PACLITAXEL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

paclitaxel (UNII: P88XT4IS4D) (paclitaxel - UNII:P88XT4IS4D)

Available from:

Alvogen Inc.

INN (International Name):

paclitaxel

Composition:

paclitaxel 30 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 clinica

Product summary:

Paclitaxel Injection, USP (6 mg/mL) is supplied in the following: 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, SOLUTION
ALVOGEN INC.
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PACLITAXEL INJECTION, USP
(Patient Information Included)
Rx only
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% 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 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 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 . 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 is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg
(50 mL) multi-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