DOXIL—About DOXIL

DOXIL (doxorubicin HCl liposome injection)

What is DOXIL?
DOXIL is:

A chemotherapy drug used to treat or control cancer cells
A different form of doxorubicin, a drug used to treat cancer

How is DOXIL Different?
DOXIL is a reformulated version of doxorubicin. DOXIL takes the active agent doxorubicin and places it into a fat bubble called a liposome and another layer of hair-like strands made from methoxypolyethylene glycol—a type of rubber. This coating allows DOXIL to evade detection and destruction by the immune system, which increases the time the drug is in the body. The majority of the drug stays inside the liposome while in the blood (at least 90%). Therefore, DOXIL has more time to reach the tumor tissue, where the medication slowly leaks out. However, DOXIL may also leak out and affect normal tissue.

DOXIL Administration
Because the drug slowly leaks out of the liposome over time, you typically receive treatments once every 4 weeks with DOXIL. DOXIL is given by intravenous (IV) infusion, normally in the doctor’s office or in a clinic. Your treatment will usually take approximately 1 hour, although the first treatment may take longer. You will typically receive DOXIL treatments every 4 weeks; however, speak with your doctor or nurse for your exact treatment schedule.

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GLOSSARY

Indications:

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy.

Important Safety Information
BOXED WARNINGS: Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution

The use of DOXIL may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550mg/m²

— Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose.

— Cardiac toxicity may also occur at lower cumulative doses (400 mg/m²) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy

Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions have resolved within several hours to a day once the infusion is terminated. In some patients, reactions resolved with slowing of the infusion rate

— Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use

— The initial rate of infusion should be 1mg/min to minimize the risk of infusion reactions.

Severe myelosuppression may occur.

DOXIL dosage should be reduced in patients with impaired hepatic function.

Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis.

Contraindiction

Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL
Nursing mothers

Additional Safety Information

Cardiac function should be carefully monitored.

	— Congestive heart failure or cardiomyopathy may occur after discontinuation of anthracycline therapy
	— For patients with a history of cardiovascular disease, or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury

Myelosuppression may occur; frequently monitor complete blood count (including platelet count), at least prior to each dose of DOXIL

	— In patients with recurrent ovarian cancer, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL
	— Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage
	— Sepsis occurring during neutropenia has resulted in discontinuation of treatment and in rare cases of death

DOXIL may potentiate the toxicity of other anticancer therapies, especially hematologic toxicities, when used in combination with other therapies that suppress bone marrow
Hand-foot syndrome (HFS) may occur during therapy with DOXIL

	— Based on HFS toxicity grade, dose reduction, delay in administration, or discontinuation of DOXIL may be required
	— HFS was generally observed after 2 to 3 cycles of treatment, but may occur earlier
	The reaction was mild in most patients, resolving in 1 to 2 weeks
	The reaction can be severe and debilitating in some patients, resulting in discontinuation of therapy

DOXIL is an irritant, not a vesicant; ; use precautions to avoid extravasation
DOXIL can cause fetal harm when used during pregnancy
Recall reaction has occurred with DOXIL administration after radiotherapy
DOXIL may interact with drugs known to interact with the conventional formulation of doxorubicin HCl
In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) ≥ 20% (DOXIL vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)

	— In addition, 19% vs 52.3% reported alopecia (all grades)
	— Grade 3/4 hematologic ARs reported in ≥ 5% (DOXIL vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)

Please see accompanying full Prescribing Information, including Boxed WARNINGS