XTANDI Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Xtandi 40 mg film-coated tablets. Xtandi 80 mg film-coated tablets.
Qualitative and quantitative composition
Xtandi 40 mg film-coated tablets: Each film-coated tablet contains 40 mg of enzalutamide. Xtandi 80 mg film-coated tablets: Each film-coated tablet contains 80 mg of enzalutamide. For the full list of ...
Pharmaceutical form
Film-coated tablet. Xtandi 40 mg film-coated tablets: Yellow round – film-coated tablets, debossed with E40. Xtandi 80 mg film-coated tablets: Yellow oval – film-coated tablets, debossed with E80.
Therapeutic indications
Xtandi is indicated for: the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are ...
Posology and method of administration
Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology The recommended dose is 160 mg enzalutamide (four ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Women who are or may become pregnant (see sections 4.6 and 6.6).
Special warnings and precautions for use
Risk of seizure Use of enzalutamide has been associated with seizure (see section 4.8). The decision to continue treatment in patients who develop seizure should be taken case by case. Posterior reversible ...
Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to affect enzalutamide exposures CYP2C8 inhibitors CYP2C8 plays an important role in the elimination of enzalutamide and in the formation of its active metabolite. ...
Pregnancy and lactation
Women of childbearing potential There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential. This medicine may cause harm to the ...
Effects on ability to drive and use machines
Xtandi has moderate influence on the ability to drive and use machines as psychiatric and neurologic events including seizure have been reported (see section 4.8). Patients should be advised of the potential ...
Undesirable effects
Summary of the safety profile The most common adverse reactions are asthenia/fatigue, hot flush, fractures, and hypertension. Other important adverse reactions include fall, cognitive disorder, and neutropenia. ...
Overdose
There is no antidote for enzalutamide. In the event of an overdose, treatment with enzalutamide should be stopped and general supportive measures initiated taking into consideration the half-life of 5.8 ...
Pharmacodynamic properties
Pharmacotherapeutic group: hormone antagonists and related agents, anti-androgens ATC code: L02BB04 Mechanism of action Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen ...
Pharmacokinetic properties
Enzalutamide is poorly water soluble. The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant. In preclinical studies, the absorption of enzalutamide was ...
Preclinical safety data
Enzalutamide treatment of pregnant mice resulted in an increased incidence of embryo-fetal deaths and external and skeletal changes. Reproductive toxicology studies were not conducted with enzalutamide, ...
List of excipients
Tablet core: Hypromellose acetate succinate Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Tablet coating: Hypromellose Talc Macrogol (8000) Titanium dioxide ...
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
40 mg film-coated tablets: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets. Each carton contains 112 film-coated tablets (4 wallets). 80 mg film-coated tablets: Cardboard ...
Special precautions for disposal and other handling
Xtandi should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant. The film-coated tablets should not be cut or crushed. Any ...
Marketing authorization holder
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands
Marketing authorization number(s)
EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg)
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 June 2013 Date of latest renewal: 8 February 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
