Doxorubicin Hydrochloride, Liposomal Injection, Suspension, Liposomal
FDA Label NDC 0338-9581

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Doxorubicin Hydrochloride, Liposomal (NDC 0338-9581). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package/label principal display panel – 20 mg/10 ml, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel – 20 Mg/10 Ml

10ml-container-label (10ml Container Label)

10ml-container-label (10ml Container Label)

Caelyx® pegylated liposomal
2 mg/ml
sterile concentrate

doxorubicin hydrochloride

20 mg/10 mL

IV after dilution.

10ml-carton-label (10ml Carton Label)

10ml-carton-label (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

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