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paclitaxel protein bound (Rx)Brand and Other Names:Abraxane

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial
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Pancreatic Cancer

Indicated for metastatic adenocarcinoma of the pancreas as first-line treatment in combination with gemcitabine

125 mg/m² IV infused over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle

Administer gemcitabine 1000 mg/m² IV infused over 30-40 minutes immediately after paclitaxel protein bound on Days 1, 8 and 15 of each 28-day cycle

Dosage modifications (pancreatic cancer)

  • 1st dose reduction: 100 mg/m² (paclitaxel); 800 mg/m² (gemcitabine)
  • 2nd dose reduction: 75 mg/m² (paclitaxel); 600 mg/m² (gemcitabine)
  • Discontinue if additional dose reduction required

Dosage modifications (pancreatic cancer – hematologic toxicities)

  • Cycle Day 1: ANC <1500/mm³ or platelets <100,000/mm³ - Delay doses until recovery
  • Cycle Day 8: ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 1 dose level
  • Cycle Day 8: ANC <500/mm³ or platelets <50,000/mm³ - Withhold doses
  • Cycle Day 15: ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 1 dose level from Day 8
  • Cycle Day 15: ANC <500/mm³ or platelets <50,000/mm³ - Withhold doses
  • Cycle Day 15 (if Day 8 doses withheld): ANC >1000/mm³ or platelets ≥75,000/mm³ - Reduce 1 dose level from Day 1
  • Cycle Day 15 (if Day 8 doses withheld): ANC 500 to <1000/mm³ or platelets 50,000 to <75,000/mm³ - Reduce 2 dose levels from Day 1
  • Cycle Day 15 (if Day 8 doses withheld): ANC <500/mm³ or platelets <50,000 /mm³ - Withhold doses

Dosage modifications (pancreatic cancer – other toxicities)

  • Febrile neutropenia (grade 3 or 4): Withhold until fever resolves and ANC ≥1500/mm³ - Resume at next lower dose level
  • Peripheral neuropathy (Grade 3 or 4): Withhold paclitaxel until improves to ≤ Grade 1, then resume at next lower dose (no need to reduce gemcitabine)
  • Cutaneous toxicity (Grade 2 or 3): Reduce to next lower dose level; discontinue treatment if toxicity persists
  • Gastrointestinal toxicity (Grade 3 mucositis or diarrhea): Withhold until improves to ≤ Grade 1; resume at next lower dose level

Breast Cancer

Microtubule inhibitor 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 contraindicated

260 mg/m² IV infused over 30 minutes q3weeks

Dosage modfications (breast cancer)

  • Severe neutropenia (<500 cells/mm³) or severe sensory neuropathy: Decrease dose to 220 mg/m²
  • Recurrence of severe neutropenia or severe sensory neuropathy: Decrease dose to 180 mg/m²
  • Grade 3 sensory neuropathy: Hold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses

Non-Small Cell Lung Cancer

Indicated for locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

100 mg/m² IV infused over 30 minutes on Days 1, 8, and 15 of each 21-day cycle, PLUS

Carboplatin AUC 6 mg•min/mL IV on Day 1 of each 21 day cycle immediately after paclitaxel protein bound infusion

Dosage modifications (NSCLS)

  • Do not administer on Day 1 of a cycle until ANC is at least 1500 cells/mm³ and platelet count is at least 100,000 cells/mm³
  • Severe neutropenia or thrombocytopenia: Withhold treatment until counts recover to an ANC of at least 1500 cells/mm³ and platelet count of at least 100,000 cells/mm³ on Day 1 or to an ANC of at least 500 cells/mm³ and platelet count of at least 50,000 cells/mm³ on Days 8 or 15 of the cycle
  • Grade 3-4 peripheral neuropathy: Withhold dose; resume paclitaxel protein bound and carboplatin at reduced doses when peripheral neuropathy improves to Grade 1 or completely resolves

Permanent dose reductions (NSCLC)

  • Neutropenic fever (ANC <500/mm³ and fever >38°C) or next cycle delayed by >7 days for ANC <1500/mm³ or ANC <500/mm³ for >7 days or severe sensory neuropathy (grade 3 or 4):
  • -First occurrence: reduce dose to 75 mg/m² (and decrease carboplatin dose to 4.5 AUC mg•min/mL)
  • -Second occurrence: reduce dose to 50 mg/m² (and decrease carboplatin dose to 3 AUC mg•min/mL)
  • -Third occurrence: Discontinue treatment
  • Platelets <50,000/mm³:
  • -First occurrence: reduce dose to 75 mg/m² (and decrease carboplatin dose to 4.5 AUC mg•min/mL)
  • -Second occurrence: Discontinue treatment

Hepatic Impairment

Breast cancer

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.25 X ULN): No dose adjustment required
  • Moderate (AST <10 x ULN; bilirubin 1.26-2 x ULN): Reduce starting dose to 200 mg/m²
  • Severe: (AST <10 x ULN; bilirubin 2.01-5 x ULN): Reduce starting dose to 130 mg/m²; may increase up to 200 mg/m² in subsequent cycles based on individual tolerance
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

NSCLC

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.25 X ULN): No dose adjustment required
  • Moderate (AST <10 x ULN; bilirubin 1.26-2 x ULN): Reduce starting dose to 75 mg/m²
  • Severe: (AST <10 x ULN; bilirubin 2.01-5 x ULN): Reduce starting dose to 50 mg/m²; may increase up to 75 mg/m2 in subsequent cycles based on individual tolerance
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

Pancreatic cancer

  • Mild (AST <10 x ULN; bilirubin >ULN to 1.25 X ULN): No dose adjustment required
  • Moderate-to-severe (AST <10 x ULN; bilirubin 1.26-5 x ULN): Not recommended
  • AST >10 x ULN or bilirubin >5 X ULN: Do not administer paclitaxel protein bound

Administration

Use cytotoxic handling precautions

Monitor for extravasation during infusion

Premedication for hypersensitivity reaction is NOT required

Melanoma (Orphan)

Orphan designation for treatment of stage IIb to IV melanoma

Orphan sponsor

  • Abraxis BioScience, LLC; 11755 Wilshire Blvd; Los Angeles, CA 90025

Gastric Cancer (Orphan)

Orphan designation for gastric cancer

Sponsor

  • Insys Therapeutics, Inc.; 1333 South Spectrum Boulevard, Suite 100; Chandler, AZ 85286

Ovarian Cancer (Orphan)

Liposomal encapsulated paclitaxel

Sponsor

  • Insys Therapeutics, Inc; 1333 South Spectrum Boulevard, Suite 100; Chandler, AZ 85286

Breast Cancer with Brain Metastases (Orphan)

Peptide-paclitaxel conjugate

Orphan designation for treatment of patients with breast cancer with brain metastases

Sponsor

  • Angiochem, Inc; 201 President Kennedy; Montreal, Quebec H2X 3Y7; Canada

Safety and efficacy not established

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Interactions

Interaction Checker

paclitaxel protein bound and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Alopecia (90%)

            Neutropenia (<2 x 10^9/L) (80%)

            Sensory neuropathy, any (71%)

            Abnormal EKG, all patients (60%)

            Asthenia (47%)

            Myalgia/arthralgia (44%)

            AST increased (39%)

            Alkaline phosphatase increased (36%)

            Abnormal EKG, patients normal at baseline (35%)

            Anemia (<11 g/dL) (33%)

            Nausea (30%)

            Diarrhea (27%)

            Infections (24%)

            Vomiting (18%)

            Dyspnea (12%)

            Neutropenia (grade 3-4)

            • NSCLC (47%)
            • Pancreatic cancer (38%)
            • Metastatic breast cancer (34%)

            1-10%

            Sensory neuropathy, severe (10%)

            Edema (10%)

            Neutropenia (<0.5 x 10^9/L) (9%)

            Cough (7%)

            Mucositis (7%)

            Bilirubin increased (7%)

            Hypotension, during infusion (5%)

            Hypersensitivity reactions (4%)

            Thrombocytopenia (2%)

            Febrile neutropenia (2%)

            Bleeding (2%)

            Anemia (<8 g/dL) (1%)

            Postmarketing Reports

            Hypersensitivity: Severe hypersensitivity reactions

            Cardiovascular: Congestive heart failure, left ventricular dysfunction, and atrioventricular block; most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history

            Respiratory: Interstitial pneumonia, pulmonary embolism, lung fibrosis

            Neurologic: Cranial nerve palsies, vocal cord paresis, autonomic neuropathy resulting in paralytic ileu

            Vision Disorders: Persistent optic nerve damage; reduced visual acuity due to cystoid macular edema

            Hepatic: Hepatic necrosis and hepatic encephalopathy leading to death

            Gastrointestinal: Intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis, neutropenic enterocolitis (typhlitis)

            Injection Site Reaction: Extravasation, severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis (may be delayed by 7-10 ten days)

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            Warnings

            Black Box Warnings

            Should not be administered if baseline neutrophil counts <1,500 cells/mm³; frequent monitoring of peripheral blood cell counts for all patients recommended to avoid bone marrow suppression

            An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution; do not substitute for or with other paclitaxel formulations

            Contraindications

            Neutrophils <1500 cells/mm³

            Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions reported; do not rechallenge in patients who experience severe hypersensitivity

            Cautions

            Causes myelosuppression; monitor CBC and withhold and/or reduce the dose as needed (see Dosage Modifications)

            Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption (see Dosage Modifications)

            Sepsis occurred in 5% of patients with or without neutropenia; biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis

            Pneumonitis, including fatalities, occurred in 4% of patients

            Exposure and toxicity increased with hepatic impairment; particularly from myelosuppression; closely monitor for development of profound myelosuppression; monitor AST and bilirubin and adjust dose if needed (see Dosage Modifications)

            Contains albumin derived from human blood which has a theoretical risk of viral transmission

            Fetal harm may occur when administered to a pregnant woman; women of childbearing potential should avoid becoming pregnant

            Men should not father a child while taking paclitaxel

            CYP3A4 and CYP2C8 substrate; inducers or inhibitors of these isoenzymes may alter metabolism; if coadministered, monitor closely

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Unknown whether distributed in breast milk; because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            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

            Microtubular inhibitor (albumin-conjugated formulation); natural taxane, prevents depolymerization of cellular microtubules, which results in DNA, RNA, and protein synthesis inhibition

            Absorption

            Peak Plasma Time: Immediately after completing infusion

            Peak Plasma Concentration: 18,741 ng/mL

            Distribution

            Protein Bound: 89-98%

            Vd: 632 L/m²

            Metabolism

            Metabolized primarily to 6- alpha hydroxypaclitaxel by CYP2C8; and to 2 minor metabolites, 3’-p-hydroxypaclitaxel and 6-alpha, 3’-p-dihydroxypaclitaxel, by CYP3A4

            Elimination

            Half-life: 27 hr

            Total body clearance: 15 L/hr/m²

            Excretion: 20% feces, 4% urine (unchanged)

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            Administration

            IV Preparation

            Aseptically reconstitute vial by slowly injecting 20 mL 0.9% NaCl over 1 min by allowing fluid to fall down inside wall of tube (this will avoid foaming)

            Swirl or invert to mix (do not shake)

            Resulting reconstituted suspension should be milky and homogenous without visible particulates

            Resulting solution is 5 mg/mL

            If foaming occurs stand solution for at least 15 min until foaming subsides

            Inject the appropriate amount of reconstituted suspension into an empty, sterile IV bag (PVC containers, PVC or non-PVC type IV bag)

            The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer paclitaxel protein bound infusions

            The use of an in-line filter is not recommended

            IV Administration

            Infuse IV over 30 min

            Do not use in-line filter

            Storage

            Unopened vials: Store between 20-25ºC (68-77ºF) in the original package; neither freezing nor refrigeration adversely affects the stability of the product

            Reconstituted suspension in vial: Preferably should be used immediately, but can be refrigerated at 2-8°C (36-46°F) for up to 8 hr if needed

            Reconstituted suspension in infusion bag: Should be used immediately but may be stored at ambient temperature (approximately 25ºC) and lighting conditions for up to 4 hr; discard any unused portion

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            Formulary

            FormularyPatient Discounts

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            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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