Doxil

What is Doxil?

• Doxil liposomal infusion is an anthracycline topoisomerase inhibitor used for the treatment of Ovarian cancer, AIDS-related Kaposi’s Sarcoma, Multiple Myeloma.

What are the uses of this medicine?

This medicine is used for: Ovarian Cancer

• DOXIL liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

AIDS-Related Kaposi’s Sarcoma

• DOXIL liposomal infusion is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Multiple Myeloma

• DOXIL liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

How does this medicine work?

• A form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin hydrochloride.
• The active ingredient of DOXIL liposomal infusion is doxorubicin hydrochloride.
• The mechanism of action of doxorubicin hydrochloride 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with DOXIL liposomal infusion.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: Ovarian Cancer

• The recommended dose of DOXIL liposomal infusion is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

AIDS-Related Kaposi’s Sarcoma

• The recommended dose of DOXIL liposomal infusion is 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.

Multiple Myeloma

• The recommended dose of DOXIL liposomal infusion is 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL liposomal infusion after bortezomib on day 4 of each cycle.

Administration

• Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Do not use if a precipitate or foreign matter is present.
• Do not use with in-line filters.
• Administer DOXIL liposomal infusion at an initial rate of 1 mg/min to minimize the risk of infusion reactions.
• If no infusion-related reactions occur, increase rate of infusion to complete administration over 1 hour.
• Do not administer as bolus injection or undiluted solution.
• Do not mix DOXIL liposomal infusion with other drugs.
• Discontinue DOXIL liposomal infusion for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Doxorubicin hydrochloride liposomal injection: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) in single dose vials.

This medicine is available in fallowing brand namesː

• DOXIL

What side effects can this medication cause?

The most common side effects of this medicine include:

• asthenia
• fatigue
• fever
• anorexia
• nausea
• vomiting
• stomatitis
• diarrhea
• constipation
• hand-foot syndrome
• rash
• neutropenia
• thrombocytopenia
• anemia

What special precautions should I follow?

• Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required.
• DOXIL Can cause fetal harm. Advise of potential risk to a fetus. Use effective contraception.
• Doxorubicin hydrochloride can cause myocardial damage, including acute left ventricular failure. Administer DOXIL liposomal infusion to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk.
• Serious, life-threatening, and fatal infusion-related reactions can occur with DOXIL liposomal infusion. Withhold DOXIL liposomal infusion for Grade 1, 2, or 3 infusion-related reactions and resume at a reduced infusion rate. Discontinue DOXIL liposomal infusion for serious or life-threatening infusion-related reactions.
• Secondary oral cancers, primarily squamous cell carcinoma, have been reported from post-marketing experience in patients with long-term (more than one year) exposure to DOXIL liposomal infusion.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe mucositis
• leukopenia
• thrombocytopenia

Management of overdosage:

• In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status.

Can this medicine be used in pregnancy?

• Based on findings in animals and its mechanism of action, DOXIL liposomal infusion can cause fetal harm when administered to a pregnant woman; avoid the use of DOXIL liposomal infusion during the 1st trimester.

Can this medicine be used in children?

• The safety and effectiveness of DOXIL liposomal infusion in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients: doxorubicin hydrochloride

Inactive ingredients:

• hydrogenated soybean lecithin
• cholesterol
• ammonium sulfate
• histidine
• hydrochloric acid
• sodium hydroxide
• sucrose

Who manufactures and distributes this medicine?

Manufactured for: Baxter Healthcare Corporation Deerfield, USA

What should I know about storage and disposal of this medication?

• Refrigerate unopened vials of DOXIL liposomal infusion at 2°C- 8°C (36°F- 46°F).
• Do not freeze.
• Discard unused portion.
• DOXIL liposomal infusion is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Doxil
• FDA Doxil

Doxil Resources
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