VERZENIOS Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Verzenios 50 mg film-coated tablets. Verzenios 100 mg film-coated tablets. Verzenios 150 mg film-coated tablets.
Qualitative and quantitative composition
Verzenios 50 mg film-coated tablets: Each film-coated tablet contains 50 mg abemaciclib. Excipients with known effect: Each film-coated tablet contains 14 mg of lactose monohydrate. Verzenios 100 mg film-coated ...
Pharmaceutical form
Film-coated tablet (tablet). Verzenios 50 mg film-coated tablets: Beige, oval tablet of 5.2 9.5 mm, debossed with Lilly on one side and 50 on the other. Verzenios 100 mg film-coated tablets: White, oval ...
Therapeutic indications
Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination ...
Posology and method of administration
Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies. Posology Verzenios in combination with endocrine therapy The recommended dose of abemaciclib ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Neutropenia Neutropenia was reported in patients receiving abemaciclib. Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2). Fatal events occurred in <1% ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on the pharmacokinetics of abemaciclib Abemaciclib is primarily metabolised by CYP3A4. CYP3A4 inhibitors Co-administration of abemaciclib with CYP3A4 inhibitors can ...
Pregnancy and lactation
Women of childbearing potential / Contraception in females Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for ...
Effects on ability to drive and use machines
Verzenios has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines in case they experience fatigue or dizziness during treatment ...
Undesirable effects
Summary of the safety profile The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite. Tabulated list of adverse ...
Overdose
In the event of an abemaciclib overdose, fatigue and diarrhoea may occur. General supportive care should be provided.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, protein kinases inhibitors ATC code: L01XE50 Mechanism of action Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 ...
Pharmacokinetic properties
Absorption Abemaciclib absorption is slow, with a T<sub>max</sub> of 8 hours and a mean absolute bioavailability of approximately 45%. In the therapeutic dose range of 50-200 mg, the increase in plasma ...
Preclinical safety data
The primary target organ findings of potential relevance to humans included gastrointestinal and haematolymphopoietic organ effects in rats and dogs in studies up to 13 weeks duration. Effects in lung ...
List of excipients
Tablet core: Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Colloidal hydrated silica Sodium stearyl fumarate Film coating: Verzenios 50 mg film-coated tablets: Polyvinyl alcohol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets. Aluminium/aluminium perforated unit dose blisters of 28 1 film-coated ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 September 2018
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