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Access & Resources

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

On this page you'll find a variety of helpful information, including:

NDC Codes

HCPCS and Revenue Codes

CPT Code

ICD-10-CM Codes

Sample Claim Forms

For more information, please download our Billing and Coding Guide. This guide includes all the codes and forms you need to obtain Paclitaxel Protein-Bound Particles for your patients, as well as important additional information.

Important things to note

Effective January 1, 2025, use the J-code designated for Abraxane^®; J-code J9264 injection, paclitaxel protein-bound particles, 1 mg. The unique J-code J9259 for American Regent's Paclitaxel Protein-Bound Particles is being discontinued.
Providers are solely responsible for ensuring compliance with Medicare, Medicaid, and all other third-party payer requirements.
Providers are also responsible for accurate coding, documentation, and medical necessity for the services provided.
Before filing claims, providers should confirm individual payer requirements and coverage/medical policies.
The information provided is not legal or coding advice; it is general reimbursement information for reference purposes only.
While we have done our best to provide information that is current, please verify the appropriate reimbursement information for services or items you provide.

Current Procedural Terminology, CPT; Healthcare Common Procedure Coding System, HCPCS; International Classificaton of Disease, 10th Revision, Clinical Modification, ICD-10-CM; National Drug Codes, NDCs.

NDC Codes

The NDC is often required in addition to the appropriate J-code when filing a claim for reimbursement.
Paclitaxel Protein-Bound Particles are supplied as a single-dose 100 mg/vial.

NDC Codes for Paclitaxel Protein-Bound Particles for Injectable Suspension
10-digit NDC	0517-4300-01
11-digit NDC	00517-4300-01
Providers should check with their local payers to determine whether reporting requires the 10-digit or 11-digit NDC code.

Points worth noting

NDCs may not be required for drugs with a product-specific HCPCS code under traditional Medicare. However, they must be included for drugs that are billed using a "miscellaneous" HCPCS code, such as C9399 or J9999, as part of the additional information that is reported on claims. Medicare Advantage plans may have different NDC reporting policies from traditional Medicare.

Providers should always check with their local payers to determine NDC reporting requirements.

For more information, please download the Billing and Coding Guide.

HCPCS and Revenue Codes

HCPCS codes are used for billing drugs and services to Medicare, Medicaid, and commercial payers. The Centers for Medicare and Medicaid Services (CMS) has discontinued American Regent's product specific J-code for Paclitaxel Protein-Bound Particles. Effective January 1, 2025, use the J-code designated for Abraxane^®; J-code J9264 injection, paclitaxel protein-bound
particles, 1 mg.

Recommended HCPCS Code for Paclitaxel Protein-Bound Particles
HCPCS Code		Description
J9264		Injection, Paclitaxel Protein-Bound Particles, 1 mg
Billing Unit Conversion
1 mg	1 unit	100-mg vial	100 units

Points worth noting

If less than the entire vial of Paclitaxel Protein-Bound Particles is administered, the remainder must be discarded. Current CMS policy for outpatient or office administered drugs permits billing for the entire vial even if the entire contents are not used—but only if the unused portion is discarded and appropriately documented. The discarded amount is billed on a second claim line with a "JW" modifier.

Revenue Codes for Administration of Paclitaxel Protein-Bound Particles in the Hospital
Revenue Code		Description
0250		General Pharmacy
0258		IV Solutions; Paclitaxel Protein-Bound Particles Administration
0260		IV Therapy (required by Medicare for separate billable drugs)
0636		Drug requiring detailed coding; may be used to specify Paclitaxel Protein-Bound Particles as the drug given

For more information, please download the Billing and Coding Guide. Healthcare Common Procedure Coding System, HCPCS.

CPT Code

CPT codes are used to indicate which medical services and procedures were performed on a patient and/or how a drug or medical supply was administered. The following CPT code may be used for administering Paclitaxel Protein-Bound Particles:

Recommended CPT Code for Paclitaxel Protein-Bound Particles
CPT Code		Description
96413		Chemotherapy administration, intravenous (IV) infusion technique; up to 1 hour, single or initial substance or drug

For more information, please download the Billing and Coding Guide. Current Procedural Terminology, CPT.

ICD-10-CM Diagnosis Codes

ICD-10-CM diagnosis codes are used to identify a patient's diagnosis and inform payers of why a service was provided.

ICD-10-CM is a 7-character, alphanumeric code. Each code begins with a letter, and that letter is followed by 2 numbers.

The first 3 characters of ICD-10-CM are the category. The category describes the general type of injury or disease.
The category is followed by a decimal point and the subcategory. This is followed by up to 2 subclassifications, which further explain the cause, manifestation, location, severity, and type of injury or disease.
The last character is the extension. The extension describes the type of encounter. If this is the first time a healthcare provider has seen the patient for this condition/injury/disease, it is listed as the initial encounter. Every encounter after the first is listed as a subsequent encounter.
Patient visits related to the effects of a previous injury or disease are listed with the term sequela.

For a full list of the ICD-10-CM diagnosis codes for the labeled indications for Paclitaxel Protein-Bound Particles, please download the Billing and Coding Guide. This guide includes all the codes and forms you need to obtain Paclitaxel Protein-Bound Particles for your patients, as well as important additional information. International Classification of Disease, 10th Revision, Clinical Modification, ICD-10-CM.

Sample Claim Forms

CMS-1500 Form: Physician Office Sample Claim Form

Download Form

UB-04 (CMS-1450) Hospital Outpatient Sample Claim Form

Download Form

*The FDA has determined that Paclitaxel Protein-Bound Particles are pharmaceutical equivalent, bioequivalent, and therapeutically equivalent, and have been assigned an AB TE Code. ^†All trademarks are the property of their respective owners

REFERENCES

Orange book: Approved drug products with therapeutic equivalence evaluations: product details for NDA N211875. US Food & Drug Administration. Accessed July 15, 2024. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). https://www/accessdata.fda.gov/scripts/cder/ob/results_product.cfm? Appl_Type=N&Appl_No=211875#74
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound). Package Insert. American Regent, Inc.

Please see Full Prescribing Information and included Boxed Warning.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING.

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/mm³.
Monitor for neutropenia, which may be severe and result in infection or sepsis.
Perform frequent complete blood cell counts on all patients receiving Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

CONTRAINDICATIONS

Baseline neutrophil counts of <1500 cells /mm³.
A history of severe hypersensitivity reactions to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).

WARNINGS AND PRECAUTIONS

Severe 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/mm³.
In the case of severe neutropenia (<500 cells/mm³ for 7 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 after ANC recovers to a level >1500 cells/mm³ and platelets recover to a level >100,000 cells/mm³.
In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly Paclitaxel Protein-Bound Particles and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm³ and platelet count of at least 100,000 cells/mm³ on Day 1, or to an ANC of at least 500 cells/mm³ and platelet count of at least 50,000 cells/mm³ on Days 8 or 15 of the cycle.
In patients with adenocarcinoma of the pancreas, withhold Paclitaxel Protein-Bound Particles and gemcitabine if the ANC is less than 500 cells/mm³ or platelets are less than 50,000 cells/mm³, and delay initiation of the next cycle if the ANC is less than 1500 cells/mm³ or platelet count is less than 100,000 cells/mm³ on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended.

Severe Neuropathy

Sensory neuropathy is dose- and schedule-dependent, occurs frequently, and may require dose reduction or treatment interruption.
If ≥ Grade 3 sensory neuropathy develops, withhold Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) treatment until resolution to Grade 1 or 2 for MBC, or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses.

Sepsis

Sepsis occurred in 5% of patients with or without neutropenia who received protein-bound paclitaxel in combination with gemcitabine.
Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis.
If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics.
For febrile neutropenia, 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/mm³, then resume treatment at reduced dose levels.

Pneumonitis

Pneumonitis, including some cases that were fatal, occurred in 4% of patients with or without neutropenia with the use of protein-bound paclitaxel in combination with gemcitabine.
Monitor patients for signs and symptoms and interrupt Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine during evaluation of suspected pneumonitis.
Permanently discontinue treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine upon making a diagnosis of pneumonitis.

Severe Hypersensitivity

Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions. Cross-hypersensitivity between protein-bound paclitaxel and other taxane products has been reported and may include severe reactions such as anaphylaxis. Closely monitor patients with a previous history of hypersensitivity to other taxanes during initiation of therapy.
Do not rechallenge patients who experience a severe hypersensitivity reaction to Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) with this drug.

Use in Patients with Hepatic Impairment

Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment. Closely monitor patients with hepatic impairment for severe myelosuppression. Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is not recommended in patients who have a total bilirubin >5 x ULN or AST >10 x ULN.
For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment.
For pancreatic adenocarcinoma, Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN).

Albumin (Human)

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) contains albumin derived from human blood, which has a remote risk of viral transmission.

Embryo-Fetal Toxicity

Can cause fetal harm when administered to a pregnant woman. (See Special Populations).
Advise females of reproductive potential of the potential risk to a fetus.
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 of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).
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).

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

The most common adverse reactions (≥20%) with single-agent use of Paclitaxel Protein-Bound Particles (Albumin-Bound) vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%), and infections (24%, 20%), respectively.
Sensory neuropathy was the cause of discontinuation in 7/229 patients.
Other adverse reactions of note with the use of Protein-Bound Paclitaxel vs paclitaxel injection included vomiting, fluid retention, mucositis, hypersensitivity reactions, thrombocytopenia, neutropenic sepsis, and injection site reactions. Dehydration and pyrexia were also reported.
Overall 11% of patients experienced creatinine elevation, 1% severe.
Ocular/visual disturbances occurred in 13% of all patients (n=366) treated with Protein-Bound Paclitaxel and 1% were severe.
Severe cardiovascular events possibly related to single-agent protein-bound paclitaxel occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension.
Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported.

Non–Small Cell Lung Cancer (NSCLC) Study

The most common adverse reactions (≥20%) of protein-bound paclitaxel in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
The most common serious adverse reactions of protein-bound paclitaxel in combination with carboplatin for NSCLC 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%).
The following common (≥10% incidence) adverse reactions were observed at a similar incidence in protein-bound paclitaxel plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the protein bound paclitaxel plus carboplatin treatment group.
Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of protein-bound paclitaxel and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively.
Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of protein-bound paclitaxel and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively.
Neutropenia (all grades) was reported in 85% of patients who received protein-bound paclitaxel and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin.

Pancreatic Adenocarcinoma Study

Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the protein-bound paclitaxel/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%).
Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the protein-bound paclitaxel/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), thrombocytopenia (13%, 9%), asthenia (7%, 4%) dehydration (7%, 2%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and hypokalemia (4%, 1%).
Thrombocytopenia (all grades) was reported in 74% of patients in the protein-bound paclitaxel/gemcitabine group vs 70% of patients in the gemcitabine group.
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 were 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%).
Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the protein-bound paclitaxel/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of protein-bound paclitaxel or with paclitaxel injection and may be expected to occur with protein-bound paclitaxel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity Reactions: Severe and sometimes fatal hypersensitivity reactions. Cross-hypersensitivity between protein bound and other taxanes has been reported.
Cardiovascular: Congestive heart failure, left ventricular dysfunction, and atrioventricular block.
Respiratory: Pneumonitis, interstitial pneumonia, pulmonary embolism, radiation pneumonitis, lung fibrosis.
Neurologic: Cranial nerve palsies, vocal cord paresis, autonomic neuropathy resulting in paralytic ileus.
Vision Disorders: Reduced visual acuity due to cystoid macular edema. Abnormal visual evoked potentials suggest persistent optic nerve damage.
Hepatic: Hepatic necrosis and hepatic encephalopathy leading to death.
Gastrointestinal: Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, neutropenic enterocolitis.
Injection Site Reaction: Extravasation. Severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis. Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel injection at a different site.
Metabolic and Nutritional Disorders: Tumor lysis syndrome.
Other Clinical Events: Skin reactions including generalized or maculopapular rash, erythema, and pruritus. Photosensitivity reactions, radiation recall phenomenon, scleroderma, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia. Stevens-Johnson syndrome and toxic epidermal necrolysis. Conjunctivitis, cellulitis, and increased lacrimation.
Accidental Exposure: Upon inhalation of paclitaxel, dyspnea, chest pain, burning eyes, sore throat, and nausea. Following topical exposure, tingling, burning, and redness.

DRUG INTERACTIONS

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 IN SPECIFIC POPULATIONS

Pregnancy

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) can cause fetal harm when administered to a pregnant woman. Advise females of the potential risk to a fetus and to avoid becoming pregnant while receiving protein-bound paclitaxel.

Lactation

Nursing must be discontinued when receiving treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and for two weeks after the last dose.

Females 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.
Verify the pregnancy status of females of reproductive potential prior to starting treatment.
Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with, and for at least six months after, the last dose of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound).
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.
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) may impair fertility in females and males of reproductive potential.

Pediatric

The safety and effectiveness in pediatric patients have not been established.

Geriatric

A higher incidence of epistaxis, diarrhea, dehydration, fatigue, and peripheral edema was found in patients 65 years or older who received protein-bound paclitaxel for MBC in a pooled analysis of clinical studies.
Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with protein-bound paclitaxel and carboplatin in NSCLC.
Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received protein-bound paclitaxel and gemcitabine in adenocarcinoma of the pancreas.

Renal Impairment

There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end-stage renal disease (estimated creatinine clearance <30 mL/min).

Hepatic Impairment

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) is not recommended for use in patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment.

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.

DOSAGE AND ADMINISTRATION

DO NOT SUBSTITUTE FOR OR WITH OTHER NON-PROTEIN BOUND PACLITAXEL FORMULATIONS.
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products.
Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity.
Closely monitor the infusion site for extravasation or drug infiltration during administration.

Refer to Full Prescribing Information for complete Dosage and Administration information.

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.
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.
Metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

For additional Important Safety Information, including BOXED WARNING, please see Full Prescribing Information.

You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1.800.734.9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1.800.FDA.1088.

^{REF-2268 7/2022}