Paclitaxel 6 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Microtubule Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), and non-small cell lung cancer (NSCLC). Paclitaxel (with polyoxyethylated castor oil) injection is also used to treat Kaposi's sarcoma (a type of cancer that causes patches of abnormal tissue to grow under the skin) in people who have acquired immunodeficiency syndrome (AIDS). Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the grow...
Read the full MedlinePlus article ↗- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Paclitaxel — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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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?
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?
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💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.7369 | $3.68 / 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?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Paclitaxel 6 mg/mL 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/mLthis 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61703-0342-09 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-342-09) / 5 mL in 1 VIAL, MULTI-DOSE | 2004-03-01 | Active |
| 61703-0342-22 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-342-22) / 16.7 mL in 1 VIAL, MULTI-DOSE | 2004-03-01 | Active |
| 61703-0342-50 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-342-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2004-03-01 | Active |
This pack accounts for about 2.1% 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 61703-0342-09?
What NDC number is used to bill for this package of Paclitaxel 6 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
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 |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Paclitaxel Injection, USP 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%-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 section.) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1,000 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.
🎯 Indications and Usage ▾
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 is indicated in combination with cisplatin. Paclitaxel 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 receptornegative 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, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.
⏱️ Dosage and Administration ▾
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 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 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, diphenhydramine (or its equivalent) 50 mg I.V. 30 to 60 minutes prior to paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before paclitaxel.
For patients with carcinoma of the ovary the following regimen is 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 ). a. Paclitaxel 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 b.
Paclitaxel 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 has been used at several doses and schedules; however, the optimal regimen is not yet clear. (See CLINICAL STUDIES: Ovarian Carcinoma section).
The recommended regimen is paclitaxel 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 section): 1) For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel, 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 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 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 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 45–50 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 only if the neutrophil count is at least 1,000 cells/mm 3 ; 3) Reduce the dose of subsequent courses of paclitaxel by 20% for patients who experience severe neutropenia (neutrophil <500 cells/mm 3 for a week or longer); and 4) Initiate con…
⛔ Contraindications ▾
CONTRAINDICATIONS Paclitaxel Injection, USP is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil, NF. Paclitaxel Injection, USP should not be used in patients with solid tumors who have baseline neutrophil counts of <1,500 cells/mm 3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1,000 cells/mm 3 .
⚠️ Warnings ▾
WARNINGS Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2%-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 section.) Patients who experience severe hypersensitivity reactions to paclitaxel 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 should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 (<1,000 cells/mm 3 for patients with KS). Frequent monitoring of blood counts should be instituted during paclitaxel treatment. Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophils recover to a level >1,500 cells/mm 3 (>1,000 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 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. Pregnancy: Paclitaxel can cause fetal harm when administered to a pregnant woman.
Administration of paclitaxel during the period of organogenesis to rabbits at doses of 3.0 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 1.0 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 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 ▾
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 Injection, USP. Two hundred and seventy-five patients were treated in eight Phase 2 studies with paclitaxel doses ranging from 135 to 300 mg/m 2 administered over 24 hours (in four 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 two doses (135 or 175 mg/m 2 ) and two 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 <2,000/mm 3 <500/mm 3 - Leukopenia <4,000/mm 3 <1,000/mm 3 - Thrombocytopenia <100,000/mm 3 <50,000/mm 3 - Anemia <11 g/dL <8 g/dL - Infections - Bleeding - Red Cell Transfusions - Platelet Transfusions 90 52 90 17 20 7 78 16 30 14 25 2 • Hypersensitivity Reaction b - All - Severe † 41 2 • Cardiovascular - Vital Sign Changes c - Bradycardia (n=537) - Hypotension (n=532) - Significant Cardiovascular Events 3 12 1 • Abnormal ECG - All Pts - Pts with normal baseline (n=559) 23 14 • Peripheral Neuropathy - Any symptoms - Severe symptoms † 60 3 • Myalgia/Arthralgia - Any symptoms - Severe symptoms † 60 8 • Gastrointestinal - Nausea and vomiting - Diarrhea - Mucositis 52 38 31 • Alopecia 87 • Hepatic (Pts with normal baseline and on study data) - Bilirubin elevations (n=765) - Alkaline phosphatase elevations (n=575) - AST (SGOT) elevations (n=591) 7 22 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 <2,000/mm 3 <500/mm 3 - Thrombocytopenia <100,000/mm 3e <50,000/mm 3 - Anemia <11 g/dL f <8 g/dL - Infections - Febrile Neutropenia 91 d 33 d 21 d 3 d 96 3 d 25 4 95 d 43 d 33 d 7 d 97 8 d 27 7 96 81 d 26 10 88 13 21 15 d 92 58 d 30 9 86 9 15 4 d • Hypersensitivity Reaction - All - Severe † 11 d 1 6 d 1 8 d,g 3 d,g 1 d,g – d,g • Neurotoxicity h - Any symptoms - Severe symptoms † 87 d 21 d 52 d 2 d 25 3 d 20 – d • Nausea and Vomiting - Any symptoms - Severe symptoms † 88 18 93 24 65 10 69 11 • Myalgia/Arthralgia - Any symptoms - Severe symptoms † 60 d 6 d 27 d 1 d 9 d 1 2 d – • Diarrhea - Any symptoms - Severe symptoms † 37 d 2 29 d 3 16 d 4 8 d 1 • Asthenia - Any symptoms - Severe symptoms † NC NC NC NC 17 d 1 10 d 1 • Alopecia - Any symptoms - Severe symptoms † 96 d 51 d 89 d 21 d 55 d 6 37 d 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 an…
🆘 Overdosage ▾
OVERDOSAGE There is no known antidote for paclitaxel 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 section).
🧬 Clinical Pharmacology ▾
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 versus 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 15-135 mg/m 2 given by 1-hour infusions (n=15), 30-275 mg/m 2 given by 6-hour infusions (n=36), and 200-275 mg/m 2 given by 24-hour infusions (n=54) in Phase 1 & 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 μg/mL, indicate that between 89%-98% of drug is bound; the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel. After intravenous administration of 15-275 mg/m 2 doses of Paclitaxel Injection, USP 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 five 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 two minor metabolites, 3’- p -hydroxypaclitaxel and 6α, 3’- p -dihydroxy-paclitaxel, by CYP3A4. In vitro , the metabolism of paclitaxel to 6α-hydroxypaclitaxel was inhibited by a number of agents (ketoconazole, verapamil, diazepam, quinidine, dexamethasone, cyclosporin, t…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Paclitaxel Injection, USP (6 mg/mL) is supplied in the following: Unit of Sale Concentration *Partial fill (5 mL) volume in a 10 mL container. NDC 61703-342-09 Carton containing 1 multiple-dose vial 30 mg/5 mL (6 mg/mL) NDC 61703-015-04 Carton containing 1 multiple-dose vial 30 mg/5 mL* (6 mg/mL) NDC 61703-342-22 Carton containing 1 multiple-dose vial 100 mg/16.7 mL (6 mg/mL) NDC 61703-342-50 Carton containing 1 multiple-dose vial 300 mg/50 mL (6 mg/mL) Storage: Store the vials in original cartons between 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 ▾
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 is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multiple-dose vials.
Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of Polyoxyl 35 Castor Oil, NF, 49.7% (v/v) Dehydrated Alcohol, USP and 2 mg Citric Acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media ‘Hicksii’.
The chemical name for paclitaxel is (2a R ,4 S ,4a S ,6 R ,9 S ,11 S ,12 S ,12a R ,12b S )-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4,6,9,11,12,-12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5 H -cyclodeca [3,4] benz [1,2-b] oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine. Paclitaxel has the following structural formula: Paclitaxel is a white to off-white crystalline powder with the empirical formula C 47 H 51 NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216-217°C.
Paclitaxel Structural Formula
💬 Patient Medication Information ▾
PATIENT INFORMATION Paclitaxel Injection, USP Read this patient information leaflet before you start taking paclitaxel. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about paclitaxel? Paclitaxel can cause serious side effects including death. Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel.
Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away. Tell your healthcare provider right away if you have any of these signs of an allergic reaction: • trouble breathing • sudden swelling of your face, lips, tongue, throat, or trouble swallowing • hives (raised bumps) or rash Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction. What is paclitaxel?
Paclitaxel is a prescription medicine used to treat some forms of: • ovarian cancer • breast cancer • lung cancer • Kaposi’s sarcoma It is not known if paclitaxel is safe or effective in children. Who should not receive paclitaxel? Do not receive paclitaxel if: • you are allergic to any of the ingredients in paclitaxel.
See the end of this leaflet for a complete list of ingredients in paclitaxel. • are allergic to medicines containing polyoxyethylated castor oil. • you have low white blood cell counts. What should I tell my healthcare provider before receiving paclitaxel? Before receiving paclitaxel, tell your healthcare provider about all your medical conditions, including if you: • have liver problems • have heart problems • are pregnant or plan to become pregnant. paclitaxel can harm your unborn baby.
Talk to your healthcare provider if you are pregnant or plan to become pregnant. • are breast-feeding or plan to breast-feed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breast-feed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How will I receive paclitaxel? • Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider. Your healthcare provider will do certain tests while you receive paclitaxel. What are the possible side effects of paclitaxel?
Tell your healthcare provider right away if you have: • severe stomach pain • severe diarrhea The most common side effects of paclitaxel include: • low red blood cell count (anemia) feeling weak or tired • hair loss • numbness, tingling, or burning in your hands or feet (neuropathy) • joint and muscle pain • nausea and vomiting • hypersensitivity reaction - trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash • diarrhea • mouth or lip sores (mucositis) • infections - if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away • swelling of your hands, face, or feet • bleeding events • irritation at the injection site • low blood pressure (hypotension) Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of paclitaxel. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or Hospira, Inc. at 1-800-441-4100. General information about the safe and effective use of paclitaxel. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.
Do not use paclitaxel for a condition for which it was not prescribed. Do not give paclitaxel t…