XTANDI Soft capsule Ref.[9661] Active ingredients: Enzalutamide

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 40 mg soft capsules) as a single oral daily dose.

Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients with CRPC or mHSPC who are not surgically castrated.

Patients with high-risk BCR nmHSPC may be treated with Xtandi with or without a LHRH analogue. For patients who receive Xtandi with or without a LHRH analogue, treatment can be suspended if PSA is undetectable (<0.2 ng/mL) after 36 weeks of therapy. Treatment should be reinitiated when PSA has increased to ≥2.0 ng/mL for patients who had prior radical prostatectomy or ≥5.0 ng/mL for patients who had prior primary radiation therapy. If PSA is detectable (≥0.2 ng/mL) after 36 weeks of therapy, treatment should continue (see section 5.1).

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.

Concomitant use with strong CYP2C8 inhibitors

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).

Elderly

No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild, moderate or severe hepatic impairment (Child-Pugh 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).

Renal impairment

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).

Paediatric population

There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC, mHSPC, or high-risk BCR nmHSPC.

Method of administration

Xtandi is for oral use. The soft capsules should not be chewed, dissolved or opened 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.

3 years.

This medicinal product does not require any special storage conditions.

Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 soft capsules. Each carton contains 4 wallets (112 soft capsules).

Xtandi should not be handled by persons other than the patient or his caregivers. Based on its mechanism of action and embryo-fetal toxicity observed in mice, Xtandi may harm a developing fetus. Women who are or may become pregnant should not handle damaged or opened Xtandi capsules without protection, e.g. gloves. See section 5.3 Pre-clinical safety data.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.