July 30, 2015
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Doxil

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Doxil

DOXIL®
(doxorubicin hydrochloride liposome) Injection




WARNING

CARDIOMYOPATHY and INFUSION-RELATED REACTIONS

DOXIL (doxorubicin HCl liposome injection) can cause myocardial damage, including congestive heart failure, as the total cumulative dose of doxorubicin HCl approaches 550 mg/m². In a clinical study of 250 patients with advanced cancer who were treated with DOXIL, the risk of cardiotoxicity was 11% when the cumulative anthracycline dose was between 450-550 mg/m² . Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation [see WARNINGS AND PRECAUTIONS].

Acute infusion-related reactions consisting of, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension occurred in 11% of patients with solid tumors treated with DOXIL. Serious, life-threatening and fatal infusion reactions have been reported [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DOXIL (doxorubicin HCl liposome injection) is doxorubicin hydrochloride (HCl), an anthracycline topoisomerase II inhibitor, that is encapsulated in STEALTH® liposomes for intravenous use.

The chemical name of doxorubicin HCl is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxohexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12naphthacenedione hydrochloride. The molecular formula is C27-H29 -NO11•HCl; its molecular weight is 579.99.

The molecular structure is:

DOXIL® (doxorubicin hydrochloride) Structural Formula Illustration

DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials. Each vial contains 20 mg or 50 mg doxorubicin HCl at a concentration of 2 mg/mL and a pH of 6.5. 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-glycero3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 2 mg; histidine as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose to maintain isotonicity. Greater than 90% of the drug is encapsulated in the STEALTH liposomes.

MPEG-DSPE has the following structural formula:

MPEG-DSPE - Structural Formula Illustration

N=ca.45

HSPC has the following structural formula:

HSPC - Structural Formula Illustration

m,n = 14 or 16

Representation of a STEALTH liposome:

STEALTH liposome - Illustration

What are the possible side effects of doxorubicin liposomal (Doxil, Lipodox, Lipodox 50)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • pain, redness, swelling, blistering, or peeling skin on your hands or feet;
  • feeling short of breath (even...

Read All Potential Side Effects and See Pictures of Doxil »

What are the precautions when taking doxorubicin hcl liposome injection (Doxil)?

Before using liposomal doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to doxorubicin; or to other drugs containing polyethylene glycol; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood cell counts (e.g., anemia, neutropenia, thrombocytopenia), gout, heart problems, a history of receiving any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), infection, liver problems, radiation treatment (especially to the chest area), kidney problems.

Do not have...

Read All Potential Precautions of Doxil »

Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Doxil - User Reviews

Doxil User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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