PACLITAXEL injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PACLITAXEL (UNII: P88XT4IS4D) (PACLITAXEL - UNII:P88XT4IS4D)

Available from:

Mylan Institutional LLC

INN (International Name):

PACLITAXEL

Composition:

PACLITAXEL 30 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paclitaxel injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel injection is indicated in combination with cisplatin. Paclitaxel injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see CLINICAL STUDIES, Breast Carcinoma ). Paclitaxel injection 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 unl

Product summary:

Paclitaxel Injection, USP (6 mg/mL) is available as follows: NDC 67457-471-52 30 mg/5 mL multidose vial individually packaged in a carton. NDC 67457-449-17 100 mg/16.7 mL multidose vial individually packaged in a carton. NDC 67457-434-51 300 mg/50 mL multidose vial individually packaged in a carton. 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. see DOSAGE AND ADMINISTRATION, Preparation and Administration Precautions.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PACLITAXEL- PACLITAXEL INJECTION
MYLAN INSTITUTIONAL LLC
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PACLITAXEL INJECTION, USP
(Patient Information Included)
Rx only
WARNING
Paclitaxel should be administered under the supervision of a physician
experienced in the use of
cancer chemotherapeutic agents. Appropriate management of
complications is possible only when
adequate diagnostic and treatment facilities are readily available.
Anaphylaxis and severe hypersensitivity reactions characterized by
dyspnea and hypotension
requiring treatment, angioedema, and generalized urticaria have
occurred in 2 to 4% of patients
receiving paclitaxel in clinical trials. Fatal reactions have occurred
in patients despite
premedication. All patients should be pretreated with corticosteroids,
diphenhydramine, and H
antagonists (see DOSAGE AND ADMINISTRATION). Patients who experience
severe
hypersensitivity reactions to paclitaxel should not be rechallenged
with the drug.
Paclitaxtel therapy should not be given to patients with solid tumors
who have baseline neutrophil
counts of less than 1,500 ccells/mm and should not be given to
patients with AIDS-related
Kaposi’s sarcoma if the baseline neutrophil count is less than
11,000 cells/mm . 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.
.
DESCRIPTION
Paclitaxel injection, USP is a clear, colorless to slightly yellow
viscous solution. It is supplied as a
nonaqueous solution intended for dilution with a suitable parenteral
fluid prior to intravenous infusion.
Paclitaxel injection, USP is available in 30 mg (5 mL), 100 mg (16.7
mL), and 300 mg (50 mL) multidose
vials. Each mL of sterile nonpyrogenic solution contains 6 mg
paclitaxel, USP; 527 mg of purified
polyoxyl 35 castor oil, 2 mg of anhydrous citric acid and 49.7% (v/v)
dehydrated alcohol.
Paclitaxel is a natural product with antitumor activity. Paclitaxel is
obtained via a