Myocet liposomal (previously Myocet) · 4.5 Interactions with other medicinal products and other forms of interactions · 1

HOS-084216 · has-adverse-reaction-information · PDF-Seite 6

During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%). The following adverse reactions have been reported with Myocet liposomal during clinical studies and post marketing experience. Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated from the available data)). All grades Grades ≥ 3 Infections and infestations Neutropenic fever Very common Very common Infections Very common Common Herpes zoster Uncommon Uncommon Sepsis Uncommon Uncommon Injection site infection Uncommon Not known Blood and lymphatic system disorders Neutropenia Very common Very common Thrombocytopenia Very common Very common Anaemia Very common Very common 6  All grades Grades ≥ 3 Leucopenia Very common Very common Lymphopenia Common Common Pancytopenia Common Uncommon Neutropenic sepsis Uncommon Uncommon Purpura Uncommon Uncommon Metabolism and nutrition disorders Anorexia Very common Very common Dehydration Common Very common Hypokalaemia Common Uncommon Hyperglycaemia Uncommon Uncommon Psychiatric disorders Agitation Uncommon Not known Nervous system disorders Insomnia Common Uncommon Abnormal gait Uncommon Uncommon Dysphonia Uncommon Not known Somnolence Uncommon Not known Cardiac disorders Arrhythmia

Auszug; vollständigen Abschnitt im Original lesen.

HOS-084212 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-084211 · has-indication-information · PDF-Seite 2

Myocet liposomal, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in adult women.

HOS-084214 · has-interaction-information · PDF-Seite 5

5 Specific medicinal product compatibility studies have not been performed with Myocet liposomal. Myocet liposomal is likely to interact with substances that are known to interact with conventional doxorubicin. Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P- glycoprotein (P-Gp). Interactions with doxorubicin have also been reported for streptozocin, phenobarbital, phenytoin and warfarin. Studies of the effect of Myocet liposomal on other substances are also lacking. However, doxorubicin may potentiate the toxicity of other antineoplastic agents. Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e.g. calcium antagonists) may increase the risk for cardiotoxicity. Concomitant therapy with other liposomal or lipid-complexed substances or intravenous fat emulsions could change the pharmacokinetic profile of Myocet liposomal.

HOS-084215 · has-pregnancy-information · PDF-Seite 6

Women of childbearing potential Women of childbearing potential should use an effective contraceptive during treatment with Myocet liposomal and for 6.5 months following discontinuation of therapy. Women desiring to have children following completion of therapy should be recommended to obtain genetic counselling and advice on fertility preservation before treatment. Pregnancy Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet liposomal should not be used during pregnancy unless clearly necessary. Breast-feeding Women receiving Myocet liposomal should not breastfeed.

HOS-084213 · has-warning-information · PDF-Seite 3

Myelosuppression Therapy with Myocet liposomal causes myelosuppression. Myocet liposomal should not be administered to individuals with absolute neutrophil counts (ANC) lower than 1,500 cells/µl or platelets less than 100,000/µl prior to the next cycle. Careful haematological monitoring (including white blood cell and platelet count, and haemoglobin) should be performed during therapy with Myocet liposomal. A meta-analysis showed a statistically significant lower rate of grade 4 neutropenia (RR = 0.82, p=0.005) in patients treated with Myocet liposomal versus conventional doxorubicin. However, no significant differences were identified in the occurrence of anaemia, thrombocytopenia and episodes of neutropenic fever. Haematological as well as other toxicity may require dose reductions or delays. The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet liposomal and cyclophosphamide. Dosing subsequent to a dose reduction is left to the discretion of the physician in charge of the patient. Haematological Toxicity Grade Nadir ANC Nadir Platelet Count Modification (cells/µl) (cells/µl) 1 1500 – 1900 75,000 – 150,000 None 2 1000 – Less than 1500 50,000 – Less than 75,000 None 3  Haematological Toxicity Grade Nadir ANC Nadir Platelet Count Modification (cells/µl) (cells/µl) 3 500 – 999 25,000 – Less than 50,000 Wait until ANC 1500 or more and/or platelets 100,000 or more then redose at 25% dose reduction 4 Less than 500 Less than 25,000 Wait until ANC 1500 and/or platelets 100,000 or more then redose at 50% dose reduction If myelotoxicity delays treatm

Auszug; vollständigen Abschnitt im Original lesen.