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Herceptin Hylecta Trastuzumab and hyaluronidase-oysk 600 mg/5mL; 10000 U/5mL Injection, Solution — NDC 50242-0077-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Herceptin Hylecta Trastuzumab and hyaluronidase-oysk 600 mg/5mL; 10000 U/5mL Injection, Solution — NDC 50242-077-01 (Billing 50242-0077-01)

by Genentech, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE

This is a package of Herceptin Hylecta Trastuzumab and hyaluronidase-oysk 600 mg/5mL; 10000 U/5mL Injection, Solution from Genentech, Inc., no longer marketed (first marketed Feb 2019), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 50242-0077-01
🏷️ FDA NDC (as labeled) 50242-077-01 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 50242-077-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50242 labeler · 077 product · 01 package
Package marketed since
Feb 28, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5024207701 9
Medicaid fills, this package
323 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2019. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50242-077-01
Product NDC 50242-077
11-digit billing NDC 50242007701
NCPDP billing unit ML — per mL (volume)
Application # BLA761106
SPL Set ID ebf30894-41cf-480c-8bc3-56f592a13813
Established class (EPC) Endoglycosidase; HER2/neu Receptor Antagonist
Mechanism of action HER2/Neu/cerbB2 Antagonists
Chemical class Glycoside Hydrolases
DEA schedule Non-controlled
Marketing category BLA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2019)
Marketing start 2019-02-28
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance TRASTUZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Biologic (Purple Book) 351(a)

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

GCN Seq No 079583
GCN 46111
HICL code 045653
Ingredient (HICL) Trastuzumab-Hyaluronidase-Oysk
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1W
Therapeutic class — specific (HIC3) Antineoplastic Egf Receptor Blocker Mclon Antibody
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name HERCEPTIN HYLECTA 600MG-10,000
FDB brand name Herceptin Hylecta
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079583
  • GCN: 46111
  • HICL (First Databank): 045653
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 50242-077-01 — 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 → 50242-0077-01. 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.

Clinical

Label name HERCEPTIN HYLECTA 600MG-10,000 Ingredient Trastuzumab-Hyaluronidase-Oysk
📖 What it is MedlinePlus · NLM

Trastuzumab and hyaluronidase-oysk injection is used along with other medications or after other medications have already been used to treat a certain type of breast cancer that has spread to other parts of the body. Trastuzumab and hyaluronidase-oysk injection is also used during and after treatment with other medications to decrease the chance that a certain type of breast cancer will return. Trastuzumab and hyaluronidase-oysk injection is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Herceptin Hylecta treats HER2-overexpressing breast cancer. That includes early-stage breast cancer after surgery and metastatic breast cancer. A lab test on your tumor confirms HE...
  • A healthcare professional gives it as a shot under the skin of your thigh. It takes about 2 to 5 minutes, once every three weeks. It is never given into a vein, and you don't take...
  • Common ones include tiredness, joint or muscle aches, nausea, diarrhea, rash, headache and injection site reactions. Tell your care team about any that bother you.
  • Call right away for shortness of breath, swelling in your legs or ankles, a racing or irregular heartbeat, or new cough. Get emergency help for signs of a severe allergic reaction,...
📖 Read our full Trastuzumab and Hyaluronidase-oysk Injection guide →

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $750.13 $4,500.81 / 6 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9356 $58.344 / J9356 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)50242-077-01
11-digit billing NDC50242-0077-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9356
DescriptorInjection, trastuzumab, 10 mg and hyaluronidase-oysk
Billing units / pkg60 units
How the units are derivedThis package is 6; the HCPCS unit is 10 MG, so one package = 60 billing units.
Medicare Part B spend (2026 (Q1))$7,413,492 · 2,001 claims · $3,704.89 per claim (all NDCs under J9356)
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
50242-0077-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 6 mL in 1 VIAL, SINGLE-DOSE 2019-02-28 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Herceptin Hylecta 600 mg/5mL; 10000 U/5mLthis 50242-0077-01 Genentech, 1 vial — — Discontinued —
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

🏛️
2019
First FDA approval
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 28, 2019 ⏳ ~4.4 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Herceptin Hylectatrastuzumab and hyaluronidase-oysk
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2019 2021 2023 2025 2027 2029 2031
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateFeb 28, 2031
Common questions
Is there a biosimilar for HERCEPTIN HYLECTA 600MG-10,000?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange 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.

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.

🧪 Avoiding an ingredient? See Trastuzumab and Hyaluronidase-oysk Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 1.95 mg / 5 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 18.35 mg / 5 mL UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • 7.45 mg / 5 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.
  • 2 mg / 5 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 397.25 mg / 5 mL UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.
  • 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.

6 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

LabelerGenentech, Inc.
FDA applicationBLA761106 (BLA)
Labeler code50242
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio93 products on file

More NDCs from Genentech, Inc. labeler code 50242

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 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 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment.

Discontinue HERCEPTIN HYLECTA for cardiomyopathy. ( 2.4 , 5.1 ) Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome. ( 5.3 ) Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death.

Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Cardiomyopathy HERCEPTIN HYLECTA administration can result in sub - clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN HYLECTA with anthracycline - containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with HERCEPTIN HYLECTA. Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvant therapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ]. Pulmonary Toxicity HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity.

Symptoms usually occur during or within 24 hours of HERCEPTIN HYLECTA administration. Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.3 , 5.5) ] . Monitor patients until symptoms completely resolve.

Embryo-Fetal Toxicity Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1 , 8.3) ].

🎯 Indications and Usage 205 words ▾

1 INDICATIONS AND USAGE HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) Select patients for therapy based on an FDA-authorized companion diagnostic for trastuzumab. ( 1 , 2.2 )

1.1Adjuvant Breast Cancer HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-authorized companion diagnostic for trastuzumab [see Dosage and Administration (2.2) ] .

1.2Metastatic Breast Cancer HERCEPTIN HYLECTA is indicated in adults: In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-authorized companion diagnostic for trastuzumab [see Dosage and Administration (2.2) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous use only. HERCEPTIN HYLECTA has different dosage and administration instructions than intravenous trastuzumab products. Do not administer intravenously.

( 2.3 ) Do not substitute HERCEPTIN HYLECTA for or with ado-trastuzumab emtansine. ( 2.3 ) Perform HER2 testing using FDA-authorized tests by laboratories with demonstrated proficiency. ( 1 , 2.2 ) The recommended dose of HERCEPTIN HYLECTA is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks.

( 2.3 )

2.1Evaluation and Testing Before Initiating HERCEPTIN HYLECTA Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCEPTIN HYLECTA [see Use in Specific Populations (8.1 , 8.3) ] .

2.2Patient Selection Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [see Indications and Usage (1) and Clinical Studies (14) ] . Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-authorized tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-authorized tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.

Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.

2.3Recommended Dosage HERCEPTIN HYLECTA is for subcutaneous use only. HERCEPTIN HYLECTA has different dosage and administration instructions than intravenous trastuzumab products. Do not administer intravenously.

Do not substitute HERCEPTIN HYLECTA for or with ado-trastuzumab emtansine. The recommended dose of HERCEPTIN HYLECTA is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks. No loading dose is required.

No dose adjustments for patient body weight or for different concomitant chemotherapy regimens are required. Duration of treatment Patients with adjuvant breast cancer should be treated with HERCEPTIN HYLECTA for 52 weeks or until disease recurrence, whichever occurs first; extending treatment in adjuvant breast cancer beyond one year is not recommended. Patients with metastatic breast cancer (MBC) should be treated with HERCEPTIN HYLECTA until progression of disease.

Missed Dose If one dose is missed, it is recommended to administer the next 600 mg/10,000 units dose (i.e. the missed dose) as soon as possible. The interval between subsequent HERCEPTIN HYLECTA doses should not be less than three weeks.

2.4Dosage Modification for Adverse Reactions Cardiomyopathy [see Boxed Warning , Warnings and Precautions (5.1) ] Assess left ventricular ejection fraction (LVEF) prior to initiation of HERCEPTIN HYLECTA and at regular intervals during treatment. Withhold HERCEPTIN HYLECTA dosing for at least 4 weeks for either of the following: ≥16% absolute decrease in LVEF from pre-treatment values LVEF below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values. HERCEPTIN HYLECTA may be resumed if, within 4–8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is ≤15%.

Permanently discontinue HERCEPTIN HYLECTA for a persistent (>8 weeks) LVEF decline or for suspension of HERCEPTIN HYLECTA dosing on more than 3 occasions for cardiomyopathy.

2.5Administration and Storage To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is HERCEPTIN HYLECTA and not ado-trastuzumab emtansine or intravenous trastuzumab. HERCEPTIN HYLECTA should be administered by a healthcare professional. Parenteral drug products sho… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS HERCEPTIN HYLECTA is a colorless to yellowish, clear to opalescent solution for subcutaneous injection: Injection: 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL) in a single-dose vial. Injection: 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL) solution in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Exacerbation of Chemotherapy-Induced Neutropenia. ( 5.4 , 6.1 ) Hypersensitivity and Administration-Related Reactions (ARRs): Severe ARRs, including anaphylaxis, have been reported with HERCEPTIN HYLECTA. Monitor patients for systemic hypersensitivity reactions. Permanently discontinue HERCEPTIN HYLECTA in patients who experience anaphylaxis or severe hypersensitivity reactions. ( 5.5 )

5.1Cardiomyopathy HERCEPTIN HYLECTA can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy ] . HERCEPTIN HYLECTA can also cause asymptomatic decline in LVEF. There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab as a single agent or in combination therapy compared with those not receiving trastuzumab.

The highest absolute incidence occurs when trastuzumab is administered with an anthracycline. The incidence of symptomatic myocardial dysfunction for intravenous trastuzumab and HERCEPTIN HYLECTA was similar in clinical trials [see Adverse Reactions (6) ]. Withhold HERCEPTIN HYLECTA for ≥16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values [see Dosage and Administration (2.4) ] .

The safety of continuation or resumption of HERCEPTIN HYLECTA in patients with HERCEPTIN HYLECTA induced left ventricular cardiac dysfunction has not been studied. Patients who receive anthracycline after stopping HERCEPTIN HYLECTA may also be at increased risk of cardiac dysfunction [see Drug Interactions (7) and Clinical Pharmacology (12.3) ] . Cardiac Monitoring Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.

The following schedule is recommended: Baseline LVEF measurement immediately prior to initiation of HERCEPTIN HYLECTA LVEF measurements every 3 months during and upon completion of HERCEPTIN HYLECTA Repeat LVEF measurement at 4 week intervals if HERCEPTIN HYLECTA is withheld for significant left ventricular cardiac dysfunction [see Dosage and Administration (2.4) ] LVEF measurements every 6 months for at least 2 years following completion of HERCEPTIN HYLECTA as a component of adjuvant therapy. HERCEPTIN HYLECTA In the HannaH study, the overall percentage of patients with at least one cardiac disorder was similar in both study arms: 15% (44/297) of patients in the HERCEPTIN HYLECTA arm and 14% (42/298) of patients in the intravenous trastuzumab arm.

The most frequent cardiac adverse reactions were left ventricular dysfunction [3.4% (10/297) and 4.0% (12/298)], tachycardia [2% (6/297) and 3% (9/298)] and palpitations [2% (6/297) and 1.3% (4/298)] in the HERCEPTIN HYLECTA arm and the intravenous trastuzumab arm, respectively. The incidence of cardiac failure and congestive cardiac failure was 1% (3/297) in the HERCEPTIN HYLECTA arm and <1% (1/298) in the intravenous trastuzumab arm. The proportion of patients in each treatment arm with a significant decrease in LVEF defined as a drop of ≥10% points to an LVEF of <50% was comparable between treatment arms [3.8% (11/297) in the HERCEPTIN HYLECTA arm and 4.2% (12/298) in the intravenous trastuzumab arm].

In patients with lower body weights (<59 kg, the lowest body weight quartile) the fixed-dose used in the HERCEPTIN HYLECTA arm was not associated with an increased risk of cardiac events or significant drop in LVEF. In the SafeHER study, in patients treated with HERCEPTIN HYLECTA , 17% (323/1864) reported a cardiac disorder during the treatment period. Decreased ejection fraction, reported in 4.5% (84/1864) of the patients was the most frequently reported cardiac disorder.

Congestive cardiac failure was reported in <1% (10/1864) of patients and <1% (4/1864) of patients reported cardiac failure during the treatm… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Cardiomyopathy [see Warnings and Precautions (5.1) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.2) ] Pulmonary Toxicity [see Warnings and Precautions (5.3) ] Exacerbation of Chemotherapy-Induced Neutropenia [see Warnings and Precautions (5.4) ] Hypersensitivity and Administration-Related Reactions [see Warnings and Precautions (5.5) ] Adjuvant Breast Cancer Most common adverse reactions (≥10%) for HERCEPTIN HYLECTA are fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity.

( 6.1 ) Metastatic Breast Cancer (based on intravenous trastuzumab) Most common adverse reactions (≥10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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. The safety of HERCEPTIN HYLECTA administered subcutaneously has been established in the HannaH and SafeHER studies conducted in patients with HER2 overexpressing breast cancer. The safety of intravenous trastuzumab has been established in studies H0648g and H0649g conducted in patients with HER2 overexpressing metastatic breast cancer.

Adjuvant Breast Cancer HannaH HannaH was a randomized, open-label study to compare the pharmacokinetics, efficacy, and safety of HERCEPTIN HYLECTA compared to intravenous trastuzumab in women with HER2-positive breast cancer. Patients randomized to the HERCEPTIN HYLECTA arm received a dose of 600 mg HERCEPTIN HYLECTA every 3 weeks throughout the treatment phase. Patients were treated for 8 cycles in combination with chemotherapy (docetaxel followed by 5FU, epirubicin and cyclophosphamide), then underwent surgery, and continued HERCEPTIN HYLECTA to complete 18 cycles of therapy.

The median age of patients was 50 (range: 25-81 years), all patients were female, and a majority of patients were white (67%). The median number of HERCEPTIN HYLECTA cycles received was 18 (range 1-18). The most common adverse reactions of any grade (occurring in ≥10% of patients) with HERCEPTIN HYLECTA were alopecia (63%), nausea (49%), ARRs (48%), neutropenia (44%), diarrhea (34%), asthenia (25%), fatigue (24%), vomiting (23%), myalgia (21%), decreased appetite (20%), stomatitis (19%), arthralgia (18%), headache (17%), rash (16%), constipation (14%), radiation skin injury (14%), pyrexia (12%), cough (12%), anemia (11%), dyspnea (11%), incision site pain (11%), peripheral sensory neuropathy (11%), leukopenia (10%), mucosal inflammation (10%), hot flush (10%), upper respiratory tract infection (10%).

The most common Grade ≥3 adverse reactions (occurring in >1% of patients) in the HERCEPTIN HYLECTA arm were neutropenia (30%), febrile neutropenia (6%), leukopenia (4%), diarrhea (3%), hypertension (2%), irregular menstruation (2%), alopecia (1%), nausea (1%), granulocytopenia (1%), vomiting (1%), amenorrhea (1%), and cellulitis (1%). Adverse reactions leading to interruption of any study drug in the HERCEPTIN HYLECTA arm occurred in 34% of patients; 31% of patients had these events during the neoadjuvant phase of the study with concurrent chemotherapy and 9% of patients had these events during the adjuvant phase.

Overall, the most common (≥ 1%) were neutropenia (21%), leukopenia (2.4%), ALT increase (1.7%), pyrexia (1.7%), anemia (1%), bronchitis (1%), and left ventricular dysfunction (1%). Adverse reactions that led to discontinuation of any study drug in the HERCEPTIN HYLECTA arm (>1 patient)… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 58 words ▾

7 DRUG INTERACTIONS Anthracyclines Patients who receive anthracycline after stopping HERCEPTIN HYLECTA may be at increased risk of cardiac dysfunction because of HERCEPTIN HYLECTA's estimated long washout period [see Clinical Pharmacology (12.3) ] . If possible, avoid anthracycline-based therapy for up to 7 months after stopping HERCEPTIN HYLECTA. If anthracyclines are used, closely monitor the patient's cardiac function.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of HERCEPTIN HYLECTA. ( 8.3 )

8.1Pregnancy If HERCEPTIN HYLECTA is administered during pregnancy, or if a patient becomes pregnant while receiving HERCEPTIN HYLECTA or within 7 months following the last dose of HERCEPTIN HYLECTA, health care providers and patients should immediately report HERCEPTIN HYLECTA exposure to Genentech at 1-888-835-2555. Risk Summary HERCEPTIN HYLECTA can cause fetal harm when administered to a pregnant woman. In post-marketing reports and published literature, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Data ].

Apprise the patient of the potential risks to a fetus. There are clinical considerations if HERCEPTIN HYLECTA is used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of HERCEPTIN HYLECTA [see Clinical Considerations ]. The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Clinical Considerations Fetal/Neonatal Adverse Reactions Monitor women who received HERCEPTIN HYLECTA during pregnancy or within 7 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal/neonatal testing that is appropriate for gestational age and consistent with community standards of care.

Data Human Data In post-marketing reports and published literature, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence. Fetal manifestations included pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy.

In most reported cases, amniotic fluid index increased after use of trastuzumab was stopped. In reported cases where Herceptin therapy was resumed after amniotic index improved, oligohydramnios recurred. Animal Data HERCEPTIN HYLECTA for subcutaneous injection contains trastuzumab and hyaluronidase [see Description (11) ] .

Trastuzumab : In studies where intravenous trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (Gestation Days 20 to 50) and late (Gestation Days 120 to 150) phases of gestation. The resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects.

Hyaluronidase: In an embryo-fetal study, mice have been 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 >7,200 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 >1,200 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 >3,600 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 is no information regarding the presence of trastuzumab or… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy If HERCEPTIN HYLECTA is administered during pregnancy, or if a patient becomes pregnant while receiving HERCEPTIN HYLECTA or within 7 months following the last dose of HERCEPTIN HYLECTA, health care providers and patients should immediately report HERCEPTIN HYLECTA exposure to Genentech at 1-888-835-2555. Risk Summary HERCEPTIN HYLECTA can cause fetal harm when administered to a pregnant woman. In post-marketing reports and published literature, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Data ].

Apprise the patient of the potential risks to a fetus. There are clinical considerations if HERCEPTIN HYLECTA is used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of HERCEPTIN HYLECTA [see Clinical Considerations ]. The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Clinical Considerations Fetal/Neonatal Adverse Reactions Monitor women who received HERCEPTIN HYLECTA during pregnancy or within 7 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal/neonatal testing that is appropriate for gestational age and consistent with community standards of care.

Data Human Data In post-marketing reports and published literature, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence. Fetal manifestations included pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy.

In most reported cases, amniotic fluid index increased after use of trastuzumab was stopped. In reported cases where Herceptin therapy was resumed after amniotic index improved, oligohydramnios recurred. Animal Data HERCEPTIN HYLECTA for subcutaneous injection contains trastuzumab and hyaluronidase [see Description (11) ] .

Trastuzumab : In studies where intravenous trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (Gestation Days 20 to 50) and late (Gestation Days 120 to 150) phases of gestation. The resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects.

Hyaluronidase: In an embryo-fetal study, mice have been 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 >7,200 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 >1,200 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 >3,600 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 effectiveness of HERCEPTIN HYLECTA in pediatric patients have not been established.

🧓 Geriatric Use 76 words ▾

8.5Geriatric Use Of the total number of patients in the HannaH and SafeHER studies treated with HERCEPTIN HYLECTA, 19% were 65 and over, while 4.7% were 75 and over. In patients receiving intravenous trastuzumab, the risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients, in both those receiving treatment for adjuvant therapy or metastatic disease. Other differences in safety or effectiveness were not observed between elderly patients and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC).

In vitro , trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. 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 HERCEPTIN HYLECTA acts transiently and locally.

The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours. Hyaluronidase has been shown to increase the absorption rate of a trastuzumab product into the systemic circulation when given in the subcutis of Göttingen Minipigs.

12.2Pharmacodynamics Cardiac Electrophysiology The effects of trastuzumab on electrocardiographic (ECG) endpoints, including QTc interval duration, were evaluated in patients with HER2-positive solid tumors. Trastuzumab had no clinically relevant effect on the QTc interval duration and there was no apparent relationship between serum trastuzumab concentrations and change in QTcF interval duration in patients with HER2-positive solid tumors.

12.3Pharmacokinetics Trastuzumab exposure following subcutaneous administration of HERCEPTIN HYLECTA 600 mg every 3 weeks as compared to intravenous trastuzumab 8 mg/kg loading dose, 6 mg/kg maintenance every 3 weeks in the HannaH Study is shown in Table 6 . The pharmacokinetic (PK) results for the co-primary endpoint, C trough pre-dose Cycle 8, showed non-inferiority of HERCEPTIN HYLECTA (78.7 mcg/mL) compared to intravenous trastuzumab (57.8 mcg/mL), with a geometric mean ratio of 1.3 (90% CI: 1.2–1.4). A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled HERCEPTIN HYLECTA and intravenous trastuzumab pharmacokinetic (PK) data from HannaH to describe the observed trastuzumab PK concentrations following HERCEPTIN HYLECTA subcutaneous administration and intravenous trastuzumab administration.

Population PK predicted trastuzumab exposure are shown in Table 6 . Following subcutaneous administration of HERCEPTIN HYLECTA, trastuzumab concentrations were approximately at steady-state after the Cycle 7 dose with < 15% increase in concentration up to Cycle 13. The mean C trough at the pre-dose Cycle 18 in HERCEPTIN HYLECTA arm is similar to that of Cycle 13, suggesting no further increase after Cycle 13.

The mean C max was 32% lower, and the mean AUC 0-21 days following the Cycle 7 dose and Cycle 12 dose was approximately 10% and 20% higher, respectively, in the HERCEPTIN HYLECTA arm than in the intravenous trastuzumab arm. Table 6 Trastuzumab Exposure (median with 5 th -95 th Percentiles) following Subcutaneous Administration of HERCEPTIN HYLECTA or Intravenous Trastuzumab Trastuzumab Exposure HERCEPTIN HYLECTA Intravenous Trastuzumab C trough (mcg/mL) Cycle 1 28.2 (14.8–40.9) 29.4 (5.8–59.5) Cycle 7 75.0 (35.1–123) 47.4 (5–114.7) C max (mcg/mL) Cycle 1 79.3 (56.1–109) 178 (117–291) Cycle 7 149 (86.1–214) 179 (107–309) AUC 0-21 days (mcg/mL∙day) Cycle 1 1065 (718–1504) 1373 (736–2245) Cycle 7 2337 (1258–3478) 1794 (673–3618) General PK parameters of trastuzumab following subcutaneous administration of HERCEPTIN HYLECTA are shown in Table 7 .

Trastuzumab is estimated to reach concentrati… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 190 words ▾

12.1Mechanism of Action The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC).

In vitro , trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. 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 HERCEPTIN HYLECTA acts transiently and locally.

The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours. Hyaluronidase has been shown to increase the absorption rate of a trastuzumab product into the systemic circulation when given in the subcutis of Göttingen Minipigs.

📦 How Supplied / Storage and Handling 106 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) injection for subcutaneous use supplied as a sterile, preservative-free, colorless to yellowish, clear to opalescent solution in a single-dose vial. The following configuration is available: Individually packaged single-dose vials: HERCEPTIN HYLECTA 600 mg/10,000 units (NDC: 50242-077-01) providing 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL. Store HERCEPTIN HYLECTA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do not freeze. Do not shake. Once removed from the refrigerator, HERCEPTIN HYLECTA must be administered within 4 hours and should not be kept above 30°C (86°F).

📦 Storage and Handling 49 words ▾

Store HERCEPTIN HYLECTA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Once removed from the refrigerator, HERCEPTIN HYLECTA must be administered within 4 hours and should not be kept above 30°C (86°F).

📋 Description 195 words ▾

11 DESCRIPTION HERCEPTIN HYLECTA is a combination of trastuzumab and hyaluronidase. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.

Trastuzumab has a molecular weight of approximately 148 kDa. Hyaluronidase (recombinant human) 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 mammalian (Chinese Hamster Ovary) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20).

Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa. HERCEPTIN HYLECTA (trastuzumab and hyaluronidase) injection is a sterile, preservative-free, colorless to yellowish, clear to opalescent solution supplied in single-dose vials for subcutaneous administration. HERCEPTIN HYLECTA is supplied as 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL in single-dose vials.

Each mL of solution contains trastuzumab (120 mg), hyaluronidase (2,000 units), L-histidine (0.39 mg), L-histidine hydrochloride monohydrate (3.67 mg), L-methionine (1.49 mg), polysorbate 20 (0.4 mg), α,α-trehalose dihydrate (79.45 mg), and Water for Injection.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Cardiomyopathy Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions (5.1) ]. Embryo-Fetal Toxicity [see Warnings and Precautions (5.2) ] Advise pregnant women and females of reproductive potential that HERCEPTIN HYLECTA exposure during pregnancy or within 7 months prior to conception can result in fetal harm.

Advise female patients to contact their healthcare provider with a known or suspected pregnancy [ see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of HERCEPTIN HYLECTA [see Use in Specific Populations (8.3) ] . Encourage women who are exposed to HERCEPTIN HYLECTA during pregnancy or who become pregnant within 7 months following the last dose of HERCEPTIN HYLECTA to report their pregnancy to Genentech [see Use in Specific Populations (8.1) ] .

Hypersensitivity and Administration-Related Reactions Advise patients to contact their healthcare provider immediately and to report any symptoms of hypersensitivity and administration-related reactions including dizziness, nausea, chills, fever, vomiting, diarrhea, urticaria, angioedema, breathing problems, or chest pain [see Warnings and Precautions (5.5) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Trastuzumab exposure following subcutaneous administration of HERCEPTIN HYLECTA 600 mg every 3 weeks as compared to intravenous trastuzumab 8 mg/kg loading dose, 6 mg/kg maintenance every 3 weeks in the HannaH Study is shown in Table 6 . The pharmacokinetic (PK) results for the co-primary endpoint, C trough pre-dose Cycle 8, showed non-inferiority of HERCEPTIN HYLECTA (78.7 mcg/mL) compared to intravenous trastuzumab (57.8 mcg/mL), with a geometric mean ratio of 1.3 (90% CI: 1.2–1.4). A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled HERCEPTIN HYLECTA and intravenous trastuzumab pharmacokinetic (PK) data from HannaH to describe the observed trastuzumab PK concentrations following HERCEPTIN HYLECTA subcutaneous administration and intravenous trastuzumab administration.

Population PK predicted trastuzumab exposure are shown in Table 6 . Following subcutaneous administration of HERCEPTIN HYLECTA, trastuzumab concentrations were approximately at steady-state after the Cycle 7 dose with < 15% increase in concentration up to Cycle 13. The mean C trough at the pre-dose Cycle 18 in HERCEPTIN HYLECTA arm is similar to that of Cycle 13, suggesting no further increase after Cycle 13.

The mean C max was 32% lower, and the mean AUC 0-21 days following the Cycle 7 dose and Cycle 12 dose was approximately 10% and 20% higher, respectively, in the HERCEPTIN HYLECTA arm than in the intravenous trastuzumab arm. Table 6 Trastuzumab Exposure (median with 5 th -95 th Percentiles) following Subcutaneous Administration of HERCEPTIN HYLECTA or Intravenous Trastuzumab Trastuzumab Exposure HERCEPTIN HYLECTA Intravenous Trastuzumab C trough (mcg/mL) Cycle 1 28.2 (14.8–40.9) 29.4 (5.8–59.5) Cycle 7 75.0 (35.1–123) 47.4 (5–114.7) C max (mcg/mL) Cycle 1 79.3 (56.1–109) 178 (117–291) Cycle 7 149 (86.1–214) 179 (107–309) AUC 0-21 days (mcg/mL∙day) Cycle 1 1065 (718–1504) 1373 (736–2245) Cycle 7 2337 (1258–3478) 1794 (673–3618) General PK parameters of trastuzumab following subcutaneous administration of HERCEPTIN HYLECTA are shown in Table 7 .

Trastuzumab is estimated to reach concentrations that are < 1 mcg/mL by 7 months in at least 95% patients. Table 7 PK parameters of Trastuzumab following Subcutaneous Administration of HERCEPTIN HYLECTA Parameters represented as geometric mean (%CV) unless otherwise specified Absorption Absolute Bioavailability 0.77 (13) First-order absorption rate, ka (day -1 ) 0.4 (2.92) Residual standard error T max (day) 3 (1-14) Median (range) Distribution Volume of Central Compartment (L) 2.9 (19.1) Elimination Linear Elimination Clearance (L/day) 0.11 (30) Non-linear Elimination V max (mg/day) 11.9 (19.9) Non-linear Elimination K m (mg/L) 33.9 (38.6) Specific Populations Body weight showed a statistically significant influence on PK.

In patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after HERCEPTIN HYLECTA than after intravenous trastuzumab treatment, whereas in the highest BW group (> 90 kg) AUC was 20% lower after HERCEPTIN HYLECTA than after intravenous trastuzumab treatment. However, no body weight based dose adjustments are needed, as the exposure changes are not considered clinically relevant. Drug Interaction Studies There have been no formal drug interaction studies performed with trastuzumab in humans.

Clinically significant interactions between trastuzumab and concomitant medications used in clinical trials have not been observed. Paclitaxel and doxorubicin : Concentrations of paclitaxel and doxorubicin and their major metabolites (i.e., 6-α hydroxyl-paclitaxel [POH], and doxorubicinol [DOL], respectively) were not altered in the presence of trastuzumab when used as combination therapy in clinical trials. Trastuzumab concentrations were not altered as part of this combination therapy.

Docetaxel and carboplatin: When intravenous trastuzumab was administered in combination with… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 57 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effects of trastuzumab on electrocardiographic (ECG) endpoints, including QTc interval duration, were evaluated in patients with HER2-positive solid tumors. Trastuzumab had no clinically relevant effect on the QTc interval duration and there was no apparent relationship between serum trastuzumab concentrations and change in QTcF interval duration in patients with HER2-positive solid tumors.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The comparability between HERCEPTIN HYLECTA administered subcutaneously and intravenous trastuzumab was established in the HannaH study. The HannaH study was conducted in patients with HER2 overexpressing breast cancer in the neoadjuvant and adjuvant settings with co-primary endpoints of pathological complete response (pCR) and the PK endpoint of C trough at cycle 7 [see Clinical Pharmacology (12.3) ] .

14.1Adjuvant Breast Cancer HERCEPTIN HYLECTA HannaH The HannaH study (NCT00950300) was a randomized, multicenter, open-label, clinical trial in 596 patients with HER2-positive operable or locally advanced breast cancer (LABC), including inflammatory breast cancer. HER2-positivity was defined as IHC 3+ or ISH+. Patients were randomized to receive 8 cycles of either HERCEPTIN HYLECTA or intravenous trastuzumab concurrently with chemotherapy (docetaxel followed by 5FU, epirubicin and cyclophosphamide), followed by surgery and continued therapy with HERCEPTIN HYLECTA or intravenous trastuzumab as treated prior to surgery, for an additional 10 cycles, to complete 18 cycles of therapy.

HannaH was designed to demonstrate non-inferiority of treatment with HERCEPTIN HYLECTA versus intravenous trastuzumab based on co-primary PK and efficacy outcomes (trastuzumab C trough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) [see Clinical Pharmacology 12.3 ] . EFS and OS were among other outcomes evaluated in this study. The majority of patients were white (69%) and the median age was 50 years (range: 24-81).

The analysis of the efficacy co-primary outcome, pCR, defined as absence of invasive neoplastic cells in the breast, resulted in rates of 45.4% (95% CI: 39.2, 51.7) in the HERCEPTIN HYLECTA arm and 40.7% (95% CI: 34.7, 46.9) in the intravenous trastuzumab arm. Table 8: Summary of Pathological Complete Response (pCR) (HannaH) HERCEPTIN HYLECTA (n=260) Intravenous Trastuzumab (n=263) pCR (absence of invasive neoplastic cells in breast [ypT0/is]) 118 (45.4%) 107 (40.7%) Exact 95% CI for pCR Rate CI for one sample binomial using Pearson-Clopper method (39.2; 51.7) (34.7; 46.9) Difference in pCR (SC minus IV arm) 4.70 95% CI for Difference in pCR Approximate 95% CI for difference of two rates using Hauck-Anderson method (-4.0; 13.4) With a median follow-up exceeding 70 months, no difference in EFS and OS was observed in the final analysis between patients who received intravenous trastuzumab and those who received HERCEPTIN HYLECTA.

SafeHER The SafeHER study (NCT01566721) was a prospective, two-cohort, non-randomized, multinational, open-label study designed to assess the overall safety and tolerability of HERCEPTIN HYLECTA with chemotherapy in 1864 patients with HER2-positive breast cancer. The secondary objectives include the evaluation of DFS and OS. HER2-positivity was defined as IHC 3+ or ISH+.

Patients received a fixed dose of 600 mg HERCEPTIN HYLECTA every 3 weeks for a total of 18 cycles throughout the study. HERCEPTIN HYLECTA treatment was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab therapy. The majority of treated patients were white (76%) and the median age was 54 years (range: 20-88).

In the primary safety analysis (median follow-up 23.7 months), no new safety signals were identified for HERCEPTIN HYLECTA. Safety and tolerability results, including in lower weight patients, were consistent with the known safety profile for HERCEPTIN HYLECTA and intravenous trastuzumab. In the ITT population (n=1867), 126 patients (7%) had a DFS event (recurrence, contralateral invasive breast cancer or death) and 28 patients (1.5%) had an OS event at the time of clinical cut-off.

Intravenous Trastuzumab The safety and efficacy of intravenous trastuzumab in women receiving adjuvant chemotherapy for HER2 overexpressing breast cancer were evaluated in an integrated ana… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 219 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility HERCEPTIN HYLECTA contains trastuzumab and hyaluronidase. Trastuzumab has not been tested for carcinogenicity potential. No evidence of mutagenic activity was observed when trastuzumab was tested in the standard Ames bacterial and human peripheral blood lymphocyte mutagenicity assays at concentrations of up to 5000 mcg/mL.

In an in vivo micronucleus assay, no evidence of chromosomal damage to mouse bone marrow cells was observed following bolus intravenous doses of up to 118 mg/kg of trastuzumab. A fertility study was conducted in female cynomolgus monkeys at doses up to 25 times the weekly recommended human dose of 2 mg/kg of intravenous trastuzumab and has revealed no evidence of impaired fertility, as measured by menstrual cycle duration and female sex hormone levels. 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 > 670 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 216 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility HERCEPTIN HYLECTA contains trastuzumab and hyaluronidase. Trastuzumab has not been tested for carcinogenicity potential. No evidence of mutagenic activity was observed when trastuzumab was tested in the standard Ames bacterial and human peripheral blood lymphocyte mutagenicity assays at concentrations of up to 5000 mcg/mL.

In an in vivo micronucleus assay, no evidence of chromosomal damage to mouse bone marrow cells was observed following bolus intravenous doses of up to 118 mg/kg of trastuzumab. A fertility study was conducted in female cynomolgus monkeys at doses up to 25 times the weekly recommended human dose of 2 mg/kg of intravenous trastuzumab and has revealed no evidence of impaired fertility, as measured by menstrual cycle duration and female sex hormone levels. 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 > 670 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.

📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL - 600 mg and 10,000 units/5 mL Vial Carton NDC 50242-077-01 Herceptin Hylecta ® (trastuzumab and hyaluronidase-oysk) Injection 600 mg and 10,000 units/5 mL (120 mg and 2,000 units/mL) For Subcutaneous Use Only Single-Dose Vial Discard Unused Portion 1 vial Rx only Genentech 11025235 PRINCIPAL DISPLAY PANEL - 600 mg and 10,000 units/5 mL Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
323
Units reimbursed last 4 qtrs
1.5K
Gross reimbursed last 4 qtrs
$1.12M
Avg / prescription
$3,455.73
Avg / unit
$750.30
Latest quarter Q1 2026
66Rx
Fee-for-service vs managed care ⓘ
46% FFS 54% MCO
Fee-for-service · 149 Rx Managed care · 174 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 75 units · 0.7 per 100k residents MI New York: 600 units · 3.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 65 units · 0.7 per 100k residents NJ Massachusetts: 175 units · 2.5 per 100k residents MA California: 335 units · 0.9 per 100k residents CA Utah: no data reported UT Colorado: 126 units · 2.1 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 57 units · 4.0 per 100k residents HI Texas: 55 units · 0.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.24.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 4.0 /100k
2 New York 3.1 /100k
3 Massachusetts 2.5 /100k
4 Colorado 2.1 /100k
5 California 0.9 /100k
6 Michigan 0.7 /100k
7 New Jersey 0.7 /100k
8 Texas 0.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Herceptin Hylecta — 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 Herceptin Hylecta. 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.
Period
Total Part D spend
$130.4K
Claims incl. refills
31
Beneficiaries
11
Spend / beneficiary
$11,852.79
Spend / claim
$4,205.83
Trend by period
💵 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 No longer marketed (per FDA listing data)
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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Genentech, 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 J9356 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.
← 50242-0070-01 · Genentech, 50242-0078-12 · Genentech, →
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.