Country: United States
Language: English
Source: NLM (National Library of Medicine)
PACLITAXEL (UNII: P88XT4IS4D) (PACLITAXEL - UNII:P88XT4IS4D)
Fresenius Kabi USA, LLC
PACLITAXEL
PACLITAXEL 6 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Paclitaxel Injection USP is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection USP is indicated in combination with cisplatin. Paclitaxel Injection USP 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 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
Product No. NDC No. Strength 763106 63323-763-06 30 mg per 5 mL (6 mg per mL) Multiple dose vial, packaged individually. 763117 63323-763-17 100 mg per 16.7 mL (6 mg per mL) Multiple dose vial, packaged individually. 763152 63323-763-52 300 mg per 50 mL (6 mg per mL) Multiple dose vial, packaged individually. Storage Store the vials in original cartons between 20°–25° C (68°–77° F). [See USP Controlled Room Temperature.] Retain in the original package until time of use to protect from light. See DOSAGE AND ADMINISTRATION: Preparation and Administration Precautions. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
PACLITAXEL- PACLITAXEL INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- PACLITAXEL INJECTION USP (FOR INTRAVENOUS USE ONLY) 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 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. Paclitaxel Injection USP therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 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 Injection USP. 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 Cremophor EL (polyoxyethylated castor oil), 2 mg citric acid, anhydrous, USP and 48.7% (v/v) dehydrated alcohol, USP. Paclitaxel is a natura Read the complete document