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CASPOFUNGIN ACETATE injection, powder, lyophilized, for solution


  1. Patient Information
  2. Revised: 3/2019document Id:

Patient Information 

Hypersensitivity

Inform patients that anaphylactic reactions have been reported during administration of caspofungin. Caspofungin can cause hypersensitivity reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm. Inform patients to report these signs or symptoms to their healthcare providers.

Hepatic Effects

Inform patients that there have been isolated reports of serious hepatic effects from caspofungin therapy.

Use in Pregnancy and Breastfeeding Mothers

Advise female patients of the potential risks to a fetus. Instruct patients to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant. Instruct patients to tell their healthcare provider if they plan to breastfeed their infant.

Brands listed are the trademarks of their respective owners.

Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
2019 Athenex.

Revised: March 2019

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-106-10

Caspofungin Acetate for Injection

50 mg per vial

Rx only

For Intravenous Use Only

Single-Dose Vial

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-107-10

Caspofungin Acetate for Injection

70 mg per vial

Rx only

For Intravenous Use Only

Single-Dose Vial

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label
CASPOFUNGIN ACETATE
caspofungin acetate injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70860-106
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
caspofungin acetate(UNII: VUW370O5QE) (caspofungin - UNII:F0XDI6ZL63)caspofungin acetate50 mg in 10.8 mL
Inactive Ingredients
Ingredient NameStrength
mannitol(UNII: 3OWL53L36A)
sucrose(UNII: C151H8M554)
acetic acid(UNII: Q40Q9N063P)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70860-106-101 in 1 CARTON10/04/2017
110.8 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20709210/04/2017
CASPOFUNGIN ACETATE
caspofungin acetate injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70860-107
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
caspofungin acetate(UNII: VUW370O5QE) (caspofungin - UNII:F0XDI6ZL63)caspofungin acetate70 mg in 10.8 mL
Inactive Ingredients
Ingredient NameStrength
mannitol(UNII: 3OWL53L36A)
sucrose(UNII: C151H8M554)
acetic acid(UNII: Q40Q9N063P)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70860-107-101 in 1 CARTON10/04/2017
110.8 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20709210/04/2017
Labeler -Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 3/2019document Id: 

f564b9a1-3773-499d-b1c4-50d2062f5d36Set id: f19aac21-b4a9-44f4-963e-f48991b3cba9Version: 3Effective Time: 20190331Athenex Pharmaceutical Division, LLC.



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