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DOXIL® (doxorubicin HCl liposome injection) is an advanced form of the anthracycline chemotherapeutic doxorubicin. Unlike conventional doxorubicin therapy, DOXIL is a liposomal formulation of doxorubicin, which means that doxorubicin is encapsulated by a thin fatty layer. The liposome is pegylated, which helps protect the drug from the immune system, resulting in the product circulating in the blood for a longer period of time. The longer circulation allows dosing once every four weeks.
DOXIL is indicated for:
- The treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy
- The treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy
Indication
DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
Important Safety Information
Boxed Warning
- Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2
- The use of DOXIL may lead to cardiac toxicity
- 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
- DOXIL should be administered to patients with a history of cardiovascular disease only when the potential benefit outweighs the risk
- Cardiac function should be carefully monitored in patients treated with DOXIL
- Acute infusion-related reactions have occurred in up to 10% of patients treated with DOXIL
- Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported
- Medications to treat such reactions, as well as emergency equipment, should be available for immediate use
- Severe myelosuppression may occur
- Dosage should be reduced in patients with impaired hepatic function
- Accidental substitution of DOXIL for doxorubicin HCl has resulted in severe side effects. DO NOT SUBSTITUTE
- Use of DOXIL should be limited to physicians experienced in the use of cancer chemotherapeutic agents
Contraindications
- DOXIL is contraindicated in patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL
- DOXIL is contraindicated in nursing mothers
Common Adverse Effects
- The most common side effects (≥10%) reported with DOXIL therapy included asthenia, abdominal pain, fever, pain, mucous membrane disorder, back pain, infection, headache, nausea, stomatitis, vomiting, constipation, diarrhea, anorexia, dyspepsia, cough increased, intestinal obstruction, peripheral edema, paresthesia, pharyngitis, dyspnea, hand-foot syndrome, rash, and alopecia
Please see the Full Prescribing Information for more details in PDF format.
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