DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL- doxorubicin hydrochloride injection, suspension, liposomal 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Doxorubicin Hydrochloride Liposome Injection

HEALTH CARE PROVIDER LETTER

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg/10 mL

10ml-container-label

Caelyx® pegylated liposomal
2 mg/ml
sterile concentrate

doxorubicin hydrochloride

20 mg/10 mL

IV after dilution.

10ml-carton-label

Caelyx®

pegylated liposomal

2 mg/ml

concentrate for

solution for infusion

doxorubicin hydrochloride

20 mg/10 mL

Intravenous use after

dilution.

Do not use interchangeably
with other formulations of
doxorubicin hydrochloride.

Cytotoxic

1 vial

Baxter Logo

One ml of Caelyx pegylated
liposomal contains 2 mg
doxorubicin hydrochloride.

Excipients: α-(2-[1,2-distearoyl-sn-glycero(3)
phosphooxy]ethylcarbamoyl)
-ϖ-methoxypoly(oxyethylen)-40
sodium salt, fully hydrogenated
soy phosphatidylcholine,
cholesterol, ammonium
sulphate, sucrose, histidine,
water for injections,
hydrochloric acid and sodium
hydroxide.

Keep out of the sight and
reach of children.

Store in a refrigerator.
Do not freeze.

Read the package leaflet
before use.

Baxter Healthcare Limited

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

PLGB 00116/0255

DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL 
doxorubicin hydrochloride injection, suspension, liposomal
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9581
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
doxorubicin hydrochloride (UNII: 82F2G7BL4E) (doxorubicin - UNII:80168379AG) doxorubicin hydrochloride2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE (UNII: 3L6NN8ZZKU) 3.19 mg  in 1 mL
hydrogenated soybean lecithin (UNII: H1109Z9J4N) 9.58 mg  in 1 mL
cholesterol (UNII: 97C5T2UQ7J) 3.19 mg  in 1 mL
ammonium sulfate (UNII: SU46BAM238) 0.6 mg  in 1 mL
histidine (UNII: 4QD397987E) 1.55 mg  in 1 mL
hydrochloric acid (UNII: QTT17582CB)  
sodium hydroxide (UNII: 55X04QC32I)  
sucrose (UNII: C151H8M554) 94 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9581-021 in 1 CARTON12/19/2023
1NDC:0338-9581-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage12/19/2023
Labeler - Baxter Healthcare Corporation (005083209)

Revised: 12/2023
Document Id: 4417c230-a8b4-46a6-a85a-c7efeb43ba55
Set id: b24afa8c-636b-4ace-99d5-51f445ad3123
Version: 2
Effective Time: 20231219
 
Baxter Healthcare Corporation