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DOXIL
Overview
What is DOXIL?
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-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; its molecular weight is 579.99.
The molecular structure is:
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-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 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:
n = ca. 45
HSPC has the following structural formula:
m, n=14 or 16
Representation of a STEALTH liposome:
What does DOXIL look like?
What are the available doses of DOXIL?
Doxorubicin hydrochloride (HCl) liposomal injection: Single use vials: 20 mg/10 mL and 50 mg/25 mL ()
What should I talk to my health care provider before I take DOXIL?
How should I use DOXIL?
DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
Do not substitute
Do not administer
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What interacts with DOXIL?
Sorry No Records found
What are the warnings of DOXIL?
Sorry No Records found
What are the precautions of DOXIL?
Sorry No Records found
What are the side effects of DOXIL?
Sorry No records found
What should I look out for while using DOXIL?
DOXIL is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin HCl
What might happen if I take too much DOXIL?
Acute overdosage with doxorubicin HCl causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.
How should I store and handle DOXIL?
RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture. RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing. RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Keep out of reach of children.DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials.Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.The following individually cartoned vials are available:DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials.Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.The following individually cartoned vials are available:DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials.Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.The following individually cartoned vials are available:DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials.Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.The following individually cartoned vials are available:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The active ingredient of DOXIL is doxorubicin HCl. The mechanism of action of doxorubicin HCl is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.
Non-Clinical Toxicology
DOXIL is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin HClDrug Interactions
Aspirin:
Antihypertensives:
Corticosteroids:
Methotrexate:
Oral Hypoglycemics Agents:
Products that effect urinary pH:
Uricosuric Agents:
Doxorubicin HCl can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy with doxorubicin HCl is generally proportional to the cumulative exposure. The relationship between cumulative DOXIL dose and the risk of cardiac toxicity has not been determined.
In a clinical study in 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/m. Cardiotoxicity was defined as >20% decrease in resting left ventricular ejection fraction (LVEF) from baseline where LVEF remained in the normal range or a >10% decrease in LVEF from baseline where LVEF was less than the institutional lower limit of normal. Two percent of patients developed signs and symptoms of congestive heart failure without documented evidence of cardiotoxicity.
Assess left ventricular cardiac function (e.g. MUGA or echocardiogram) prior to initiation of DOXIL, during treatment to detect acute changes, and after treatment to detect delayed cardiotoxicity. Administer DOXIL to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk.
The following adverse reactions are discussed in more detail in other sections of the labeling.
The most common adverse reactions (>20%) observed with DOXIL are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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