Patient Affordability Introduction

This page includes resources for health care professionals to share with patients using DOXIL® (doxorubicin HCl liposome injection) and their family members and caregivers. Please click on any of the links below to get more detailed information.

Janssen Prescription Assistance for DOXIL® (doxorubicin HCl liposome injection)

Click here for information about prescription assistance programs sponsored by relevant Janssen Pharmaceutical Companies as well as up-to-date information about independent foundations that may have available funding to help minimize drug costs for DOXIL®.

DOXILine® Call Center

The DOXILine® Call Center provides access to reimbursement information and support.

Benefit Verification Form

Click here to view and to print the application for Insurance Benefit Verification for DOXIL®.

Johnson & Johnson Patient Assistance Foundation

Johnson & Johnson Patient Assistance Foundation, Inc. is committed to providing access to uninsured patients that lack the financial resources to pay for their medicines. If you need DOXIL® and are uninsured and unable to pay for your medicine, please call the program at 1-800-652-6227 or visit the foundation Web site at JJPAF.org to see if you might qualify for assistance.

Indications for DOXIL® (doxorubicin HCl liposome injection)

  • DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy
  • DOXIL® in combination with VELCADE® (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE® and have received at least one prior therapy

Important Safety Information for DOXIL® (doxorubicin HCl liposome injection)

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 550 mg/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 1 mg/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.

Contraindications

  • Patients with a history of hypersensitivity reactions to a conventional doxorubicin formulation or the components of DOXIL®

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
    • In the randomized multiple myeloma study, 25 patients (8%) in the VELCADE® arm and 42 patients (13%) in the DOXIL® plus VELCADE® arm experienced left ventricular ejection fraction decrease (defined as absolute decrease ≥ 15% over baseline or a ≥ 5% decrease below institutional lower limit of normal)
  • 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®
    • In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL® and/or VELCADE®
    • 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, 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
  • Because of the potential for serious adverse reactions in nursing infants, discontinue nursing during treatment with DOXIL®
  • 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%)
  • In patients with multiple myeloma, the most common all-grade ARs ≥ 20% (DOXIL® plus VELCADE® vs VELCADE®, respectively) included: neutropenia (36% vs 22%), thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue (36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%), nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs 22%), constipation (31% vs 31%), mucositis/stomatitis (20% vs 5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%), and rash (22% vs 18%)
    • In addition, 19% vs < 1% reported HFS

VELCADE® is a registered trademark of Millennium Pharmaceuticals, Inc.

Please click here for DOXIL® full Prescribing Information, including Boxed WARNINGS.

K08D121023

December 3, 2012