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PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN 100 mg/20mL Injection, Powder, Lyophilized, For Suspension — NDC 00517-4300-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN 100 mg/20mL Injection, Powder, Lyophilized, For Suspension — NDC 0517-4300-01 (Billing 00517-4300-01)

by American Regent, Inc. · 1 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN 100 mg/20mL Injection, Powder, Lyophilized, For Suspension from American Regent, Inc., marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 00517-4300-01
🏷️ FDA NDC (as labeled) 0517-4300-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 0517-4300-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0517 labeler · 4300 product · 01 package
Package marketed since
May 2, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0517430001 8
Medicaid fills, this package
2,694 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0517-4300-01
Product NDC 0517-4300
11-digit billing NDC 00517430001
NCPDP billing unit EA — each (per item)
RxCUI 583214
UNII P88XT4IS4D
Application # NDA211875
SPL Set ID f06d1bb3-83f1-4d84-8004-4c6681ad8a5a
Established class (EPC) Microtubule Inhibitor
Physiologic effect Microtubule Inhibition
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-02
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Substance PACLITAXEL
TE code (Orange Book) AB · RLD · RS

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

GPI-14 21500012201920
GCN Seq No 058624
GCN 24094
HICL code 026856
Ingredient (HICL) Paclitaxel Protein-Bound
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1F
Therapeutic class — specific (HIC3) Antineoplastics,Miscellaneous
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name PACLITAXEL PROTEIN-BOUND 100MG
FDB brand name Paclitaxel Protein-Bound
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058624
  • GCN: 24094
  • GPI-14 (Medi-Span): 21500012201920
  • HICL (First Databank): 026856
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 583214
Why two NDCs? The FDA registers this code as 0517-4300-01 — a 4-4-2 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 labeler segment → 00517-4300-01. 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 Microtubule Inhibitor class.

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

Clinical

Label name PACLITAXEL PROTEIN-BOUND 100MG Ingredient Paclitaxel Protein-Bound
📖 What it is MedlinePlus · NLM

Paclitaxel (with albumin) injection is used to treat certain types of breast cancer, lung cancer, and cancer of the pancreas. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Paclitaxel can only be given intravenously — there's no pill form. It needs to get directly into your bloodstream to reach cancer cells throughout the body effectively. Your infusi...
  • Why is paclitaxel given as an IV infusion instead of a pill?
  • Yes, it matters a lot. Standard paclitaxel injection and albumin-bound paclitaxel (such as Abraxane) are not interchangeable — they work differently in the body, are approved for d...
  • I've heard there are different 'versions' of paclitaxel — does it matter which one I get?
📖 Read our full Paclitaxel guide →
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 $1,084.32 $21,686.38 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9264 $6.586 / J9264 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)0517-4300-01
11-digit billing NDC00517-4300-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9264
DescriptorINJECTION, PACLITAXEL PROTEIN-BOUND PARTICLES, 1 MG
Billing units / pkg100 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$42,140,764 · 21,913 claims · $1,923.09 per claim (all NDCs under J9264)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
00517-4300-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 20 mL in 1 VIAL 2023-05-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Paclitaxel 100 mg/20mL 00480-3290-01 Teva 1 vial — AB FDA listed —
Paclitaxel Protein Bound Particles Albumin Bound 100 mg/20mLthis 00517-4300-01 American 1 vial — AB FDA listed —
Paclitaxel 100 mg/20mL 00781-3531-91 Sandoz 1 vial — AB FDA listed —
Paclitaxel 100 mg/20mL 67457-0937-50 Mylan 20 ml — AB FDA listed —
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/20mL 68001-0651-37 BluePoint 1 vial — AB FDA listed —
Abraxane 100 mg/20mL 68817-0134-50 Abraxis 1 vial — AB FDA listed —
Paclitaxel protein-bound particles 100 mg/20mL 69097-0398-78 Cipla 1 vial — AB FDA listed —
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/20mL 71288-0183-50 Meitheal 1 vial — AB FDA listed —
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/20mL 72603-0408-01 NorthStar 1 vial — AB FDA listed —
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg/20mL 24979-0710-51 Upsher-Smith 1 vial — AB Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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 & generic status

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic 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 Paclitaxel 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.

  • UNII ZIF514RVZR
    A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 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

LabelerAmerican Regent, Inc.
Application holderAMERICAN REGENT INC
FDA applicationNDA211875 (NDA)
Labeler code00517
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio72 products on file

More NDCs from American Regent, Inc. labeler code 00517

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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 162 words ▾

WARNING: SEVERE MYELOSUPPRESSION Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications ( 4 )]. Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions ( 5.1 , 5.3 )]. Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.3 )].

WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) Monitor for neutropenia, which may be severe and result in infection or sepsis.

( 5.1 , 5.3 ) Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 5.1 , 5.3 )

🎯 Indications and Usage 216 words ▾

1 INDICATIONS AND USAGE Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ( 1.1 ) Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

( 1.2 ) Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. ( 1.3 )

1.1Metastatic Breast Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

1.2Non-Small Cell Lung Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

1.3Adenocarcinoma of the Pancreas Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do not substitute Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) for other non-protein-bound paclitaxel products. ( 2.1 ) Extravasation : Closely monitor the infusion site for extravasation and infiltration. ( 2.1 ) Metastatic Breast Cancer (MBC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 260 mg/m 2 intravenously over 30 minutes every 3 weeks.

( 2.2 ) Non-Small Cell Lung Cancer (NSCLC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 100 mg/m 2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). ( 2.2 ) Adenocarcinoma of the Pancreas : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 125 mg/m 2 intravenously over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle; administer gemcitabine on Days 1, 8 and 15 of each 28-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

( 2.4 ) Use in Patients with Hepatic Impairment: Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is not recommended for use in patients with AST greater than 10 x the upper limit of normal (ULN); or bilirubin greater than 5 x ULN or patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment. For MBC or NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment. ( 2.5 ) Dose Reductions for Adverse Reactions : Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicities.

( 2.6 ) See Full Prescribing Information for instructions on reconstitution of lyophilized powder, and preparation and administration of the injection.

2.1Important Administration Instructions DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products. Closely monitor the infusion site for extravasation or drug infiltration during administration.

Limiting the infusion of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to 30 minutes may reduce the risk of infusion-related reactions [see Adverse Reactions ( 6.2 )]. Consider premedication in patients who have had prior hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Do not re-challenge patients who experience a severe hypersensitivity reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Contraindications ( 4 ) and Warnings and Precautions ( 5.5 )].

2.2Recommended Dosage for Metastatic Breast Cancer After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 260 mg/m 2 administered intravenously over 30 minutes every 3 weeks.

2.3Recommended Dosage for Non-Small Cell Lung Cancer The recommended dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 100 mg/m 2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Administer carboplatin on Day 1 of each 21-day cycle immediately after Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Clinical Studies ( 14.2 )] .

2.4Recommended Dosage for Adenocarcinoma of the Pancreas The recommended dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is 125 mg/m 2 administered as an intravenous infusion over 30… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS For injectable suspension, for intravenous use: white to yellow, sterile lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution. For injectable suspension: white to yellow, sterile, lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is contraindicated in patients with: Baseline neutrophil counts of < 1,500 cells/mm 3 [see Warnings and Precautions ( 5.1 )] A history of severe hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Warnings and Precautions ( 5.5 )] Neutrophil counts of < 1,500 cells/mm 3 . ( 4 ) Severe hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ( 5.2 ) Sepsis occurred in patients with or without neutropenia who received protein bound paclitaxel in combination with gemcitabine; interrupt Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3 , then resume treatment at reduced dose levels. ( 5.3 ) Pneumonitis occurred with the use of protein bound paclitaxel in combination with gemcitabine; permanently discontinue treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine.

( 5.4 ) Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug. ( 4 , 5.5 ) Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment.

( 2.5 , 5.6 ) Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) contains albumin derived from human blood, which has a theoretical risk of viral transmission. ( 5.7 ) Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

( 5.8 , 8.1 , 8.3 )

5.1Severe Myelosuppression Severe myelosuppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of protein bound paclitaxel. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non-small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer. Monitor for severe neutropenia and thrombocytopenia by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer).

Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mm 3 [see Contraindications ( 4 )] . In the case of severe neutropenia (<500 cells/mm 3 for seven days or more) during a course of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) therapy, reduce the dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) in subsequent courses in patients with either MBC or NSCLC.

In patients with MBC, resume treatment with every-3-week cycles of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) after ANC recovers to a level >1,500 cells/mm 3 and platelets recover to a level >100,000 cells/mm 3 . In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm 3 and platelet count of at least 100,000 cells/mm 3 on Day 1 or to an ANC of at least 500 cells/mm 3 and platelet count of at least 50,000 cells/mm 3 on Days 8 or 15 of the cycle [see Dosage and Administration ( 2.6 )].

In patients with adenocarcinoma of the pancreas, withhold Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine if the ANC is less than 500 cells/mm 3 or platelets are less than 50,000 cells/mm 3 and delay initiation of the next cycle if the ANC is less than 1500 cells/mm 3 or platelet count is less than 100,000 cells/mm 3 on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended [see Dosage and Administration ( 2.6 )].

5.2Severe Neuropathy Sensory neuropathy is dose- and schedule-dependent [see Adverse Reactions ( 6.1 )] . If ≥ Grade 3 sensory neuropathy develops, withhold Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) treatm… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 most common adverse reactions (≥ 20%) with single-agent use of protein bound paclitaxel in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea [see Adverse Reactions ( 6.1 )] .

The most common adverse reactions (≥ 20%) of protein bound paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue [see Adverse Reactions ( 6.1 )]. The most common serious adverse reactions of protein bound paclitaxel in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%). The most common adverse reactions resulting in permanent discontinuation of protein bound paclitaxel are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%).

The most common adverse reactions resulting in dose reduction of protein bound paclitaxel are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in protein bound paclitaxel dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%). In a randomized open-label trial of protein bound paclitaxel in combination with gemcitabine for pancreatic adenocarcinoma [see Clinical Studies ( 14.3 )] , the most common (≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of protein bound paclitaxel are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration [see Adverse Reactions ( 6.1 )] .

The most common serious adverse reactions of protein bound paclitaxel (with a ≥ 1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%). The most common adverse reactions resulting in permanent discontinuation of protein bound paclitaxel are peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of protein bound paclitaxel are neutropenia (10%) and peripheral neuropathy (6%).

The most common adverse reactions leading to withholding or delay in protein bound paclitaxel dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%). The most common adverse reactions (≥ 20%) in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea. ( 6.1 ) The most common adverse reactions (≥ 20%) in NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

( 6.1 ) The most common (≥ 20%) adverse reactions of protein bound paclitaxel in adenocarcinoma of the pancreas are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-888-532-7998 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Metastatic Breast Cancer Table 6 shows the frequency of important adverse reactions in the randomized comparative trial for the patients who received either single-agent protein bound paclitaxel or paclitaxel injection for the treatment of metastatic breast cancer. Table 6: Adverse Reactions in the Randomized Metastatic Breast Cancer Study on an Every-3-Weeks Schedule Percent of Patients Protein-Bound Paclitaxel… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 62 words ▾

7 DRUG INTERACTIONS The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4. Caution should be exercised when administering Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4. Use caution when concomitantly administering Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) with inhibitors or inducers of either CYP2C8 or CYP3A4.

( 7 )

👥 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 its mechanism of action and findings in animals, Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis ( see Data ).

Advise females of reproductive potential of the potential risk to a fetus. The background rate of major birth defects and miscarriage is unknown for the indicated population. 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 In embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m 2 (approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis) caused embryo-fetal toxicities, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight, and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles.

8.2Lactation Risk Summary There are no data on the presence of paclitaxel in human milk, or its effect on the breastfed child or on milk production. In animal studies, paclitaxel and/or its metabolites were excreted into the milk of lactating rats ( see Data ). Because of the potential for serious adverse reactions in a breastfed child from Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), advise lactating women not to breastfeed during treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for two weeks after the last dose.

Data Animal Data Following intravenous administration of radiolabeled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.

8.3Females and Males of Reproductive Potential Based on animal studies and mechanism of action, Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to starting treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Contraception Females Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for at least six months after the last dose.

Males Based on findings in genetic toxicity and animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for at least three months after the last dose [see Use in Specific Populations ( 8.1 ) and Nonclinical Toxicology ( 13.1 )]. Infertility Females and Males Based on findings in animals, Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) may impair fertility in females and males of reprod… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of paclitaxel formulated as albumin-bound particles to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at doses approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis ( see Data ).

Advise females of reproductive potential of the potential risk to a fetus. The background rate of major birth defects and miscarriage is unknown for the indicated population. 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 In embryo-fetal development studies, intravenous administration of paclitaxel formulated as albumin-bound particles to rats during pregnancy, on gestation days 7 to 17 at doses of 6 mg/m 2 (approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis) caused embryo-fetal toxicities, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight, and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles.

🧒 Pediatric Use 105 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Pharmacokinetics, safety, and antitumor activity of protein bound paclitaxel were assessed in an open-label, dose escalation, dose expansion study (NCT01962103) in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults.

No new safety signals were observed in pediatric patients across these studies. Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients (aged 1.4 to < 17 years) as compared to those in adults.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 229 patients in the randomized study who received protein bound paclitaxel for the treatment of metastatic breast cancer, 13% were at least 65 years of age and < 2% were 75 years or older. This study of protein bound paclitaxel did not include a sufficient number of patients with metastatic breast cancer who were 65 years and older to determine whether they respond differently from younger patients. A subsequent pooled analysis was conducted in 981 patients receiving protein bound paclitaxel monotherapy for metastatic breast cancer, of which 15% were 65 years of age or older and 2% were 75 years of age or older.

A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years of age or older. Of the 514 patients in the randomized study who received protein bound paclitaxel and carboplatin for the first-line treatment of non-small cell lung cancer, 31% were 65 years or older and 3.5% were 75 years or older. Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years old.

No overall difference in effectiveness, as measured by response rates, was observed between patients 65 years or older compared to patients younger than 65 years old. Of the 431 patients in the randomized study who received protein bound paclitaxel and gemcitabine for the first-line treatment of pancreatic adenocarcinoma, 41% were 65 years or older and 10% were 75 years or older. No overall differences in effectiveness were observed between patients who were 65 years of age or older and younger patients.

Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old. Clinical studies of protein bound paclitaxel did not include sufficient number of patients with pancreatic cancer who were 75 years and older to determine whether they respond differently from younger patients.

🆘 Overdosage 32 words ▾

10 OVERDOSAGE There is no known antidote for Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, sensory neurotoxicity, and mucositis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

12.3Pharmacokinetics The pharmacokinetics of total paclitaxel following 30 and 180-minute infusions of protein bound paclitaxel at dose levels of 80 to 375 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage) were determined in clinical studies. Dose levels of mg/m 2 refer to mg of paclitaxel in protein bound paclitaxel. Following intravenous administration of protein bound paclitaxel to patients with solid tumors, paclitaxel plasma concentrations declined in a biphasic manner, the initial rapid decline representing distribution to the peripheral compartment and the slower second phase representing drug elimination.

Following protein bound paclitaxel infusion, paclitaxel exhibited linear drug exposure (AUC) across clinical doses ranging from 80 to 300 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage). The pharmacokinetics of paclitaxel in protein bound paclitaxel were independent of the duration of intravenous administration. The pharmacokinetic data of 260 mg/m 2 protein bound paclitaxel administered over a 30-minute infusion was compared to the pharmacokinetics of 175 mg/m 2 paclitaxel injection over a 3-hour infusion.

Clearance was larger (43%) and the volume of distribution was higher (53%) for protein bound paclitaxel than for paclitaxel injection. There were no differences in terminal half-lives. Distribution Following protein bound paclitaxel administration to patients with solid tumors, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).

The total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel. In a within-patient comparison study, the fraction of unbound paclitaxel in plasma was significantly higher with protein bound paclitaxel (6.2%) than with solvent-based paclitaxel (2.3%). This contributes to significantly higher exposure to unbound paclitaxel with protein bound paclitaxel compared with solvent-based paclitaxel, when the total exposure is comparable.

In vitro studies of binding to human serum proteins, using paclitaxel concentrations ranging from 0.1 to 50 μg/mL, indicated that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. Elimination At the clinical dose range of 80 to 300 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage), the mean total clearance of paclitaxel ranges from 13 to 30 L/h/m 2 and the mean terminal half-life ranges from 13 to 27 hours. Metabolism In vitro studies with human liver microsomes and tissue slices showed that paclitaxel in protein bound paclitaxel was metabolized primarily to 6α-hydroxypaclitaxel by CYP2C8; and to two minor metabolites, 3'- p -hydroxypaclitaxel and 6α, 3'- p -dihydroxypaclitaxel, by CYP3A4.

In vitro , the metabolism of paclitaxel to 6α-hydroxypaclitaxel was inhibited by a number of agents (ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporin, teniposide, etoposide, and vincristine), but the concentrations used exceeded those found in vivo following normal therapeutic doses. Testosterone, 17α-ethinyl estradiol, retinoic acid, and quercetin, a specific inhibitor of CYP2C8, also inhibited the formation of 6α-hydroxypaclitaxel in vitro . The pharmacokinetics of paclitaxel may also… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 74 words ▾

12.1Mechanism of Action Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

📦 How Supplied / Storage and Handling 84 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a white to yellow, sterile, lyophilized powder supplied as: NDC: 0517-4300-01 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton. Store the vials in original cartons at 20°C to 25°C (68°F to 77°F) (see USP Controlled Room Temperature). Retain in the original package to protect from bright light.

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a hazardous drug. Follow applicable special handling and disposal procedures. 1

📋 Description 195 words ▾

11 DESCRIPTION Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is paclitaxel formulated as albumin‑bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor.

The chemical name for paclitaxel is 5β,20 Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine. The empirical formula is C 47 H 51 NO 14 and the molecular weight is 853.91. Paclitaxel has the following structural formula: Paclitaxel is a white to off-white crystalline powder.

It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single‑dose vial contains 100 mg of paclitaxel (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate), and sodium hydroxide and hydrochloric acid for pH adjustment.

Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin‑bound particles. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is free of solvents. Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Severe Myelosuppression Patients must be informed of the risk of low blood cell counts and severe and life-threatening infections and instructed to contact their healthcare provider immediately for fever or evidence of infection [see Warnings and Precautions ( 5.1 ), ( 5.3 )]. Severe Neuropathy Patients must be informed that sensory neuropathy occurs frequently with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and patients should advise their healthcare providers of numbness, tingling, pain or weakness involving the extremities [see Warnings and Precautions ( 5.2 )].

Pneumonitis Instruct patients to contact their healthcare provider immediately for sudden onset of dry persistent cough, or shortness of breath [see Warnings and Precautions ( 5.4 )] . Severe Hypersensitivity Instruct patients to contact their healthcare provider for signs of an allergic reaction, which could be severe and sometimes fatal [see Warnings and Precautions ( 5.5 )]. Common Adverse Reactions Explain to patients that alopecia, fatigue/asthenia, and myalgia/arthralgia occur frequently with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

Instruct patients to contact their healthcare providers for persistent vomiting, diarrhea, or signs of dehydration [see Adverse Reactions ( 6 )] . Embryo-Fetal Toxicity Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) injection can cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug.

Females of reproductive potential should use effective contraception during treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for at least six months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.1 , 8.3 )]. Advise male patients with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for at least three months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) [see Use in Specific Populations ( 8.3 )].

Lactation Advise patients not to breastfeed while taking Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for two weeks after receiving the last dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise males and females of reproductive potential that Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) may impair fertility [see Use in Specific Populations ( 8.3 )] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of total paclitaxel following 30 and 180-minute infusions of protein bound paclitaxel at dose levels of 80 to 375 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage) were determined in clinical studies. Dose levels of mg/m 2 refer to mg of paclitaxel in protein bound paclitaxel. Following intravenous administration of protein bound paclitaxel to patients with solid tumors, paclitaxel plasma concentrations declined in a biphasic manner, the initial rapid decline representing distribution to the peripheral compartment and the slower second phase representing drug elimination.

Following protein bound paclitaxel infusion, paclitaxel exhibited linear drug exposure (AUC) across clinical doses ranging from 80 to 300 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage). The pharmacokinetics of paclitaxel in protein bound paclitaxel were independent of the duration of intravenous administration. The pharmacokinetic data of 260 mg/m 2 protein bound paclitaxel administered over a 30-minute infusion was compared to the pharmacokinetics of 175 mg/m 2 paclitaxel injection over a 3-hour infusion.

Clearance was larger (43%) and the volume of distribution was higher (53%) for protein bound paclitaxel than for paclitaxel injection. There were no differences in terminal half-lives. Distribution Following protein bound paclitaxel administration to patients with solid tumors, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).

The total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel. In a within-patient comparison study, the fraction of unbound paclitaxel in plasma was significantly higher with protein bound paclitaxel (6.2%) than with solvent-based paclitaxel (2.3%). This contributes to significantly higher exposure to unbound paclitaxel with protein bound paclitaxel compared with solvent-based paclitaxel, when the total exposure is comparable.

In vitro studies of binding to human serum proteins, using paclitaxel concentrations ranging from 0.1 to 50 μg/mL, indicated that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. Elimination At the clinical dose range of 80 to 300 mg/m 2 (0.31 to 1.15 times the maximum approved recommended dosage), the mean total clearance of paclitaxel ranges from 13 to 30 L/h/m 2 and the mean terminal half-life ranges from 13 to 27 hours. Metabolism In vitro studies with human liver microsomes and tissue slices showed that paclitaxel in protein bound paclitaxel was metabolized primarily to 6α-hydroxypaclitaxel by CYP2C8; and to two minor metabolites, 3'- p -hydroxypaclitaxel and 6α, 3'- p -dihydroxypaclitaxel, by CYP3A4.

In vitro , the metabolism of paclitaxel to 6α-hydroxypaclitaxel was inhibited by a number of agents (ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporin, teniposide, etoposide, and vincristine), but the concentrations used exceeded those found in vivo following normal therapeutic doses. Testosterone, 17α-ethinyl estradiol, retinoic acid, and quercetin, a specific inhibitor of CYP2C8, also inhibited the formation of 6α-hydroxypaclitaxel in vitro . The pharmacokinetics of paclitaxel may also be altered in vivo as a result of interactions with compounds that are substrates, inducers, or inhibitors of CYP2C8 and/or CYP3A4 [see Drug Interactions ( 7 )] .

Excretion After a 30-minute infusion of 260 mg/m 2 doses of protein bound paclitaxel, the mean values for cumulative urinary recovery of unchanged drug (4%) indicated extensive non-renal clearance. Less than 1% of the total administered dose was excreted in urine as the metabolites 6α-hydroxypaclitaxel and 3'- p -hydroxypaclitaxel. Fecal excretion was approximately 20% of the total dose administered.

Specific Populations No cli… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Metastatic Breast Cancer Data from 106 patients accrued in two single arm open label studies and from 460 patients enrolled in a randomized comparative study were available to support the use of protein bound paclitaxel in metastatic breast cancer. Single Arm Open Label Studies In one study, protein bound paclitaxel was administered as a 30-minute infusion at a dose of 175 mg/m 2 to 43 patients with metastatic breast cancer. The second trial utilized a dose of 300 mg/m 2 as a 30-minute infusion in 63 patients with metastatic breast cancer.

Cycles were administered at 3-week intervals. Objective responses were observed in both studies. Randomized Comparative Study This multicenter trial was conducted in 460 patients with metastatic breast cancer.

Patients were randomized to receive protein bound paclitaxel at a dose of 260 mg/m 2 given as a 30-minute infusion, or paclitaxel injection at 175 mg/m 2 given as a 3-hour infusion. Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases. Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting, 40% in the metastatic setting and 19% in both metastatic and adjuvant settings.

Fifty-nine percent received study drug as second or greater than second-line therapy. Seventy-seven percent of the patients had been previously exposed to anthracyclines. In this trial, patients in the protein bound paclitaxel treatment arm had a statistically significantly higher reconciled target lesion response rate (the trial primary endpoint) of 21.5% (95% CI: 16.2% to 26.7%), compared to 11.1% (95% CI: 6.9% to 15.1%) for patients in the paclitaxel injection treatment arm.

See Table 11. There was no statistically significant difference in overall survival between the two study arms. Table 11: Efficacy Results from Randomized Metastatic Breast Cancer Trial a Reconciled Target Lesion Response Rate (TLRR) was the prospectively defined protocol specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy.

The reconciled TLRR was lower than the investigator Reported Response Rates, which are based on all cycles of therapy. b From Cochran-Mantel-Haenszel test stratified by 1 st line vs. > 1 st line therapy. c Prior therapy included an anthracycline unless clinically contraindicated. Protein Bound Paclitaxel 260 mg/m 2 Paclitaxel Injection 175 mg/m 2 Reconciled Target Lesion Response Rate (primary endpoint) a All randomized patients Response Rate [95% CI] 50/233 (21.5%) [16.19% – 26.73%] 25/227 (11.1%) [6.94% – 15.09%] p-value b 0.003 Patients who had failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy c Response Rate [95% CI] 20/129 (15.5%) [9.26% – 21.75%] 12/143 (8.4%) [3.85% – 12.94%]

14.2Non-Small Cell Lung Cancer A multicenter, randomized, open-label study was conducted in 1052 chemotherapy naive patients with Stage IIIb/IV non-small cell lung cancer to compare protein bound paclitaxel in combination with carboplatin to paclitaxel injection in combination with carboplatin as first- line treatment in patients with advanced non-small cell lung cancer. Protein bound paclitaxel was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m 2 on Days 1, 8, and 15 of each 21-day cycle.

Paclitaxel injection was administered as an intravenous infusion over 3 hours at a dose of 200 mg/m 2 , following premedication. In both treatment arms carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 of each 21-day cycle after completion of protein bound paclitaxel/paclitaxel infusion. Treatment was administered until disease progression or development of an unacceptable toxicity.

The major efficacy outcome measure was overall… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 219 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has not been studied. Paclitaxel was clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice). Paclitaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay.

Administration of paclitaxel formulated as albumin-bound particles to male rats at 42 mg/m 2 on a weekly basis (approximately 16% of the daily maximum recommended human exposure on a body surface area basis) for 11 weeks prior to mating with untreated female rats resulted in significantly reduced fertility accompanied by decreased pregnancy rates and increased loss of embryos in mated females. A dose of 42 mg/m 2 also reduced male reproductive organ weights, mating performance, and sperm production. Testicular atrophy/degeneration was observed in single-dose toxicology studies in animals administered paclitaxel formulated as albumin-bound particles at doses lower than the recommended human dose; doses were 54 mg/m 2 in rodents and 175 mg/m 2 in dogs.

Similar testicular degeneration was seen in monkeys administered three weekly doses of 108 mg/m 2 paclitaxel formulated as albumin bound particles. Administration of paclitaxel prior to and during mating produced impairment of fertility in male and female rats. Paclitaxel caused reduced fertility and reproductive indices, and increased embryo-fetal toxicity.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 216 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has not been studied. Paclitaxel was clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice). Paclitaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay.

Administration of paclitaxel formulated as albumin-bound particles to male rats at 42 mg/m 2 on a weekly basis (approximately 16% of the daily maximum recommended human exposure on a body surface area basis) for 11 weeks prior to mating with untreated female rats resulted in significantly reduced fertility accompanied by decreased pregnancy rates and increased loss of embryos in mated females. A dose of 42 mg/m 2 also reduced male reproductive organ weights, mating performance, and sperm production. Testicular atrophy/degeneration was observed in single-dose toxicology studies in animals administered paclitaxel formulated as albumin-bound particles at doses lower than the recommended human dose; doses were 54 mg/m 2 in rodents and 175 mg/m 2 in dogs.

Similar testicular degeneration was seen in monkeys administered three weekly doses of 108 mg/m 2 paclitaxel formulated as albumin bound particles. Administration of paclitaxel prior to and during mating produced impairment of fertility in male and female rats. Paclitaxel caused reduced fertility and reproductive indices, and increased embryo-fetal toxicity.

📚 References 7 words ▾

15 REFERENCES OSHA Hazardous Drugs. OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 07/2022 Patient Information Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) What is Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)?

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is a prescription medicine used to treat: advanced breast cancer in people who have already received certain other medicines for their cancer. advanced non-small cell lung cancer (NSCLC), in combination with carboplatin in people who cannot be treated with surgery or radiation. advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer. It is not known if Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is safe or effective in children.

Do not receive Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) if: your white blood cell count is below 1,500 cells/ mm 3 . you have had a severe allergic reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Before you receive Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems. had a prior allergic reaction to a taxane. are pregnant or plan to become pregnant.

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). You should not become pregnant during your treatment and for at least six months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

You should use effective birth control (contraception) during your treatment and for at least six months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Talk to your healthcare provider about birth control methods you can use during this time. Males with a female sexual partner who can become pregnant: Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can harm the unborn baby of your partner.

You should not father a child during your treatment and for at least three months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). You should use effective birth control (contraception) during your treatment and for at least three months after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). are breastfeeding or plan to breastfeed. Do not breastfeed during your treatment and for two weeks after the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

How will I receive Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)? Your healthcare provider will prescribe Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) in an amount that is right for you. Your healthcare provider may give you certain medicines to help prevent allergic reactions if you have had an allergic reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) in the past.

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) will be given to you by intravenous (IV) infusion into your vein. Your healthcare provider should do blood tests regularly during treatment with Pac… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 98 words ▾

Principal Display Panel - Vial Label NDC 0517- 4300 -01 Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single-Dose Vial Discard any unused portion. For Intravenous Use Only Rx only Do not substitute Paclitaxel Protein-Bound Particles for other non-protein-bound paclitaxel products. Paclitaxel Vial Label

Principal Display Panel - Printed Carton NDC 0517- 4300 -01 Read all sides of carton. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) 100 mg per vial Single-Dose Vial Discard any unused portion. For Intravenous Use Only Rx only Do not substitute Paclitaxel Protein-Bound Particles for other non-protein-bound paclitaxel products. Printed 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
2.7K
Units reimbursed last 4 qtrs
4.2K
Gross reimbursed last 4 qtrs
$4.59M
Avg / prescription
$1,704.56
Avg / unit
$1,084.28
Latest quarter Q1 2026
441Rx
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 1,102 Rx Managed care · 1,592 Rx
State Medicaid map
Alaska: no data reported AK Maine: 189 units · 13.5 per 100k residents ME Washington: 67 units · 0.9 per 100k residents WA Idaho: 24 units · 1.2 per 100k residents ID Montana: 37 units · 3.3 per 100k residents MT North Dakota: no data reported ND Minnesota: 92 units · 1.6 per 100k residents MN Wisconsin: 51 units · 0.9 per 100k residents WI Michigan: 387 units · 3.9 per 100k residents MI New York: 234 units · 1.2 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: 309 units · 2.5 per 100k residents IL Indiana: no data reported IN Ohio: 227 units · 1.9 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 20 units · 0.3 per 100k residents MA California: 614 units · 1.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 102 units · 1.6 per 100k residents MO Kentucky: 83 units · 1.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 15 units · 0.4 per 100k residents CT Rhode Island: no data reported RI Arizona: 45 units · 0.6 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 17 units · 0.6 per 100k residents AR Tennessee: 234 units · 3.3 per 100k residents TN North Carolina: 400 units · 3.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 20 units · 0.5 per 100k residents OK Louisiana: 44 units · 1.0 per 100k residents LA Mississippi: no data reported MS Alabama: 172 units · 3.4 per 100k residents AL Georgia: 204 units · 1.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 134 units · 0.4 per 100k residents TX Florida: 401 units · 1.8 per 100k residents FL
Units reimbursed · per 100k residents
0.313.5
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 Maine 13.5 /100k
2 Michigan 3.9 /100k
3 North Carolina 3.7 /100k
4 Alabama 3.4 /100k
5 Tennessee 3.3 /100k
6 Montana 3.3 /100k
7 Illinois 2.5 /100k
8 Ohio 1.9 /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 Paclitaxel (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ 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 Paclitaxel. 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
$42.7K
Claims incl. refills
519
Beneficiaries
244
Spend / beneficiary
$174.99
Spend / claim
$82.27
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.

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 PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND (this brand).

Top reported reactions

Nausea4,618
Dyspnoea4,594
Neutropenia4,492
Diarrhoea4,266
Anaemia3,941
Malignant Neoplasm Progression3,780
Myelosuppression3,421

Age at onset

Neonate140
Infant27
Child26
Adolescent33
Adult9,346
Elderly6,116

Reporter sex

0 reports
Male · 26%
Female · 74%
Unknown · 0%

Serious outcomes

Death11,389
Life-threatening6,680
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,136 0
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.

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 ✓ 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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by American Regent, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Regent, 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 J9264 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.
← 00517-4201-25 · American 00517-4601-25 · American →
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.