paclitaxel (Rx)

Brand and Other Names:Taxol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 6mg/mL
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Ovarian Cancer

Premedicate to prevent hypersensitivity reactions (eg, dexamethasone, diphenhydramine, H2 blockers)

Previously untreated: 175 mg/m² IV over 3 hours q3Weeks (follow with cisplatin), OR 

135 mg/m² IV over 24 hours q3Weeks (follow with cisplatin)

Previously treated: Various regimens exist: 135-175 mg/m² IV over 3 hours q3Weeks

Breast Cancer

Node positive (adjuvant chemotherapy): 175 mg/m² IV over 3 hours q3Weeks 4 times (with doxorubicin-containing regimen) 

Metastatic Disease (failure of initial chemotherapy or relapse within 6 months following adjuvant chemotherapy): 175 mg/m² IV over 3 hours q3Weeks

Non-small Cell Lung Cancer

135 mg/m² IV over 24 hours q3Weeks (follow with cisplatin) 

AIDS-related Kaposi's Sarcoma (2nd-line Treatment)

135 mg/m² IV over 3 hours q3Weeks; OR 

100 mg/m² IV over 3 hours q2Weeks

Pancreatic Cancer (Off-label)

Investigational: 125 mg/m² IV with gemcitabine 

Dosage Modifications

If baseline PMN <1500/m³, do not re-treat until PMN >1500/m³ and platelet count >100,000/m³

If severe neutropenia occurs (PMN <500/m³ for 7 days), reduce subsequent doses by 20%

Renal impairment: No dosage adjustment required

Hepatic Impairment

With solid carcinomas and not Kaposi sarcoma

24-hr infusion

  • AST/ALT <2 x ULN and bilirubin ≤1.5 mg/dL: 135 mg/m² over 24 hr
  • AST/ALT 2-<10 x ULN and bilirubin ≤1.5 mg/dL: 100 mg/m² over 24 hr
  • AST/ALT <10 x ULN and bilirubin 1.6-7.5 mg/dL: 50 mg/m² over 24 hr
  • AST/ALT ≥10 x ULN OR bilirubin >7.5 mg/dL: Do not administer

3-hr infusion

  • AST/ALT <10 x ULN and bilirubin <1.25 x ULN: 175 mg/m² over 3 hr
  • AST/ALT <10 x ULN and bilirubin 1.26-2 x ULN: 135 mg/m² over 3 hr
  • AST/ALT <10 x ULN and bilirubin 2.01-5 x ULN: 90 mg/m² over 3 hr
  • AST/ALT ≥10 x ULN OR bilirubin >5 x ULN: Do not administer

Orphan Designations

Pancreatic cancer

  • Sponsors
  • MediGene AG; Lochhamer Strasse 11, D-82152 Planegg/Martinsried, Germany
  • Abraxis BioScience, LLC; 11755 Wilshire Blvd; Los Angeles, CA 90025
  • Luitpold Pharmaceuticals, Inc; Clinical Research and Development, 800 Adams Avenue; Valley Forge, PA 19403

Esophageal cancer

  • Sponsor: Protherics, Inc; 5214 Maryland Way, Suite 405; Brentwood, TN 37027

Adenocarcinoma of the stomach or lower esophagus

  • Sponsor: Luitpold Pharmaceuticals, Inc; Clinical Research and Development, 800 Adams Avenue; Valley Forge, PA 19403

Brain cancer

  • Sponsor: Protherics, Inc; 5214 Maryland Way, Suite 405; Brentwood, TN 37027

Hormone-refractory prostate cancer

  • Sponsor: Luitpold Pharmaceuticals, Inc; Clinical Research and Development, 800 Adams Avenue; Valley Forge, PA 19403

Non-Small Cell Lung Cancer

  • Polymer surgical mesh delivering paclitaxel
  • Sponsor: AcuityBio, Inc; 200 Upland Road; Newton, MA 02460

Ovarian Cancer

  • Sponsor: NanOlogy, LLC; 231 Bonetti Drive; San Luis Obispo, California 93401

Other Indications & Uses

Off-label: head/neck cancer, small-cell lung cancer, upper GI adenocarcinoma, hormone-refractory prostate cancer, NHL, urothelium transitional cell carcinoma, stage IIB-IV melanoma

Safety and efficacy not established

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Interactions

Interaction Checker

and paclitaxel

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            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%)

            1-10%

            Bradycardia (3%)

            <1%

            Grand mal seizures

            Cardiac conduction abnormalities

            Frequency Not Defined

            Pyrexia

            Dehydration

            Pancytopenia

            Congestive heart failure

            Left ventricular dysfunction

            Stevens-Johnson syndrome, toxic epidermal necrolysis, and extravasation

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications

            The drug is contraindicated in patients with solid tumor who have baseline neutrophil counts <1500 cells/m³ and in patients with AIDS-related Kaposi sarcoma who have baseline neutrophil counts <1000 cells/m³; perform frequent peripheral blood counts to monitor for occurrence of bone marrow suppression, primarily neutropenia, which may result in infection

            Fatal anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in patients despite premedication

            Pretreat all patients with corticosteroids, diphenhydramine, and H2 antagonists

            Do not rechallenge patients who experience severe hypersensitivity reactions to the drug

            Contraindications

            Hypersensitivity to paclitaxel or castor oil

            Pregnancy

            Solid tumor w/baseline PMN <1500 cells/m³

            AIDS-related Kaposi's sarcoma with baseline PMN <1000 cells/m³

            Cautions

            Irritant

            Concomitant radiation therapy

            Elderly

            Avoid pregnancy

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

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            Pregnancy & Lactation

            Pregnancy Category: D

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

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Natural taxane, prevents depolymerization of cellular microtubules, which results in DNA, RNA, and protein synthesis inhibition

            Pharmacokinetics

            Protein bound: 89-98%

            Vd: 227-688 L/m²

            Metabolism: Metabolized by CYP2C8, CYP3A4

            Metabolites: 6-alpha-hydroxypaclitaxel (major)

            Half-life elimination: 27hr terminal

            Excretion: Feces (20%); urine (4%)

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            Administration

            IV Incompatibilities

            Additive: cisplatin (comp at low paxlitaxel conc; incomp at high paclitaxel conc)

            Y-site: amphotericin B, amphotericin B cholesteryl sulfate, chlorpromazine, doxorubicin liposomal, hydroxyzine, methylprednisolone sodium succinate, mitoxantrone

            IV Compatibilities

            Additive: carboplatin, doxorubicin

            Y-site (partial list): acyclovir, ampicillin-sulbactam, bleomycin, carboplatin, cisplatin, cytarabine, diphenhydramine, famotidine, furosemide, granisetron, heparin, linezolid, lorazepam, MgSO4, morphine SO4, ondansetron, KCl, propofol, NaHCO3, vancomycin

            IV Preparation

            Further dilution in NS or D5W to a concentration of 0.3-1.2 mg/mL

            Standard dilution (IVPB): dose/500-1000 mL D5W or NS

            IV Administration

            Irritant

            Mfr recommends administration over 1-24 hr

            Administer taxane derivatives before platinum derivatives (cisplatin, carboplatin) in sequential infusions to limit myelosuppression and to enhance efficacy

            Administer corticosteroids, H1-antagonists, H2 antagonists, prior to paclitaxel administration to minimize potential for anaphylaxis

            Non-PVC tubing should be used to minimize leaching

            Contact of undiluted concentrate with plasticized PVC equipment or devices is not recommended

            Administer through IV tubing containing an in-line (0.22 micron) filter

            Should be dispensed in either glass or Excel/PAB

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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