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Doxil

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Doxil

DOXIL®
(doxorubicin HCl liposome injection) for Intravenous Infusion

Doxil

WARNING

INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION

  1. The use of DOXIL (doxorubicin HCl liposome injection) may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m². In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL (doxorubicin hcl liposome injection) at a starting dose of 50 mg/m² every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m² or between 500-550 mg/m², the risk of cardiac toxicity for patients treated with DOXIL (doxorubicin hcl liposome injection) was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see WARNINGS and PRECAUTIONS].
  2. Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL (doxorubicin hcl liposome injection) . In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoidlike infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. DOXIL (doxorubicin hcl liposome injection) should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see WARNINGS and PRECAUTIONS].
  3. Severe myelosuppression may occur [see WARNINGS and PRECAUTIONS)].
  4. Dosage should be reduced in patients with impaired hepatic function [see DOSAGE AND ADMINISTRATION and Use in Specific Populations].
  5. Accidental substitution of DOXIL (doxorubicin hcl liposome injection) for doxorubicin HCl has resulted in severe side effects. DOXIL (doxorubicin hcl liposome injection) should not be substituted for doxorubicin HCl on a mg per mg basis [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION

DOXIL (doxorubicin HCl liposome injection) is doxorubicin hydrochloride (HCl) encapsulated in STEALTH® liposomes for intravenous administration.

Doxorubicin is an anthracycline topoisomerase inhibitor isolated from Streptomyces peucetius var. caesius.

Doxorubicin HCl, which is the established name for (8S,10S)-10-[(3-amino-2,3,6-trideoxyα- L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy5,12- naphthacenedione hydrochloride, has the following structure:

DOXIL® (doxorubicin HCl) Structural Formula Illustration

The molecular formula of the drug is C27H29NO11•HCl; its molecular weight is 579.99.

DOXIL (doxorubicin hcl liposome injection) is provided as 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 N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero3- phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and cholesterol, 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

HSPC has the following structural formula:

HSPC Structural Formula Illustration

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

If you experience all of the following serious side effects from doxorubicin liposomal, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • congestive heart failure (difficulty breathing, fluid retention, chest pain);
  • irregular heartbeats;
  • tissue or vein reactions near...

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of receiving your total maximum dose of any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, gout, heart problems,...

Read All Potential Precautions of Doxil »

Last reviewed on RxList: 7/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

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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