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Docetaxel 80 mg/4mL Injection, Solution, 4 mL

by Dr. Reddy's Laboratories Inc. · 4 mL in 1 VIAL, GLASS (43598-610-40)
NDC 43598-0610-40
🏷️ FDA NDC (as labeled) 43598-610-40 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 43598-610-40
Product NDC 43598-610
11-digit billing NDC 43598061040
NCPDP billing unit ML — per mL (volume)
RxCUI 1860480, 1860485
UNII 15H5577CQD
Application # ANDA204193
SPL Set ID be3df07d-ea56-453a-25ad-c3cedc22712a
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 2017-08-22
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DOCETAXEL
GPI-14 21500005001315
GPI class DOCEtaxel
GCN Seq No 066751
GCN 29066
HICL code 010280
Ingredient (HICL) Docetaxel
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 DOCETAXEL 80 MG/4 ML VIAL
FDB brand name Docetaxel
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 43598-610-40 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43598-0610-40. 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

LabelerDr. Reddy's Laboratories Inc.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA204193 (ANDA)
Labeler code43598
First marketedAug 2017
Product typeHuman Prescription Drug
Portfolio158 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 DOCETAXEL 80 MG/4 ML VIAL Ingredient Docetaxel
📖 What it is MedlinePlus · NLM

Docetaxel injection is used alone or in combination with other medications to treat certain types of breast, lung, prostate, stomach, and head and neck cancers. Docetaxel injection is in a class of medications called taxanes. It works by stopping the growth and spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Docetaxel is a chemotherapy drug used for several types of cancer — most commonly breast cancer, non-small cell lung cancer, prostate cancer that no longer responds to hormone ther...
  • What exactly is docetaxel being used to treat me for?
  • You'll get docetaxel as an IV infusion — a drip into a vein — that takes about one hour. Treatments are usually given once every three weeks at your cancer center or hospital. Befo...
  • How will I receive my docetaxel treatment, and how often?
📖 Read our full Docetaxel 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Docetaxel 20 mg/mL 00143-9205-01 Hikma 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 00955-1021-04 Sanofi-Aventis 1 vial — — FDA listed —
Docetaxel 80 mg/4mL 23155-0904-31 Heritage 1 vial — AP FDA listed —
Docetaxel 20 mg/mL 25021-0245-01 Sagent 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 43598-0259-40 Dr. 4 ml — AP FDA listed —
Docetaxel 80 mg/4mLthis 43598-0610-40 Dr. 4 ml — AP FDA listed —
Docetaxel 20 mg/mL 45963-0765-52 Actavis 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 47335-0895-40 Sun 1 vial — — FDA listed —
Docetaxel 80 mg/4mL 57884-3042-01 Jiangsu 1 vial — AP FDA listed —
Docetaxel 80 mg/4mL 70121-1222-01 Amneal 1 vial — AP FDA listed —
Beizray 20 mg/mL 70710-2152-01 Zydus 1 vial — — FDA listed —
Docetaxel 20 mg/mL 71288-0152-04 Meitheal 1 vial — — FDA listed —
Beizray 20 mg/mL 83513-0009-01 Zhuhai 4 ml — — 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.

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

Medicare Part D (outpatient prescription) spending for Docetaxel — the program that covers self-administered drugs. 8 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 Docetaxel. 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
$295.3K
Claims incl. refills
534
Beneficiaries
263
Spend / beneficiary
$1,122.66
Spend / claim
$552.92
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 Docetaxel — the ingredient across all brands.

Top reported reactions

Alopecia16,970
Madarosis6,717
Hair Texture Abnormal5,993
Hair Colour Changes5,874
Hair Disorder5,625
Diarrhoea5,243
Nausea3,815

Reporter sex

0 reports

Serious outcomes

Death8,848
Disabling3,068
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,728 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43598-0610-40 You're viewing this 4 mL in 1 VIAL, GLASS (43598-610-40) 2017-08-22 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43598-610-40, 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: 43598-0610-40, written without dashes as 43598061040. 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 43598-0610-40, the first segment (43598) is the labeler code FDA assigned to Dr. Reddy's Laboratories Inc.; the middle segment (0610) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddy's Laboratories 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.
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 💊 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
🚨 Boxed Warning ~2 min read ▾

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION ONE-VIAL FORMULATION Treatment-related mortality associated with docetaxel injection is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel injection as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions ( 5.1 )]. Avoid the use of docetaxel injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN.

Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel injection [see Warnings and Precautions ( 5.2 )].

Do not administer docetaxel injection to patients with neutrophil counts of <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection. [see Warnings and Precautions ( 5.3 )] . Do not administer docetaxel injection to patients who have a history of severe hypersensitivity reactions to docetaxel injection or to other drugs formulated with polysorbate 80 [see Contraindications ( 4 )].

Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy [see Warnings and Precautions ( 5.5 )]. Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a dexamethasone premedication.

It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions ( 5.6 )]. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel injection at 100 mg/m 2 ( 5.1 ) Avoid use of docetaxel injection if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN.

LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) Do not administer docetaxel injection to patients with neutrophil counts < 1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia ( 4 , 5.3) Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication.

Severe reactions require immediate discontinuation of docetaxel injection and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to docetaxel injection or to drugs formulated with polysorbate 80 ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 )

1.1Breast Cancer Docetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

1.2Non-small Cell Lung Cancer Docetaxel injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Docetaxel injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

1.3Prostate Cancer Docetaxel injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

1.4Gastric Adenocarcinoma Docetaxel injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

1.5Head and Neck Cancer Docetaxel injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration ( 2.7 )]. Administer in a facility equipped to manage possible complications (e.g. anaphylaxis). Administer in a facility equipped to manage possible complications (e.g., anaphylaxis).

Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.

BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent ( 2.1 ) BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles ( 2.1 ) NSCLC: after platinum therapy failure: 75 mg/m 2 single agent ( 2.2 ) NSCLC: chemotherapy-naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 ( 2.2 ) HRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously ( 2.3 ) GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1 to 5), starting at end of cisplatin infusion ( 2.4 ) SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1 to 5), starting at end of cisplatin infusion; for 4 cycles ( 2.5 ) SCCHN: 75 mg/m 2 followed by cisplatin 100 mg/m 2 IV (day 1), followed by fluorouracil 1000 mg/m 2 per day as a 24-hr IV (days 1 to 4); for 3 cycles ( 2.5 ) For all patients: Premedicate with oral corticosteroids ( 2.6) Adjust dose as needed ( 2.7 )

2.1Breast Cancer For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of docetaxel injection is 60 mg/m 2 to 100 mg/m 2 administered intravenously over 1 hour every 3 weeks. For the adjuvant treatment of operable node-positive breast cancer, the recommended docetaxel injection dose is 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities [see Dosage and Administration ( 2.7 ) ].

2.2Non-Small Cell Lung Cancer For treatment after failure of prior platinum-based chemotherapy, docetaxel injection was evaluated as monotherapy, and the recommended dose is 75 mg/m 2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m 2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized controlled trials [see Boxed Warning, Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5 ), Clinical Studies ( 14 )].  For chemotherapy-naive patients, docetaxel injection wasevaluated in combination with cisplatin.

The recommendeddose of docetaxel injection is 75 mg/m 2 administeredintravenously over 1 hour immediately followed by cisplatin75 mg/m 2 over 30 to 60 minutes every 3 weeks [see Dosage and Administration ( 2.7) ].

2.3Prostate Cancer For metastatic castration-resistant prostate cancer, therecommended dose of docetaxel injection is 75 mg/m2every 3 weeks as a 1 hour intravenous infusion.Prednisone 5 mg orally twice daily is administeredcontinuously [see Dosage and Administration ( 2.7 ) ].

2.4Gastric Adenocarcinoma For gastric adenocarcinoma, the recommended dose of docetaxel injection is 75 mg/m 2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m 2 , as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m 2 per day given as a 24 hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration [see Dosage and Administration ( 2.7) ].

2.5Head and Neck Cancer Patients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for…

💊 Dosage Forms and Strengths 86 words ▾

3 DOSAGE FORMS AND STRENGTHS One-vial formulation Docetaxel Injection USP Docetaxel 20 mg/mL Docetaxel Injection USP, 20 mg/1 mL single-dose vial: 20 mg docetaxel and 3 mg citric acid anhydrous in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. Docetaxel 80 mg/4 mL Docetaxel Injection USP, 80 mg/4 mL single-dose vial: 80 mg docetaxel and 12 mg citric acid anhydrous in 4 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. One-vial formulation docetaxel injection: Single-dose vials, 20 mg/mL, and 80 mg/4 mL ( 3 )

⛔ Contraindications 69 words ▾

4 CONTRAINDICATIONS Docetaxel injection is contraindicated in patients with: neutrophil counts of <1500 cells/mm 3 [see Warnings andPrecautions ( 5.3 )]. a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred [see Warnings and Precautions ( 5.5 ) ]. Hypersensitivity to docetaxel or polysorbate 80 ( 4 ) Neutrophil counts of <1500 cells/mm 3 ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Second primary malignancies: In patients treated with docetaxel injection-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ( 5.7 ) Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported.

Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. ( 5.8 ) Neurologic reactions: Reactions including. paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent.

( 5.9 ) Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. ( 5.10 ) Asthenia: Severe asthenia may occur and may require treatment discontinuation. ( 5.11 ) Embryo-fetal toxicity: Can cause fetal harm.

Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 , 8.3 ) Alcohol content: The alcohol content in a dose of docetaxel injection may affect the central nervous system. This may include impairment of a patient’s ability to drive or use machines immediately after infusion.

( 5.13 ) Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment (5.14)

5.1Toxic Deaths Breast Cancer Docetaxel injection administered at 100 mg/m 2 was associated with deaths considered possibly or probably related to treatment in 2% (19/965) of metastatic breast cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN). Among patients dosed at 60 mg/m 2 , mortality related to treatment occurred in 0.6% (3/481) of patients with normal liver function, and in 3 of 7 patients with abnormal liver function.

Approximately half of these deaths occurred during the first cycle. Sepsis accounted for the majority of the deaths. Non-small Cell Lung Cancer Docetaxel injection administered at a dose of 100 mg/m 2 in patients with locally advanced or metastatic non-small cell lung cancer who had a history of prior platinum-based chemotherapy was associated with increased treatment-related mortality (14% and 5% in two randomized, controlled studies).

There were 2.8% treatment-related deaths among the 176 patients treated at the 75 mg/m 2 dose in the randomized trials. Among patients who experienced treatment-related mortality at the 75 mg/m2 dose level, 3 of 5 patients had an ECOG PS of 2 at study entry [see Dosage and Administration ( 2.2 ), Clinical Studies ( 14 )].

5.2Hepatic Impairment Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Avoid docetaxel injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN [see Warnings and Precautions ( 5.1 ) ].

For patients with isolated elevations of transaminase >1.5 × ULN, consider docetaxel injection dose modifications [see Dosage and Administration ( 2.7 ) ]. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel injection therapy.

5.3Hematologic Effects Perform frequent peripheral blood cell counts on all patients receiving docetaxel injection. Do not retreat patients with subsequent cycles of docetaxel injection until neutrophils recover to a level >1500 cells/mm 3 [see Contraindications ( 4 ) ]. Avoid retreating patients until platelets recover to a level > 100,000 cells/mm 3 . A 25% reduction in the dose of docetaxel injection is recommended during subsequent cycles fo…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reactions from docetaxel injection are: • Toxic Deaths [see Boxed Warning, Warnings and Precautions ( 5.1) ] • Hepatic Impairment [see Boxed Warning, Warnings and Precautions ( 5.2) ] • Hematologic Effects [see Boxed Warning, Warnings and Precautions ( 5.3) ] • Enterocolitis and Neutropenic Colitis [see Warnings and Precautions ( 5.4) ] • Hypersensitivity Reactions [see Boxed Warning , Warnings and Precautions ( 5.5 )] • Fluid Retension [ see Boxed Warning , see Warnings and Precautions (5.6) ] • Second Primary Malignancies [see Warnings and Precautions (5.7) ] • Cutaneous Reactions [see Warnings and Precautions (5.8) ] • Neurologic Reactions [see Warnings and Precautions (5.9) ] • Eye Disorders [see Warnings and Precautions (5.10) ] • Asthenia [see Warnings and Precautions (5.11) ] • Alcohol Content [ see Warnings and Precations ( 5.13 )] The most common adverse reactions across all docetaxel injection indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.

Incidence varies depending on the indication. Adverse reactions are described according to indication. 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.

Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established. Most common adverse reactions across all docetaxel injection indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.

Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Breast Cancer Monotherapy with Docetaxel Injection for locally advanced or metastatic breast cancer after failure of prior chemotherapy Docetaxel injection 100 mg/m 2 : Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received docetaxel injection administered at 100 mg/m 2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline.

These reactions were described using COSTART terms and were considered possibly or probably related to docetaxel injection. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving docetaxel injection for the treatment of breast cancer and in patients with other tumor types.

(See Table 3). Table 3 : Summary of Adverse Reactions in Patients Receiving Docetaxel Injection at 100 mg/m 2 Adverse Reaction All Tumor TypesNormal LFTs * n=2045% All Tumor TypesElevated LFTs** n=61% Breast CancerNormal LFTs * n=965% Hematologic Neutropenia <2000 cells/mm 3 96 96 99 <500 cells/mm 3 75 88 86 Leukopenia <4000 cells/mm 3 96 98 99 <1000 cells/mm 3 32 47 44 Thrombocytopenia <100,000 cells/mm 3 8 25 9 Anemia <11 g/dL 90 92 94 <8 g/dL 9 31 8 Febrile Neutropenia*** 11 26 12 Septic Death 2 5 1 Non-Septi…

🔄 Drug Interactions 145 words ▾

7 DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4.

Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of docetaxel injection and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with docetaxel injection, close monitoring for toxicity and a docetaxel injection dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see Dosage and Administration ( 2.7 )], Clinical Pharmacology ( 12.3 )].

Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 ) Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of docetaxel injection. ( 8.3 )

8.1Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action, docetaxel injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Docetaxel injection contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations].

In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [see Data]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Docetaxel injection contains alcohol [see Warnings and Precautions ( 5.13 )].

Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal data Intravenous administration of ≥0.3 and 0.03 mg/kg/day docetaxel to pregnant rats and rabbits, respectively, during the period of organogenesis caused an increased incidence of intrauterine mortality, resorptions, reduced fetal weights, and fetal ossification delays. Maternal toxicity was also observed at these doses, which were approximately 0.02 and 0.003 times the daily maximum recommended human dose based on body surface area, respectively.

8.2Lactation Risk Summary There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with docetaxel injection and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating docetaxel injection. Contraception Females Docetaxel injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of docetaxel injection.

Males Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of docetaxel injection. Infertility Based on findings in animal studies, docetaxel injection may impair fertility in males of reproductive potential [see Nonclinical Toxicology ( 13.1 )].

8.4Pediatric Use The alcohol content of docetaxel injection should be taken into account when given to pediatric patients [see Warnings and Precautions ( 5.13 )]. The efficacy of docetaxel injection in pediatric patients as monotherapy or in combination has not been established. The overall safety profile of docetaxel injection in pediatric patients receiving monotherapy or TCF was…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action, docetaxel injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Docetaxel injection contains alcohol which can interfere with neurobehavioral development [see Clinical Considerations].

In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [see Data]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Docetaxel injection contains alcohol [see Warnings and Precautions ( 5.13 )].

Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal data Intravenous administration of ≥0.3 and 0.03 mg/kg/day docetaxel to pregnant rats and rabbits, respectively, during the period of organogenesis caused an increased incidence of intrauterine mortality, resorptions, reduced fetal weights, and fetal ossification delays. Maternal toxicity was also observed at these doses, which were approximately 0.02 and 0.003 times the daily maximum recommended human dose based on body surface area, respectively.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The alcohol content of docetaxel injection should be taken into account when given to pediatric patients [see Warnings and Precautions ( 5.13 )]. The efficacy of docetaxel injection in pediatric patients as monotherapy or in combination has not been established. The overall safety profile of docetaxel injection in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.

Docetaxel injection has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluorouracil (TCF). Docetaxel Injection Monotherapy Docetaxel injection monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1 to 22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m 2 as a 1-hour intravenous infusion every 21 days.

The primary dose limiting toxicity was neutropenia. The recommended dose for docetaxel injection monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patients (median age 12 years, range 1 to 26 years) with a variety of recurrent/refractory solid tumors.Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma.

Docetaxel Injection in Combination Docetaxel injection was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients (median age 16 years, range 9 to 21 years) were randomized (2:1) to docetaxel injection (75 mg/m²) in combination with cisplatin (75 mg/m²) and 5-fluorouracil (750 mg/m²) (TCF) or to cisplatin (80 mg/m²) and 5-fluorouracil (1000 mg/m²/day) (CF).

The primary endpoint was the CR rate following induction treatment of NPC. One patient out of 50 in the TCF group (2%) had a complete response while none of the 25 patients in the CF group had a complete response. Pharmacokinetics Pharmacokinetic parameters for docetaxel were determined in 2pediatric solid tumor trials.

Following docetaxel administrationat 55 mg/m2 to 235 mg/m2 in a 1-hour intravenous infusionevery 3 weeks in 25 patients aged 1 to 20 years (median 11years), docetaxel clearance was 17.3±10.9 L/h/m2. Docetaxel was administered in combination with cisplatin and5-fluorouracil (TCF), at dose levels of 75 mg/m2 in a 1-hourintravenous infusion day 1 in 28 patients aged 10 to 21 years(median 16 years, 17 patients were older than 16). Docetaxelclearance was 17.9±8.75 L/h/m 2 , corresponding to an AUC of4.20±2.57 mcg.h/mL.

In summary, the body surface area adjusted clearance ofdocetaxel monotherapy and TCF combination in childrenwere comparable to those in adults [see Clinical Pharmacology ( 12.3 )].

🧓 Geriatric Use ~3 min read ▾

8.5Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients. Non-small Cell Lung Cancer In a study conducted in chemotherapy-naive patients with NSCLC (TAX326), 148 patients (36%) in the docetaxel injection+cisplatin group were 65 years of age or greater. There were 128 patients (32%) in the vinorelbine+cisplatin group 65 years of age or greater.

In the docetaxel injection+cisplatin group, patients less than 65 years of age had a median survival of 10.3 months (95% CI: 9.1 months, 11.8 months) and patients 65 years or older had a median survival of 12.1 months (95% CI: 9.3 months, 14 months). In patients 65 years of age or greater treated with docetaxel injection+cisplatin, diarrhea (55%), peripheral edema (39%) and stomatitis (28%) were observed more frequently than in the vinorelbine+cisplatin group (diarrhea 24%, peripheral edema 20%, stomatitis 20%). Patients treated with docetaxel injection+cisplatin who were 65 years of age or greater were more likely to experience diarrhea (55%), infections (42%),peripheral edema (39%) and stomatitis (28%) compared to patients less than the age of 65 administered the same treatment (43%, 31%, 31% and 21%, respectively).

When docetaxel injection was combined with carboplatin for the treatment of chemotherapy-naive, advanced non-small cell lung carcinoma, patients 65 years of age or greater (28%) experienced higher frequency of infection compared to similar patients treated with docetaxel injection+cisplatin, and a higher frequency of diarrhea, infection and peripheral edema than elderly patients treated with vinorelbine+cisplatin. Prostate Cancer Of the 333 patients treated with docetaxel injection every three weeks plus prednisone in the prostate cancer study (TAX327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.

In patients treated with docetaxel injection every three weeks, the following treatment-emergent adverse reactions occurred at rates ≥10% higher in patients 65 years of age or greater compared to younger patients: anemia (71% vs. 59%), infection (37% vs. 24%), nail changes (34% vs.

23%), anorexia (21% vs. 10%), weight loss (15% vs. 5%), respectively.

Breast Cancer In the adjuvant breast cancer trial (TAX316), docetaxel injection in combination with doxorubicin and cyclophosphamide was administered to 744 patients of whom 48 (6%) were 65 years of age or greater. The number of elderly patients who received this regimen was not sufficient to determine whether there were differences in safety and efficacy between elderly and younger patients. Gastric Cancer Among the 221 patients treated with docetaxel injection in combination with cisplatin and fluorouracil in the gastric cancer study, 54 were 65 years of age or older and 2 patients were older than 75 years.In this study, the number of patients who were 65 years of age or older was insufficient to determine whether they respond differently from younger patients.

However, the incidence of serious adverse reactions was higher in the elderly patients compared to younger patients. The incidence of the following adverse reactions (all grades, regardless of relationship): lethargy, stomatitis, diarrhea, dizziness, edema, febrile neutropenia/neutropenic infection occurred at rates ≥10% higher in patients who were 65 years of age or older compared to younger patients. Elderly patients treated with TCF should be closely monitored.

Head and Neck Cancer Among the 174 and 251 patients who received the induction treatment with docetaxel injection in combination with cisplatin and fluorouracil (TPF) for SCCHN in the TAX323 and TAX324 studies, 18 (10%) and 32 (13%) of the patients were 65 years of age or older, respectively. These clinical studies of docetaxel injection in combination with cisplatin and fluorouracil in patients…

🆘 Overdosage 199 words ▾

10 OVERDOSAGE There is no known antidote for docetaxel injection overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis.

Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m 2 and the other received 200 mg/m 2 as 1-hour infusions.

Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥ 154 mg/kg (about 4.5 times the human dose of 100 mg/m 2 on a mg/m 2 basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m 2 basis). In male and female rats, lethality was observed at a dose of 20 mg/kg (comparable to the human dose of 100 mg/m 2 on a mg/m 2 basis) and was associated with abnormal mitosis and necrosis of multiple organs.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells.

Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

12.3Pharmacokinetics Absorption The pharmacokinetics of docetaxel has been evaluated in cancer patients after administration of 20 mg/m 2 to 115 mg/m 2 in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m 2 to 115 mg/m 2 with infusion times of 1 to 2 hours. Docetaxel’s pharmacokinetic profile is consistent with a three-compartment pharmacokinetic model, with half-lives for the α, β, and γ phases of 4 min, 36 min, and 11.1 hr, respectively.

Mean total body clearance was 21 L/h/m 2 . Distribution The initial rapid decline represents distribution to the peripheral compartments and the late (terminal) phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment. Mean steady state volume of distribution was 113 L.

In vitro studies showed that docetaxel is about 94% protein bound, mainly to α 1 -acid glycoprotein, albumin, and lipoproteins. In three cancer patients, the in vitro binding to plasma proteins was found to be approximately 97%. Dexamethasone does not affect the protein binding of docetaxel.

Metabolism In vitro drug interaction studies revealed that docetaxel is metabolized by the CYP3A4 isoenzyme, and its metabolism may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4 [see Drug Interactions ( 7 )]. Elimination A study of 14 C-docetaxel was conducted in three cancer patients. Docetaxel was eliminated in both the urine and feces following oxidative metabolism of the tert-butyl ester group, but fecal excretion was the main elimination route.

Within 7 days, urinary and fecal excretion accounted for approximately 6% and 75% of the administered radioactivity, respectively. About 80% of the radioactivity recovered in feces is excreted during the first 48 hours as 1 major and 3 minor metabolites with very small amounts (less than 8%) of unchanged drug. Specific Populations Effect of Age: A population pharmacokinetic analysis was carried out after docetaxel injection treatment of 535 patients dosed at 100 mg/m 2 .

Pharmacokinetic parameters estimated by this analysis were very close to those estimated from phase 1 studies. The pharmacokinetics of docetaxel was not influenced by age. Effect of Gender: The population pharmacokinetics analysis described above also indicated that gender did not influence the pharmacokinetics of docetaxel.

Hepatic Impairment: The population pharmacokinetic analysis described above indicated that in patients with clinical chemistry data suggestive of mild to moderate liver impairment (AST and/or ALT >1.5 times ULN concomitant with alkaline phosphatase >2.5 times ULN), total body clearance was lowered by an average of 27%, resulting in a 38% increase in systemic exposure (AUC). This average, however, includes a substantial range and there is, at present, no measurement that would allow recommendation for dose adjustment in such patients.

Patients with combined abnormalities of transaminase and alkaline phosphatase should not be treated with docetaxel injection. Patients with severe hepatic impairment have not been studied.[see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.6 )]. Effect of Race: Mean total body clearance for Japanese p…

🧬 Mechanism of Action 99 words ▾

12.1Mechanism of Action Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. This leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, which results in the inhibition of mitosis in cells.

Docetaxel’s binding to microtubules does not alter the number of protofilaments in the bound microtubules, a feature which differs from most spindle poisons currently in clinical use.

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied One-vial Formulation Docetaxel Injection USP Docetaxel Injection USP (20 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution. Docetaxel injection USP is supplied in a single-dose vial as a sterile, pyrogen-free, non-aqueous, solution. Discard unused portion.

Docetaxel injection USP 20 mg/mL (NDC 43598-611-11) Docetaxel injection USP 20 mg/1 mL: 20 mg docetaxel and 3 mg citric acid anhydrous in 1 mL in 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol. One single-dose vial in blister in one carton. Docetaxel injection USP 80 mg/4 mL (NDC 43598-610-40) Docetaxel injection USP 80mg/4 mL: 80 mg docetaxel and 12 mg citric acid anhydrous in 4 mL in 50/50 (v/v) ratio polysorbate 80/dehyd rated alcohol.

One single-dose vial in blister in one carton.

16.2Storage Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.

16.3Handling and Disposal Docetaxel injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 182 words ▾

11 DESCRIPTION Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate.

Docetaxel has the following structural formula: Docetaxel USP is a white to almost-white crystalline powder with molecular formula of C 43 H 53 NO 14 and a molecular weight of 808. It is freely soluble in anhydrous ethanol, soluble in methylene chloride and methanol, practically insoluble in water. One-vial Docetaxel Injection USP Docetaxel injection USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.

Each mL contains 20 mg docetaxel (anhydrous) 3 mg citric acid anhydrous in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution. The pH of the formulation is 3 to 4.5. Docetaxel injection USP is available in single-dose vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).

Docetaxel injection USP requires NO prior dilution with a diluent and is ready to add to the infusion solution.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Bone Marrow Suppression Advise patients that periodic assessment of their blood count will be performed to detect neutropenia, thrombocytopenia, and/ or anemia [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 )]. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.

Enterocolitis and Neutropenic Colitis Advise patients of the symptoms of colitis, such as abdominal pain or tenderness, and/or diarrhea, with or without fever, and instruct patients to promptly contact their healthcare provider if they experience these symptoms [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.4 )]. Hypersensitivity Reactions Ask patients whether they have previously received paclitaxel therapy, and if they have experienced a hypersensitivity reaction to paclitaxel. Instruct patients to immediately report to their healthcare provider signs of a hypersensitivity reaction. [see Contraindications ( 4 ), Warnings and Precautions ( 5.5 )].

Fluid Retention Advise patients to report signs of fluid retention such as peripheral edema in the lower extremities, weight gain, and dyspnea immediately to their healthcare provider [see Warnings and Precautions ( 5.6 )]. Second Primary Malignancies Advise patients on the risk of second primary malignancies during treatment with docetaxel injection [see Warnings and Precautions ( 5.7 )]. Cutaneous Reactions Advise patients that localized erythema of the extremities and severe skin toxicities may occur.

Instruct patients to immediately report severe cutaneous reactions to their healthcare provider [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.8 )]. Neurologic Reactions Advise patients that neurosensory symptoms or peripheral neuropathy may occur. Instruct patients to immediately report neurologic reactions to their healthcare provider [see Dosage and Administration ( 2.7 ) and Warnings and Precautions ( 5.9 )].

Eye Disorders Advise patients that vision disturbances and excessive tearing are associated with docetaxel injection administration. Instruct patients to immediately report any vision changes to their healthcare provider [see Warnings and Precautions ( 5.10 )]. Gastrointestinal Reactions Explain to patients that nausea, vomiting, diarrhea, and constipation are associated with docetaxel injection administration.

Instruct patients to report any severe events to their healthcare provider [see Adverse Reactions ( 6 )]. Cardiac Disorders Advise patients to report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting immediately to their healthcare provider [see Adverse Reactions ( 6 )]. Other Common Adverse Reactions Advise patients that other common adverse reactions associated with docetaxel injection may include alopecia (cases of permanent hair loss have been reported), asthenia, anorexia, dysgeusia, mucositis, myalgia, nail disorders, or pain.

Instruct patients to report these reactions to their healthcare provider if serious events occur [see Adverse Reactions ( 6 )]. Importance of Corticosteroids Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report to their healthcare provider if they were not compliant with the oral corticosteroid regimen [see Dosage and Administration ( 2.6 )].

Embryo-Fetal Toxicity Docetaxel injection can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug.

Advise female patients of reproductive potential to use effective contraceptives during treatment and for 6 months after the last dose of docetaxel injection. Advise male patients with female partners of reproductive potential to use effective con…

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