Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands
Xtandi is indicated for:
Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
The recommended dose is 160 mg enzalutamide (four 40 mg film-coated tablets or two 80 mg film-coated tablets) as a single oral daily dose.
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily. If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5).
No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
No dose adjustment is necessary for patients with mild, moderate or severe hepatic impairment (ChildPugh Class A, B or C, respectively). An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2).
No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2). Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4).
There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC.
Xtandi is for oral use. The film-coated tablets should not be cut, crushed or chewed but should be swallowed whole with water, and can be taken with or without food.
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 days. Patients may be at increased risk of seizures following an overdose.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
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 wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets. Each carton contains 56 film-coated tablets (4 wallets).
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 unused medicinal product or waste material should be disposed of in accordance with local requirements.
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