Prescription medicine
Amivantamab and hyaluronidase Brand names: Rybrevant
Amivantamab and hyaluronidase (Rybrevant) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the amivantamab and hyaluronidase FDA label on DailyMed (effective June 17, 2026); every amivantamab and hyaluronidase label on DailyMed.
Highlights of the record
FDA label of June 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Forms and strengths
- 1600 mg/10ml / 20000 mg/10ml
- 2240 mg/14ml / 28000 mg/14ml
- 2400 mg/15ml / 30000 mg/15ml
- 3520 mg/22ml / 44000 mg/22ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 125 through July 30, 2026
What is amivantamab and hyaluronidase used for?
From the label: indications and usageRYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. […]
Conditions named in the indications of amivantamab and hyaluronidase's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endoglycosidase.
Source: FDA drug label (Rybrevant Faspro), Janssen Biotech, Inc., effective June 17, 2026 (SPL set 9e58b045-e352-4f62-99bf-77fae1bebc69), via openFDA; the full label on DailyMed
What does the patient leaflet for amivantamab and hyaluronidase say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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.
Source: FDA drug label (Rybrevant Faspro), Janssen Biotech, Inc., effective June 17, 2026 (SPL set 9e58b045-e352-4f62-99bf-77fae1bebc69), via openFDA; the full label on DailyMed
Is there a generic for amivantamab and hyaluronidase (Rybrevant)?
No generic amivantamab and hyaluronidase is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the amivantamab and hyaluronidase label say about other medicines?
The amivantamab and hyaluronidase label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | Intravenous Amivantamab with Carboplatin and Pemetrexed Based on the pooled safety population [see Adverse Reactions (6.1) ], in 281 patients who received intravenous amivantamab in combination with carboplatin and pemetrexed, ocular toxicity occurred in 16%. |
| Lazertinib | warnings and precautions | Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold RYBREVANT FASPRO and lazertinib based on severity. |
| Pemetrexed | warnings and precautions | Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued intravenous amivantamab and 3.1% discontinued pemetrexed. |
Source: FDA drug label (Rybrevant Faspro), Janssen Biotech, Inc., effective June 17, 2026 (SPL set 9e58b045-e352-4f62-99bf-77fae1bebc69), via openFDA; the full label on DailyMed
What do FAERS reports show for amivantamab and hyaluronidase?
The FDA Adverse Event Reporting System holds 125 reports that list amivantamab and hyaluronidase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 17 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amivantamab and hyaluronidase?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as amivantamab and hyaluronidase or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Berahyaluronidase alfa and pembrolizumab | Lung cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other endoglycosidases
- the pharmacologic class, with prices and generics
- Amivantamab and hyaluronidase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other