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Doxorubicin Hydrochloride liposome

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Overview

What is Doxorubicin Hydrochloride liposome?

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:

Doxorubicin HCl liposome injection 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 Doxorubicin Hydrochloride liposome look like?



What are the available doses of Doxorubicin Hydrochloride liposome?

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 Doxorubicin Hydrochloride liposome?

How should I use Doxorubicin Hydrochloride liposome?

Doxorubicin HCl liposome injection 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 Doxorubicin Hydrochloride liposome?

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What are the warnings of Doxorubicin Hydrochloride liposome?

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What are the precautions of Doxorubicin Hydrochloride liposome?

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What are the side effects of Doxorubicin Hydrochloride liposome?

Sorry No records found


What should I look out for while using Doxorubicin Hydrochloride liposome?

Doxorubicin HCl liposome injection 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 Doxorubicin Hydrochloride liposome?

Acute overdosage with doxorubicin HCl causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.


How should I store and handle Doxorubicin Hydrochloride liposome?

Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Do not store unpouched. Insert immediately upon removal from the protective pouch.Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Do not store unpouched. Insert immediately upon removal from the protective pouch.Doxorubicin HCl liposome injection 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:Doxorubicin HCl liposome injection 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:Doxorubicin HCl liposome injection 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:Doxorubicin HCl liposome injection 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:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The active ingredient of doxorubicin HCl liposome injection 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
Doxorubicin HCl liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin HCl

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors

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 doxorubicin HCl liposome injection 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 doxorubicin HCl liposome injection, 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 doxorubicin HCl liposome injection, during treatment to detect acute changes, and after treatment to detect delayed cardiotoxicity. Administer doxorubicin HCl liposome injection 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 doxorubicin HCl liposome injection are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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