PACLITAXEL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

PACLITAXEL

Composition:

PACLITAXEL 6 mg in 1 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 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. 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/mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1,000 cells/mm3 .

Product summary:

Paclitaxel Injection, USP (6 mg/mL) is supplied in the following: NDC 61703-342-09 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 .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PACLITAXEL- PACLITAXEL INJECTION, SOLUTION
HOSPIRA, INC.
----------
PACLITAXEL
Injection, USP
(Patient Information Included)
Rx only
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 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) 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
2
3
3
e