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Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 1600 mg/10mL; 20000 mg/10mL Injection — NDC 57894-0510-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 1600 mg/10mL; 20000 mg/10mL Injection — NDC 57894-510-01 (Billing 57894-0510-01)

by Janssen Biotech, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 1600 mg/10mL; 20000 mg/10mL Injection from Janssen Biotech, Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 57894-0510-01
🏷️ FDA NDC (as labeled) 57894-510-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 57894-510-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
57894 labeler · 510 product · 01 package
Package marketed since
Dec 19, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0357894522010
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57894-510-01
Product NDC 57894-510
11-digit billing NDC 57894051001
NCPDP billing unit ML — per mL (volume)
RxCUI 2729297, 2729304, 2729306, 2729307, 2735796, 2735797, 2735803, 2735804
UNII 743QUY4VD8, 0JSR7Z0NB6
UPC 0357894522010
Application # BLA761433
SPL Set ID 9e58b045-e352-4f62-99bf-77fae1bebc69
Established class (EPC) Endoglycosidase
Chemical class Glycoside Hydrolases
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-19
Route SUBCUTANEOUS
Dosage form INJECTION
Substance AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21990002032020
GCN Seq No 088502
GCN 58633
HICL code 051068
Ingredient (HICL) Amivantamab-Hyaluronidase-Lpuj
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V15
Therapeutic class — specific (HIC3) Antineoplastic - Egfr And Met Receptor Inhib, Mab
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name RYBREVANT FASPRO 1,600 MG VIAL
FDB brand name Rybrevant Faspro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088502
  • GCN: 58633
  • GPI-14 (Medi-Span): 21990002032020
  • HICL (First Databank): 051068
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2729297
Why two NDCs? The FDA registers this code as 57894-510-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57894-0510-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other monoclonal antibodies and antibody drug conjugates class.

Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RYBREVANT FASPRO 1,600 MG VIAL Ingredient Amivantamab-Hyaluronidase-Lpuj

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9062 $40.743 / J9062 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)57894-510-01
11-digit billing NDC57894-0510-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9062
Descriptor5 MG
Billing units / pkg320 units
How the units are derivedThis package is 10; the HCPCS unit is 5 MG, so one package = 320 billing units.
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57894-0510-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2025-12-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rybrevant Faspro 1600 mg/10mL; 20000 mg/10mLthis 57894-0510-01 Janssen 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 1.9 mg / 10 mL UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 0.18 mg / 10 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 10 mg / 10 mL UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • 6 mg / 10 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 22.1 mg / 10 mL UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • 710 mg / 10 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJanssen Biotech, Inc.
FDA applicationBLA761433 (BLA)
Labeler code57894
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio36 products on file

More NDCs from Janssen Biotech, Inc. labeler code 57894

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE RYBREVANT 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.

( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. ( 1 , 2.2 ) as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ( 1 , 2.2 )

1.1First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT FASPRO, in combination with lazertinib, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .

1.2Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT FASPRO, in combination with carboplatin and pemetrexed, is indicated 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 [see Dosage and Administration (2.2) ].

1.3First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT FASPRO, in combination with carboplatin and pemetrexed, is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .

1.4Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT FASPRO is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] , whose disease has progressed on or after platinum-based chemotherapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous use only. (2.1) RYBREVANT FASPRO has different recommended dosage and administration than intravenous amivantamab products. ( 2.1 ) Administer each injection of RYBREVANT FASPRO subcutaneously in the abdomen over approximately 5 minutes.

( 2.1 ) The recommended dosage of RYBREVANT FASPRO is based on baseline body weight. ( 2.3 ) Administer premedications as recommended. ( 2.4 ) Recommended dosage for RYBREVANT FASPRO in combination with carboplatin and pemetrexed (every 3-week dosing), see Table 2 .

( 2.3 ) Recommended dosage for RYBREVANT FASPRO in combination with lazertinib or for RYBREVANT FASPRO as a single agent (every 4-week dosing), see Table 4 . ( 2.3 ) Recommended dosage for RYBREVANT FASPRO in combination with lazertinib or for RYBREVANT FASPRO as a single agent (every 2-week dosing), see Table 5 . ( 2.3 )

2.1Important Dosage and Administration Information RYBREVANT FASPRO is for subcutaneous use only. Do not administer RYBREVANT FASPRO intravenously. RYBREVANT FASPRO must be administered by a healthcare professional.

To reduce the risk of medication errors, prior to administration, check the vial labels to ensure that the drug being prepared and administered is subcutaneous RYBREVANT FASPRO and not intravenous amivantamab. RYBREVANT FASPRO has different recommended dosage and administration than intravenous amivantamab products. Do not substitute RYBREVANT FASPRO for or with intravenous amivantamab products.

Adult patients currently receiving intravenous amivantamab at an every 2-week dosing regimen may switch to subcutaneous RYBREVANT FASPRO at an every 2-week dosing regimen or at an every 4-week dosing regimen at their next scheduled dose on or after Week 5. Adult patients currently receiving intravenous amivantamab at an every 3-week dosing regimen may switch to subcutaneous RYBREVANT FASPRO at an every 3-week dosing regimen at their next scheduled dose on or after Week 4. Adult patients currently receiving RYBREVANT FASPRO at an every 2-week dosing regimen may switch to an every 4-week dosing regimen at their next scheduled dose on or after Week 5.

RYBREVANT FASPRO is not indicated for use in pediatric patients. Administer premedications before each RYBREVANT FASPRO dose as recommended, to reduce the risk of administration-related reactions (ARRs) [see Dosage and Administration (2.4) ] . Administer each injection of RYBREVANT FASPRO subcutaneously in the abdomen over approximately 5 minutes to minimize injection site irritation.

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard, not intact or within 2 inches (5 cm) around the periumbilical area. If the total dose requires multiple injections of RYBREVANT FASPRO, administer each injection consecutively in separate quadrants of the abdomen, with each injection taking approximately 5 minutes. Rotate injection sites at the next scheduled dose.

Pause or slow the delivery rate if the patient experiences pain. In the event pain is not alleviated by pausing or slowing down delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. If administering with a subcutaneous infusion set, ensure that the full dose is delivered through the infusion set, 0.9% sodium chloride solution may be utilized to flush remaining drug product through the line.

Discard unused portion.

2.2Patient Selection Select patients for treatment with RYBREVANT FASPRO based on the presence of a mutation as detected by an FDA-approved test as shown in Table 1. Table 1: Patient Selection Indication Treatment Regimen Source for Testing Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics. First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations [see Indications and Usage (1.1) ] RYBREVANT FASPRO in combination with lazertinib Tumor or plasma specimens.

Testing may be performed… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 212 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection 1,600 mg amivantamab and 20,000 units hyaluronidase per 10 mL (160 mg and 2,000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial. 2,240 mg amivantamab and 28,000 units hyaluronidase per 14 mL (160 mg and 2,000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial. 2,400 mg amivantamab and 30,000 units hyaluronidase per 15 mL (160 mg and 2,000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial.

3,520 mg amivantamab and 44,000 units hyaluronidase per 22 mL (160 mg and 2,000 units/mL) clear to opalescent and colorless to pale yellow solution in a single-dose vial. Injection : 1,600 mg amivantamab and 20,000 units hyaluronidase per 10 mL (160 mg and 2,000 units/mL) solution in a single-dose vial. ( 3 ) 2,240 mg amivantamab and 28,000 units hyaluronidase per 14 mL (160 mg and 2,000 units/mL) solution in a single-dose vial.

( 3 ) 2,400 mg amivantamab and 30,000 units hyaluronidase per 15 mL (160 mg and 2,000 units/mL) solution in a single-dose vial. ( 3 ) 3,520 mg amivantamab and 44,000 units hyaluronidase per 22 mL (160 mg and 2,000 units/mL) solution in a single-dose vial. ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. Patients with known hypersensitivity to hyaluronidase or to any of its excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions (ARR) : Premedicate with antihistamines, antipyretics, and glucocorticoids. Monitor patients for any signs and symptoms of ARRs. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.

( 2.8 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening symptoms indicative of ILD/pneumonitis. Immediately withhold RYBREVANT FASPRO in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. ( 2.8 , 5.2 ) Venous Thromboembolic (VTE) Events with Concomitant Use with Lazertinib: Prophylactic anticoagulation is recommended for the first four months of treatment.

Monitor for signs and symptoms of VTE and treat as medically appropriate. Withhold RYBREVANT FASPRO and lazertinib based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO and lazertinib at the same dose at the discretion of the healthcare provider.

Permanently discontinue RYBREVANT FASPRO and continue lazertinib for recurrent VTE despite therapeutic anticoagulation. ( 2.8 , 5.3 ) Dermatologic Adverse Reactions : Can cause severe rash including toxic epidermal necrolysis (TEN) and dermatitis acneiform. At treatment initiation, prophylactic and concomitant medications are recommended.

Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO based on severity. ( 2.5 , 2.8 , 5.4 ) Ocular Toxicity : Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO based on severity.

( 5.5 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 )

5.1Hypersensitivity and Administration-Related Reactions RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours. Local injection site reactions are described separately in Section 6.1.

RYBREVANT FASPRO (Subcutaneous Amivantamab) with Lazertinib In PALOMA-3 [see Adverse Reactions (6.1) ] , in the 206 patients who received RYBREVANT FASPRO in combination with lazertinib, all Grade ARR occurred in 13%, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1). Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended [see Dosage and Administration (2.4) ] .

Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection, if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity [see Dosage and Administration (2.8) ] .

5.2Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT FASPRO (Subcutaneous Amivantamab) with Lazertinib In PALOMA-3 [see Adverse Reactions (6.1) ] , in 206 patients who received RYBREVANT FASPRO in combination with lazertinib, ILD/pneumonitis occurred in 6%, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9%. In total, 5% of patients permanently discontinued RYBREVANT FASPRO and lazertinib due to ILD/pneumonitis.

Intravenous Amivantamab with Lazertinib In MARIPOSA [see Adverse Reactions (6.1) ] , in 421 patients who received intravenous amivantamab in combination with lazertinib, ILD/pneumonitis occurred in 3.1%, including Grade 3 in 1% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued int… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Hypersensitivity and Administration-Related Reactions [see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Venous Thromboembolic Events with Concomitant Use with Lazertinib [see Warnings and Precautions (5.3) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.4) ] Ocular Toxicity [see Warnings and Precautions (5.5) ] RYBREVANT FASPRO in Combination with Lazertinib The most common adverse reactions (≥ 20%) were rash, nail toxicity, musculoskeletal pain, fatigue, stomatitis, edema, nausea, diarrhea, vomiting, constipation, decreased appetite, and headache.

( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased lymphocyte count, decreased sodium, decreased potassium, decreased albumin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, increased gamma-glutamyl transferase, and decreased hemoglobin. (6.1) Intravenous Amivantamab in Combination with Lazertinib The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction, musculoskeletal pain, stomatitis, edema, VTE, paresthesia, fatigue, diarrhea, constipation, COVID-19, hemorrhage, dry skin, decreased appetite, pruritus, and nausea.

( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased albumin, decreased sodium, increased ALT, decreased potassium, decreased hemoglobin, increased AST, increased GGT, and increased magnesium. ( 6.1 ) Intravenous Amivantamab in Combination with Carboplatin and Pemetrexed The most common adverse reactions (≥ 20%) were rash, nail toxicity, infusion-related reaction, fatigue, nausea, stomatitis, constipation, edema, decreased appetite, musculoskeletal pain, vomiting, and COVID-19. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were decreased neutrophils, decreased leukocytes, decreased platelets, decreased hemoglobin, decreased potassium, decreased sodium, increased alanine aminotransferase, increased gamma-glutamyl transferase, and decreased albumin.

( 6.1 ) Intravenous Amivantamab as a Single Agent The most common adverse reactions (≥ 20%) were rash, infusion-related reaction, paronychia, musculoskeletal pain, dyspnea, nausea, edema, cough, fatigue, stomatitis, constipation, vomiting, and pruritus. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were increased gamma-glutamyl transferase, decreased sodium, decreased potassium, and increased alkaline phosphatase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. RYBREVANT FASPRO in Combination with Lazertinib The safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to RYBREVANT FASPRO in combination with lazertinib in 206 patients with previously treated locally advanced or metastatic NSCLC whose tumors have either an EGFR exon 19 deletion or an exon 21 L858R substitution mutation in PALOMA-3 [see Clinical Pharmacology (12.3) ].

Patients received RYBREVANT FASPRO (N=206) or intravenous amivantamab (N=210), both in combination with lazertinib, at the recommended dosages until disease progression or unacceptable toxicity. Among 206 patients who received RYBREVANT FASPRO in combination with lazertinib, 47% were exposed for 6 months or longer and 12% were exposed for greater than one year. The most common adverse reactions (≥ 20%) were rash, nail toxicity, musculoskeletal pain, fatigue, stomatitis, edema, nausea, diarrhea, vomiting, constipation, decreased… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal models, RYBREVANT FASPRO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of RYBREVANT FASPRO in pregnant women or animal data to assess the risk of RYBREVANT FASPRO in pregnancy. Disruption or depletion of EGFR in animal models resulted in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development.

The absence of EGFR or MET signaling has resulted in embryo lethality, malformations, and post-natal death in animals (see Data ). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data RYBREVANT FASPRO for subcutaneous injection contains amivantamab and hyaluronidase [see Description (11) ]. Amivantamab: No animal studies have been conducted to evaluate the effects of amivantamab on reproduction and fetal development; however, based on its mechanism of action, RYBREVANT FASPRO can cause fetal harm or developmental anomalies. In mice, EGFR is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development.

Reduction or elimination of embryo-fetal or maternal EGFR signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. Adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted EGFR signaling. Similarly, knock out of MET or its ligand HGF was embryonic lethal due to severe defects in placental development, and fetuses displayed defects in muscle development in multiple organs.

Human IgG1 is known to cross the placenta; therefore, amivantamab has the potential to be transmitted from the mother to the developing fetus. Hyaluronidase: In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (recombinant human) at dose levels up to 2,200,000 U/kg, which is > 3600 times higher than the human dose. The study found no evidence of teratogenicity.

Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which is > 600 times higher than the human dose. In a peri-and post-natal reproduction study, mice have been dosed daily by subcutaneous injection, with hyaluronidase (recombinant human) from implantation through lactation and weaning at dose levels up to 1,100,000 U/kg, which is > 1800 times higher than the human dose. The study found no adverse effects on sexual maturation, learning and memory or fertility of the offspring.

8.2Lactation Risk Summary There are no data on the presence of amivantamab or hyaluronidase in human milk or its effects on the breastfed child, or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to RYBREVANT FASPRO are unknown.

Because of the potential for serious adverse reactions from RYBREVANT FASPRO in breastfed children, advise women not to breastfeed during treatment with RYBREVANT FASPRO and for 3 months after the last dose.

8.3Females and Males of Reproductive Potential RYBREVANT FASPRO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO [see… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal models, RYBREVANT FASPRO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of RYBREVANT FASPRO in pregnant women or animal data to assess the risk of RYBREVANT FASPRO in pregnancy. Disruption or depletion of EGFR in animal models resulted in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development.

The absence of EGFR or MET signaling has resulted in embryo lethality, malformations, and post-natal death in animals (see Data ). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data RYBREVANT FASPRO for subcutaneous injection contains amivantamab and hyaluronidase [see Description (11) ]. Amivantamab: No animal studies have been conducted to evaluate the effects of amivantamab on reproduction and fetal development; however, based on its mechanism of action, RYBREVANT FASPRO can cause fetal harm or developmental anomalies. In mice, EGFR is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development.

Reduction or elimination of embryo-fetal or maternal EGFR signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. Adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted EGFR signaling. Similarly, knock out of MET or its ligand HGF was embryonic lethal due to severe defects in placental development, and fetuses displayed defects in muscle development in multiple organs.

Human IgG1 is known to cross the placenta; therefore, amivantamab has the potential to be transmitted from the mother to the developing fetus. Hyaluronidase: In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (recombinant human) at dose levels up to 2,200,000 U/kg, which is > 3600 times higher than the human dose. The study found no evidence of teratogenicity.

Reduced fetal weight and increased numbers of fetal resorptions were observed, with no effects found at a daily dose of 360,000 U/kg, which is > 600 times higher than the human dose. In a peri-and post-natal reproduction study, mice have been dosed daily by subcutaneous injection, with hyaluronidase (recombinant human) from implantation through lactation and weaning at dose levels up to 1,100,000 U/kg, which is > 1800 times higher than the human dose. The study found no adverse effects on sexual maturation, learning and memory or fertility of the offspring.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and efficacy of RYBREVANT FASPRO have not been established in pediatric patients.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 206 patients with locally advanced or metastatic NSCLC treated with RYBREVANT FASPRO in combination with lazertinib (every 2-week dosing) in the PALOMA-3 study, 35% were ≥ 65 years of age, and 9% were ≥ 75 years of age. The safety of RYBREVANT FASPRO in combination with other antineoplastic drugs or as a single agent for its approved indications [see Indications and Usage (1.1 , 1.2 , 1.3 , 1.4) ] has been established in adequate and well-controlled studies of intravenous amivantamab in combination with other antineoplastic drugs and as a single agent.

Of the 421 patients with locally advanced or metastatic NSCLC treated with intravenous amivantamab in combination with lazertinib in the MARIPOSA study, 45% were ≥ 65 years of age and 12% were ≥ 75 years of age. Of the 130 patients with locally advanced or metastatic NSCLC treated with intravenous amivantamab in combination with carboplatin and pemetrexed in the MARIPOSA-2 study, 40% were ≥ 65 years of age and 10% were ≥ 75 years of age. Of the 151 patients with locally advanced or metastatic NSCLC treated with intravenous amivantamab in combination with carboplatin and pemetrexed in the PAPILLON study, 37% were ≥ 65 years of age and 8% were ≥ 75 years of age.

Of the 302 patients with locally advanced or metastatic NSCLC treated with intravenous amivantamab as a single agent in the CHRYSALIS study, 39% were ≥ 65 years of age and 11% were ≥ 75 years of age. No clinically important differences in safety or efficacy were observed between patients who were ≥ 65 years of age and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies, amivantamab was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 19 deletions, exon 21 L858R substitutions, and exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively.

Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days.

Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. In the doses administered, hyaluronidase in RYBREVANT FASPRO acts transiently and locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

12.2Pharmacodynamics The exposure-response relationship and time-course of pharmacodynamic response of amivantamab have not been fully characterized in patients with NSCLC with EGFR mutations.

12.3Pharmacokinetics Amivantamab exposure and accumulation following the approved recommended dosages are provided in Table 20. Amivantamab exposure increases dose-proportionally across the recommended dosing regimens. Amivantamab maximum trough concentration is typically observed at the end of the weekly dosing (Cycle 2 Day 1).

Amivantamab steady-state concentration is reached by approximately Week 13. Table 20: Amivantamab Exposure and Accumulation Dose Frequency Geometric Mean C trough,max (%CV) Geometric Mean C trough,steady-state (%CV) AUC 1week Accumulation 1,600 mg amivantamab / 20,000 units hyaluronidase to 2,240 mg amivantamab / 28,000 units hyaluronidase every 2-week 335 µg/mL (33%) 206 µg/mL (39%) Increase 3.5-fold 2,400 mg amivantamab / 30,000 units hyaluronidase to 3,360 mg amivantamab / 42,000 units hyaluronidase every 3-week 464 µg/mL (24%) 218 µg/mL (42%) Increase 4.5-fold 3,520 mg amivantamab / 44,000 units hyaluronidase to 4,640 mg amivantamab / 58,000 units hyaluronidase every 4-week 350 µg/mL (31%) 129 µg/mL (52%) Increase 4.8-fold Adult patients with NSCLC were randomized (1:1) to RYBREVANT FASPRO or intravenous amivantamab in combination with lazertinib in PALOMA-3, an open-label, randomized trial.

The primary outcome measure was amivantamab steady-state C trough (Cycle 4 Day 1) and Cycle 2 AUC Day 1–15 of RYBREVANT FASPRO as compared to intravenous amivantamab. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Amivantamab exposure following administration of RYBREVANT FASPRO and intravenous amivantamab were comparable.

At the recommended every 2-week dosage, the observed geometric mean ratios (GMRs) (90% CI) for Cycle 2 AUC Day 1–15 was 1.03 (0.98, 1.09) and for steady-state C trough (Cycle 4 Day 1) was 1.43 (1.27, 1.61). At the recommended every 3-week dosage, the simulated GMRs (90% CI) for average concentration of Cycle 2 Day 1 to Day 21 was 1.20 (1.15, 1.26) and steady-state C trough was 1.32 (1.23, 1.42). At the recommended every 4-week dosage, the simulated GMRs (90% CI) for average concentration of Cycle 2 Day 1 to Day 28 was 1.20 (1.15, 1.26) and steady-state C trough was 1.01 (0.93, 1.09).

Absorption Amivantamab bioavailability is 67% (15%) with a median time to reach maximum concentration of 3 days following administration of RYBREVANT FASPRO. Distribution Amivantamab apparent volume of distribution is

5.7L (24%). Elimination Amivantamab is cleared by paralle… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 181 words ▾

12.1Mechanism of Action Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies, amivantamab was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 19 deletions, exon 21 L858R substitutions, and exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively.

Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days.

Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. In the doses administered, hyaluronidase in RYBREVANT FASPRO acts transiently and locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.

📦 How Supplied / Storage and Handling 145 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection for subcutaneous use is a sterile, preservative free, clear to opalescent and colorless to pale yellow solution supplied as follows: Strength NDC 1,600 mg amivantamab and 20,000 units hyaluronidase per 10 mL (160 mg and 2,000 units per mL) NDC 57894-510-01 2,240 mg amivantamab and 28,000 units hyaluronidase per 14 mL (160 mg and 2,000 units per mL) NDC 57894-514-01 2,400 mg amivantamab and 30,000 units hyaluronidase per 15 mL (160 mg and 2,000 units per mL) NDC 57894-515-01 3,520 mg amivantamab and 44,000 units hyaluronidase per 22 mL (160 mg and 2,000 units per mL) NDC 57894-522-01 Storage and Handling Store RYBREVANT FASPRO vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F) in original carton to protect from light.

Do not freeze. Do not shake.

📦 Storage and Handling 34 words ▾

Storage and Handling Store RYBREVANT FASPRO vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F) in original carton to protect from light. Do not freeze. Do not shake.

📋 Description ~1 min read ▾

11 DESCRIPTION RYBREVANT FASPRO is a fixed-combination drug product containing amivantamab and hyaluronidase (human recombinant). Amivantamab is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa. Hyaluronidase (human recombinant) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously.

It is a glycosylated single-chain protein produced by CHO cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (human recombinant) has a molecular weight of approximately 61 kDa. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection for subcutaneous use is a sterile, preservative free, clear to opalescent and colorless to pale yellow solution supplied in a single-dose vial with a pH of 5.7.

Each RYBREVANT FASPRO 10 mL single-dose vial contains 1,600 mg of amivantamab and 20,000 units of hyaluronidase (human recombinant), edetate disodium (0.18 mg), glacial acetic acid (1.9 mg), methionine (10 mg), polysorbate 80 (6 mg), sodium acetate (22.1 mg), sucrose (710 mg), and Water for Injection, USP. Each RYBREVANT FASPRO 14 mL single-dose vial contains 2,240 mg of amivantamab and 28,000 units of hyaluronidase (human recombinant), edetate disodium (0.25 mg), glacial acetic acid (2.6 mg), methionine (14 mg), polysorbate 80 (8.4 mg), sodium acetate (30.9 mg), sucrose (994 mg), and Water for Injection, USP.

Each RYBREVANT FASPRO 15 mL single-dose vial contains 2,400 mg of amivantamab and 30,000 units of hyaluronidase (human recombinant), edetate disodium (0.27 mg), glacial acetic acid (2.8 mg), methionine (15 mg), polysorbate 80 (9 mg), sodium acetate (33.1 mg), sucrose (1,065 mg), and Water for Injection, USP. Each RYBREVANT FASPRO 22 mL single-dose vial contains 3,520 mg of amivantamab and 44,000 units of hyaluronidase (human recombinant), edetate disodium (0.4 mg), glacial acetic acid (4.1 mg), methionine (22 mg), polysorbate 80 (13.2 mg), sodium acetate (48.6 mg), sucrose (1,562 mg), and Water for Injection, USP.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity and Administration-Related Reactions Advise patients that RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions, the majority of which may occur with the first injection. Advise patients to alert their healthcare provider immediately for any signs or symptoms of administration-related reactions during treatment with RYBREVANT FASPRO [see Warnings and Precautions (5.1) ] .

Interstitial Lung Disease/Pneumonitis Advise patients that RYBREVANT FASPRO can cause interstitial lung disease (ILD)/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms during treatment with RYBREVANT FASPRO [see Warnings and Precautions (5.2) ] . Venous Thromboembolic Events with Concomitant Use with Lazertinib Advise patients that when RYBREVANT FASPRO is used in combination with lazertinib, it can cause serious and life threatening venous thromboembolic events (VTE), including deep venous thrombosis and pulmonary embolism.

Advise patients that prophylactic anticoagulants are recommended to be used for the first four months of treatment. Advise patients to immediately contact their healthcare provider for signs and symptoms of VTE during treatment with RYBREVANT FASPRO [see Warnings and Precautions (5.3) ]. Dermatologic Adverse Reactions Advise patients that RYBREVANT FASPRO can cause dermatologic adverse reactions.

Advise patients that prophylactic oral antibiotics are recommended starting on Day 1 for the first 12 weeks of treatment and, after completion of oral antibiotic treatment, topical antibiotic lotion to the scalp for the next 9 months of treatment. Advise patients to use a non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying components) on the face and whole body (except scalp) and 4% chlorhexidine solution to wash hands and feet, while on treatment.

Advise patients to limit direct sun exposure during and for 2 months after treatment, to wear protective clothing, and to use broad-spectrum UVA/UVB sunscreen to reduce the risk and severity of dermatologic adverse reactions [see Warnings and Precautions (5.4) ] . Ocular Toxicity Advise patients that RYBREVANT FASPRO can cause ocular toxicity. Advise patients to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated [see Warnings and Precautions (5.5) ] .

Paronychia/Nail toxicity Advise patients that RYBREVANT FASPRO can cause paronychia. Advise patients to contact their healthcare provider for signs or symptoms of paronychia [see Adverse Reactions (6.1) ]. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus, to use effective contraception during treatment with RYBREVANT FASPRO and for 3 months after the last dose, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1 , 8.3) ].

Lactation Advise women not to breastfeed during treatment with RYBREVANT FASPRO and for 3 months after the last dose [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Amivantamab exposure and accumulation following the approved recommended dosages are provided in Table 20. Amivantamab exposure increases dose-proportionally across the recommended dosing regimens. Amivantamab maximum trough concentration is typically observed at the end of the weekly dosing (Cycle 2 Day 1).

Amivantamab steady-state concentration is reached by approximately Week 13. Table 20: Amivantamab Exposure and Accumulation Dose Frequency Geometric Mean C trough,max (%CV) Geometric Mean C trough,steady-state (%CV) AUC 1week Accumulation 1,600 mg amivantamab / 20,000 units hyaluronidase to 2,240 mg amivantamab / 28,000 units hyaluronidase every 2-week 335 µg/mL (33%) 206 µg/mL (39%) Increase 3.5-fold 2,400 mg amivantamab / 30,000 units hyaluronidase to 3,360 mg amivantamab / 42,000 units hyaluronidase every 3-week 464 µg/mL (24%) 218 µg/mL (42%) Increase 4.5-fold 3,520 mg amivantamab / 44,000 units hyaluronidase to 4,640 mg amivantamab / 58,000 units hyaluronidase every 4-week 350 µg/mL (31%) 129 µg/mL (52%) Increase 4.8-fold Adult patients with NSCLC were randomized (1:1) to RYBREVANT FASPRO or intravenous amivantamab in combination with lazertinib in PALOMA-3, an open-label, randomized trial.

The primary outcome measure was amivantamab steady-state C trough (Cycle 4 Day 1) and Cycle 2 AUC Day 1–15 of RYBREVANT FASPRO as compared to intravenous amivantamab. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Amivantamab exposure following administration of RYBREVANT FASPRO and intravenous amivantamab were comparable.

At the recommended every 2-week dosage, the observed geometric mean ratios (GMRs) (90% CI) for Cycle 2 AUC Day 1–15 was 1.03 (0.98, 1.09) and for steady-state C trough (Cycle 4 Day 1) was 1.43 (1.27, 1.61). At the recommended every 3-week dosage, the simulated GMRs (90% CI) for average concentration of Cycle 2 Day 1 to Day 21 was 1.20 (1.15, 1.26) and steady-state C trough was 1.32 (1.23, 1.42). At the recommended every 4-week dosage, the simulated GMRs (90% CI) for average concentration of Cycle 2 Day 1 to Day 28 was 1.20 (1.15, 1.26) and steady-state C trough was 1.01 (0.93, 1.09).

Absorption Amivantamab bioavailability is 67% (15%) with a median time to reach maximum concentration of 3 days following administration of RYBREVANT FASPRO. Distribution Amivantamab apparent volume of distribution is

5.7L (24%). Elimination Amivantamab is cleared by parallel linear and nonlinear saturable target mediated clearances after subcutaneous administration. Amivantamab estimated terminal half-life is 19 days (34%) with an associated linear apparent clearance of

0.22L/day (26%). Specific Populations No clinically significant differences in the pharmacokinetics of amivantamab were observed based on age (range: 28–85 years), baseline albumin level (range: 26–51 g/L), sex, race, ethnicity, mild and moderate renal impairment (creatinine clearance [CL Cr ] 29 to < 90 mL/min estimated by Cockcroft Gault equation), mild hepatic impairment [(total bilirubin ≤ ULN and AST > ULN) or (ULN < total bilirubin ≤ 1.5 times ULN)], Eastern Cooperative Oncology Group (ECOG) performance status, history of brain metastases, and EGFR primary mutation type.

The effect of severe renal (CL Cr 15 to 29 mL/min) impairment or moderate (total bilirubin 1.5 to 3 times ULN) to severe (total bilirubin > 3 times ULN) hepatic impairment on amivantamab pharmacokinetics is unknown. Increases in body weight increased the volume of distribution and clearance of amivantamab. With the recommended dosages, exposures of amivantamab were comparable between patients who weighed < 80 kg and received 1,600 mg amivantamab and 20,000 units hyaluronidase (every 2-week dosing)/2,400 mg amivantamab and 30,000 units hyaluronidase (every 3-week dosing)/3,520 mg amivantamab and 44,000 units hyaluronidase (every 4-week dosing) and patients who weighed ≥ 80 kg a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 24 words ▾

12.2Pharmacodynamics The exposure-response relationship and time-course of pharmacodynamic response of amivantamab have not been fully characterized in patients with NSCLC with EGFR mutations.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of RYBREVANT FASPRO has been established based on adequate and well controlled studies of intravenous amivantamab: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Indications and Usage (1.1) ] 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 [see Indications and Usage (1.2) ] in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test [see Indications and Usage (1.3) ] as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA‑approved test whose disease has progressed on or after platinum‑based chemotherapy [see Indications and Usage (1.4) ].

14.1First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations – Intravenous Amivantamab in Combination with Lazertinib MARIPOSA The efficacy of intravenous amivantamab, in combination with lazertinib, was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial. Eligible patients were required to have untreated locally advanced or metastatic NSCLC with either exon 19 deletions or exon 21 L858R substitution EGFR mutations identified by local testing, not amenable to curative therapy.

Patients with asymptomatic or previously treated and stable intracranial metastases were eligible to enroll. Patients were randomized (2:2:1) to receive intravenous amivantamab in combination with lazertinib (N=429), osimertinib monotherapy (N=429), or lazertinib monotherapy (an unapproved regimen for NSCLC) until disease progression or unacceptable toxicity. The evaluation of efficacy for the treatment of untreated metastatic NSCLC relied upon comparison between: Amivantamab administered intravenously at 1,050 mg (for patients < 80 kg) or 1,400 mg (for patients ≥ 80 kg) once weekly for 4 weeks, then every 2 weeks thereafter starting at week 5 in combination with lazertinib administered at 240 mg orally once daily.

Osimertinib administered at a dose of 80 mg orally once daily. Randomization was stratified by EGFR mutation type (exon 19 deletion or exon 21 L858R substitution mutation), Asian race (yes or no), and history of brain metastasis (yes or no). Tumor assessments were performed every 8 weeks for 30 months, and then every 12 weeks until disease progression.

The major efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR). Additional efficacy outcome measures included overall survival (OS), overall response rate (ORR), and duration of response (DOR). A total of 858 patients were randomized between the two study arms, 429 to the intravenous amivantamab in combination with lazertinib arm and 429 to the osimertinib arm.

The median age was 63 (range: 25–88) years; 61% were female; 58% were Asian, 38% were White, 1.6% were American Indian or Alaska Native, 0.8% were Black or African American, 0.2% were Native Hawaiian or other Pacific Islander, 0.6% were unknown race or multiple races; and 12% were Hispanic or Latino. Eastern Cooperative Oncology Group (ECOG) performance status was 0 (34%) or 1 (66%); 69% never smoked; 41% had prior brain metastases; and 89% had Stage IV cancer at initial diagnosis. Sixty percent of patients had tumors harboring exon 19 deletions and the remaining 40% had exon 21 L858R substitution mutation… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 149 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to assess the potential of amivantamab for carcinogenicity or genotoxicity. Fertility studies have not been performed to evaluate the potential effects of amivantamab. In 6-week and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs.

Hyaluronidases are found in most tissues of the body. Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when hyaluronidase (recombinant human) was administered to cynomolgus monkeys for 39 weeks at dose levels up to 220,000 U/kg, which is >300 times higher than the human dose, no evidence of toxicity to the male or female reproductive system was found through periodic monitoring of in-life parameters, e.g., semen analyses, hormone levels, menstrual cycles, and also from gross pathology, histopathology and organ weight data.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 146 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to assess the potential of amivantamab for carcinogenicity or genotoxicity. Fertility studies have not been performed to evaluate the potential effects of amivantamab. In 6-week and 3-month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs.

Hyaluronidases are found in most tissues of the body. Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase. In addition, when hyaluronidase (recombinant human) was administered to cynomolgus monkeys for 39 weeks at dose levels up to 220,000 U/kg, which is >300 times higher than the human dose, no evidence of toxicity to the male or female reproductive system was found through periodic monitoring of in-life parameters, e.g., semen analyses, hormone levels, menstrual cycles, and also from gross pathology, histopathology and organ weight data.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION RYBREVANT (RYE-breh-vant) FASPRO™ (Fas-pro) (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2026 What is RYBREVANT FASPRO?

RYBREVANT FASPRO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and has certain abnormal epidermal growth factor receptor (EGFR) gene(s): in combination with lazertinib as a first-line treatment for NSCLC in combination with carboplatin and pemetrexed for NSCLC in people whose disease has worsened on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) in combination with carboplatin and pemetrexed as a first-line treatment for NSCLC alone for the treatment of NSCLC in people whose disease has worsened on or after platinum-based chemotherapy.

Your healthcare provider will perform a test to make sure that RYBREVANT FASPRO is right for you. It is not known if RYBREVANT FASPRO is safe and effective in children. Do not receive RYBREVANT FASPRO if you are allergic to hyaluronidase or any of the ingredients in RYBREVANT FASPRO.

See the end of this leaflet for a complete list of ingredients in RYBREVANT FASPRO. Before you receive RYBREVANT FASPRO, 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. RYBREVANT FASPRO can harm your unborn baby.

Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with RYBREVANT FASPRO. You should use effective birth control (contraception) during treatment and for 3 months after your last dose of RYBREVANT FASPRO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with RYBREVANT FASPRO. are breastfeeding or plan to breastfeed.

It is not known if RYBREVANT FASPRO passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of RYBREVANT FASPRO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive RYBREVANT FASPRO? RYBREVANT FASPRO will be given to you by your healthcare provider as an injection under the skin (subcutaneous injection), in the stomach area (abdomen). RYBREVANT FASPRO is injected over about 5 minutes for each injection.

Your healthcare provider will decide the time between doses as well as how many treatments you will receive. Your healthcare provider will give you medicines before each dose of RYBREVANT FASPRO to help reduce the risk and severity of allergic and injection-related reactions. Your healthcare provider may give you medicines in addition to RYBREVANT FASPRO to reduce the risk and severity of skin and nail reactions.

RYBREVANT FASPRO 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 FASPRO is given in combination with the medicine lazertinib, you should take your dose of lazertinib by mouth anytime before your injection with RYBREVANT FASPRO.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. 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. What are the possible side effects of RYBREVANT FASPRO?

RYBREVANT FASPRO may cause serious side effects, including: allergic and injection-related reactions. Allergic and injection-rela… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 35 words ▾

Dosage and Administration ( 2.1 ) 02/2026 Dosage and Administration ( 2.3 ) 02/2026 Dosage and Administration ( 2.7 ) 02/2026 Dosage and Administration ( 2.8 ) 02/2026 Dosage and Administration ( 2.9 ) 02/2026

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton NDC 57894-510-01 Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection 1,600 mg and 20,000 units/10 mL (160 mg and 2,000 units/mL) For subcutaneous injection by a healthcare provider only. Administer each injection over approximately 5 minutes. Single-dose vial Discard unused portion. Rx only One 10 mL Vial Johnson & Johnson PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 14 mL Vial Carton NDC 57894-514-01 Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection 2,240 mg and 28,000 units/14 mL (160 mg and 2,000 units/mL) For subcutaneous injection by a healthcare provider only. Administer each injection over approximately 5 minutes. Single-dose vial Discard unused portion. Rx only One 14 mL Vial Johnson & Johnson PRINCIPAL DISPLAY PANEL - 14 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 15 mL Vial Carton NDC 57894-515-01 Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection 2,400 mg and 30,000 units/15 mL (160 mg and 2,000 units/mL) For subcutaneous injection by a healthcare provider only. Administer each injection over approximately 5 minutes. Single-dose vial Discard unused portion. Rx only One 15 mL Vial Johnson & Johnson PRINCIPAL DISPLAY PANEL - 15 mL Vial Carton

PRINCIPAL DISPLAY PANEL -22 mL Vial Carton NDC 57894-522-01 Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection 3,520 mg and 44,000 units/22 mL (160 mg and 2,000 units/mL) For subcutaneous injection by a healthcare provider only. Administer each injection over approximately 5 minutes. Single-dose vial Discard unused portion. Rx only One 22 mL Vial Johnson & Johnson PRINCIPAL DISPLAY PANEL -22 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rybrevant Faspro — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rybrevant Faspro. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$408K
Claims incl. refills
23
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$17,740.70
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Janssen Biotech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Janssen Biotech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9062 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 57894-0505-05 · Janssen 57894-0514-01 · Janssen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.