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DOCETAXEL injection, solution


  1. Patient Information
  2. See "what Is The Most Important Information I Should Know About Docetaxel Injection?
  3. The Most Common Side Effects Of Docetaxel Injection Include:
  4. What Are The Ingredients In Docetaxel Injection?active Ingredient:
  5. Inactive Ingredients: (20 Mg Injection):
  6. The Chance Of Death In People Who Receive Docetaxel Injection Is Higher If You:
  7. Docetaxel Injection Is A Prescription Anti-cancer Medicine Used To Treat Certain People With:
  8. Before You Receive Docetaxel Injection, Tell Your Doctor If You:
  9. Active Ingredient:
  10. Oral Corticosteroid Dosing:
  11. Revised: 11/2016document Id:
  12. What Is The Most Important Information I Should Know About Docetaxel Injection?
  13. Tell Your Healthcare Provider Right Away If You Have Any Of These Signs Of A Severe Allergic Reaction:
  14. Do Not Receive Docetaxel Injection If You:
  15. What Are The Possible Side Effects Of Docetaxel Injection?
  16. Inactive Ingredients:
  17. Manufactured For:
  18. Manufactured By:

Patient Information 


Docetaxel Injection is a prescription anti-cancer medicine used to treat certain people with:

  • breast cancer
  • non-small cell lung cancer
  • prostate cancer
  • stomach cancer
  • head and neck cancer
It is not known if Docetaxel Injection is effective in children.Do not receive Docetaxel Injection if you:
  • have had a severe allergic reaction to:
    • docetaxel, the active ingredient in Docetaxel Injectionor
    • any other medicines that contain polysorbate 80. Ask your doctor or pharmacist if you are not sure.
    • Docetaxel Injection will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
    • Docetaxel Injection is usually given every 3 weeks.
    • Your doctor will decide how long you will receive treatment with Docetaxel Injection.
    • Your doctor will check your blood cell counts and other blood tests during your treatment with Docetaxel Injection to check for side effects of Docetaxel Injection.
    • Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while taking Docetaxel Injection.
    What are the possible side effects of Docetaxel Injection?
    Docetaxel Injection may cause serious side effects including death.

See "what Is The Most Important Information I Should Know About Docetaxel Injection? 

"
  • Acute Myeloid Leukemia (AML),a type of blood cancer, can happen in people who receive Docetaxel Injection along with certain other medicines.
  • Other blood disorders.Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection.
  • Skin reactionsincluding redness and swelling of your arms and legs with peeling of your skin.
  • Neurologic problems.Neurologic problems are common in people who receive Docetaxel Injection, but can be severe. Tell your doctor if you have any numbness, tingling, or burning in your hands or feet (peripheral neuropathy) and weakness of your legs, feet, arms, or hands (motor weakness).
  • Vision problemsincluding blurred vision or loss of vision.
  • Docetaxel Injection contains alcohol.The alcohol content in Docetaxel Injection may impair your ability to drive or use machinery right after receiving Docetaxel Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Docetaxel Injection treatment.
  • The Most Common Side Effects Of Docetaxel Injection Include: 

    • infections
    • low white blood cell, red blood cell, and platelet counts
    • changes in your sense of taste
    • feeling short of breath
    • constipation
    • decreased appetite
    • changes in your fingernails or toenails
    • swelling of your hands, face or feet
    • feeling weak or tired
    • joint and muscle pain
    • nausea and vomiting
    • diarrhea
    • mouth or lips sores
    • hair loss: In some people, permanent hair loss has been reported.
    • rash
    • redness of the eye, excess tearing
    • skin reactions at the site of Docetaxel Injection administration such as increased skin pigmentation, redness, tenderness, swelling, and warmth or dryness of the skin.
    • tissue damage if Docetaxel Injection leaks out of the vein into the tissues
    Tell your doctor if you have a fast or irregular heartbeat, severe shortness of breath, dizziness or fainting during your infusion. If any of these events occurs after your infusion, get medical help right away.
    These are not all the possible side effects of Docetaxel Injection. For more information ask your doctor 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 Docetaxel Injection
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Docetaxel Injection that is written for healthcare professionals.

    What Are The Ingredients In Docetaxel Injection?active Ingredient: 

    docetaxel

    Inactive Ingredients: (20 Mg Injection): 

    polysorbate 80, citric acid monohydrate USP and dehydrated alcohol.

    Logo


    Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA
    LAB-0906-9.0
    Every three-week injection of Docetaxel Injection for breast, non-small cell lung, and stomach, and head and neck cancers
    Take your oral corticosteroid medicine as your doctor tells you.

    The Chance Of Death In People Who Receive Docetaxel Injection Is Higher If You: 

    1.
    have liver problems
    2.
    receive high doses of Docetaxel Injection
    3.
    have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
    2.
    Docetaxel Injection can affect your blood cells.Your doctor should do routine blood tests during treatment with Docetaxel Injection. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with Docetaxel Injection until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor s instructions for how often to take your temperature while taking Docetaxel Injection. Call your doctor right away if you have a fever.
    3.
    Serious allergic reactionscan happen in people who take Docetaxel Injection. Serious allergic reactions are medical emergencies that can lead to death and must be treated right away.
    Tell your doctor right away if you have any of these signs of a serious allergic reaction:
    4.
    trouble breathing
    5.
    sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    6.
    hives (raised bumps), rash, or redness all over your body
    4.
    Your body may hold too much fluid (severe fluid retention)during treatment with Docetaxel Injection. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each Docetaxel Injection treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your Docetaxel Injection treatment if you forget to take corticosteroid dose or do not take it as your doctor tells you.

    Docetaxel Injection Is A Prescription Anti-cancer Medicine Used To Treat Certain People With: 

    breast cancer
    non-small cell lung cancer
    prostate cancer
    stomach cancer
    head and neck cancer
    It is not known if Docetaxel Injection is effective in children.

    Before You Receive Docetaxel Injection, Tell Your Doctor If You: 

    1.
    are allergic to any medicines.

    Docetaxel Injection will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
    Docetaxel Injection is usually given every 3 weeks.
    Your doctor will decide how long you will receive treatment with Docetaxel Injection.
    Your doctor will check your blood cell counts and other blood tests during your treatment with Docetaxel Injection to check for side effects of Docetaxel Injection.
    Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Docetaxel Injection.

    Active Ingredient: 

    docetaxel anhydrous USP

    Oral Corticosteroid Dosing: 

    Date:________ Time:_____

    Date:________ Time:_____

    (Docetaxel Injection Treatment Day)

    Time:_____

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80mg/2 mL -Before Initial Dilution

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg-Diluent

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/05 - Before Initial Dilution

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg-Diluent
    DOCETAXEL
    docetaxel injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63739-971
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCETAXEL ANHYDROUS(UNII: 699121PHCA) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)DOCETAXEL ANHYDROUS20 mg in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)4 mg in 1 mL
    POLYSORBATE 80(UNII: 6OZP39ZG8H)520 mg in 1 mL
    ALCOHOL(UNII: 3K9958V90M)395 mg in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-971-171 in 1 CARTON01/01/2015
    14 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20119507/01/2012
    DOCETAXEL
    docetaxel injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63739-932
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCETAXEL ANHYDROUS(UNII: 699121PHCA) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)DOCETAXEL ANHYDROUS20 mg in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)4 mg in 1 mL
    POLYSORBATE 80(UNII: 6OZP39ZG8H)520 mg in 1 mL
    ALCOHOL(UNII: 3K9958V90M)395 mg in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-932-111 in 1 CARTON01/01/2015
    11 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20119505/15/2013
    Labeler -McKesson Packaging Services a business unit of McKesson Corporation (140529962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intas Pharmaceuticals Limited915837971ANALYSIS(63739-971, 63739-932) , MANUFACTURE(63739-971, 63739-932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intas Pharmaceuticals Limited725927649ANALYSIS(63739-971, 63739-932) , MANUFACTURE(63739-971, 63739-932)

    Revised: 11/2016document Id: 

    d0cd1191-df76-4b7f-9518-e5f941c347a7Set id: c482c813-1eb7-40dd-907a-845a7df112bfVersion: 7Effective Time: 20161129McKesson Packaging Services a business unit of McKesson Corporation

    What Is The Most Important Information I Should Know About Docetaxel Injection? 

    Docetaxel Injection can cause serious side effects, including death.

    Tell Your Healthcare Provider Right Away If You Have Any Of These Signs Of A Severe Allergic Reaction: 

    o
    trouble breathing
    o
    sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    o
    hives (raised bumps), rash, or redness all over your body
    Your body may hold too much fluid (severe fluid retention)during treatment with Docetaxel Injection. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each Docetaxel Injection treatment. You must take the corticosteroid exactly as your healthcare provider tells you. Tell your healthcare provider or nurse before your Docetaxel Injection treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you. Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath.

    Do Not Receive Docetaxel Injection If You: 

    have a low white blood cell count
    have had a severe allergic reaction to:
    o
    docetaxel, the active ingredient in Docetaxel Injection
    or
    o
    any other medicines that contain polysorbate 80. Ask your healthcare provider or pharmacist if you are not sure.

    Docetaxel Injection will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
    Docetaxel Injection is usually given every 3 weeks.
    Your healthcare provider will decide how long you will receive treatment with Docetaxel Injection.
    Your healthcare provider will check your blood cell counts and other blood tests during your treatment with Docetaxel Injection to check for side effects of Docetaxel Injection.
    Your healthcare provider may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Docetaxel Injection.

    What Are The Possible Side Effects Of Docetaxel Injection? 

    Docetaxel Injection may cause serious side effects including death.

    "
    Acute Myeloid Leukemia (AML),a type of blood cancer, can happen in people who receive Docetaxel Injection along with certain other medicines.
    Other Blood Disorders.Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection.
    Skin Reactionsincluding redness and swelling of your arms and legs with peeling of your skin. Tell your healthcare provider if you have any skin reactions.
    Neurologic Problems.Neurologic symptoms are common in people who receive Docetaxel Injection, but can be severe. Tell your healthcare provider if you have any numbness, tingling, or burning in your hands or feet (peripheral neuropathy) or weakness of your legs, feet, arms, or hands (motor weakness).
    Vision Problemsincluding blurred vision or loss of vision. Tell your healthcare provider right away if you have any vision changes.
    Docetaxel Injection contains alcohol.The alcohol content in Docetaxel Injection may impair your ability to drive or use machinery right after receiving Docetaxel Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Docetaxel Injection treatment.

    The most common side effects of Docetaxel Injection include:

    infections
    low white blood cells (help fight infections), low red blood cells (anemia), and low platelets (help blood to clot)
    allergic reactions ()
    changes in your sense of taste
    shortness of breath
    constipation
    decreased appetite
    changes in your fingernails or toenails
    swelling of your hands, face or feet
    feeling weak or tired
    joint and muscle pain
    nausea and vomiting
    diarrhea
    mouth or lips sores
    hair loss: in some people, permanent hair loss has been reported
    redness of the eye, excess tearing
    skin reactions at the site of Docetaxel Injection administration such as increased skin pigmentation, redness, tenderness, swelling, and warmth or dryness of the skin
    tissue damage if Docetaxel Injection leaks out of the vein into the tissues

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

    Call your healthcare provider 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 Docetaxel Injection

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Docetaxel Injection that is written for healthcare professionals.

    Inactive Ingredients: 

    alcohol, citric acid, polyethylene glycol 300, and polysorbate 80

    Every three-week injection of Docetaxel Injection for breast, non-small cell lung, and stomach, and head and neck cancers

    Take your oral corticosteroid medicine as your healthcare provider tells you.

    Oral corticosteroiddosing:

    Day 1Date:________ Time: _____AM_____ PM

    Day 2Date:________ Time: _____AM_____ PM

    (Docetaxel Injection Treatment Day)

    Day 3Date:________ Time: _____AM_____ PM

    Every three-week injection of Docetaxel Injection for prostate cancer

    Take your oral corticosteroid medicine as your healthcare provider tells you.

    Oral corticosteroiddosing:

    Date:________ Time: ________

    Date:________ Time: ________

    (Docetaxel Injection Treatment Day)

    Time: ________

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Manufactured For: 

    Logo 1

    Princeton, NJ 08540

    Manufactured By: 

    Logo 2

    EBEWE Pharma Ges.m.b.H. Nfg.KG

    A-4866 Unterach, Austria

    For more information, call 1-800-525-8747.

    Revised: March 2019



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