Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.3 · PDF-Seite 3

HOS-091141 · Präparat HOS-084209

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.5 · PDF-Seite 5–6

HOS-091142 · Präparat HOS-084209

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): streptozocin (HOS-091143) phenobarbital (HOS-085617) phenytoin (HOS-084531) warfarin (HOS-085950) calcium (HOS-085615) verapamil (HOS-090602) paclitaxel (HOS-087959)

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 6

HOS-091144 · Präparat HOS-084209

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%).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 6

HOS-091145 · Präparat HOS-084209

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)).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 6

HOS-091146 · Präparat HOS-084209

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 6–7

HOS-091147 · Präparat HOS-084209

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 Common Uncommon Cardiomyopathy Common Common Congestive cardiac failure Common Common Pericardial effusion Uncommon Uncommon Vascular disorders Hot flushes Common Uncommon Hypotension Uncommon Uncommon Respiratory, thoracic and mediastinal disorders Chest pain Common Uncommon Dyspnoea Common Uncommon Epistaxis Common Uncommon Haemoptysis Uncommon Not known Pharyngitis Uncommon Not known Pleural effusion Uncommon Uncommon Pneumonitis Uncommon Uncommon Gastrointestinal disorders Nausea/vomiting Very common Very common Stomatitis/mucositis Very common Common Diarrhoea Very common Common Constipation Common Uncommon Oesophagitis Common Uncommon Gastric ulcer Uncommon Uncommon Hepatobiliary disorders Increased hepatic transaminases Common Uncommon Increased alkaline phosphatase Uncommon Uncommon Jaundice Uncommon Uncommon Increased serum bilirubin Uncommon Not known

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 7–8

HOS-091148 · Präparat HOS-084209

7  All grades Grades ≥ 3 Skin and subcutaneous tissue disorders Alopecia Very Common Common Rash Common Not known Palmar-plantar Not known Not known erythrodysaesthesia syndrome Nail disorder Common Uncommon Pruritus Uncommon Uncommon Folliculitis Uncommon Uncommon Dry skin Uncommon Not known Musculoskeletal and connective tissue disorders Back pain Common Uncommon Myalgia Common Uncommon Muscle weakness Uncommon Uncommon Renal and urinary disorders Haemorrhagic cystitis Uncommon Uncommon Oliguria Uncommon Uncommon General disorders and administration site conditions Asthenia/Fatigue Very Common Common Fever Very common Common Pain Very Common Common Rigors Very Common Uncommon Dizziness Common Uncommon Headache Common Uncommon Weight loss Common Uncommon Injection site reaction Uncommon Uncommon Malaise Uncommon Not known

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Myocet liposomal (previously Myocet)

Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 8

HOS-091149 · Präparat HOS-084209

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.