DOXIL—What to Expect

DOXIL (doxorubicin HCl liposome injection)

Before Treatment
Taking an active role in your care will help you foster an open, productive partnership with your healthcare team. Be sure to talk to your doctor or nurse about how you feel or any concerns you may have.

Knowledge is power. Educate yourself and your family and friends about:

Possible side effects
How to optimize your DOXIL treatment by proactively managing side effects
How you and your healthcare team will work together
Available community groups as well as resources through the Community Connection

During Treatment
DOXIL is given by intravenous (IV) infusion, normally in the doctor’s office or in a clinic. Your treatment will usually take approximately one hour, although the first treatment may be longer. You will typically receive DOXIL treatments every 4 weeks for a minimum of 4 courses. However, speak with your doctor or nurse for your exact treatment schedule.

A rise in CA-125 levels may seem troubling. However, CA-125 is only one of the many indicators of how you may be doing. A single CA-125 test is never definitive. For this reason, serial testing of CA-125 is very useful during therapy for recurrent ovarian cancer. In addition, CA-125 is only one indicator of response. It is important to remember that while CA-125 can aid the process of diagnosis and treatment decisions in recurrent ovarian cancer, it is not often used as the only tool for screening or monitoring treatment response. If you are concerned about your CA-125 results, talk to your doctor. Work with your healthcare team to understand what tests are being used to evaluate your progress.

Continuing Treatment
It is important to complete the first four cycles of DOXIL therapy as long as you do not clinically progress, continue to tolerate treatment, and show no evidence of cardiotoxicity because clinical trials have shown this is the median time to response. If DOXIL is well-tolerated, your physician may decide to continue your DOXIL treatment for as long as you are seeing a benefit to therapy.

RELATED RESOURCES

FREQUENTLY ASKED QUESTIONS

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