DOXIL® safety profile1,2
Cardia safety data1,2
DOXIL® can cause myocardial damage, including congestive heart failure, as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2.
- The incidence of symptomatic cardiac adverse events was 10% in the DOXIL® + bortezomib group and 7% in the bortezomib-only group across all grades of severity2
- Two-thirds of patients in both arms had prior anthracycline treatment2
- No difference in congestive heart failure* incidence between groups (3% in each study arm)2
- In the Phase 3 study, left ventricular ejection fraction (LVEF) decrease was defined as an absolute decrease ≥15% from the subject's baseline or decrease to less than the institutional lower limit of normal and at least an absolute decrease ≥5% from the subject's baseline2
- 9% of subjects in the DOXIL® + bortezomib arm and 7% in the bortezomib arm experienced a LVEF-defined decrease2
- Among all subjects with protocol-defined LVEF decrease in the combination group, there were 3% of subjects with LVEF <45%2
- The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation1
*Includes ventricular dysfunction, cardiac failure, right ventricular failure, congestive cardiac failure, chronic cardiac failure, acute pulmonary edema, and pulmonary edema.
Please see Important Safety Information, including BOXED WARNINGS, for additional information.
Infusion-related reactions warning1
Serious and sometimes life-threatening infusion-related reactions characterized by 1 or more of the following symptoms can occur with DOXIL®: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. The majority of infusion-related events occurred during the first infusion. Across multiple studies of DOXIL® monotherapy enrolling 760 patients with various solid tumors, 11% of patients had infusion-related reactions.1
Hematologic adverse reactions (ARs)1
Nonhematologic adverse reactions (ARs)1
†Peripheral neuropathy includes the following adverse reactions: peripheral sensory neuropathy, neuropathy peripheral, polyneuropathy, peripheral motor neuropathy, and neuropathy NOS.
‡Rash includes the following adverse reactions: rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, exfoliative rash, and rash generalized. Only patients with concomitant medication forms are included in these data (DOXIL® [n=238]; topotecan [n=234]).
DOXIL® with bortezomib has an established tolerability profile in a pretreated patient population (all patients had at least 1 prior therapy; 66% had ≥1 prior therapy). Patients in the DOXIL® + bortezomib combination group were treated for a median number of 4.5 months (range, 21 days-13.5 months)1:
- No increase in neuropathy in the combination arm
- Incidence of thromboembolic events was 1% in both treatment arms
DOXIL® (doxorubicin HCl liposome injection) Prescribing Information. Janssen Products, LP, Horsham, PA.
Data on file. Janssen Products, LP, Horsham, PA.