amivantamab
Rybrevant · ATC code L01FX18
- Key facts
- Active substance
- amivantamab
- ATC code
- L01FX18
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Rybrevant 350 mg concentrate for solution for infusion. · Rybrevant 1 600 mg solution for injection / Rybrevant 2 240 mg solution for injection / Rybrevant 2 400 mg solution for injection
- Marketing authorisation holder
- 5343
- Information as of
- 2026-10-27
Key facts
Amivantamab is a bispecific IgG1 monoclonal antibody against EGFR and MET used to treat adults with advanced non-small cell lung cancer (NSCLC) carrying specific EGFR mutations.
What it is used for
- With lazertinib: first-line advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- With carboplatin and pemetrexed: NSCLC with exon 19 deletions or L858R after failure of prior therapy including an EGFR TKI
- With carboplatin and pemetrexed: first-line NSCLC with activating EGFR exon 20 insertion mutations
- Monotherapy: NSCLC with exon 20 insertions after failure of platinum-based therapy
- Applies to both the intravenous and subcutaneous formulations
Dosing
- EGFR mutation status must be established with a validated test before starting; premedication (antihistamines, antipyretics, and glucocorticoids initially) to reduce reactions
- Intravenous, every 3 weeks (with carboplatin/pemetrexed): under 80 kg 1,400 mg weekly in weeks 1 to 4, then 1,750 mg every 3 weeks from week 7; 80 kg or more 1,750 mg and 2,100 mg respectively
- Intravenous, every 2 weeks (monotherapy or with lazertinib): under 80 kg 1,050 mg, 80 kg or more 1,400 mg, weekly in weeks 1 to 4, then every 2 weeks from week 5
- Intravenous: first infusion split over Day 1 and Day 2 of week 1
- Subcutaneous (monotherapy or with lazertinib): under 80 kg 1,600 mg, 80 kg or more 2,240 mg weekly in weeks 1 to 4, then every 2 weeks, or alternatively 3,520 mg or 4,640 mg every 4 weeks
- No adjustment for later body weight changes; further schedules and dose modifications in the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Infusion- or administration-related reactions are common; premedicate, interrupt at the first sign, permanently discontinue for Grade 4 or recurrent Grade 3 reactions
- Interstitial lung disease/pneumonitis, including fatal events; interrupt treatment if symptoms develop
- Skin and nail toxicity (e.g. rash) and eye disorders can occur (details in the full text)
- Traceability: record name and batch number
Side effects
- IV monotherapy (N=380), most frequent: rash (76%), infusion-related reactions (67%), nail toxicity (47%), hypoalbuminaemia (31%), oedema (26%), fatigue (26%), stomatitis (24%), nausea and constipation (23% each)
- Serious: interstitial lung disease (1.3%), infusion-related reactions (1.1%), rash (1.1%)
Interactions
- No interaction studies; as an IgG1 antibody, effects on drug-metabolising enzymes are not anticipated
- Avoid live or live-attenuated vaccines during treatment
Pregnancy and breastfeeding
- Women of child-bearing potential should use effective contraception during and for 3 months after treatment; pregnancy and breastfeeding details are in the full text
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Rybrevant5343 · EMEA/H/C/005454
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Rybrevant
- Liechtenstein
- Rybrevant
- Norway
- Rybrevant
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Rybrevant – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.