PACLITAXEL injection, solution

Paclitaxel by

Drug Labeling and Warnings

Paclitaxel by is a Prescription medication manufactured, distributed, or labeled by Alvogen Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

For patients with carcinoma of the breast, the following is recommended (see CLINICAL STUDIES, Breast Carcinoma section):

  • 1) For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel, at a dose of 175 mg/m2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide (see CLINICAL STUDIES, Breast Carcinoma).
  • 2) After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel at a dose of 175 mg/m2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.

    • For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.

    For patients with AIDS-Related Kaposi's Sarcoma, paclitaxel administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules (see CLINICAL STUDIES, AIDS-Related Kaposi's Sarcoma), the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks).

    Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:

  • 1) Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);
  • 2) Initiate or repeat treatment with paclitaxel only if the neutrophil count is at least 1,000 cells/mm3;
  • 3) Reduce the dose of subsequent courses of paclitaxel by 20% for patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer); and
  • 4) Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

    • For the therapy of patients with solid tumors (ovary, breast and NSCLC), courses of paclitaxel should not be repeated until the neutrophil count is at least 1,500 cells/mm3 and the platelet count is at least 100,000 cells/mm3. Paclitaxel should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline or subsequent neutrophil count is less than 1,000 cells/mm3. Patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer) or severe peripheral neuropathy during Paclitaxel Injection, USP therapy should have dosage reduced by 20% for subsequent courses of paclitaxel. The incidence of neurotoxicity and the severity of neutropenia increase with dose.

    Hepatic Impairment

    Patients with hepatic impairment may be at increased risk of toxicity, particularly grade III–IV myelosuppression (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Hepatic). Recommendations for dosage adjustment for the first course of therapy are shown in Table 17 for both 3- and 24-hour infusions. Further dose reduction in subsequent courses should be based on individual tolerance. Patients should be monitored closely for the development of profound myelosuppression.

    Table 17. Recommendations for Dosing in Patients with Hepatic Impairment Based on Clinical Trial Dataa

    a These recommendations are based on dosages for patients without hepatic impairment of 135 mg/m2 over 24 hours or 175 mg/m2 over 3 hours; data are not available to make dose adjustment recommendations for other regimens (e.g., for AIDS-related Kaposi's sarcoma).

    b Differences in criteria for bilirubin levels between the 3- and 24-hour infusion are due to differences in clinical trial design.

    c Dosage recommendations are for the first course of therapy; further dose reduction in subsequent courses should be based on individual tolerance.

    Degree of Hepatic Impairment

    Recommended Paclitaxel Dosec
    Transaminase
    Levels
    Bilirubin Levelsb
    24-Hour Infusion
    <2 x ULN and ≤1.5 mg/dL 135 mg/m2
    2 to <10 x ULN and ≤1.5 mg/dL 100 mg/m2
    <10 x ULN and 1.6-7.5 mg/dL 50 mg/m2
    ≥10 x ULN or >7.5 mg/dL Not recommended
    3-Hour Infusion
    <10 x ULN and ≤1.25 x ULN 175 mg/m2
    <10 x ULN and 1.26-2.0 x ULN 135 mg/m2
    <10 x ULN and 2.01-5.0 x ULN 90 mg/m2
    ≥10 x ULN or >5.0 x ULN Not recommended

    Preparation and Administration Precautions

    Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing paclitaxel Injection. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.

    Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration (see PRECAUTIONS, Injection Site Reaction section).

    Preparation for Intravenous Administration

    Paclitaxel must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP or 5% Dextrose in Ringer's Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following simulated delivery of the solution through I.V. tubing containing an in-line (0.22 micron) filter.

    Data collected for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl) phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended.

    Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

    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-2® filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.

    The Chemo Dispensing Pin™ device or similar devices with spikes should not be used with vials of paclitaxel since they can cause the stopper to collapse resulting in loss of sterile integrity of the paclitaxel solution.

    Stability

    Unopened vials of Paclitaxel Injection, USP are stable until the date indicated on the package when stored between 20° to 25°C (68° to 77°F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration components in the paclitaxel vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25°C) and lighting conditions for up to 27 hours.

  • HOW SUPPLIED

    Paclitaxel Injection, USP (6 mg/mL) is supplied in the following:

    NDC No.Fill volumePackage
    47781-593-07 5 mL fill in 5 mL Multiple-dose vial One Multiple-dose vial in one carton
    47781-594-07 16.7 mL fill in 20 mL Multiple-dose vial One Multiple-dose vial in one carton
    47781-595-07 50 mL fill in 50 mL Multiple-dose vial One Multiple-dose vial in one carton

    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.

  • REFERENCES

    1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004165.
    2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
    3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
    4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.

    *DaunoXome® is a registered trademark of Gilead Sciences, Inc.
    DOXIL® is a registered trademark of ALZA Corporation.
    IVEX-2® is a registered trademark of the Millipore Corporation.
    Chemo Dispensing Pin™ is a trademark of B. Braun Medical Incorporated.

  • PATIENT INFORMATION

    Paclitaxel Injection, USP

    Read this patient information leaflet before you start taking paclitaxel. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    What is the most important information I should know about paclitaxel?

    Paclitaxel can cause serious side effects including death.

    Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel.

    Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away.

    Tell your healthcare provider right away if you have any of these signs of an allergic reaction:

    • trouble breathing
    • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    • hives (raised bumps) or rash

    Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction.

    What is paclitaxel?

    Paclitaxel is a prescription medicine used to treat some forms of:

    • ovarian cancer
    • breast cancer
    • lung cancer
    • Kaposi's sarcoma

    It is not known if paclitaxel is safe or effective in children.

    Who should not receive paclitaxel?

    Do not receive paclitaxel if:

    • you are allergic to any of the ingredients in paclitaxel. See the end of this leaflet for a complete list of ingredients in paclitaxel.
    • are allergic to medicines containing polyoxyethylated castor oil.
    • you have low white blood cell counts.

    What should I tell my healthcare provider before receiving paclitaxel?

    Before receiving paclitaxel, tell your healthcare provider about all your medical conditions, including if you:

    • have liver problems
    • have heart problems
    • are pregnant or plan to become pregnant. paclitaxel can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
    • are breast-feeding or plan to breast-feed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breast-feed.

    Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

    Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

    How will I receive paclitaxel?

    • Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider.

    Your healthcare provider will do certain tests while you receive paclitaxel.

    What are the possible side effects of paclitaxel?

    Tell your healthcare provider right away if you have:

    • severe stomach pain
    • severe diarrhea

    The most common side effects of paclitaxel include:

    • low red blood cell count (anemia) feeling weak or tired
    • hair loss
    • numbness, tingling, or burning in your hands or feet (neuropathy)
    • joint and muscle pain
    • nausea and vomiting
    • hypersensitivity reaction - trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash
    • diarrhea
    • mouth or lip sores (mucositis)
    • infections - if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away
    • swelling of your hands, face, or feet
    • bleeding events
    • irritation at the injection site
    • low blood pressure (hypotension)

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of paclitaxel. For more information, ask your healthcare provider or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    General information about the safe and effective use of paclitaxel.

    Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use paclitaxel for a condition for which it was not prescribed.

    Do not give paclitaxel to other people, even if they have the same symptoms that you have. It may harm them.

    This patient information leaflet summarizes the most important information about paclitaxel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about paclitaxel that is written for health professionals.

    What are the ingredients in paclitaxel?

    Active ingredient: paclitaxel.

    Inactive ingredients include: Polyoxyl 35 castor oil, NF and dehydrated alcohol, USP and Citric Acid, USP.

    What is cancer?

    Under normal conditions, the cells in your body divide and grow in an orderly, controlled way. Cell division and growth are necessary for the human body to perform its functions and to repair itself, when necessary. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood. A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue, it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body if not found and treated early.

    Manufactured by:
    Gland Pharma Limited
    Visakhapatnam - 530049,
    Andhra Pradesh, India

    Distributed by:
    Alvogen, Inc.
    Pine Brook, NJ 07058 USA

    PI593-00
    Rev. 04/2017

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton

    NDC 47781-593-07

    Paclitaxel Injection, USP

    30 mg/5 mL
    (6 mg/mL)

    Sterile
    Cytotoxic Agent

    Caution: Dilution required prior to IV Infusion

    5ml-carton
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton

    NDC 47781-594-07

    Paclitaxel Injection, USP

    100 mg/16.7 mL
    (6 mg/mL)

    Sterile
    Cytotoxic Agent

    Caution: Dilution required prior to IV Infusion

    16-7ml-carton

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton

    NDC 47781-595-07

    Paclitaxel Injection, USP

    300 mg/50 mL
    (6 mg/mL)

    Sterile
    Cytotoxic Agent

    Caution: Dilution required prior to IV Infusion

    50ml-carton

  • INGREDIENTS AND APPEARANCE
    PACLITAXEL 
    paclitaxel injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 47781-593
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    paclitaxel (UNII: P88XT4IS4D) (paclitaxel - UNII:P88XT4IS4D) paclitaxel30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    polyoxyl 35 castor oil (UNII: 6D4M1DAL6O)  
    alcohol (UNII: 3K9958V90M)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 47781-593-071 in 1 CARTON12/27/201708/01/2020
    15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20732612/27/201708/01/2020
    PACLITAXEL 
    paclitaxel injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 47781-594
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    paclitaxel (UNII: P88XT4IS4D) (paclitaxel - UNII:P88XT4IS4D) paclitaxel100 mg  in 16.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    polyoxyl 35 castor oil (UNII: 6D4M1DAL6O)  
    alcohol (UNII: 3K9958V90M)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 47781-594-071 in 1 CARTON12/27/201701/01/2020
    116.7 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20732612/27/201701/01/2020
    PACLITAXEL 
    paclitaxel injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 47781-595
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    paclitaxel (UNII: P88XT4IS4D) (paclitaxel - UNII:P88XT4IS4D) paclitaxel300 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    polyoxyl 35 castor oil (UNII: 6D4M1DAL6O)  
    alcohol (UNII: 3K9958V90M)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 47781-595-071 in 1 CARTON12/27/2017
    150 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20732612/27/2017
    Labeler - Alvogen Inc. (008057330)
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