Amivantamab-vmjw Injection
Amivantamab-vmjw is a targeted antibody injection used to treat certain types of locally advanced or metastatic non-small cell lung cancer (NSCLC) defined by specific genetic mutations in the EGFR gene.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Amivantamab-vmjw Injection: Patient Information Guide
A plain-language walkthrough of Amivantamab-vmjw Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Rybrevant (amivantamab-vmjw) is approved to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. The right regimen depends on which mutation is present and whether prior treatment has been given.
- Rybrevant + lazertinib: First-line treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (confirmed by an FDA-approved test)
- Rybrevant + carboplatin + pemetrexed: Treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose cancer worsened during or after an EGFR tyrosine kinase inhibitor (a targeted oral cancer pill)
- Rybrevant + carboplatin + pemetrexed: First-line treatment for NSCLC with EGFR exon 20 insertion mutations (confirmed by an FDA-approved test)
- Rybrevant as a single agent: Treatment for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy has been tried
⚙️How it works▾
Amivantamab-vmjw is a bispecific antibody — a lab-engineered protein that can grab onto two different targets at the same time. It binds to EGFR and MET, proteins on the outer surface of lung cancer cells that normally tell cells to grow. By blocking these proteins and causing their breakdown, the drug cuts off key growth signals in cancer cells carrying exon 19, exon 21, or exon 20 mutations. It also helps the immune system recognize and destroy tumor cells directly, using immune cells called natural killer cells and macrophages.
When combined with lazertinib (which works inside cancer cells), the two drugs work together at different points in the cancer cell's growth pathway, showing greater anti-tumor activity than either drug alone in laboratory models.
💊How it's taken▾
Rybrevant is given intravenously (through an IV) by a healthcare professional — you never take it at home. The dose is based on your body weight measured at the start of treatment and does not change if your weight changes later. The first dose of every new treatment course is always split across two consecutive days.
- When used with lazertinib or as a single agent: given weekly for 5 weeks, then every 2 weeks starting at Week 7
- When used with carboplatin and pemetrexed: given weekly for 4 weeks, then every 3 weeks starting at Week 7
- Premedications are given before every infusion; additional skin-protective medicines are started on Day 1 of treatment
- Continue treatment until your doctor says the cancer has progressed or side effects become unmanageable
🤒Side effects — in detail▾
Rybrevant causes side effects in most patients. The most commonly reported ones include:
- Rash and acne-like skin reactions (very common; occurs in the majority of patients)
- Nail changes or toxicity
- Infusion-related reactions — flushing, chills, fever, nausea, or shortness of breath during the infusion
- Swelling (edema)
- Fatigue
- Mouth sores (stomatitis)
- Nausea, constipation, or diarrhea
- Musculoskeletal (muscle and joint) pain
- Decreased appetite
- Tingling or numbness (paresthesia), particularly with the lazertinib combination
Serious reactions — including severe lung inflammation, dangerous blood clots, severe skin reactions, and eye problems — can occur and require prompt medical attention. Report any new or worsening symptoms to your care team right away.
⚠️Warnings & precautions▾
- Infusion-related reactions (IRR): Very common, especially with the first infusion. Premedications and a peripheral IV line are used to reduce risk. Staff monitor you during infusions, and equipment for emergency treatment is on hand.
- Blood clots (VTE — venous thromboembolism): A serious risk specifically when Rybrevant is combined with lazertinib. Most clots occur in the first four months. Preventive blood thinners are recommended during this period. Watch for leg swelling, leg pain, or sudden shortness of breath.
- Lung inflammation (ILD/pneumonitis): Can be severe or fatal. Report any new cough, shortness of breath, or fever to your doctor immediately. Rybrevant will be stopped if this is confirmed.
- Skin reactions: Rash occurs in the large majority of patients and can occasionally be severe, including a rare life-threatening reaction called toxic epidermal necrolysis (TEN). Preventive skin care is started on Day 1. Limit sun exposure during treatment and for 2 months after.
- Eye toxicity: Eye problems such as inflammation of the cornea (keratitis), eye redness, blurred vision, and dry eyes can occur. Tell your doctor about any eye changes promptly — you may need to see an eye specialist.
- Fetal harm: Rybrevant can harm an unborn baby. Effective contraception is required during treatment and for 3 months after the last dose.
🔀What it interacts with▾
The FDA label for Rybrevant does not describe specific drug-drug, food, alcohol, or supplement interactions. Always give your oncology team a complete list of every medication and supplement you take, as interactions may still apply in your individual situation.
- Lazertinib (taken with Rybrevant): This combination significantly increases the risk of blood clots (VTE); preventive anticoagulation is required for the first four months
- Vitamin K antagonists (e.g., warfarin): Not recommended for anticoagulation when Rybrevant is combined with lazertinib — ask your team which blood thinner is appropriate
- Carboplatin and pemetrexed (taken with Rybrevant): When used together, Rybrevant must always be infused last, after pemetrexed and carboplatin
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Rybrevant can harm a developing baby — tell your doctor immediately if you are pregnant or become pregnant during treatment
- Contraception: Women who could become pregnant must use effective birth control during treatment and for 3 months after the last dose; a pregnancy test is required before starting
- Breastfeeding: Do not breastfeed during treatment or for 3 months after the last dose due to the potential for serious harm to the nursing child
- Children: Safety and effectiveness have not been established in patients under 18 years old
- Older adults (65+): Included in clinical studies; no meaningful differences in safety or effectiveness compared to younger patients were observed
- Kidney problems: Mild-to-moderate kidney impairment does not significantly affect how the drug works in the body, but severe kidney impairment or end-stage kidney disease has not been studied
- Liver problems: Mild liver impairment appears safe, but moderate-to-severe liver impairment has not been studied — tell your doctor about any liver conditions
- Genetic testing required: Your tumor must be tested with an FDA-approved test to confirm the specific EGFR mutation before Rybrevant can be prescribed
📡Pharmacodynamics — effects in the body▾
The full exposure-response relationship and time-course of pharmacodynamic effects of amivantamab-vmjw have not been completely characterized in patients with EGFR-mutated NSCLC. In other words, researchers are still working to fully understand exactly how the drug's levels in the blood relate to how well it works and how long its effects last in the body.
🔬Pharmacokinetics — how your body processes it▾
Rybrevant reaches steady-state blood levels (a stable, consistent concentration) by about Week 13 of treatment, regardless of whether the 2-week or 3-week dosing schedule is used. Its average half-life — the time it takes the body to reduce the drug concentration by half — is about 14 days, and it is cleared from the body at a rate of roughly 0.26 liters per day. Body weight matters: patients weighing 80 kg or more have 30–40% lower drug exposure at the same dose, which is why dosing is weight-based. Mild-to-moderate kidney or liver problems do not meaningfully change how the drug behaves in the body, but severe kidney disease or significant liver disease has not been studied.
📦How to store it▾
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.
📄 Written from Amivantamab-vmjw Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Amivantamab-vmjw Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why does my tumor have to be tested before I can get Rybrevant? ▾
Why did my nurse give me so many medications before my first Rybrevant infusion? ▾
I'm getting a bad rash — is that normal, and what should I do? ▾
I'm on Rybrevant with lazertinib — why do I also need to take a blood thinner? ▾
Can I get pregnant or breastfeed while on Rybrevant? ▾
What symptoms should make me call my doctor right away? ▾
Is Amivantamab-vmjw Injection available over the counter? ▾
When was Amivantamab-vmjw Injection first available? ▾
💬 Answers drafted from Amivantamab-vmjw Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Amivantamab-vmjw Injection comes
Amivantamab-vmjw Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Rybrevant is used intravenously with lazertinib as a first-line treatment for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Rybrevant is used intravenously with carboplatin and pemetrexed for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after prior EGFR-targeted therapy has failed
- Rybrevant is used intravenously with carboplatin and pemetrexed as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations
- Rybrevant is used intravenously as a single agent for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy
- Rybrevant is always given by a healthcare professional as an intravenous infusion, never self-administered
- Rybrevant's first dose is split across Day 1 and Day 2 of Week 1, and is given through a peripheral (arm) IV line during Week 1 and Week 2 to reduce infusion reaction risk
- Rybrevant requires premedications (antihistamines, fever reducers, steroids) before each infusion to reduce the chance and severity of infusion-related reactions
- When given with carboplatin and pemetrexed, Rybrevant is always infused last — after pemetrexed and carboplatin
📊 Amivantamab-vmjw Injection across the U.S. market
How Amivantamab-vmjw Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Amivantamab-vmjw Injection is used
A general measure of how commonly Amivantamab-vmjw Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Amivantamab-vmjw Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Amivantamab-vmjw Injection prescribed? Of the 1,596 medications we measure, Amivantamab-vmjw Injection ranks #1,335 by Medicaid prescriptions — more than 16% of them.
Utilization by Amivantamab-vmjw Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Amivantamab-vmjw Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 1 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amivantamab-vmjw Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Amivantamab-vmjw Injection NDCs with Medicaid activity.
🔍 Compare Amivantamab-vmjw Injection products
A representative set of FDA-listed product records for Amivantamab-vmjw Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 350 mg | Intravenous | Janssen Biotech, Inc. × 4 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Amivantamab-vmjw Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amivantamab-vmjw Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amivantamab-vmjw Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Amivantamab-vmjw Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2549199 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 2549733In current FDA listingsClinical drug / strength (SCD) 7 ML amivantamab-vmjw 50 MG/MLRxCUI 2549734
Look up RxCUI 2549199 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Amivantamab-vmjw Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Amivantamab-vmjw Injection belongs to the Other monoclonal antibodies and antibody drug conjugates class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.