Docetaxel (Page 11 of 11)

15 REFERENCES

1. “OSHA Hazardous Drugs.” http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

One-vial Docetaxel Injection USP

Docetaxel Injection USP, 20 mg/mL, (one-vial formulation) is supplied in a single-dose vial as a sterile, pyrogen-free, nonaqueous solution. Discard unused portion.

Docetaxel Injection USP 20 mg/mL (NDC 57884-3041-1)

Docetaxel Injection USP 20 mg/1 mL : 20 mg docetaxel in 1 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

The vial is in a blister pack in one carton.

Docetaxel Injection USP 80 mg/4mL (NDC 57884-3042-1)

Docetaxel Injection USP 80 mg/4 mL : 80 mg docetaxel in 4 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

The vial is in a blister pack in one carton.

Docetaxel Injection USP 160 mg/8mL (NDC 57884-3043-1)

Docetaxel Injection USP 160 mg/8 mL : 160 mg docetaxel in 8 mL 50/50 (v/v) ratio polysorbate 80/dehydrated alcohol.

The vial is in a blister pack in one carton.

16.2 Storage

Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.

16.3 Handling and Disposal

Docetaxel Injection USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

17 PATIENT COUNSELING 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), 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), 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), Warnings 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), 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), 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), 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)].

Tumor Lysis Syndrome
Advise patients of the potential risk of tumor lysis syndrome and to immediately report any signs or symptoms associated with this event (nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps) to their healthcare provider. Advise patients of the importance of keeping scheduled appointment for blood work or other laboratory tests and of drinking adequate fluids to avoid dehydration. [see Warnings and Precautions (5.14)].

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)].

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

Revised: June 2020

10VUF05

Patient Information

Docetaxel (doe” se tax’ el) Injection

for intravenous use

What is the most important information I should know about Docetaxel Injection?

Docetaxel Injection can cause serious side effects, including death.

  1. 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
  2. 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.
  3. 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.
  4. Severe allergic reactions are 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
  5. 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.
  • 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.

  • Severe skin problems

Tell your healthcare provider right away if you have any of these signs of a severe skin reaction:
◦ redness and swelling of your arms and legs.
◦ blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches.
◦ red, scaly rash all over your body with blisters small red or white bumps under the skin that contain pus (pustules) and fever.

What is Docetaxel Injection?

Docetaxel Injection is a prescription anticancer 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.

    See “ What is the most important information I should know about Docetaxel Injection?” for the signs and symptoms of a severe allergic reaction.

See the end of this Patient Information for a complete list of the ingredients in Docetaxel Injection.

Before you receive Docetaxel Injection, tell your healthcare provider about all of your medical conditions, including if you:

  • are allergic to any medicines, including paclitaxel. See ” Do not receive Docetaxel Injection if you “.
  • have liver problems
  • have kidney problems
  • are pregnant or plan to become pregnant. Docetaxel Injection can harm your unborn baby. You should not become pregnant during treatment with Docetaxel Injection. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with Docetaxel Injection.

Females who are able to become pregnant:

o Your healthcare provider will check to see if you are pregnant before you start treatment with Docetaxel Injection.

o You should use effective birth control (contraception) during treatment with Docetaxel Injection and for 6 months after the last dose.
Males with female partners who are able to become pregnant should use effective birth control during treatment with Docetaxel Injection and for 3 months after the last dose.

Talk to your healthcare provider if you have questions about birth control options that are right for you.

  • are breastfeeding or plan to breastfeed. It is not known if Docetaxel Injection passes into your breast milk. Do not breastfeed during treatment with Docetaxel Injection and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Docetaxel Injection may affect the way other medicines work, and other medicines may affect the way Docetaxel Injection works.

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

How will I receive Docetaxel Injection?

  • 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.

  • See “ What is the most important information I should know about Docetaxel Injection?”
  • 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 problems including 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.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, or heart problems, and may lead to death. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with Docetaxel Injection. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with Docetaxel Injection, including:
  • nausea
  • irregular heartbeat
  • vomiting
  • dark or cloudy urine
  • confusion
  • reduced amount of urine
  • shortness of breath
  • unusual tiredness
  • muscle cramps
  • 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
  • low white blood cells (help fight infections), low red blood cells (anemia) and low platelets (help blood to clot)
  • allergic reactions (See “ What is the most important information I should know about Docetaxel Injection? ”)
  • 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 administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
  • 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.

What are the ingredients in Docetaxel Injection?

Active ingredient: docetaxel

Inactive ingredients: polysorbate 80 and dehydrated alcohol solution

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: 06/2020

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 corticosteroid dosing:
Day 1 Date: ________ Time:_____ AM ______ PM
Day 2 Date: ________ Time:_____ AM ______ PM
(Docetaxel Injection Treatment Day)
Day 3 Date: ________ 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 corticosteroid dosing:
Date: _________ Time: ________
Date: _________ Time: ________
( Docetaxel Injection Treatment Day)
Time: ________

Revised: June 2020

10VUF05

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
DOCETAXEL docetaxel injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57884-3041
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57884-3041-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (57884-3041-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207252 08/09/2017
DOCETAXEL docetaxel injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57884-3042
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 80 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57884-3042-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 4 mL in 1 VIAL, GLASS This package is contained within the CARTON (57884-3042-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207252 08/09/2017
DOCETAXEL docetaxel injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57884-3043
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 160 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57884-3043-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 8 mL in 1 VIAL, GLASS This package is contained within the CARTON (57884-3043-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207252 08/09/2017
Labeler — Jiangsu Hengrui Medicine Co., Ltd. (654147255)

Revised: 06/2020 Jiangsu Hengrui Medicine Co., Ltd.

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