Pronunciation: RYE–breh–vant
Generic name: amivantamab-vmjw
Dosage form: Intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 17, 2024.

What is Rybrevant?

Rybrevant is a treatment for non-small cell lung cancers (NSCLC) with an EGFR exon 20 insertion mutation when the cancer is advanced. Rybrevant may help reduce the size of non-small cell lung cancer, and in some cases, it may disappear.  Rybrevant works by binding to EGFR and MET receptor on the cancer cell, which stops the tumors from multiplying, spreading, and surviving. Rybrevant also helps your immune system to identify cancer cells and destroy them.

What is Rybrevant used for?

Rybrevant FDA approval is to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations when used:

• in combination with carboplatin and pemetrexed as a first-line treatment
• as a single agent when cancer has progressed on or after platinum-based chemotherapy.

EGFR exon 20 insertion mutations must be detected by an FDA-approved test,

What is an EGRF mutation?

Epidermal growth factor receptor (EGFR) is a receptor on cells that helps to control how much they grow and multiply. When there is an EGRF mutation or change, it is like the cells have been switched on to grow uncontrollably and multiply, which causes cancer. There are different types of EGFR mutations, the EGFR exon 20 insertion mutation is a rarer type of mutation that is typically resistant to treatment with conventional targeted EGFR tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors used alone

How does Rybrevant work?

Rybrevant is a bispecific antibody targeting EGFR and mesenchymal-epithelial transition (MET) receptors. Rybrevant mechanism of action involves binding to these two receptors which disrupts growth signals to cancer cells to help prevent cancer cells from growing, multiplying, and surviving. It also helps direct immune cells to detect and fight the cancer cells.

Rybrevant side effects

Common Rybrevant side effects 

Common Rybrevant side effects may include a reaction during the injection, cough, shortness of breath, feeling very tired, rash, infection of the skin around your nails, swelling anywhere in your body, nausea, vomiting, constipation, mouth sores, joint or muscle pain or abnormal blood tests.

Serious Rybrevant side effects 

Get emergency medical help if you have signs of an allergic reaction (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).

Some side effects may occur during the injection. Tell your care provider if you feel nauseated, light-headed, short of breath, chilled, or feverish or if you have chest discomfort.

Rybrevant may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, itching, watery eyes, sensitivity to light;
• vision changes;
• dark floating spots in your field of vision (floaters);
• skin changes such as acne, itching, or dryness; or
• lung problems (may be similar to symptoms of your cancer) - new or worsening cough, fever, or shortness of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

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.

Warnings

Infusion-Related Reactions (IRR): Interrupt infusion at the first sign of IRRs. Reduce infusion rate or permanently discontinue Rybrevant based on severity of reaction.

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening lung symptoms indicative of ILD. In patients with suspected ILD/pneumonitis immediately withhold Rybrevant and permanently discontinue if ILD/pneumonitis is confirmed. 

Dermatologic Adverse Reactions: May cause rash including a type of dermatitis and toxic epidermal necrolysis (TEN). Withhold, dose reduce or permanently discontinue Rybrevant based on severity. Rybrevant can cause skin reactions. Avoid sunlight while you are receiving amivantamab and for 2 months after your last dose.

Ocular Toxicity: Promptly refer patients with worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue medicine based on severity. 

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. 

Before taking this medicine

Tell your doctor if you have ever had lung problems other than cancer.

Pregnancy

Rybrevant may harm an unborn baby. Females who are able to 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

Do not breastfeed while using this medicine, and for at least 3 months after your last dose.

How will I receive Rybrevant?

Rybrevant is given as an infusion into a vein (intravenous infusion) by a healthcare provider, which takes several hours.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

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.

Rybrevant dosing information

Usual Adult Rybrevant Dose for Non-Small Cell Lung Cancer:

Dose Weeks 1 to 4:
Less than 80 kg: 1050 mg IV once a week for 4 doses
At least 80 kg: 1400 mg IV once a week for 4 doses

Dose Week 5 onwards:
Less than 80 kg: 1050 mg IV every 2 weeks
At least 80 kg: 1400 mg IV every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity.

Comments:
The dose should be based on baseline body weight; dose adjustments are not needed for subsequent body weight changes.
The initial dose should be administered as a split infusion in Week 1, on Day 1 and Day 2.
Before the initial infusion on Week 1 (Days 1 and 2), premedication should be administered to reduce the risk of infusion-related reactions.
-An antihistamine and antipyretic should be administered before all infusions.
-A glucocorticoid is required for Week 1 (Days 1 and 2) doses only and should be used as needed for subsequent infusions.
The initial infusion rate may be increased to the subsequent infusion rate after 2 hours without an infusion-related reaction.

Rybrevant is available as a single-dose vial 350 mg/7 mL (50 mg/mL) solution.

For more detailed information on dosage, including infusion rates, click the link below.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your next injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while taking Rybrevant?

Rybrevant can cause skin reactions. Avoid sunlight and tanning beds during treatment and for two 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 doctor about all other medicines you use. This is not a complete list of interactions; for more information on interactions click on the link below.

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.

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.

Storage 

Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

Company

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

Popular FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer