Docetaxel (Page 12 of 12)

15. REFERENCES

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

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

One-vial formulation (Injection)

Docetaxel Injection is supplied in single dose and multiple dose vials as a sterile, pyrogen-free, non-aqueous solution.

Docetaxel Injection 80 mg/4 mL: The vial is in one carton. NDC 63739-971-17

Docetaxel Injection 20 mg/mL: The vial is in one carton. NDC 63739-932-11

16.2 Storage

Two-vial formulation (Injection with Diluent)

Store at 25°C (77°F); excursions permitted from 15°C — 30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

One-vial formulation (Injection)

Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.

After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.

16.3 Handling and Disposal

Follow procedures for proper handling and disposal of anticancer drugs. 1

17. PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Docetaxel Injection may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug. Women of childbearing potential should use effective contraceptives if receiving Docetaxel Injection [see Warnings and Precautions (5.12) and Use in Specific Populations (8.1)].
Obtain detailed allergy and concomitant drug information from the patient prior to Docetaxel Injection administration.
Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report if they were not compliant with oral corticosteroid regimen.
Instruct patients to immediately report signs of a hypersensitivity reaction.
Tell patients to watch for signs of fluid retention such as peripheral edema in the lower extremities, weight gain and dyspnea.
Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.
Instruct patients to report myalgia, cutaneous, or neurologic reactions.
Explain to patients the possible effects of the alcohol content in Docetaxel Injection, including possible effects on the central nervous system. Patients in whom alcohol should be avoided or minimized should consider the alcohol content of Docetaxel Injection. Alcohol could impair their ability to drive or use machines immediately after infusion.
Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.

Manufactured by:

Intas Pharmaceuticals Limited,

Ahmedabad-380 009, India.

Distributed by:

McKesson Packaging Services,

A business unit of McKesson Corporation.

7101 Weddington Rd, Concord, NC 28027

Toll Free: 1-888-243-4363

10 10580 2 665816

Revised July 2016

INP058

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: July 2016
Patient Information
DOCETAXEL (doe-se-TAKS-el) injection for intravenous use

Read this Patient Information before you receive your first treatment with Docetaxel Injection and each time before you are treated. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

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:
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 reactions can 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.
What is Docetaxel Injection? 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.

Who should not receive Docetaxel Injection?

Do not receive Docetaxel Injection if you:
1.
have had a severe allergic reaction to: ‑ docetaxel, the active ingredient in Docetaxel Injection, or ‑ any other medicines that contain polysorbate 80. Ask your doctor 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.
2.
have a low white blood cell count.
What should I tell my doctor before receiving Docetaxel Injection? Before you receive Docetaxel Injection, tell your doctor if you:
1.
are allergic to any medicines. See “ Who should not receive Docetaxel Injection?” Also, see the end of this leaflet for a complete list of the ingredients in Docetaxel Injection.
2.
have liver problems
3.
have any other medical conditions
4.
are pregnant or plan to become pregnant. Docetaxel Injection can harm your unborn baby.
5.
are breastfeeding or plan to breastfeed. It is not known if Docetaxel Injection passes into your breast milk. You and your doctor should decide if you will receive Docetaxel Injection or breastfeed.
Tell your doctor 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 doctor 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 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.

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 take 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 Reactions including redness and swelling of your arms and legs with peeling of your skin.
Neurologic Symptoms including numbness, tingling, or burning in your hands and feet.
Vision Problems including 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:

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 most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.
rash
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 doctor if you have any side effect that bothers you or does not go 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 Docetaxel Injection Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. This Patient Information leaflet summarizes the most important information about Docetaxel Injection. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Docetaxel Injection that is written for health professionals.

What are the ingredients in Docetaxel Injection?

Two-vial formulation (Injection with Diluent)

Active ingredient: docetaxel anhydrous USP

Inactive ingredients: dehydrated alcohol, polysorbate 80, anhydrous citric acid and polyethylene glycol 400

One-vial formulation (Injection)

Active ingredient: docetaxel anhydrous USP

Inactive ingredients: anhydrous citric acid, polysorbate 80 and dehydrated alcohol

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.

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 doctor tells you.

Oral corticosteroid dosing:

Date:________ Time:_____

Date:________ Time:_____

(Docetaxel Injection Treatment Day)

Time:_____

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 80mg/2 mL -Before Initial Dilution
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 80 mg-Diluent
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg/05 -- Before Initial Dilution
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg-Diluent
(click image for full-size original)
DOCETAXEL docetaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-971
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID 4 mg in 1 mL
POLYSORBATE 80 520 mg in 1 mL
ALCOHOL 395 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-971-17 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 4 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63739-971-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201195 07/01/2012
DOCETAXEL docetaxel injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-932
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS (DOCETAXEL ANHYDROUS) DOCETAXEL ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID 4 mg in 1 mL
POLYSORBATE 80 520 mg in 1 mL
ALCOHOL 395 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-932-11 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 1 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63739-932-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201195 05/15/2013
Labeler — McKesson Packaging Services a business unit of McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 ANALYSIS (63739-971), ANALYSIS (63739-932), MANUFACTURE (63739-971), MANUFACTURE (63739-932)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 ANALYSIS (63739-971), ANALYSIS (63739-932), MANUFACTURE (63739-971), MANUFACTURE (63739-932)

Revised: 11/2016 McKesson Packaging Services a business unit of McKesson Corporation

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