Caelyx pegylated liposomal · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-083162 · has-adverse-reaction-information · PDF-Seite 10

Summary of the safety profile The most frequent adverse reactions (≥ 20%) were neutropaenia, nausea, leukopaenia, anaemia, and fatigue. Severe adverse reactions (Grade 3/4 adverse reactions occurring in ≥ 2% of patients) were neutropaenia, PPE, leukopaenia, lymphopaenia, anaemia, thrombocytopaenia, stomatitis, fatigue, diarrhoea, vomiting, nausea, pyrexia, dyspnoea, and pneumonia. Less frequently reported severe adverse reactions included Pneumocystis jirovecii pneumonia, abdominal pain, cytomegalovirus infection including cytomegalovirus chorioretinitis, asthenia, cardiac arrest, cardiac failure, cardiac failure congestive, pulmonary embolism, thrombophlebitis, venous thrombosis, anaphylactic reaction, anaphylactoid reaction, toxic epidermal necrolysis, and Stevens-Johnson syndrome. Tabulated list of adverse reactions Table 5 summarises the adverse drug reactions that occurred in patients receiving Caelyx pegylated liposomal in 4,231 patients for the treatment of breast cancer, ovarian cancer, multiple myeloma, and AIDS-related KS. Post-marketing adverse reactions are also included, as indicated by “b”. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness. Table 5: Adverse reactions in patients treated with Caelyx pegylated liposomal System Organ Class Frequency All Grades Adverse Drug Reaction Infections and Common Sepsis infestations Pneumonia Pneumocystis jirovecii pneumonia Cytomegalovirus infection including cytomegalovirus chorioretinitis Mycobacterium avium complex infection Candidiasis Herpes zoster Urinary tract infection Infection Upper respir

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HOS-083158 · has-contraindication-information · PDF-Seite 6

Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section 6.1. Caelyx pegylated liposomal must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon. 6

HOS-083157 · has-indication-information · PDF-Seite 2

Caelyx pegylated liposomal is indicated: - As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. - For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. - In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. - For treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Caelyx pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

HOS-083160 · has-interaction-information · PDF-Seite 9

No formal medicinal product interaction studies have been performed with Caelyx pegylated liposomal, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies. Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride. Caelyx pegylated liposomal, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies. During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted. In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride. Caution must be exercised when giving any other cytotoxic agents, especially myelotoxic agents, at the same time.

HOS-083161 · has-pregnancy-information · PDF-Seite 9

Pregnancy Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy. Therefore, Caelyx pegylated liposomal should not be used during pregnancy unless clearly necessary. Women of child-bearing potential/contraception in men and women Due to the genotoxic potential of Doxorubicin hydrochloride (see section 5.3), women of child-bearing potential should use effective contraceptive measures while being treated with Caelyx pegylated liposomal and for 8 months following completion of treatment. Men are recommended to use effective contraceptive measures and to not father a child while receiving Caelyx pegylated liposomal and for 6 months following completion of treatment. Breast-feeding It is not known whether Caelyx pegylated liposomal is excreted in human milk. Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx pegylated liposomal treatment. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV. 9 Fertility The effect of doxorubicin hydrochloride on human fertility has not been evaluated (see section 5.3).

HOS-083159 · has-warning-information · PDF-Seite 7

Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx pegylated liposomal should not be used interchangeably with other formulations of doxorubicin hydrochloride. Cardiac toxicity It is recommended that all patients receiving Caelyx pegylated liposomal routinely undergo frequent ECG monitoring. Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx pegylated liposomal therapy. However, reduction of the QRS complex is considered more indicative of cardiac toxicity. If this change occurs, the most definitive test for anthracycline myocardial injury, i.e., endomyocardial biopsy, must be considered. More specific methods for the evaluation and monitoring of cardiac functions as compared to ECG are a measurement of left ventricular ejection fraction by echocardiography or preferably by Multigated Angiography (MUGA). These methods must be applied routinely before the initiation of Caelyx pegylated liposomal therapy and repeated periodically during treatment. The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx pegylated liposomal that exceeds a lifetime cumulative anthracycline dose of 450 mg/m2. The evaluation tests and methods mentioned above concerning the monitoring of cardiac performance during anthracycline therapy are to be employed in the following order: ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy. If a test result indicates possible cardiac injury associated with Caelyx pegylated liposomal therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury. In patients with cardiac disease requiring treatment, administer Caelyx pegylated liposomal only when the benefit outweighs the risk to the patient. Exercise caution in patients with impaired cardiac function who receive Caelyx pegylated liposomal. Whenever cardiomyopathy is suspected, i.e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/or left ventricular ejection fraction is lower than a prognostically relevant value (e.g., < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage. Congestive heart failure due to cardiomyopathy may occur sud

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