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Paclitaxel 6 mg/mL Injection, Solution, Concentrate — NDC 00703-3213-81 package photo

Paclitaxel 6 mg/mL Injection, Solution, Concentrate

by Teva Parenteral Medicines, Inc. · 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE
NDC 00703-3213-81
🏷️ FDA NDC (as labeled) 0703-3213-81 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 vial, multi-dose Medicaid pays$0.9576 / unit · 12 mo Per package$4.79 / 5 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 5 mL 00703-3213-01
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 6, 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

🆔 Identity & classification

FDA NDC (as labeled) 0703-3213-81
Product NDC 0703-3213
11-digit billing NDC 00703321381
NCPDP billing unit ML — per mL (volume)
RxCUI 312199
UNII P88XT4IS4D
Application # ANDA075184
SPL Set ID fbd32bd2-9685-41cb-bee2-730a45526b65
Established class (EPC) Microtubule Inhibitor
Physiologic effect Microtubule Inhibition
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-07
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance PACLITAXEL
GCN Seq No 046997
GCN 85602
HICL code 007625
Ingredient (HICL) Paclitaxel
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 30 MG/5 ML VIAL
FDB brand name Paclitaxel
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0703-3213-81 — 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 → 00703-3213-81. 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.

🏭 Manufacturer & labeler

LabelerTeva Parenteral Medicines, Inc.
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA075184 (ANDA)
Labeler code00703
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio28 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PACLITAXEL 30 MG/5 ML VIAL Ingredient Paclitaxel
📗 Our plain-language guide HelloPharmacist
  • Paclitaxel can trigger serious — sometimes life-threatening — allergic reactions, including anaphylaxis. Receiving antihistamines, steroids, and acid-blocking medicines before your...
  • Why is it so important that I get pre-medications before my paclitaxel infusion?
  • Paclitaxel lowers the number of white blood cells — especially neutrophils, the ones that fight infection — and this is the most common serious side effect. If your counts drop too...
  • Why do they keep checking my blood counts before every treatment?
📖 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.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 6D4M1DAL6O
    Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.

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.

💲 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 $0.9576 $4.79 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9267 $0.112 / J9267 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)0703-3213-81
11-digit billing NDC00703-3213-81
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9267
DescriptorINJECTION, PACLITAXEL, 1 MG
Billing units / pkg6 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Paclitaxel 6 mg/mLthis 00703-3213-81 Teva 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 00703-3216-81 Teva 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 00703-3217-01 Teva 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 00703-3218-81 Teva 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 16714-0137-01 Northstar 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 23155-0882-31 Heritage 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 23155-0883-31 Heritage 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 23155-0884-31 Heritage 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 25021-0255-05 Sagent 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 46708-0620-05 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 46708-0621-17 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 46708-0622-50 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 61703-0015-04 Hospira, 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 61703-0342-09 Hospira, 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 62332-0620-05 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 62332-0621-17 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 62332-0622-50 Alembic 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 63323-0763-05 Fresenius 1 vial — AP Discontinued —
Paclitaxel 6 mg/mL 68001-0516-27 BluePoint 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 68001-0705-27 BluePoint 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 68083-0178-01 Gland 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 68083-0179-01 Gland 1 vial — AP FDA listed —
Paclitaxel Paclitaxel 6 mg/mL 68083-0180-01 Gland 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 69339-0227-05 Natco 1 vial — — FDA listed —
Paclitaxel 6 mg/mL 69339-0228-17 Natco 1 vial — — FDA listed —
Paclitaxel 6 mg/mL 69339-0229-50 Natco 1 vial — — FDA listed —
Paclitaxel 6 mg/mL 72162-2640-02 Bryant 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 72205-0061-01 Novadoz 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 72205-0062-01 Novadoz 1 vial — AP FDA listed —
Paclitaxel 6 mg/mL 72205-0063-01 Novadoz 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ 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 00703-3213-81, 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 – Q4 2025 · 4 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
17
Units reimbursed last 4 qtrs
425
Gross reimbursed last 4 qtrs
$406.98
Avg / prescription
$23.94
Avg / unit
$0.9576
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 17 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 425 units · 3.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.33.3
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 Pennsylvania 3.3 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial00703-3213-01 301 Rx · $31,448
1 vial this page00703-3213-81 17 Rx · $407
Drug total (last 4 qtrs): 318 Rx · 7,112 units · $31,855 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Paclitaxel — 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 — the ingredient across all brands.

Top reported reactions

Nausea5,500
Neutropenia5,424
Diarrhoea5,152
Dyspnoea5,113
Anaemia4,794
Death4,452
Malignant Neoplasm Progression4,345

Age at onset

Neonate140
Infant27
Child30
Adolescent33
Adult10,301
Elderly7,314

Reporter sex

98,465 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization40,357
Disabling1,752
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10,684 4,985
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00703-3213-81 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE 2020-07-07 Active
00703-3213-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSE 2020-07-07 Active

This pack accounts for about 5.3% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00703-3213-81?
NDC 00703-3213-81 is listed by the FDA — 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of Paclitaxel 6 mg/mL Injection, Solution, Concentrate?
Bill NDC 00703-3213-81 — the 11-digit billing format is 00703321381. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 0703-3213-81, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00703-3213-81, written without dashes as 00703321381. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00703-3213-81, the first segment (00703) is the labeler code FDA assigned to Teva Parenteral Medicines, Inc.; the middle segment (3213) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (81) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Teva Parenteral Medicines, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00703-3213-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Parenteral Medicines, 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 J9267 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 189 words ▾

WARNING Paclitaxel injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials.

Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel injection should not be rechallenged with the drug.

Paclitaxel injection therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel injection.

🎯 Indications and Usage 188 words ▾

INDICATIONS AND USAGE Paclitaxel Injection USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection is indicated in combination with cisplatin. Paclitaxel Injection USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma ). Paclitaxel Injection USP 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. Paclitaxel Injection USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel Injection USP is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel injection solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets. All patients should be premedicated prior to paclitaxel injection administration in order to prevent severe hypersensitivity reactions.

Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel injection, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel injection, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel injection. For patients with carcinoma of the ovary , the following regimens are recommended (see CLINICAL STUDIES, Ovarian Carcinoma ): 1) For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks.

In selecting the appropriate regimen, differences in toxicities should be considered (see TABLE 11 in ADVERSE REACTIONS, Disease-Specific Adverse Event Experiences ). Paclitaxel injection administered intravenously over 3 hours at a dose of 175 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2 ; or Paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m 2 followed by cisplatin at a dose of 75 mg/m 2 . 2) In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel injection has been used at several doses and schedules; however, the optimal regimen is not yet clear (see CLINICAL STUDIES, Ovarian Carcinoma ).

The recommended regimen is paclitaxel injection 135 mg/m 2 or 175 mg/m 2 administered intravenously over 3 hours every 3 weeks. For patients with carcinoma of the breast , the following is recommended (see CLINICAL STUDIES, Breast Carcinoma ): 1) For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel injection, at a dose of 175 mg/m 2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide (see CLINICAL STUDIES, Breast Carcinoma ).

2) After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel injection at a dose of 175 mg/m 2 administered intravenously over 3 hours every 3 weeks has been shown to be effective. For patients with non-small cell lung carcinoma , the recommended regimen, given every 3 weeks, is paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m 2 followed by cisplatin, 75 mg/m 2 . For patients with AIDS-related Kaposi’s sarcoma , paclitaxel injection administered at a dose of 135 mg/m 2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m 2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m 2 /week).

In the 2 clinical trials evaluating these schedules (see CLINICAL STUDIES, AIDS-Related Kaposi’s Sarcoma ), the former schedule (135 mg/m 2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m 2 every 2 weeks). Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients: 1) Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO); 2) Initiate or repeat treatment with paclitaxel injection only if the neutrophil count is at least 1000 cells/mm 3 ; 3) Reduce the dose of subsequent courses of paclitaxel inje…

⛔ Contraindications 65 words ▾

CONTRAINDICATIONS Paclitaxel injection is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel injection or other drugs formulated in polyoxyl 35 castor oil, NF. Paclitaxel injection should not be used in patients with solid tumors who have baseline neutrophil counts of < 1500 cells/mm 3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of < 1000 cells/mm 3 .

⚠️ Warnings ~2 min read ▾

WARNINGS Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ).

Patients who experience severe hypersensitivity reactions to paclitaxel injection should not be rechallenged with the drug. Bone marrow suppression (primarily neutropenia) is dose-dependent and is the dose-limiting toxicity. Neutrophil nadirs occurred at a median of 11 days.

Paclitaxel injection should not be administered to patients with baseline neutrophil counts of less than 1500 cells/mm 3 (< 1000 cells/mm 3 for patients with KS). Frequent monitoring of blood counts should be instituted during paclitaxel injection treatment. Patients should not be re-treated with subsequent cycles of paclitaxel injection until neutrophils recover to a level > 1500 cells/mm 3 (> 1000 cells/mm 3 for patients with KS) and platelets recover to a level > 100,000 cells/mm 3 .

Severe conduction abnormalities have been documented in < 1% of patients during paclitaxel injection therapy and in some cases requiring pacemaker placement. If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel injection. Pregnancy Paclitaxel injection can cause fetal harm when administered to a pregnant woman.

Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3 mg/kg/day (about 0.2 the daily maximum recommended human dose on a mg/m 2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, and increased fetal deaths. Maternal toxicity was also observed at this dose. No teratogenic effects were observed at 1 mg/kg/day (about 1/15 the daily maximum recommended human dose on a mg/m 2 basis); teratogenic potential could not be assessed at higher doses due to extensive fetal mortality.

There are no adequate and well-controlled studies in pregnant women. If paclitaxel injection is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Pooled Analysis of Adverse Event Experiences from Single-Agent Studies Data in the following table are based on the experience of 812 patients (493 with ovarian carcinoma and 319 with breast carcinoma) enrolled in 10 studies who received single-agent paclitaxel. Two hundred and seventy-five patients were treated in 8, Phase 2 studies with paclitaxel doses ranging from 135 to 300 mg/m 2 administered over 24 hours (in 4 of these studies, G-CSF was administered as hematopoietic support). Three hundred and one patients were treated in the randomized Phase 3 ovarian carcinoma study which compared 2 doses (135 or 175 mg/m 2 ) and 2 schedules (3 or 24 hours) of paclitaxel.

Two hundred and thirty-six patients with breast carcinoma received paclitaxel (135 or 175 mg/m 2 ) administered over 3 hours in a controlled study. TABLE 10: SUMMARY a OF ADVERSE EVENTS IN PATIENTS WITH SOLID TUMORS RECEIVING SINGLE-AGENT PACLITAXEL Percent of Patients (n = 812) • Bone Marrow —Neutropenia < 2000/mm 3 90 < 500/mm 3 52 —Leukopenia < 4000/mm 3 90 < 1000/mm 3 17 —Thrombocytopenia < 100,000/mm 3 20 < 50,000/mm 3 7 —Anemia < 11 g/dL 78 < 8 g/dL 16 —Infections 30 —Bleeding 14 —Red Cell Transfusions 25 —Platelet Transfusions 2 • Hypersensitivity Reaction b —All 41 —Severe † 2 • Cardiovascular —Vital Sign Changes c —Bradycardia (n = 537) 3 —Hypotension (n = 532) 12 —Significant Cardiovascular Events 1 • Abnormal ECG —All Pts 23 —Pts with normal baseline (n = 559) 14 • Peripheral Neuropathy —Any symptoms 60 —Severe symptoms † 3 • Myalgia/Arthralgia —Any symptoms 60 —Severe symptoms † 8 • Gastrointestinal —Nausea and vomiting 52 —Diarrhea 38 —Mucositis 31 • Alopecia 87 • Hepatic (Pts with normal baseline and on study data) —Bilirubin elevations (n = 765) 7 —Alkaline phosphatase elevations (n = 575) 22 —AST (SGOT) elevations (n = 591) 19 • Injection Site Reaction 13 a Based on worst course analysis. b All patients received premedication. c During the first 3 hours of infusion. † Severe events are defined as at least Grade III toxicity.

None of the observed toxicities were clearly influenced by age. Disease-Specific Adverse Event Experiences First-Line Ovary in Combination For the 1084 patients who were evaluable for safety in the Phase 3 first-line ovary combination therapy studies, TABLE 11 shows the incidence of important adverse events. For both studies, the analysis of safety was based on all courses of therapy (6 courses for the GOG-111 study and up to 9 courses for the Intergroup study).

TABLE 11: FREQUENCY a OF IMPORTANT ADVERSE EVENTS IN THE PHASE 3 FIRST-LINE OVARIAN CARCINOMA STUDIES Percent of Patients Intergroup GOG-111 T175/3 b c75 c (n = 339) C750 c c75 c (n = 336) T135/24 b c75 c (n = 196) C750 c c75 c (n = 213) • Bone Marrow —Neutropenia < 2000/mm 3 91 d 95 d 96 92 < 500/mm 3 33 d 43 d 81 d 58 d —Thrombocytopenia < 100,000/mm 3e 21 d 33 d 26 30 < 50,000/mm 3 3 d 7 d 10 9 —Anemia < 11 g/dL f 96 97 88 86 < 8 g/dL 3 d 8 d 13 9 —Infections 25 27 21 15 —Febrile Neutropenia 4 7 15 d 4 d • Hypersensitivity Reaction —All 11 d 6 d 8 d,g 1 d,g —Severe † 1 1 3 d,g — d,g • Neurotoxicity h —Any symptoms 87 d 52 d 25 20 —Severe symptoms † 21 d 2 d 3 d — d • Nausea and Vomiting —Any symptoms 88 93 65 69 —Severe symptoms † 18 24 10 11 • Myalgia/Arthralgia —Any symptoms 60 d 27 d 9 d 2 d —Severe symptoms † 6 d 1 d 1 — • Diarrhea —Any symptoms 37 d 29 d 16 d 8 d —Severe symptoms † 2 3 4 1 • Asthenia —Any symptoms NC NC 17 d 10 d —Severe symptoms † NC NC 1 1 • Alopecia —Any symptoms 96 d 89 d 55 d 37 d —Severe symptoms † 51 d 21 d 6 8 a Based on worst course analysis. b Paclitaxel (T) dose in mg/m 2 /infusion duration in hours. c Cyclophosphamide (C) or cisplatin (c) dose in mg/m 2 . d p < 0.05 by Fisher exact test. e < 130,000/mm 3 in the Intergroup study. f < 12 g/dL in the Intergroup study. g All patients received premedication. h In the GOG-111 study, neurotoxicity was collected as peripheral neuropathy and in the Intergroup study, neurotoxi…

🆘 Overdosage 42 words ▾

OVERDOSAGE There is no known antidote for paclitaxel injection overdosage. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity, and mucositis. Overdoses in pediatric patients may be associated with acute ethanol toxicity (see PRECAUTIONS, Pediatric Use ).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Paclitaxel is a novel antimicrotubule agent 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. In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Following intravenous administration of paclitaxel, paclitaxel plasma concentrations declined in a biphasic manner. The initial rapid decline represents distribution to the peripheral compartment and elimination of the drug. The later phase is due, in part, to a relatively slow efflux of paclitaxel from the peripheral compartment.

Pharmacokinetic parameters of paclitaxel following 3 and 24 hour infusions of paclitaxel at dose levels of 135 and 175 mg/m 2 were determined in a Phase 3 randomized study in ovarian cancer patients and are summarized in the following table. TABLE 1: SUMMARY OF PHARMACOKINETIC PARAMETERS—MEAN VALUES Dose (mg/m 2 ) Infusion Duration (h) N (patients) C max (ng/mL) AUC (0-∞) (ng•h/mL) T-HALF (h) CL T (L/h/m 2 ) 135 24 2 195 6300 52.7 21.7 175 24 4 365 7993 15.7 23.8 135 3 7 2170 7952 13.1 17.7 175 3 5 3650 15007 20.2

12.2C max = Maximum plasma concentration AUC (0-∞) = Area under the plasma concentration-time curve from time 0 to infinity CL T = Total body clearance It appeared that with the 24 hour infusion of paclitaxel, a 30% increase in dose (135 mg/m 2 vs. 175 mg/m 2 ) increased the C max by 87%, whereas the AUC (0-∞) remained proportional. However, with a 3 hour infusion, for a 30% increase in dose, the C max and AUC (0-∞) were increased by 68% and 89%, respectively.

The mean apparent volume of distribution at steady state, with the 24 hour infusion of paclitaxel, ranged from 227 to 688 L/m 2 , indicating extensive extravascular distribution and/or tissue binding of paclitaxel. The pharmacokinetics of paclitaxel were also evaluated in adult cancer patients who received single doses of 15 to 135 mg/m 2 given by 1 hour infusions (n = 15), 30 to 275 mg/m 2 given by 6 hour infusions (n = 36), and 200 to 275 mg/m 2 given by 24 hour infusions (n = 54) in Phase 1 and 2 studies. Values for CL T and volume of distribution were consistent with the findings in the Phase 3 study.

The pharmacokinetics of paclitaxel in patients with AIDS-related Kaposi’s sarcoma have not been studied. In vitro studies of binding to human serum proteins, using paclitaxel concentrations ranging from 0.1 to 50 mcg/mL, indicate that between 89 to 98% of drug is bound; the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. After intravenous administration of 15 to 275 mg/m 2 doses of paclitaxel as 1, 6, or 24 hour infusions, mean values for cumulative urinary recovery of unchanged drug ranged from 1.3% to 12.6% of the dose, indicating extensive non-renal clearance.

In 5 patients administered a 225 or 250 mg/m 2 dose of radiolabeled paclitaxel as a 3 hour infusion, a mean of 71% of the radioactivity was excreted in the feces in 120 hours, and 14% was recovered in the urine. Total recovery of radioactivity ranged from 56% to 101% of the dose. Paclitaxel represented a mean of 5% of the administered radioactivity recovered in the feces, while metabolites, primarily 6α-hydroxypaclitaxel, accounted for the balance.

In vitro studies with human liver microsomes and tissue slices showed that paclitaxel was metabolized primarily to 6α-hydroxypaclitaxel by the cytochrome P450 isozyme CYP2C8; and to 2 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, tenipos…

📦 How Supplied / Storage and Handling 85 words ▾

HOW SUPPLIED Paclitaxel Injection USP is available as follows: NDC 0703- 3213 -81 30 mg/5 mL Carton containing 1 multiple-dose vial. NDC 0703- 3216 -81 100 mg/16.7 mL Carton containing 1 multiple-dose vial. NDC 0703- 3218 -81 300 mg/50 mL Carton containing 1 multiple-dose vial.

Storage Store the vials in original cartons at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in the original package to protect from light. Handling and Disposal See DOSAGE AND ADMINISTRATION, Preparation and Administration Precautions .

📋 Description 161 words ▾

DESCRIPTION Paclitaxel Injection USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials.

Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, 2 mg of anhydrous citric acid, and 49.7% (v/v) and 39.6% (w/v) dehydrated alcohol. Paclitaxel, USP is a semi-synthetic product with antitumor activity. Paclitaxel, USP is obtained from Taxus species.

The chemical name for paclitaxel, USP 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. Paclitaxel, USP has the following structural formula: C 47 H 51 NO 14 M.W. 853.9 Paclitaxel, USP is a white to off-white crystalline powder.

It is highly lipophilic, insoluble in water, and melts at around 216 to 217° C. structural formula

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