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DOCETAXEL injection, solution, concentrate


  1. The Chance Of Death In People Who Receive Docetaxel Injection Usp Is Higher If You:
  2. Docetaxel Injection Usp Is A Prescription Anti-cancer Medicine Used To Treat Certain People With:
  3. Do Not Receive Docetaxel Injection Usp If You:
  4. What Are The Possible Side Effects Of Docetaxel Injection Usp?
  5. Active Ingredient:
  6. Manufactured By:
  7. Distributed By:
  8. Oral Corticosteroid Dosing:
  9. Revised: 6/2019document Id:
  10. Have A Low White Blood Cell Count.have Had A Severe Allergic Reaction To:
  11. The Most Common Side Effects Of Docetaxel Injection Usp Include:
  12. Oral Corticosteroiddosing:
  13. What Is The Most Important Information I Should Know About Docetaxel Injection?
  14. The Chance Of Death In People Who Receive Docetaxel Injection Is Higher If You:
  15. Tell Your Healthcare Provider Right Away If You Have Any Of These Signs Of A Severe Allergic Reaction:
  16. Docetaxel Injection Is A Prescription Anti-cancer Medicine Used To Treat Certain People With:
  17. Do Not Receive Docetaxel Injection If You:
  18. What Are The Possible Side Effects Of Docetaxel Injection?
  19. The Most Common Side Effects Of Docetaxel Injection Include:
  20. Inactive Ingredients:
  21. Patient Information

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

  • have liver problems
  • receive high doses of Docetaxel Injection USP
  • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
  • Docetaxel Injection USP can affect your blood cells.Your healthcare provider should do routine blood tests during treatment with Docetaxel Injection USP. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your healthcare provider may not treat you with Docetaxel Injection USP 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 healthcare provider's instructions for how often to take your temperature during treatment with Docetaxel Injection USP. Call your healthcare provider right away if you have a fever.
  • Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever.
  • Severe allergic reactionsare medical emergencies that can happen in people who receive Docetaxel Injection USP and can lead to death. You may be at higher risk of developing a severe allergic reaction to Docetaxel Injection USP if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your Docetaxel Injection USP infusion.
    Tell your healthcare provider right away if you have any of these signs of a severe allergic reaction:
    • trouble breathing
    • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    • 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 USP. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each Docetaxel Injection USP treatment. You must take the corticosteroid exactly as your healthcare provider tells you. Tell your healthcare provider or nurse before your Docetaxel Injection, USP 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.
  • Docetaxel Injection Usp 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 USP is effective in children.

    Do Not Receive Docetaxel Injection Usp If You: 

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

      • Docetaxel Injection USP will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
      • Docetaxel Injection USP is usually given every 3 weeks.
      • Your healthcare provider will decide how long you will receive treatment with Docetaxel Injection USP.
      • Your healthcare provider will check your blood cell counts and other blood tests during your treatment with Docetaxel Injection USP to check for side effects of Docetaxel Injection USP.
      • 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 USP.

    What Are The Possible Side Effects Of Docetaxel Injection Usp? 

    Docetaxel Injection USP may cause serious side effects including death.

    • )
    • 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 lip 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 USP administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
    • tissue damage if Docetaxel Injection USP leaks out of the vein into the tissues

    Tell your healthcare provider 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.

    Docetaxel Injection USP may affect fertility in males. Talk to your healthcare provider if this is a concern for you.

    These are not all the possible side effects of Docetaxel Injection, USP. 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 USP.

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

    Active Ingredient: 

    docetaxel

    Manufactured By: 

    Jiangsu Hengrui Medicine Co., Ltd.

    Lianyungang, Jiangsu 222047 China

    Distributed By: 

    eVenus Pharmaceutical Laboratories, Inc. (eVenus)

    506 Carnegie Center, Suite 100, NJ 08540, USA

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


    Revised: 06/2019

    Every three-week injection of Docetaxel Injection USP 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 Corticosteroid Dosing: 

    Date: _________ Time: ________Date: _________ Time: ________( Docetaxel Injection USP Treatment Day)Time: ________

    Revised: June 2019

    10VUF03

    PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

    NDC 57884-3041-1

    Rx only

    Docetaxel Injection USP

    20 mg/mL

    1 mL single dose vial

    For Intravenous Infusion Only

    Ready to add to infusion solution.

    See package insert for complete instructions.

    20mg vial label

    PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

    NDC 57884-3042-1

    Rx only

    Docetaxel Injection USP

    80 mg/4 mL (20 mg/mL)

    4 mL single dose vial

    For Intravenous Infusion Only

    Ready to add to infusion solution.

    See package insert for complete instructions.

    80mg vial label

    PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

    NDC 57884-3043-1

    Rx only

    Docetaxel Injection USP

    160 mg/8 mL (20 mg/mL)

    8 mL single dose vial

    For Intravenous Infusion Only

    Ready to add to infusion solution.

    See package insert for complete instructions.

    160mg vial label

    DOCETAXEL
    docetaxel injection, solution, concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57884-3041
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCETAXEL(UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)DOCETAXEL ANHYDROUS20 mg in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57884-3041-11 in 1 CARTON08/09/2017
    11 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20725208/09/2017
    DOCETAXEL
    docetaxel injection, solution, concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57884-3042
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCETAXEL(UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)DOCETAXEL ANHYDROUS80 mg in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57884-3042-11 in 1 CARTON08/09/2017
    14 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20725208/09/2017
    DOCETAXEL
    docetaxel injection, solution, concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57884-3043
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCETAXEL(UNII: 15H5577CQD) (DOCETAXEL ANHYDROUS - UNII:699121PHCA)DOCETAXEL ANHYDROUS160 mg in 8 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57884-3043-11 in 1 CARTON08/09/2017
    18 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20725208/09/2017
    Labeler -Jiangsu Hengrui Medicine Co., Ltd. (654147255)

    Revised: 6/2019document Id: 

    90cbbcf1-4cb8-2b10-e053-2995a90ac175Set id: e488100d-6728-4f44-9282-f63a805b8e13Version: 7Effective Time: 20190623Jiangsu Hengrui Medicine Co., Ltd.

    Have A Low White Blood Cell Count.have Had A Severe Allergic Reaction To: 

    docetaxel, the active ingredient in Docetaxel Injection USP, or
    any other medicines that contain polysorbate 80. Ask your healthcare provider or pharmacist if you are not sure.

    Docetaxel Injection USP will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
    Docetaxel Injection USP is usually given every 3 weeks.
    Your healthcare provider will decide how long you will receive treatment with Docetaxel Injection USP.
    Your healthcare provider will check your blood cell counts and other blood tests during your treatment with Docetaxel Injection USP to check for side effects of Docetaxel Injection USP.

    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 USP.

    What are the possible side effects of Docetaxel Injection USP? Docetaxel Injection USP may cause serious side effects including death.

    Risk of new cancers.An increase in new (second) cancers has happened in people treated with Docetaxel Injection USP together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin s Lymphoma (NHL), and kidney cancer.

    Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection USP.

    Your healthcare provider will check you for new cancers during and after your treatment with Docetaxel Injection USP.

    Skin reactionsincluding redness and swelling of your arms and legs with peeling of your skin. Tell your healthcare provider if you are having a skin reaction.
    Neurologic problems.Neurologic symptoms are common in people who receive Docetaxel Injection USP but can be severe. Tell your healthcare provider right away if you have 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 USP contains alcohol.The alcohol content in Docetaxel Injection USP may impair your ability to drive or use machinery right after receiving Docetaxel Injection USP. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Docetaxel Injection USP treatment.

    You may experience side effects of this medicine that may impair your ability to drive, use tools, or operate machines.

    If this happens, do not drive or use any tools or machines before discussing with your healthcare provider.

    The Most Common Side Effects Of Docetaxel Injection Usp Include: 

    infections
    low white blood cells (help fight infections), low red blood cells (anemia) and low platelets (help blood to clot)
    allergic reactions (

    Oral Corticosteroiddosing: 

    Day 1Date: ________ Time:_____ AM ______ PM

    Day 2Date: ________ Time:_____ AM ______ PM

    (Docetaxel Injection USP Treatment Day)

    Day 3Date: ________ Time:_____ AM ______ PM

    Every three-week injection ofDocetaxel Injection USP for prostate cancer

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

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

    Docetaxel Injection can cause serious side effects, including death.

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

    • have liver problems
    • receive high doses of Docetaxel Injection
    • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
  • Docetaxel Injection can affect your blood cells.Your healthcare provider 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 healthcare provider may not treat you with Docetaxel Injection until you have enough white blood cells. People with low white blood cell counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your healthcare provider s instructions for how often to take your temperature during treatment with Docetaxel Injection. Call your healthcare provider right away if you have a fever.
  • Swelling (inflammation) of the small intestine and colon.This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever.
  • Severe allergic reactionsare medical emergencies that can happen in people who receive Docetaxel Injection and can lead to death. You may be at higher risk of developing a severe allergic reaction to Docetaxel Injection if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your Docetaxel Injection infusion.
  • Tell Your Healthcare Provider Right Away If You Have Any Of These Signs Of A Severe Allergic Reaction: 

    • trouble breathing
    • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    • 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.

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

    for the signs and symptoms of a severe allergic reaction.

    • 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.

    • Risk of new cancers.An increase in new (second) cancers has happened in people treated with Docetaxel Injection together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin s Lymphoma (NHL), and kidney cancer.
      • Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docetaxel Injection.
        Your healthcare provider will check you for new cancers during and after your 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 are having a skin reaction.
    • Neurologic problems.Neurologic symptoms are common in people who receive Docetaxel Injection but can be severe. Tell your healthcare provider right away if you have 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.
    • You may experience side effects of this medicine that may impair your ability to drive, use tools, or operate machines. If this happens, do not drive or use any tools or machines before discussing with your healthcare provider.

    The Most Common Side Effects Of Docetaxel Injection Include: 

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

    Tell your healthcare provider 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.

    Docetaxel Injection may affect fertility in males. Talk to your healthcare provider if this is a concern for you.

    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 this Patient Information. You can ask your pharmacist or healthcare provider for information about Docetaxel Injection that is written for health professionals.

    Inactive Ingredients: 

    citric acid anhydrous, kollidon 12 PF (povidone P12), polysorbate 80, and ethanol

    Made in Italy

    Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA

    For more information call 1-800-432-8534.

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

    Revised: 7/2019

    chart

    Patient Information 

    Advise the patient to read the FDA-approved Patient Labeling (Patient Information).

    Bone Marrow Suppression

    Advise patients that periodic assessment of their blood count will be performed to detect neutropenia, thrombocytopenia and/ or anemia[see Contraindications (4) and Warnings and Precautions (5.3)]. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.

    Enterocolitis and Neutropenic Colitis

    Advise patients of the symptoms of colitis, such as abdominal pain or tenderness, and/or diarrhea, with or without fever, and instruct patients to promptly contact their healthcare provider if they experience these symptoms[see Dosage and Administration (2.7) and Warnings and Precautions (5.4)].

    Hypersensitivity Reactions

    Ask patients whether they have previously received paclitaxel therapy, and if they have experienced a hypersensitivity reaction to paclitaxel. Instruct patients to immediately report to their healthcare provider signs of a hypersensitivity reaction.[see Contraindications (4)andWarnings and Precautions (5.5)].

    Fluid Retention

    Advise patients to report signs of fluid retention such as peripheral edema in the lower extremities, weight gain and dyspnea immediately to their healthcare provider[see Warnings and Precautions (5.6)].

    Second Primary Malignancies

    Advise patients on the risk of second primary malignancies during treatment with Docetaxel Injection[see Warnings and Precautions (5.7)].

    Cutaneous Reactions

    Advise patients that localized erythema of the extremities and severe skin toxicities may occur. Instruct patients to immediately report severe cutaneous reactions to their healthcare provider[see Dosage and Administration (2.7) and Warnings and Precautions (5.8)].

    Neurologic Reactions

    Advise patients that neurosensory symptoms or peripheral neuropathy may occur. Instruct patients to immediately report neurologic reactions to their healthcare provider[see Dosage and

    Administration (2.7) and Warnings and Precautions (5.9)].

    Eye Disorders

    Advise patients that vision disturbances and excessive tearing are associated with Docetaxel Injection administration. Instruct patients to immediately report any vision changes to their healthcare provider[see Warnings and Precautions (5.10)].

    Gastrointestinal Reactions

    Explain to patients that nausea, vomiting, diarrhea, and constipation are associated with Docetaxel Injection administration. Instruct patients to report any severe events to their healthcare provider[see Adverse Reactions (6)].

    Cardiac disorders

    Advise patients to report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting immediately to their healthcare provider[see Adverse Reactions (6)].

    Other Common Adverse Reactions

    Advise patients that other common adverse reactions associated with Docetaxel Injection may include alopecia (cases of permanent hair loss have been reported), asthenia, anorexia, dysgeusia, mucositis, myalgia, nail disorders, or pain. Instruct patients to report these reactions to their

    healthcare provider if serious events occur[see Adverse Reactions (6)].

    Importance of Corticosteroids

    Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report to their healthcare provider if they were not compliant with the oral corticosteroid regimen[see Dosage and Administration (2.6)].

    Embryo-Fetal Toxicity

    Docetaxel Injection can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 6 months after the last dose of Docetaxel Injection. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of Docetaxel Injection[see Warnings and Precautions (5.12), and Use in Specific Populations (8.1, 8.3)].

    Lactation

    Advise women not to breastfeed during Docetaxel Injection treatment and for 1 week after the last dose[see Use in Specific Populations (8.2)].

    Infertility

    Advise males of reproductive potential that Docetaxel Injection may impair fertility[see Nonclinical Toxicology (13.1)].

    Alcohol Content in Docetaxel Injection

    Explain to patients the possible effects of the alcohol content in Docetaxel Injection, including possible effects on the central nervous system[see Warnings and Precautions (5.13)].

    Ability to Drive or Operate Machines

    Explain to patients that Docetaxel Injection may impair their ability to drive or operate machines due to its side effects[see Adverse Reactions (6)]or due to the alcohol content of Docetaxel Injection[see Warnings and Precautions (5.13)]. Advise them not to drive or use machines if they experience these side effects during treatment.

    Drug Interactions

    Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to their healthcare provider[see Drug Interactions (7)].

    Made in Italy



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