Before you continue...

Before you continue to the State Medicare Guideline page, please read the following:

Information on the following pages is cited from the Local Coverage Determinations / Supporting Information of the individual state and reflects the coverage specific to the Medicare insurance carrier, fiscal intermediary, or Medicare Administrative Contractor (MAC) of that state. Janssen Biotech, Inc. has no responsibility for the LCDs and/or the information contained therein. This information may not be consistent with the current DOXIL® (doxorubicin HCl liposome injection) prescribing information and is not intended as an endorsement and makes no representations regarding any usage which is inconsistent with the FDA-approved prescribing information.

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

If you enable cookies, your agreement to this warning will be saved and you will not be prompted again today.

            
            

December 3, 2012