Doxorubicin Hydrochloride Liposome (Page 7 of 7)

15 REFERENCES

1.
“Hazardous Drugs”, OSHA, http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials.

The following individually cartoned vials are available:

Table 14

vial concentration

vial size

NDC #s

20 mg/ 10 mL

(2 mg/mL)

10-mL

0338-0080-01

50 mg/25 mL

(2 mg/mL)

30-mL

0338-0086-01

Refrigerate unopened vials of doxorubicin hydrochloride liposome injection at 2°C- 8°C (36°F- 46°F). Do not freeze. Discard unused portion.

Doxorubicin hydrochloride liposome injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

17 PATIENT COUNSELING INFORMATION

Cardiomyopathy

Advise patients to contact their healthcare provider if they develop symptoms of heart failure [see Warnings and Precautions (5.1)].

Infusion-Related Reactions

Advise patients about the symptoms of infusion-related reactions and to seek immediate medical attention if they develop any of these symptoms [see Warnings and Precautions (5.2)].

Myelosuppression

Advise patients to contact their healthcare provider for a new onset fever or symptoms of infection.

Hand-Foot Syndrome

Advise patients to notify their healthcare provider if they experience tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (symptoms of Hand-Foot Syndrome) [see Warnings and Precautions (5.3)].

Stomatitis

Advise patients to notify their healthcare provider if they develop painful redness, swelling, or sores in the mouth (symptoms of stomatitis).

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

Advise females and males of reproductive potential to use effective contraception during and for 6 months following treatment with doxorubicin hydrochloride liposome injection [see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with doxorubicin hydrochloride liposome injection [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that doxorubicin hydrochloride liposome injection may cause temporary or permanent infertility [see Use in Specific Populations (8.3)].

Discoloration of Urine and Body Fluids

Inform patients that following doxorubicin hydrochloride liposome injection administration, a reddish-orange color to the urine and other body fluids may be observed. This nontoxic reaction is due to the color of the product and will dissipate as the drug is eliminated from the body.

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Baxter and Stealth are registered trademarks of Baxter International Inc. HA-30-01-925

USA — 749705

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative Doxorubicin Container Label 0338-0080-01
(click image for full-size original)

Container Label

LOT
EXP
696989

NDC 0338-0080-01

DOXOrubicin Hydrochloride
liposome injection

20 mg in 10 mL
(2 mg/mL)
Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION – DO NOT
SUBSTITUTE FOR DOXORUBICIN
Hydrochloride

FOR INTRAVENOUS INFUSION ONLY

Rx only
Cytotoxic

HA-65-01-807

Refrigerate, 2°-8°C
(36°-46°F). Do not Freeze.

See packaging insert for
dosage information.

Manufactured for:
Baxter Healthcare
Corporation
Deerfield, IL 60015

Baxter and Stealth are
registered trademarks of
Baxter International Inc.,
or its subsidiaries.

Barcode0100303380080014

Representative Doxorubicin Carton Label 0338-0080-01 -- 1 of 4
(click image for full-size original)
Representative Doxorubicin Carton Label 0338-0080-01 -- 2 of 4
(click image for full-size original)

Carton Label

USA
696989
882

Barcode

NDC 0338-0080-01

DOXOrubicin
Hydrochloride
liposome injection

20 mg in 10 mL
(2 mg/mL)

Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

FOR INTRAVENOUS
INFUSION ONLY

Refrigerate, 2°-8°C
(36°-46°F). Do Not Freeze.
Cytotoxic

Rx only

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

N
3
Bar Code
0338-0080-01 4

Note: Liposomal formulation.
See package insert for dosage
information.

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN HCL

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015
Product of Taiwan

Baxter Stealth are
registered trademarks of
Baxter International Inc.,
or its subsidiaries.

GTIN 00303380080014
2D Bar Code
S/N
EXP
LOT

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

Each mL contains
doxorubicin HCl, 2 mg.
STEALTH liposome carriers
are composed of cholesterol,
3.19 mg; fully hydrogenated soy
phosphatidylcholine (HSPC),
9.58 mg; and N-(carbonyl-
methoxypolyethylene
glycol 2000)-1,2-distearoyl-sn-
glycerol-3-phosphoethanolamine
sodium salt (MPEG-DSPE),
3.19 mg. Each mL also contains
ammonium sulfate,
approximately 0.6 mg;
histidine; hydrochloric acid
and/or sodium hydroxide;and sucrose.

HA-80-02-748

Representative Doxorubicin Carton Label 0338-0080-01 -- 3 of 4
(click image for full-size original)
Representative Doxorubicin Carton Label 0338-0080-01 -- 4 of 4
(click image for full-size original)

Carton Label

US
749702
882

Barcode

NDC 0338-0080-01

DOXOrubicin
Hydrochloride
liposome injection

20 mg in 10 mL
(2 mg/mL)

Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION.

Refrigerate, 2°-8°C
(36°-46°F). Do Not Freeze.
Cytotoxic

Rx only

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

Use 5% Dextrose Injection, USP
when diluting Doxorubicin
Hydrochloride liposome injection.

Bar Code
3 03380 08001 4

Note: Liposomal formulation.
Recommended Dosage: see
prescribing information.

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015
Product of Italy

Baxter Stealth are
registered trademarks of
Baxter International Inc.,
or its subsidiaries.

GTIN 00303380080014
2D Bar Code
S/N
EXP
LOT

NDC 0338-0080-01
DOXOrubicin
Hydrochloride
liposome injection

Each mL contains
doxorubicin Hydrochloride, 2 mg.
STEALTH liposome carriers
are composed of cholesterol,
3.19 mg; fully hydrogenated soy
phosphatidylcholine (HSPC),
9.58 mg; and N-(carbonyl-
methoxypolyethylene
glycol 2000)-1,2-distearoyl-sn-
glycerol-3-phosphoethanolamine
sodium salt (MPEG-DSPE),
3.19 mg. Each mL also contains
ammonium sulfate, approximately
0.6 mg; histidine, 1.55 mg;
hydrochloric acid and/or sodium
hydroxide may have been added
for pH adjustment (6.0 to 7.0)and sucrose, 94 mg.

HA-80-02-885

Representative Doxorubicin Container Label 0338-0086-01
(click image for full-size original)

Container Label

LOT
EXP
696990

NDC 0338-0086-01

DOXOrubicin Hydrochloride
liposome injection

50 mg in 25 mL
(2 mg/mL)
Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION – DO NOT
SUBSTITUTE FOR DOXORUBICIN
Hydrochloride

FOR INTRAVENOUS INFUSION ONLY

Rx only
Cytotoxic

HA-85-01-808

Refrigerate, 2°-8°C
(36°-46°F). Do not Freeze.

See packaging insert for
dosage information.

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015

Baxter and Stealth are registered trademarks of
Baxter International Inc., or its subsidiaries.

Barcode0100303380086016

Representative Doxorubicin Carton Label 0338-0086-01 -- 1 of 4
(click image for full-size original)
Representative Doxorubicin Carton Label 0338-0086-01 -- 2 of 4
(click image for full-size original)

Carton Label

USA
696986
882

Barcode

NDC 0338-0086-01

DOXOrubicin
Hydrochloride
liposome injection

50 mg in 25 mL
(2 mg/mL)

Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

FOR INTRAVENOUS
INFUSION ONLY

Refrigerate, 2°-8°C
(36°-46°F). Do Not Freeze.
Cytotoxic

Rx only

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

N
3
Bar Code
0338-0086-01 6

Note: Liposomal formulation.
See package insert for dosage
information.

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

NDC 0338-0086-01
DOXOrubicin
Hydrochloriode
liposome injection

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015
Product of Taiwan

Baxter Stealth are
registered trademarks of
Baxter International Inc.,
or its subsidiaries.

GTIN 00303380086016
2D Bar Code
S/N
EXP
LOT

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

Each mL contains
doxorubicin HCl, 2 mg.
STEALTH liposome carriers
are composed of cholesterol,
3.19 mg; fully hydrogenated soy
phosphatidylcholine (HSPC),
9.58 mg; and N-(carbonyl-
methoxypolyethylene
glycol 2000)-1,2-distearoyl-sn-
glycerol-3-phosphoethanolamine
sodium salt (MPEG-DSPE),
3.19 mg. Each mL also contains
ammonium sulfate,
approximately 0.6 mg;
histidine; hydrochloric acid
and/or sodium hydroxide;and sucrose.

HA-80-02-886

Representative Doxorubicin Carton Label 0338-0086-01 -- 3 of 4
(click image for full-size original)
Representative Doxorubicin Carton Label 0338-0086-01 -- 4 of 4
(click image for full-size original)

Carton Label

US
749701
882

Barcode

NDC 0338-0086-01

DOXOrubicin
Hydrochloirde
liposome injection

50 mg in 25 mL
(2 mg/mL)

Single-Dose Vial. Discard unused portion.

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

FOR INTRAVENOUS INFUSION
ONLY AFTER DILUTION.

Refrigerate, 2°-8°C
(36°-46°F). Do Not Freeze.
Cytotoxic

Rx only

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

Use 5% Dextrose Injection,
USP when diluting Doxorubicin
Hydrochloride liposome injection.


Bar Code
3 03380 08601 6

Note: Liposomal formulation.
Recommended Dosage: see
prescribing information.

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

NDC 0338-0086-01
DOXOrubicin HCl
liposome injection

LIPOSOMAL FORMULATION –
DO NOT SUBSTITUTE
FOR DOXORUBICIN Hydrochloride

Manufactured for:
Baxter Healthcare Corporation
Deerfield, IL 60015
Product of Italy

Baxter Stealth are
registered trademarks of
Baxter International Inc.,
or its subsidiaries.

GTIN 00303380086016
2D Bar Code
S/N
EXP
LOT

NDC 0338-0086-01
DOXOrubicin
Hydrochloride
liposome injection

Each mL contains
doxorubicin Hydrochloride, 2 mg.
STEALTH liposome carriers
are composed of cholesterol,
3.19 mg; fully hydrogenated soy
phosphatidylcholine (HSPC),
9.58 mg; and N-(carbonyl-
methoxypolyethylene
glycol 2000)-1,2-distearoyl-sn-
glycerol-3-phosphoethanolamine
sodium salt (MPEG-DSPE),
3.19 mg. Each mL also contains
ammonium sulfate, approximately
0.6 mg; histidine, 1.55 mg;
hydrochloric acid and/or sodium hydroxide may have been added
for pH adjustment (6.0 to 7.0)and sucrose, 94 mg.

HA-80-02-887

DOXORUBICIN HYDROCHLORIDE LIPOSOME doxorubicin hydrochloride liposome injection, suspension, liposomal
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0080
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) 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 3.19 mg in 1 mL
CHOLESTEROL 3.19 mg in 1 mL
HYDROGENATED SOYBEAN LECITHIN 9.58 mg in 1 mL
AMMONIUM SULFATE 0.6 mg in 1 mL
HISTIDINE 1.55 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SUCROSE 94 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0080-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0338-0080-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050718 08/15/2019
DOXORUBICIN HYDROCHLORIDE LIPOSOME doxorubicin hydrochloride liposome injection, suspension, liposomal
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0086
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN) 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 3.19 mg in 1 mL
CHOLESTEROL 3.19 mg in 1 mL
HYDROGENATED SOYBEAN LECITHIN 9.58 mg in 1 mL
AMMONIUM SULFATE 0.6 mg in 1 mL
HISTIDINE 1.55 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SUCROSE 94 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0086-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 25 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0338-0086-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050718 08/15/2019
Labeler — Baxter Healthcare Corporation (005083209)

Revised: 05/2022 Baxter Healthcare Corporation

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