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ERBITUX- cetuximab solution


  1. Patient Information
  2. Revised: 4/2019document Id:

Patient Information 

Infusion Reactions

Advise patients that the risk of serious infusion reactions may be increased in patients who have had a tick bite or red meat allergy. Advise patients to contact their healthcare provider and to report signs and symptoms of infusion reactions, including late onset infusion reactions, such as fever, chills, or breathing problems[see Warnings and Precautions (5.1)].

Cardiopulmonary Arrest

Advise patients of the risk of cardiopulmonary arrest or sudden death and to report any history of coronary artery disease, congestive heart failure, or arrhythmias[see Warnings and Precautions (5.2)].

Pulmonary Toxicity

Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath[see Warnings and Precautions (5.3)].

Dermatologic Toxicities

Advise patients to limit sun exposure during ERBITUX treatment and for 2 months after the last dose of ERBITUX. Advise patients to notify their healthcare provider of any sign of acne-like rash, (which can include itchy, dry, scaly, or cracking skin and inflammation, infection or swelling at the base of the nails or loss of the nails), conjunctivitis, blepharitis, or decreased vision[see Warnings and Precautions (5.4)].

Embryo-Fetal Toxicity

Advise female patients of reproductive potential of the potential risk to a fetus and to use effective contraception during ERBITUX treatment and for 2 months after the last dose of ERBITUX. Advise patients to inform their healthcare provider of a known or suspected pregnancy[see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].

Lactation

Advise patients not to breastfeed during ERBITUX treatment and for 2 months after the last dose of ERBITUX[see Use in Specific Populations (8.2)].

ERBITUXis a registered trademark of ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company.

Manufactured by ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA

Eli Lilly and Company, Indianapolis, IN 46285, USA
US License No. 1827

Copyright 2004, 2019, ImClone LLC a wholly-owned subsidiary of Eli Lilly and Company. All rights reserved.

ERB-0005-USPI-20190423

PACKAGE LABEL- Erbitux 50 mL (2mg/mL) Vial Carton

NDC 66733-948-23

ERBITUX

CETUXIMAB

Injection

For intravenous infusion

Rx only

100 mg/50 mL

(2 mg/mL)

DO NOT DILUTE

Lilly

erbitux-100mg-car

PACKAGE LABEL- Erbitux 100 mL (2mg/mL) Vial Carton

NDC 66733-958-23

ERBITUX

CETUXIMAB

Injection

For intravenous infusion

Rx only

200 mg/100 mL

(2 mg/mL)

DO NOT DILUTE

Lilly

erbitux-200mg-car
ERBITUX
cetuximab solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66733-948
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetuximab(UNII: PQX0D8J21J) (cetuximab - UNII:PQX0D8J21J)cetuximab2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.48 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)1.88 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)0.41 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66733-948-231 in 1 CARTON02/12/2004
150 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12508402/12/2004
ERBITUX
cetuximab solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66733-958
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetuximab(UNII: PQX0D8J21J) (cetuximab - UNII:PQX0D8J21J)cetuximab2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.48 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)1.88 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)0.41 mg in 1 mL
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66733-958-231 in 1 CARTON10/02/2007
1100 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12508410/02/2007
Labeler -ImClone LLC (832474493)

Revised: 4/2019document Id: 

0eb3bea0-63e0-4a5d-8e49-e83b095f641aSet id: 8bc6397e-4bd8-4d37-a007-a327e4da34d9Version: 45Effective Time: 20190423ImClone LLC



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