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DOCETAXEL- docetaxel anhydrous injection, solution


  1. Do Not Receive Docetaxel Injection, Usp If You:
  2. What Are The Possible Side Effects Of Docetaxel Injection, Usp?
  3. Active Ingredient:
  4. Inactive Ingredients:
  5. Oral Corticosteroid Dosing:
  6. Revised: 7/2019document Id:
  7. Patient Information
  8. Manufactured For:

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.

Active Ingredient: 

docetaxel

Inactive Ingredients: 

polysorbate 80 and dehydrated alcohol solution
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: ________

SAGENT
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in China
2019 Sagent Pharmaceuticals, Inc.

Revised: July 2019

SAGENT Pharmaceuticals

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 25021-245-01

Rx only

Docetaxel Injection, USP

20 mg per mL

1 mL single dose vial

For Intravenous Infusion Only

Ready to add to infusion solution.

See package insert for complete instructions.

Warning: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 25021-245-04

Rx only

Docetaxel Injection, USP

80 mg per 4 mL

(20 mg per mL)

4 mL single dose vial

For Intravenous Infusion Only

Ready to add to infusion solution.

See package insert for complete instructions.

Warning: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label
DOCETAXEL
docetaxel anhydrous injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25021-245
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
Polysorbate 80(UNII: 6OZP39ZG8H)
Alcohol(UNII: 3K9958V90M)
Anhydrous citric acid(UNII: XF417D3PSL)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25021-245-011 in 1 CARTON09/15/2017
11 mL in 1 VIAL; Type 0: Not a Combination Product
2NDC:25021-245-041 in 1 CARTON09/15/2017
24 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20725209/15/2017
Labeler -Sagent Pharmaceuticals (796852890)

Revised: 7/2019document Id: 

a55c8fba-f3c4-467f-92ae-c00a54d60458Set id: 30077f79-341f-4618-9ec5-23b17b212faeVersion: 3Effective Time: 20190723Sagent Pharmaceuticals

Patient 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 [seeWarnings and Precautions (5.11)andUse in Specific Populations (8.1)].
  • Obtain detailed allergy and concomitant drug information from the patient prior to Docetaxel Injection, USP 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 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 Injection administration.
  • Explain to patients the possible side effects of the alcohol content in Docetaxel Injection, including possible side 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.

Manufactured For: 

Ingenus Pharmaceuticals, LLC

Orlando, FL 32839-6408

Made in Switzerland

Revision: 06/2019



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