NDC 57894-0515-01 — Rybrevant Faspro AMIVANTAMAB and

🆔 Identity & classification

FDA NDC (as labeled) 57894-515-01

Product NDC 57894-515

11-digit billing NDC 57894051501

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 2026-02-13

Route SUBCUTANEOUS

Dosage form INJECTION

Substance AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)

GPI-14 21990002032034

GCN Seq No 088677

GCN 58823

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 2,400 MG VIAL

FDB brand name Rybrevant Faspro

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 57894-515-01 — 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 → 57894-0515-01. 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.

🏭 Manufacturer & labeler

LabelerJanssen Biotech, Inc.

FDA applicationBLA761433 (BLA)

Labeler code57894

First marketedFeb 2026

Product typeHuman Prescription Drug

Portfolio36 products on file

🔎 All NDCs from Janssen Biotech, Inc.

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.

🩺 Clinical

Label name RYBREVANT FASPRO 2,400 MG VIAL Ingredient Amivantamab-Hyaluronidase-Lpuj

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 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.

2.8 mg / 15 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.
0.27 mg / 15 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.
15 mg / 15 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.
9 mg / 15 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.
33.1 mg / 15 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.
1065 mg / 15 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.

💲 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 system	Per each	Per 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)57894-515-01

11-digit billing NDC57894-0515-01

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 / pkg480 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Rybrevant Faspro 2400 mg/15mL; 30000 mg/15mLthis 57894-0515-01	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

🏛️

2026

On the market since

Feb 2026

📍

2026

Currently FDA-listed

listed with the FDA

🧬

·

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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Rybrevant Faspro (this brand).

Top reported reactions

Rash24

Infusion Related Reaction11

Paronychia10

Administration Related Reaction9

Pyrexia7

Myelosuppression6

Skin Disorder6

Age at onset

Adult13

Elderly18

Reporter sex

Male · 48%

Female · 52%

Serious outcomes

Hospitalization17

Life-threatening3

Death1

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
57894-0515-01 You're viewing this	1 VIAL, SINGLE-DOSE in 1 CARTON (57894-515-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2026-02-13	Active

🧭 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 FDA registers it as 57894-515-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 57894-0515-01, written without dashes as 57894051501. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 57894-0515-01, the first segment (57894) is the labeler code FDA assigned to Janssen Biotech, Inc.; the middle segment (0515) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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

🎯 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…

💊 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…

🤒 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…

👥 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…

🤰 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…

🧬 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) ] .

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

broad-spectrum: Describes an antibiotic that works against a wide range of different bacteria.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

gamma-glutamyl transferase: A liver enzyme measured in blood; higher levels can signal the liver or bile ducts are irritated.

GGT: A liver enzyme measured in blood; higher levels can signal the liver or bile ducts are irritated.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

infusion-related reaction: Symptoms such as fever, chills, flushing, or rash that happen during or shortly after a medicine is given into a vein.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

interstitial lung disease: A group of conditions in which the tissue around the lungs' air sacs becomes scarred or inflamed, making breathing harder.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

overall survival: In a study, the length of time that patients stay alive after starting a treatment.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

progression-free survival: In a study, the length of time during and after treatment that a patient lives without the disease getting worse.

pruritus: Itching of the skin.

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Amivantamab And Hyaluronidase-Lpuj (Human Recombinant) NDCsSame ingredient 🏭 All Janssen labeler NDCsLabeler code 57894 📚 All Endoglycosidase NDCsDrug class

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Other drugs that share this product’s specific therapeutic class — Antineoplastic - Egfr And Met Receptor Inhib, Mab.

Amivantamab-Vmjw 57894-0501-01

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Rybrevant Faspro AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT) 2400 mg/15mL; 30000 mg/15mL Injection

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

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📄 Full prescribing information FDA SPL

12 CLINICAL PHARMACOLOGY

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