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® (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
DOXIL® in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Important Safety Information for DOXIL® (doxorubicin HCl liposome injection)
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.
- 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 bortezomib arm and 42 patients (13%) in the DOXIL® plus bortezomib 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 bortezomib
- 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
- 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
- Very rare cases of secondary oral cancer have been reported in patients with more than one year exposure to DOXIL® or those receiving a cumulative dose greater than 720 mg/m2. Cases were diagnosed both during treatment and up to 6 years after the last dose. Patients should be examined at regular intervals for the presence of oral ulceration or any oral discomfort that may be indicative of secondary oral cancer
In patients with recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) ≥20% (DOXIL® vs topotecan, respectively) included: asthenia (40% vs 52%), 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% reported alopecia (all grades)
- Hematologic ARs, reported in ≥5% (DOXIL® vs topotecan, respectively) were neutropenia (12% vs 76%), anemia (6% vs 29%), and thrombocytopenia (1% vs 34%)
In patients with multiple myeloma, the most common all-grade adverse reactions ≥20% (DOXIL® plus bortezomib vs bortezomib, 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