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Paclitaxel

    Brands

    DEA Class; Rx

    Common Brand Names; Taxol

    • Antineoplastics, Antimicrotubular (Taxanes)

    Semisynthetic, diterpenoid taxane derivative from the bark of the Pacific yew tree; sequence of administration in combination with other agents is important in toxicity and efficacy; effective in numerous disease including breast, lung, ovarian, and bladder cancers, Kaposi’s sarcoma alone or as part of combination regimens.

    Indicated for the treatment of breast cancer.

    For second line treatment of AIDS-related Kaposi’s sarcoma.
    For the treatment of non-small cell lung cancer (NSCLC).
    For the treatment of ovarian cancer.
    For the first line treatment of advanced transitional-cell bladder cancer, in combination with carboplatin.

    Patients with solid tumors or patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1,500 cells/mm3

    Documented hypersensitivity to drug or excipients

    • Neutropenia (78-100%)
    • Alopecia (55-96%)
    • Anemia (47-96%)
    • Arthralgia/myalgia (93%)
    • Diarrhea (90%)
    • Leukopenia (90%)
    • Nausea/vomiting (9-88%)
    • Opportunistic infections (76%)
    • Peripheral neuropathy (42-79%)
    • Thrombocytopenia (4-68%)
    • Mucositis (5-45%)
    • Hypersensitivity (2-45%)
    • Renal impairment (34%)
    • Hypotension (17%)
    • Bradycardia (3%)
    • Grand mal seizures
    • Cardiac conduction abnormalities

    All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists; fatal reactions have occurred in patients despite premedication; 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 dose-limiting toxicity; should not be administered to patients with baseline neutrophil counts <1,500 cells/mm3 (<1,000 cells/mm3 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/mm3 (>1,000 cells/mm3 for patients with KS) and platelets recover to a level >100,000 cells/mm3

    Severe conduction abnormalities have been documented in <1% of patients during paclitaxel therapy and in some cases requiring pacemaker placement; if patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel

    Contact of the undiluted concentrate with plasticized polyvinyl chloride (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 preferably be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets

    Paclitaxel should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns; use of filter devices such as IVEX-2R filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP

    May increase the risk of cardiac dysfunction if received in conjunction with trastuzumab or anthracyclines

    Pregnancy Category: D

    Lactation: not known if excreted in breast milk, do not nurse

    The suggested maximum tolerated dose (MTD) for paclitaxel is dependent on performance status, other chemotherapy agents or radiation given in combination, and disease state. The optimal dose or infusion duration of paclitaxel has not been determined. Therefore, dosing may vary from protocol to protocol. If questions arise, clinicians should consult the appropriate references to verify the dose.

    Adults

    135—175 mg/m2 IV over 3 hours or up to 250 mg/m2 IV over 24 hours every 3 weeks. Weekly paclitaxel at doses of 80—100 mg/m2 IV over 1 hour are under investigation. Studies of weekly doses have given paclitaxel for 3 consecutive weeks with 1 week off, 6 weeks consecutively with 2 weeks off, or weekly for >12 weeks continuously. Higher doses may be given as part of preparative regimens for bone marrow transplantation. For intraperitoneal administration, the maximum tolerated dose was 175 mg/m2 IP every 3—4 weeks. When given IP weekly, significant Grade 2 toxicities were seen at 75 mg/m2; the recommended dose for weekly IP administration is 60—65 mg/m2 IP.

    Paclitaxel 

    injectable solution

    • 6mg/mL