weeks. The initial dose is split and given on Day 1 and Day 2 of Week 1. Rybrevant is then administered every 3 weeks starting at Week 7.
Usual adult dose in combination with lazertinib or as a single agent
Less than 80 kg:
- Weeks 1 through 5: Rybrevant 1050 mg IV
- Week 7 onwards: Rybrevant 1050 mg IV
Greater than or equal to 80 kg:
- Weeks 1 through 5: Rybrevant 1400 mg IV
- Week 7 onwards: Rybrevant 1400 mg IV
Administer Rybrevant weekly for 5 weeks. The initial dose is split and given on Day 1 and Day 2 of Week 1. Rybrevant is then administered every 2 weeks starting at Week 7.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your next injection.
What should I avoid while taking Rybrevant?
Rybrevant can cause skin reactions. Avoid sunlight and tanning beds during treatment and 2 months after your last dose. Wear protective clothing and use sunscreen (SPF 30 or higher) when outdoors.
If you have eye problems, avoid wearing contact lenses until an eye doctor can examine your symptoms.
What other drugs will affect Rybrevant?
Other drugs may affect Rybrevant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. No formal drug interaction studies have been conducted with Rybrevant.
Rybrevant Package Insert
Review the Rybrevant Package Insert for more detailed information about this medicine. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
Rybrevant ingredients
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.
Who makes Rybrevant?
Rybrevant (amivantamab) is made by Janssen Biotech, a pharmaceutical company owned by Johnson & Johnson. Janssen developed and commercialized this bispecific antibody therapy for non-small cell lung cancer.
Rybrevant Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Rybrevant.
Rybrevant (amivantamab-vmjw) - Janssen Biotech, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 350 mg/7 mL (50 mg/mL) |
Popular FAQ
How do Exkivity and Rybrevant compare for NSCLC?
Exkivity has been withdrawn from the U.S. market. In clinical studies, close to 28% of patients had a partial response (tumor shrinkage) to Exkivity treatment for Exon 20 mutations and the response lasted for about 17.5 months. About 40% of participants had a response to single agent Rybrevant treatment, and the duration of response (DoR) lasted for a median of 11.5 months. Continue reading
How does Rybrevant work?
Rybrevant is a targeted medicine that works at the epidermal growth factor receptor (EGFR) gene mutation and MET receptor found in certain types of non-small cell lung cancer (NSCLC). EGFR and MET are proteins that help cells to grow. Targeting these proteins helps to slow down or stop cancer growth. Continue reading
How is Rybrevant administered?
Rybrevant is given as an intravenous (IV) infusion into your vein. Your healthcare provider will administer this medication to you and determine your dose. It may be given alone, in combination with chemotherapy (carboplatin and pemetrexed), or with a kinase inhibitor called Lazcluze (lazertinib) for the treatment of EGFR mutated non-small cell lung cancer (NSCLC). Continue reading
More about Rybrevant (amivantamab)
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- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous bispecific antibodies
- Breastfeeding
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.