Drugplain

PACLITAXEL PACLITAXEL 6 mg/mL

paclitaxel · INJECTION, SOLUTION · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

No Recall History
Plain English

PACLITAXEL PACLITAXEL is a injection, solution containing paclitaxel at 6 mg/mL, taken intravenous. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Key Facts

Brand Name
PACLITAXEL PACLITAXEL
Generic Name
paclitaxel
NDC Code (Product)
23155-882
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Strength
6 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA207326
Drug Class
Microtubule Inhibitor [EPC]
Marketing Start
08/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea4,526 reports
nausea4,524 reports
neutropenia4,404 reports
off label use4,278 reports
diarrhoea4,190 reports
anaemia3,857 reports
malignant neoplasm progression3,612 reports
disease progression3,338 reports
fatigue3,311 reports
neuropathy peripheral3,185 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 ar…

Dosage & 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 app…

Warnings

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

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 .

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 Transfus…

Frequently Asked Questions

What is PACLITAXEL PACLITAXEL used for?

PACLITAXEL PACLITAXEL contains paclitaxel. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is PACLITAXEL PACLITAXEL a controlled substance?

PACLITAXEL PACLITAXEL is not classified as a controlled substance by the DEA.

What is the generic name for PACLITAXEL PACLITAXEL?

The generic name for PACLITAXEL PACLITAXEL is paclitaxel. There are 9 other brand versions of paclitaxel.

What is the NDC code for PACLITAXEL PACLITAXEL 6 mg/mL?

The NDC (National Drug Code) for PACLITAXEL PACLITAXEL 6 mg/mL is 23155-882, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Product NDC

23155-882

Package NDC

23155-882-31

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)