DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL- doxorubicin hydrochloride injection, suspension, liposomal

doxorubicin hydrochloride, Liposomal by

Drug Labeling and Warnings

doxorubicin hydrochloride, Liposomal by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

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

Caelyx® pegylated liposomal
2 mg/ml
sterile concentrate

doxorubicin hydrochloride

20 mg/10 mL

IV after dilution.

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

INGREDIENTS AND APPEARANCE

DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL 
doxorubicin hydrochloride injection, suspension, liposomal

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9581
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
doxorubicin hydrochloride (UNII: 82F2G7BL4E) (doxorubicin - UNII:80168379AG)	doxorubicin hydrochloride	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9581-02	1 in 1 CARTON	12/19/2023
1	NDC: 0338-9581-01	10 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		12/19/2023

Labeler - Baxter Healthcare Corporation (005083209)