VERZENIOS Film-coated tablet (2024)
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. <u>Excipients with known effect:</u> Each film-coated tablet contains 14 mg of lactose monohydrate. Verzenios 100 ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Verzenios 50 mg film-coated tablets:</u> Beige, oval tablet of 5.2 9.5 mm, debossed with Lilly on one side and 50 on the other. <u>Verzenios 100 mg film-coated tablets: ...
Therapeutic indications
Early breast cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor ...
Posology and method of administration
Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies. Posology The recommended dose of abemaciclib is 150 mg twice daily when used in combination ...
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 of neutropenic ...
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 ...
Fertility, 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 at ...
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, leukopenia, anaemia, fatigue, nausea, vomiting, alopecia and decreased appetite. Of the ...
Overdose
In the event of an abemaciclib overdose, fatigue and diarrhoea may occur. General supportive care should be provided.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, protein kinases inhibitors <b>ATC code:</b> L01EF03 Mechanism of action Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases ...
Pharmacokinetic properties
Absorption Abemaciclib absorption is slow, with a Tmax of 8 hours and a mean absolute bioavailability of approximately 45%. In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) ...
Preclinical safety data
The primary target organ findings of potential relevance to humans occurred in the gastrointestinal tract, haematolymphopoietic organs, and male reproductive tract in mice, rats and dogs in studies up ...
List of excipients
<u>Tablet core:</u> Croscarmellose sodium Lactose monohydrate Microcrystalline cellulose Colloidal hydrated silica Sodium stearyl fumarate <u>Film coating:</u> <em>Verzenios 50 mg film-coated tablets</em> ...
Incompatibilities
Not applicable.
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 packs of 14, 28, 42, 56, 70 or 168 film-coated tablets. Aluminium/aluminium perforated unit dose blisters of 28 1 film-coated tablets. Not all pack ...
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 Date of latest renewal: 23 June 2023
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