DOXIL—Resources for Healthcare Professionals

DOXIL (doxorubicin HCl liposome injection)

For information about DOXIL, contact the Customer Communications Center at (877) 732-2488 or your local product specialist. The following materials are available through your product representative:

Keep Her Fighting: DOXIL First
Optimizing DOXIL Therapy
Information for Women Living with Ovarian Cancer
DOXIL Administration Guide

Ortho Biotech Products, L.P. also provides a variety of resources and support programs to healthcare professionals to assist you in partnering with your patients to optimize DOXIL therapy.

DOXIL Body Surface Area Calculator
Use our Body Surface Area Calculator to assist in calculating dosages for DOXIL treatments.

Patient Education Materials
Downloadable patient education materials, including the “Meet the Challenge: What to Expect from DOXIL” video are available in the Resource Library on the DOXIL.com Web site. Additional educational materials are also available. Ask your product specialist for a complete set of patient education materials.

DOXIL C.A.R.E.S.
The DOXIL C.A.R.E.S. program is a patient support program designed to assist your recurrent ovarian cancer patients who are starting DOXIL therapy.

DOXIL C.A.R.E.S. provides regularly scheduled telephone calls by nurses to assist patients by reminding them of the helpful tips to manage and/or help prevent hand-foot syndrome (HFS) and stomatitis, two adverse events sometimes associated with DOXIL. With information, patients can play a more active role in preventing or managing these side effects associated with their therapy.

For complete information about the program download the DOXIL C.A.R.E.S. Program brochure.

DOXIL Patient Starter Kit
Patients receiving DOXIL treatment can receive a DOXIL Patient Starter Kit. The Starter Kit is a tote bag which includes items that help manage and/or help prevent possible side effects of DOXIL therapy such as hand-foot syndrome and stomatitis. To view the contents of the Starter Kit, download the DOXIL Patient Starter Kit fact sheet (file size: 159 KB). To secure a DOXIL Patient Starter Kit for your patient, contact your local product specialist.

DOXILine™ Hotline
Formerly known as the DOXIL Oncology Connection

Tel: 1-800-609-1083
Tel: 1-800-533-3851
Fax: 1-800-987-5572
Hours: Monday thru Friday 9:00 AM-8:00 PM EST.

Reimbursement Support

DOXILine™ provides easy access to reimbursement information and support:

Verifies insurance coverage
Shares insurance guidelines for private, federal and state programs and plans
Provides general information and assistance with product specific claims appeals

The information provided represents no statement, promise, or guarantee by Ortho Biotech Products, L.P. concerning levels of reimbursement, payment, or charge. Please consult your payor organization with regard to local or actual coverage and reimbursement policies and determination processes.

Patient Assistance Program
Ortho Biotech Products, L.P. will provide assistance to certain eligible DOXIL patients at no charge, based on medical and financial need. We are available via the DOXILine™ Hotline to answer questions from patients and healthcare providers.

When calling about a patient-specific reimbursement issue, please have the following information available:

Selected patient’s information
Name and telephone number of insurance plan(s), policy numbers(s) and name of subscriber
Physician’s name, address, and telephone number
Patient’s financial information if calling on behalf of an uninsured patient

Patients must authorize disclosure of this information.

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