Brand Name
Doxil
Generic Name
DOXOrubicin
View Brand Information FDA approval date: December 23, 1987
Classification: Anthracycline Topoisomerase Inhibitor
Form: Injection, Injectable
What is Doxil (DOXOrubicin)?
Doxorubicin is an anthracycline topoisomerase II inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.
Approved To Treat
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Brand Information
DOXIL (doxorubicin hydrochloride)
WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS
- DOXIL liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m
- Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold DOXIL liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions
1DOSAGE FORMS AND STRENGTHS
DOXIL (doxorubicin hydrochloride liposome injection): 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) translucent, red liposomal dispersion in single dose vials.
2CONTRAINDICATIONS
DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride
3ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling.
- Cardiomyopathy
- Infusion-Related Reactions
- Hand-Foot Syndrome
- Secondary Oral Neoplasms
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.
The safety data reflect exposure to DOXIL liposomal infusion in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma.
The most common adverse reactions (>20%) observed with DOXIL liposomal infusion are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.
The following tables present adverse reactions from clinical trials of single-agent DOXIL liposomal infusion in ovarian cancer and AIDS-Related Kaposi’s sarcoma.
3.2Postmarketing Experience
The following additional adverse reactions have been identified during postapproval use of DOXIL liposomal infusion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal and Connective Tissue Disorders: muscle spasms
Respiratory, Thoracic and Mediastinal Disorders: pulmonary embolism (in some cases fatal)
Hematologic Disorders: Secondary acute myelogenous leukemia
Skin and Subcutaneous Tissue Disorders: erythema multiforme, Stevens‑Johnson syndrome, toxic epidermal necrolysis, lichenoid keratosis
Secondary Oral Neoplasms: [see
4DRUG INTERACTIONS
No formal drug interaction studies have been conducted with DOXIL liposomal infusion.
5OVERDOSAGE
Acute overdosage with doxorubicin hydrochloride causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.
6DESCRIPTION
The active ingredient in DOXIL liposomal infusion is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in STEALTH liposomes for intravenous use.
The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6‑trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11‑trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C27-H29 -NO11•HCl and the molecular weight is 579.99.
The structural formula is:
DOXIL liposomal infusion is a sterile, translucent, red liposomal dispersion. Each single- dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The STEALTH liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine, 1.55 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 94 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH liposomes.
MPEG-DSPE has the following structural formula:
HSPC has the following structural formula:
Representation of a STEALTH liposome:
7REFERENCES
- “Hazardous Drugs”,
8HOW SUPPLIED/STORAGE AND HANDLING
DOXIL (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:
9PRINCIPAL DISPLAY PANEL - 20 mg Vial Carton
NDC 0338-0063-01
DOXIL
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION - DO NOT
FOR INTRAVENOUS INFUSION ONLY
Rx only
Cytotoxic
HA-65-01-805
Refrigerate, 2°-8°C
See package insert for
Baxter Healthcare
Baxter, Doxil, and
Bar Code
Bar Code
LOT
EXP
US
749703
Barcode
NDC 0338-0063-01
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0063-01
Use 5% Dextrose Injection, USP
Bar Code
Note: Liposomal formulation.
NDC 0338-0063-01
NDC 0338-0063-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
GTIN 00303380063017
NDC 0338-0063-01
Each mL contains
HA-80-02-881
NDC 0338-0063-01
20 mg in 10 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0063-01
N
Note: Liposomal formulation.
USA
Bar Code
NDC 0338-0063-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
NDC 0338-0063-01
GTIN 00303380063017
NDC 0338-0063-01
Each mL contains
HA-80-02-880
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION - DO NOT
FOR INTRAVENOUS
Rx only
Cytotoxic
HA-65-01-806
Refrigerate, 2°-8°C (36°-46°F).
See package insert for dosage
Baxter Healthcare Corporation
Baxter, Doxil, and Stealth are registered trademarks of
Bar Code
Bar Code
LOT
EXP
US
Barcode
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0067-01
Use 5% Dextrose Injection, USP
Bar Code
Note: Liposomal formulation.
NDC 0338-0067-01
NDC 0338-0067-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
GTIN 00303380067015
NDC 0338-0067-01
Each mL contains
HA-80-02-883
NDC 0338-0067-01
DOXIL
50 mg in 25 mL
Single-Dose Vial. Discard unused portion.
LIPOSOMAL FORMULATION -
FOR INTRAVENOUS
Refrigerate, 2°-8°C
Rx only
Baxter Logo
NDC 0338-0067-01
N
Note: Liposomal formulation.
USA
Bar Code
NDC 0338-0067-01
LIPOSOMAL FORMULATION -
Manufactured for:
Baxter, Doxil, and Stealth
NDC 0338-0067-01
GTIN 00303380067015
NDC 0338-0067-01
Each mL contains
HA-80-02-882