ERLEADA Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Erleada 60 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 60 mg of apalutamide. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), debossed with AR 60 on one side.
Therapeutic indications
Erleada is indicated: in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). in adult men ...
Posology and method of administration
Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology The recommended dose is 240 mg (four 60 mg tablets) ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women who are or may become pregnant (see section 4.6).
Special warnings and precautions for use
Seizure Erleada is not recommended in patients with a history of seizures or other predisposing factors including, but not limited to, underlying brain injury, recent stroke (within one year), primary ...
Interaction with other medicinal products and other forms of interaction
The elimination of apalutamide and formation of its active metabolite, N-desmethyl apalutamide, is mediated by both CYP2C8 and CYP3A4 to a similar extent at steady-state. No clinically meaningful changes ...
Fertility, pregnancy and lactation
Contraception in males and females It is not known whether apalutamide or its metabolites are present in semen. Erleada may be harmful to a developing foetus. For patients having sex with female partners ...
Effects on ability to drive and use machines
Erleada has no or negligible influence on the ability to drive and use machines. However, seizures have been reported in patients taking Erleada. Patients should be advised of this risk in regards to driving ...
Undesirable effects
Summary of the safety profile The most common adverse reactions are fatigue (26%), skin rash (26% of any grade and 6% Grade 3 or 4), hypertension (22%), hot flush (18%), arthralgia (17%), diarrhoea (16%), ...
Overdose
There is no known specific antidote for apalutamide overdose. In the event of an overdose, Erleada should be stopped and general supportive measures should be undertaken until clinical toxicity has been ...
Pharmacodynamic properties
Pharmacotherapeutic group: Endocrine therapy, anti-androgens ATC code: L02BB05 Mechanism of action Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly ...
Pharmacokinetic properties
Following repeat once-daily dosing, apalutamide exposure (C<sub>max</sub> and area under the concentration curve [AUC]) increased in a dose-proportional manner across the dose range of 30 to 480 mg. Following ...
Preclinical safety data
Apalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of apalutamide. Male ...
List of excipients
Tablet core: Colloidal anhydrous silica Croscarmellose sodium Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Microcrystalline cellulose (silicified) Film-coating: Iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in the original package in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
Nature and contents of container
White opaque high-density polyethylene (HDPE) bottle with a polypropylene (PP) child-resistant closure. Each bottle contains 120 film-coated tablets and a total of 6 g of silica gel desiccant. PVC-PCTFE ...
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
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Marketing authorization number(s)
EU/1/18/1342/001 EU/1/18/1342/002 EU/1/18/1342/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 January 2019
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