Beipackzettel - Amlyo 75 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Zusammenfassung des Risikomanagement-Plans gemäß § 34
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Amlyo 75 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Administrative Information:
| Wirkstoff | Amsacrin |
| ATC-Code | L01XX01 |
| Darreichungsform | Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
| Art der Anwendung | intravenöse Anwendung |
| Inhaber der Zulassung | Eurocept International B.V. Trapgans 5 1244 RL ANKEVEEN Niederlande |
| Zulassungsnummer | 7010166.00.00 |
| Datum der Zulassung | 02.02.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.2 / 05.03.2018 |
| Datum der Genehmigung des RMPs | 02.02.2024 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass dieses Arzneimittel so sicher wie möglich angewendet wird.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 25. März 2024 veröffentlicht.
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(1)
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(2)
Risk Management Plan on
Date of the RMP
Amsacrine 75 mg powder for solution for infusion
05 March 2018
Part VI – Summary of the risk management plan by product
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V I.1 Elements for summary tables in the EPAR
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V I.1.1 Summary table of Safety concerns
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V I.1.2 Table of ongoing and planned studies in the Post-authorisation Pharmacovigilance
Development Plan
Not applicable.
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V I.1.3 Summary Post authorisation efficacy development plan
Not applicable.
| Risk Management Plan on | Date of the RMP |
| Amsacrine 75 mg powder for solution for infusion | 05 March 2018 |
VI.1.4 Summary table of risk minimisation measures
| Important potential risks | ||
| Safety concern | Routine risk minimisation measures | Additional risk minimisation measures |
| Interaction with drugs | Text in SmPC: – Risk is listed in section 4.5 of the SmPC | Not applicable |
| Embryo-foetal toxicity and teratogenicity | Text in SmPC: – Risk is listed in section 4.6 of the SmPC | Not applicable |
| Impaired fertility | Text in SmPC: – Risk is listed in section 4.6 of the SmPC with recoomendations on contraception. | Not applicable |
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V I.2 Elements for a public summary
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V I.2.1 Overview of disease epidemiology
Acute Myeloblastic Leukemia
Acute myeloblastic leukemia (AML) is a form of cancer characterized by presence of abnormal undifferentiated myeloid cells in the blood, bone marrow, and other tissues [4]. These abnormal myeloid cells are primarily granulocytes (which destroy bacteria) or monocytes (which produce large cells called macrophages, which digest foreign substances and diseased cells) [6]. These leukemias comprise a spectrum of cancers that, if untreated, range from slowly growing to rapidly fatal. In 2013, the estimated number of new AML cases in the United States was 14,590. The incidence of AML is ~3.5 per 100,000 people per year, and the age-adjusted incidence is higher in men than in women (4.5 vs 3.1). AML incidence increases with age; it is 1.7 in individuals age <65 years and 15.9 in those age >65 years. The median age at diagnosis is 67 years [4].
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V I.2.2 Summary of treatment benefits
The standard of treatment includes combination chemotherapy. Young patients can be candidates for bone marrow transplantation. Bone marrow transplantation can be curative but is associated with a significant treatment-related death rate [4]. Amsacrine is a kind of chemotherapy and it is administered through in the veins. It blocks the production of DNA, which is the hereditary material found in cells. Blockage of DNA production will lead to reduction of cancer cells.
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V I.2.3 Unknowns relating to treatment benefits
There is not enough information on the effects of amsacrine exposure during pregnancy.
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V I.2.4 Summary of safety concerns
Summary of safety concerns – important potential risks
| Risk Management Plan on | Date of the RMP |
| Amsacrine 75 mg powder for solution for infusion | 05 March 2018 |
| Risk | What is known |
| Interaction with drugs | When an influenza or pneumococcal vaccination is administered at the same time with Amsacrine, this has been linked to the possibility that the body will not respond well to the administered vaccine.. In general, concomitant administration of all types of live vaccines are a potential risk. |
| Embryo-foetal toxicity and teratogenicity | Data from the use of Amsacrine in pregnant women are not available to judge possible harm to the unborn foetus. However, harmful pharmacological effects during pregnancy are possible. Based on animal studies and the mechanism of action of the substance, use during pregnancy is discouraged, especially during the first trimester. In every individual case, the advantages of treatment should be weighed against the risks to the foetus. |
| Impaired fertility | Due to the mechanism of action of amsacrine and possible adverse effects on the foetus, women of child-bearing potential have to use effective contraception during and up to 3 months after treatment and also males during and up to 6 months after treatment. There have been reports of low sperm count in males, although this effect is reversible. Although there is no evidence, some reports suggest that amsacrine can affect fertility in females. |
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V I.2.5 Summary of risk minimisation measures by safety concern
All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures.
This medicine has no additional risk minimisation measures.
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V I.2.6 Planned post-authorisation development plan
No post-authorisation studies are planned and therefore this section is not applicable.
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V I.2.7 Summary of changes to the risk management plan over time