Doxorubicin Hydrochloride Liposome

Doxorubicin Hydrochloride Liposome is a pegylated liposomal formulation of doxorubicin hydrochloride. It contains doxorubicin encapsulated in Stealth Liposomes, with more than 90% of the drug remaining liposome-encapsulated during circulation. This formulation reduces cardiotoxicity compared to conventional doxorubicin and improves drug delivery to tumor tissues. Doxorubicin binds to DNA and inhibits nucleic acid synthesis, leading to cancer cell death. It is used for ovarian cancer (after platinum-based chemotherapy failure), AIDS-related Kaposi's sarcoma, multiple myeloma (with bortezomib), and metastatic breast cancer (with increased cardiac risk).

• Ovarian Cancer (disease progressed or recurred after platinum-based chemotherapy)
• AIDS-Related Kaposi's Sarcoma (disease progressed on prior combination chemotherapy or intolerant to such therapy)
• Multiple Myeloma (in combination with Bortezomib, who have not previously received Bortezomib and have received at least one prior therapy)
• Metastatic Breast Cancer (where patient is associated with increased cardiac risk with conventional Doxorubicin)

Doxorubicin Hydrochloride Liposome is Doxorubicin Hydrochloride encapsulated in Stealth Liposomes. More than 90% of the drug is encapsulated in the liposomes. This liposomal formulation maintains the drug active in circulation for longer periods and reduces toxicity to healthy tissues. It binds to DNA and inhibits nucleic acid synthesis in cancer cells.

Doxorubicin Hydrochloride Liposome binds to cancer cell DNA and inhibits nucleic acid synthesis. It demonstrates rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations, leading to cancer cell death.

Ovarian Cancer: 50 mg/m² IV over 60 minutes every 28 days until disease progression or unacceptable toxicity.

AIDS-Related Kaposi's Sarcoma: 20 mg/m² IV over 60 minutes every 21 days until disease progression or unacceptable toxicity.

Multiple Myeloma: 30 mg/m² IV over 60 minutes on day 4 of each 21-day cycle (after Bortezomib) for 8 cycles or until disease progression or unacceptable toxicity.

Metastatic Breast Cancer: 50 mg/m² IV every 4 weeks.

Dose Modification: Dose delays and adjustments may be required for Palmar-Plantar Erythema (PPE), hematologic toxicities, and stomatitis.

Administered as intravenous infusion only by a doctor or nurse. Do not self-administer.

Preparation: Dilute doses up to 90 mg in 250 mL of 5% Dextrose Injection; doses exceeding 90 mg in 500 mL of 5% Dextrose Injection. Refrigerate diluted solution at 2-8°C and use within 24 hours.

Administration: First dose at 1 mg/min rate. If no infusion-related reactions, increase rate to complete infusion over one hour. Do not rapidly flush the infusion line.

If you miss a dose of Doxorubicin Hydrochloride Liposome, please consult your doctor.

Common Side Effects:

• Increased risk of infection (due to decreased white blood cells)
• Breathlessness and looking pale (anemia)
• Tiredness and weakness
• Nausea or vomiting
• Inflammation of the lining of the mouth, throat, food pipe and stomach (stomatitis)
• Soreness, redness and peeling of hands and feet (Hand-Foot Syndrome)
• Loss of appetite
• Hair loss
• Diarrhea or constipation
• Pain in different parts of the body
• Skin changes

• Cardiomyopathy: Doxorubicin Hydrochloride can cause myocardial damage, including acute left ventricular failure. Monitor cardiac function before and during treatment.
• Infusion-Related Reactions: Flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension.
• Hand-Foot Syndrome (HFS): Skin toxicity required discontinuation in 4.2% of patients.
• Secondary Oral Neoplasms: Secondary oral cancers (primarily squamous cell carcinoma) reported with long-term (more than one year) use.
• Embryo-Fetal Toxicity: Advise pregnant women of potential risk to fetus.
• Females and males of reproductive potential must use effective contraception during and for 6 months after treatment.

• History of severe hypersensitivity reactions, including anaphylaxis to Doxorubicin Hydrochloride
• First trimester of pregnancy (can cause fetal harm)

Exercise caution with medicinal products known to interact with standard doxorubicin hydrochloride. Pegylated Liposomal Doxorubicin may potentiate the toxicity of other anti-cancer therapies.

It is not known whether it is safe to consume alcohol with Doxorubicin Hydrochloride Liposome. Please consult your doctor.

Pregnancy Category: D

Based on animal findings and mechanism of action, Doxorubicin Hydrochloride Liposome can cause fetal harm when administered to a pregnant woman. Avoid use during the first trimester.

Verify pregnancy status of females of reproductive potential and use effective contraception.

May cause oligospermia, azoospermia, and permanent loss of fertility in males.

It is not known whether Doxorubicin Hydrochloride Liposome is present in human milk. Because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, discontinue breastfeeding during treatment.

Safety and effectiveness in pediatric patients have not been established.

Limited information available regarding dose adjustment for elderly patients. Use with caution.

Renal impairment: Dose adjustment may be needed. Consult your doctor.

Hepatic impairment: Dose adjustment may be needed based on bilirubin levels.

Overdose may cause severe myelosuppression, cardiotoxicity, and mucositis. Provide symptomatic and supportive care.

Store unopened vials at 2-8°C. Do not freeze. Prolonged freezing may adversely affect liposomal drug products; however, short-term freezing (less than 1 month) does not appear to have a deleterious effect.

Doxorubicin Hydrochloride Liposome